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Trial Outcomes & Findings for Trial to Model Primary, Secondary, and Tertiary Dengue Using a Monovalent Vaccine (NCT NCT05691530)

NCT ID: NCT05691530

Last Updated: 2026-04-28

Results Overview

Number of participants with at least one solicited local adverse events occurring within twenty-eight days of vaccine administration. Local reactogenicity included injection site pain, injection site tenderness, injection site bruising, injection site redness, injection site erythema, injection site swelling/induration, and injection site pruritus. Adverse events were captured by investigator examination and history from participants.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE1

Target enrollment

127 participants

Primary outcome timeframe

Through day 28 after vaccine administration

Results posted on

2026-04-28

Participant Flow

127 participants consented to this study: * 45 participants started the study intervention * 69 were screen failures * 13 were eligible but not randomized (back up)

Participant milestones

Participant milestones
Measure
Primary Heterotypic Dengue Virus Antibody Profile
Participants where the highest plaque reduction neutralization test (PRNT50) titer is ≥4-fold higher than the second highest serotype (or one serotype ≥10 and others \<10) were considered monotypic. Of these, participants with their highest titer to DENV3 were excluded, and all others were included in the heterotypic group. Participants received a single 0.5 mL subcutaneous injection of 10\^3.3 PFU/mL rDEN3Δ30/31-7164 vaccine formulated in Plasma-Lyte A (pH 7.4) diluent in the deltoid region on day 0.
Flavivirus naïve
Participants were classified as flavivirus-naive if they met any of the following criteria: a 50% plaque reduction neutralization test (PRNT50) titer \<10 for all dengue serotypes, no history of flavivirus vaccination, or no travel history associated with an increased risk of other flavivirus infections. If there was any concern regarding prior flavivirus exposure, antibody testing was performed to confirm the absence of exposure. Participants received a single 0.5 mL subcutaneous injection of 10\^3.3 PFU/mL rDEN3Δ30/31-7164 vaccine formulated in Plasma-Lyte A (pH 7.4) diluent in the deltoid region on day 0.
Polytypic Dengue Virus Antibody Profile
Participants were considered dengue immune if they had a 50% plaque reduction neutralization test (PRNT50) titer of ≥10 against any dengue serotype. Among these participants, those whose highest PRNT50 titer was \<4-fold higher than the second-highest serotype were further categorized as follows: participants with PRNT50 titers ≥60 for at least two serotypes were classified as "polytypic", whereas those with PRNT50 titers between 10 and 60 were classified as "expanded polytypic". Participants received a single 0.5 mL subcutaneous injection of 10\^3.3 PFU/mL rDEN3Δ30/31-7164 vaccine formulated in Plasma-Lyte A (pH 7.4) diluent in the deltoid region on day 0.
Overall Study
STARTED
18
14
13
Overall Study
COMPLETED
18
14
13
Overall Study
NOT COMPLETED
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Trial to Model Primary, Secondary, and Tertiary Dengue Using a Monovalent Vaccine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Flavivirus naïve
n=14 Participants
Participants were classified as flavivirus-naive if they met any of the following criteria: a 50% plaque reduction neutralization test (PRNT50) titer \<10 for all dengue serotypes, no history of flavivirus vaccination, or no travel history associated with an increased risk of other flavivirus infections. If there was any concern regarding prior flavivirus exposure, antibody testing was performed to confirm the absence of exposure. Participants received a single 0.5 mL subcutaneous injection of 10\^3.3 PFU/mL rDEN3Δ30/31-7164 vaccine formulated in Plasma-Lyte A (pH 7.4) diluent in the deltoid region on day 0.
Polytypic Dengue Virus Antibody Profile
n=13 Participants
Participants were considered dengue immune if they had a 50% plaque reduction neutralization test (PRNT50) titer of ≥10 against any dengue serotype. Among these participants, those whose highest PRNT50 titer was \<4-fold higher than the second-highest serotype were further categorized as follows: participants with PRNT50 titers ≥60 for at least two serotypes were classified as "polytypic", whereas those with PRNT50 titers between 10 and 60 were classified as "expanded polytypic". Participants received a single 0.5 mL subcutaneous injection of 10\^3.3 PFU/mL rDEN3Δ30/31-7164 vaccine formulated in Plasma-Lyte A (pH 7.4) diluent in the deltoid region on day 0.
Primary Heterotypic Dengue Virus Antibody Profile
n=18 Participants
Participants where the highest plaque reduction neutralization test (PRNT50) titer is ≥4-fold higher than the second highest serotype (or one serotype ≥10 and others \<10) were considered monotypic. Of these, participants with their highest titer to DENV3 were excluded, and all others were included in the heterotypic group. Participants received a single 0.5 mL subcutaneous injection of 10\^3.3 PFU/mL rDEN3Δ30/31-7164 vaccine formulated in Plasma-Lyte A (pH 7.4) diluent in the deltoid region on day 0.
Total
n=45 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=9 Participants
0 Participants
n=24 Participants
0 Participants
n=23 Participants
0 Participants
n=73 Participants
Age, Categorical
Between 18 and 65 years
14 Participants
n=9 Participants
13 Participants
n=24 Participants
18 Participants
n=23 Participants
45 Participants
n=73 Participants
Age, Categorical
>=65 years
0 Participants
n=9 Participants
0 Participants
n=24 Participants
0 Participants
n=23 Participants
0 Participants
n=73 Participants
Sex: Female, Male
Female
7 Participants
n=9 Participants
6 Participants
n=24 Participants
15 Participants
n=23 Participants
28 Participants
n=73 Participants
Sex: Female, Male
Male
7 Participants
n=9 Participants
7 Participants
n=24 Participants
3 Participants
n=23 Participants
17 Participants
n=73 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants
n=9 Participants
3 Participants
n=24 Participants
5 Participants
n=23 Participants
12 Participants
n=73 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
10 Participants
n=9 Participants
10 Participants
n=24 Participants
13 Participants
n=23 Participants
33 Participants
n=73 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=9 Participants
0 Participants
n=24 Participants
0 Participants
n=23 Participants
0 Participants
n=73 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=9 Participants
0 Participants
n=24 Participants
0 Participants
n=23 Participants
0 Participants
n=73 Participants
Race (NIH/OMB)
Asian
2 Participants
n=9 Participants
5 Participants
n=24 Participants
4 Participants
n=23 Participants
11 Participants
n=73 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=9 Participants
0 Participants
n=24 Participants
0 Participants
n=23 Participants
0 Participants
n=73 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=9 Participants
1 Participants
n=24 Participants
0 Participants
n=23 Participants
2 Participants
n=73 Participants
Race (NIH/OMB)
White
8 Participants
n=9 Participants
4 Participants
n=24 Participants
11 Participants
n=23 Participants
23 Participants
n=73 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=9 Participants
1 Participants
n=24 Participants
1 Participants
n=23 Participants
3 Participants
n=73 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants
n=9 Participants
2 Participants
n=24 Participants
2 Participants
n=23 Participants
6 Participants
n=73 Participants

PRIMARY outcome

Timeframe: Through day 28 after vaccine administration

Population: The 'per protocol subset', which is based on participants assignment determined by day 0 dengue antibody profile.

Number of participants with at least one solicited local adverse events occurring within twenty-eight days of vaccine administration. Local reactogenicity included injection site pain, injection site tenderness, injection site bruising, injection site redness, injection site erythema, injection site swelling/induration, and injection site pruritus. Adverse events were captured by investigator examination and history from participants.

Outcome measures

Outcome measures
Measure
Primary Heterotypic Dengue Virus Antibody Profile
n=18 Participants
Participants where the highest plaque reduction neutralization test (PRNT50) titer is ≥4-fold higher than the second highest serotype (or one serotype ≥10 and others \<10) were considered monotypic. Of these, participants with their highest titer to DENV3 were excluded, and all others were included in the heterotypic group. Participants received a single 0.5 mL subcutaneous injection of 10\^3.3 PFU/mL rDEN3Δ30/31-7164 vaccine formulated in Plasma-Lyte A (pH 7.4) diluent in the deltoid region on day 0.
Flavivirus naïve
n=14 Participants
Participants were classified as flavivirus-naive if they met any of the following criteria: a 50% plaque reduction neutralization test (PRNT50) titer \<10 for all dengue serotypes, no history of flavivirus vaccination, or no travel history associated with an increased risk of other flavivirus infections. If there was any concern regarding prior flavivirus exposure, antibody testing was performed to confirm the absence of exposure. Participants received a single 0.5 mL subcutaneous injection of 10\^3.3 PFU/mL rDEN3Δ30/31-7164 vaccine formulated in Plasma-Lyte A (pH 7.4) diluent in the deltoid region on day 0.
Polytypic Dengue Virus Antibody Profile
n=13 Participants
Participants were considered dengue immune if they had a 50% plaque reduction neutralization test (PRNT50) titer of ≥10 against any dengue serotype. Among these participants, those whose highest PRNT50 titer was \<4-fold higher than the second-highest serotype were further categorized as follows: participants with PRNT50 titers ≥60 for at least two serotypes were classified as "polytypic", whereas those with PRNT50 titers between 10 and 60 were classified as "expanded polytypic". Participants received a single 0.5 mL subcutaneous injection of 10\^3.3 PFU/mL rDEN3Δ30/31-7164 vaccine formulated in Plasma-Lyte A (pH 7.4) diluent in the deltoid region on day 0.
Number of Participants With Local Adverse Events (AEs)
Injection site bruising
0 Participants
0 Participants
0 Participants
Number of Participants With Local Adverse Events (AEs)
Injection site redness
1 Participants
1 Participants
0 Participants
Number of Participants With Local Adverse Events (AEs)
Injection site erythema
1 Participants
0 Participants
0 Participants
Number of Participants With Local Adverse Events (AEs)
Injection site swelling/induration
0 Participants
0 Participants
0 Participants
Number of Participants With Local Adverse Events (AEs)
Injection site pruritus
0 Participants
0 Participants
0 Participants
Number of Participants With Local Adverse Events (AEs)
Injection site pain
4 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: Through day 28 after vaccine administration

Population: The 'per protocol subset', which is based on participants assignment determined by day 0 dengue antibody profile.

Number of participants with systemic adverse events occurring within twenty-eight days of vaccine administration. Systemic reactogenicity events included fever, headache, eye pain (retro-orbital pain), photophobia, nausea, fatigue, myalgia, arthralgia, and maculo-papular rash (dengue-like rash). Adverse events were captured by investigator examination and history from participants.

Outcome measures

Outcome measures
Measure
Primary Heterotypic Dengue Virus Antibody Profile
n=18 Participants
Participants where the highest plaque reduction neutralization test (PRNT50) titer is ≥4-fold higher than the second highest serotype (or one serotype ≥10 and others \<10) were considered monotypic. Of these, participants with their highest titer to DENV3 were excluded, and all others were included in the heterotypic group. Participants received a single 0.5 mL subcutaneous injection of 10\^3.3 PFU/mL rDEN3Δ30/31-7164 vaccine formulated in Plasma-Lyte A (pH 7.4) diluent in the deltoid region on day 0.
Flavivirus naïve
n=14 Participants
Participants were classified as flavivirus-naive if they met any of the following criteria: a 50% plaque reduction neutralization test (PRNT50) titer \<10 for all dengue serotypes, no history of flavivirus vaccination, or no travel history associated with an increased risk of other flavivirus infections. If there was any concern regarding prior flavivirus exposure, antibody testing was performed to confirm the absence of exposure. Participants received a single 0.5 mL subcutaneous injection of 10\^3.3 PFU/mL rDEN3Δ30/31-7164 vaccine formulated in Plasma-Lyte A (pH 7.4) diluent in the deltoid region on day 0.
Polytypic Dengue Virus Antibody Profile
n=13 Participants
Participants were considered dengue immune if they had a 50% plaque reduction neutralization test (PRNT50) titer of ≥10 against any dengue serotype. Among these participants, those whose highest PRNT50 titer was \<4-fold higher than the second-highest serotype were further categorized as follows: participants with PRNT50 titers ≥60 for at least two serotypes were classified as "polytypic", whereas those with PRNT50 titers between 10 and 60 were classified as "expanded polytypic". Participants received a single 0.5 mL subcutaneous injection of 10\^3.3 PFU/mL rDEN3Δ30/31-7164 vaccine formulated in Plasma-Lyte A (pH 7.4) diluent in the deltoid region on day 0.
Number of Participants With Systemic Adverse Events (AEs)
Fever
0 Participants
0 Participants
0 Participants
Number of Participants With Systemic Adverse Events (AEs)
Headache
5 Participants
7 Participants
4 Participants
Number of Participants With Systemic Adverse Events (AEs)
Arthralgia
4 Participants
1 Participants
1 Participants
Number of Participants With Systemic Adverse Events (AEs)
Maculo-papular rash (Dengue-like rash)
8 Participants
11 Participants
3 Participants
Number of Participants With Systemic Adverse Events (AEs)
Nausea
3 Participants
2 Participants
2 Participants
Number of Participants With Systemic Adverse Events (AEs)
Myalgia
7 Participants
1 Participants
2 Participants
Number of Participants With Systemic Adverse Events (AEs)
Eye pain (Retro-orbital pain)
2 Participants
0 Participants
1 Participants
Number of Participants With Systemic Adverse Events (AEs)
Photophobia
2 Participants
0 Participants
0 Participants
Number of Participants With Systemic Adverse Events (AEs)
Fatigue
9 Participants
8 Participants
5 Participants

PRIMARY outcome

Timeframe: Through day 28 after vaccine administration

Population: The 'per protocol subset', which is based on participants assignment determined by day 0 dengue antibody profile.

The severity of local AEs was graded using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Clinical Trials. Grade 1: Pain, Pruritis = does not interfere with activity; Tenderness = mild discomfort to touch; Erythema/Redness, Bruising = 2.5-5 cm; Induration/Swelling = 2.5-5 cm and does not interfere with activity. Grade 2: Pain, Pruritis = Some interference with activity or requires \>1 dose of medication; Tenderness= Discomfort with movement; Erythema/Redness, Bruising = 5.1-10 cm; Induration/Swelling = 5.1-10 cm or interferes with activity. Grade 3: Pain, Pruritis= Prevents daily activity and requires medical intervention; Tenderness = Significant discomfort at rest; Erythema/Redness, Bruising = \> 10 cm; Induration/Swelling = \> 10 cm or prevents daily activity. Grade 4: Pain, Tenderness = Hospitalization; Erythema/Redness, Induration/Swelling = Necrosis or exfoliative dermatitis; Bruising, Pruritus: Requiring medical attention

Outcome measures

Outcome measures
Measure
Primary Heterotypic Dengue Virus Antibody Profile
n=18 Participants
Participants where the highest plaque reduction neutralization test (PRNT50) titer is ≥4-fold higher than the second highest serotype (or one serotype ≥10 and others \<10) were considered monotypic. Of these, participants with their highest titer to DENV3 were excluded, and all others were included in the heterotypic group. Participants received a single 0.5 mL subcutaneous injection of 10\^3.3 PFU/mL rDEN3Δ30/31-7164 vaccine formulated in Plasma-Lyte A (pH 7.4) diluent in the deltoid region on day 0.
Flavivirus naïve
n=14 Participants
Participants were classified as flavivirus-naive if they met any of the following criteria: a 50% plaque reduction neutralization test (PRNT50) titer \<10 for all dengue serotypes, no history of flavivirus vaccination, or no travel history associated with an increased risk of other flavivirus infections. If there was any concern regarding prior flavivirus exposure, antibody testing was performed to confirm the absence of exposure. Participants received a single 0.5 mL subcutaneous injection of 10\^3.3 PFU/mL rDEN3Δ30/31-7164 vaccine formulated in Plasma-Lyte A (pH 7.4) diluent in the deltoid region on day 0.
Polytypic Dengue Virus Antibody Profile
n=13 Participants
Participants were considered dengue immune if they had a 50% plaque reduction neutralization test (PRNT50) titer of ≥10 against any dengue serotype. Among these participants, those whose highest PRNT50 titer was \<4-fold higher than the second-highest serotype were further categorized as follows: participants with PRNT50 titers ≥60 for at least two serotypes were classified as "polytypic", whereas those with PRNT50 titers between 10 and 60 were classified as "expanded polytypic". Participants received a single 0.5 mL subcutaneous injection of 10\^3.3 PFU/mL rDEN3Δ30/31-7164 vaccine formulated in Plasma-Lyte A (pH 7.4) diluent in the deltoid region on day 0.
Severity of Local Adverse Events (AEs) by Grade
Grade 1
5 Participants
1 Participants
0 Participants
Severity of Local Adverse Events (AEs) by Grade
Grade 2
0 Participants
0 Participants
0 Participants
Severity of Local Adverse Events (AEs) by Grade
Grade 3
0 Participants
0 Participants
0 Participants
Severity of Local Adverse Events (AEs) by Grade
Grade 4
0 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: Through day 28 after vaccine administration

Population: The 'per protocol subset', which is based on participants assignment determined by day 0 dengue antibody profile.

The severity of systemic AEs was assessed using the grading scale below: Grade 1: Fever = 100.4-101.1\^oF; Fatigue, Retro-orbital pain, Photophobia, Nausea, Headache, Myalgia, Arthralgia = No interference with activity, may require one dose of medication/treatment; Dengue-like rash: Rash is present but asymptomatic. Grade 2: Fever = 101.2-102.0\^oF; Fatigue, Retro-orbital pain, Photophobia, Nausea, Headache, Myalgia, Arthralgia = Some interference with activity or requires \>1 dose of medication/treatment; Dengue-like rash: Rash is symptomatic but does not interfere with activity. Grade 3: Fever = 102.1-104\^oF; Fatigue, Retro-orbital pain, Photophobia, Nausea, Headache, Myalgia, Arthralgia = Prevents daily activity and requires medical intervention; Dengue-like rash: Rash is symptomatic and interferes with activity. Grade 4: Fever = \>104\^oF; Fatigue, Retro-orbital pain, Photophobia, Nausea, Headache, Myalgia, Arthralgia, Dengue-like rash: Hospitalization.

Outcome measures

Outcome measures
Measure
Primary Heterotypic Dengue Virus Antibody Profile
n=18 Participants
Participants where the highest plaque reduction neutralization test (PRNT50) titer is ≥4-fold higher than the second highest serotype (or one serotype ≥10 and others \<10) were considered monotypic. Of these, participants with their highest titer to DENV3 were excluded, and all others were included in the heterotypic group. Participants received a single 0.5 mL subcutaneous injection of 10\^3.3 PFU/mL rDEN3Δ30/31-7164 vaccine formulated in Plasma-Lyte A (pH 7.4) diluent in the deltoid region on day 0.
Flavivirus naïve
n=14 Participants
Participants were classified as flavivirus-naive if they met any of the following criteria: a 50% plaque reduction neutralization test (PRNT50) titer \<10 for all dengue serotypes, no history of flavivirus vaccination, or no travel history associated with an increased risk of other flavivirus infections. If there was any concern regarding prior flavivirus exposure, antibody testing was performed to confirm the absence of exposure. Participants received a single 0.5 mL subcutaneous injection of 10\^3.3 PFU/mL rDEN3Δ30/31-7164 vaccine formulated in Plasma-Lyte A (pH 7.4) diluent in the deltoid region on day 0.
Polytypic Dengue Virus Antibody Profile
n=13 Participants
Participants were considered dengue immune if they had a 50% plaque reduction neutralization test (PRNT50) titer of ≥10 against any dengue serotype. Among these participants, those whose highest PRNT50 titer was \<4-fold higher than the second-highest serotype were further categorized as follows: participants with PRNT50 titers ≥60 for at least two serotypes were classified as "polytypic", whereas those with PRNT50 titers between 10 and 60 were classified as "expanded polytypic". Participants received a single 0.5 mL subcutaneous injection of 10\^3.3 PFU/mL rDEN3Δ30/31-7164 vaccine formulated in Plasma-Lyte A (pH 7.4) diluent in the deltoid region on day 0.
Severity of Systemic Adverse Events (AEs)
Grade 1
15 Participants
13 Participants
8 Participants
Severity of Systemic Adverse Events (AEs)
Grade 2
8 Participants
5 Participants
2 Participants
Severity of Systemic Adverse Events (AEs)
Grade 3
0 Participants
0 Participants
0 Participants
Severity of Systemic Adverse Events (AEs)
Grade 4
0 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: Through day 28 after vaccine administration

Population: The 'per protocol subset', which is based on participants assignment determined by day 0 dengue antibody profile.

Number of participants with unexpected adverse (AE) events occurring up to 28 days after vaccine administration of vaccine. Unexpected adverse event is defined as an AE that is not listed in the investigator's brochure at the frequency, AND specificity, AND severity that has been observed.

Outcome measures

Outcome measures
Measure
Primary Heterotypic Dengue Virus Antibody Profile
n=18 Participants
Participants where the highest plaque reduction neutralization test (PRNT50) titer is ≥4-fold higher than the second highest serotype (or one serotype ≥10 and others \<10) were considered monotypic. Of these, participants with their highest titer to DENV3 were excluded, and all others were included in the heterotypic group. Participants received a single 0.5 mL subcutaneous injection of 10\^3.3 PFU/mL rDEN3Δ30/31-7164 vaccine formulated in Plasma-Lyte A (pH 7.4) diluent in the deltoid region on day 0.
Flavivirus naïve
n=14 Participants
Participants were classified as flavivirus-naive if they met any of the following criteria: a 50% plaque reduction neutralization test (PRNT50) titer \<10 for all dengue serotypes, no history of flavivirus vaccination, or no travel history associated with an increased risk of other flavivirus infections. If there was any concern regarding prior flavivirus exposure, antibody testing was performed to confirm the absence of exposure. Participants received a single 0.5 mL subcutaneous injection of 10\^3.3 PFU/mL rDEN3Δ30/31-7164 vaccine formulated in Plasma-Lyte A (pH 7.4) diluent in the deltoid region on day 0.
Polytypic Dengue Virus Antibody Profile
n=13 Participants
Participants were considered dengue immune if they had a 50% plaque reduction neutralization test (PRNT50) titer of ≥10 against any dengue serotype. Among these participants, those whose highest PRNT50 titer was \<4-fold higher than the second-highest serotype were further categorized as follows: participants with PRNT50 titers ≥60 for at least two serotypes were classified as "polytypic", whereas those with PRNT50 titers between 10 and 60 were classified as "expanded polytypic". Participants received a single 0.5 mL subcutaneous injection of 10\^3.3 PFU/mL rDEN3Δ30/31-7164 vaccine formulated in Plasma-Lyte A (pH 7.4) diluent in the deltoid region on day 0.
Number of Participants With Unexpected Adverse Events (AEs)
0 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: Through day 180 after vaccine administration

Population: The 'per protocol subset', which is based on participants assignment determined by day 0 dengue antibody profile.

Number of participants with serious adverse events defined as any grade 4 or higher local or systemic adverse events based on the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Clinical Trials. Local AEs: Grade 4: Pain, Tenderness = Hospitalization; Erythema/Redness, Induration/Swelling = Necrosis or exfoliative dermatitis requiring medical attention; Bruising: Hematoma requiring medical attention; Pruritis: Pruritis requiring medical attention Systemic AEs: Grade 4: Fever = \>104\^oF; Fatigue, Retro-orbital pain, Photophobia, Nausea, Headache, Myalgia, Arthralgia, Dengue-like rash: Hospitalization. Grade 5: Death

Outcome measures

Outcome measures
Measure
Primary Heterotypic Dengue Virus Antibody Profile
n=18 Participants
Participants where the highest plaque reduction neutralization test (PRNT50) titer is ≥4-fold higher than the second highest serotype (or one serotype ≥10 and others \<10) were considered monotypic. Of these, participants with their highest titer to DENV3 were excluded, and all others were included in the heterotypic group. Participants received a single 0.5 mL subcutaneous injection of 10\^3.3 PFU/mL rDEN3Δ30/31-7164 vaccine formulated in Plasma-Lyte A (pH 7.4) diluent in the deltoid region on day 0.
Flavivirus naïve
n=14 Participants
Participants were classified as flavivirus-naive if they met any of the following criteria: a 50% plaque reduction neutralization test (PRNT50) titer \<10 for all dengue serotypes, no history of flavivirus vaccination, or no travel history associated with an increased risk of other flavivirus infections. If there was any concern regarding prior flavivirus exposure, antibody testing was performed to confirm the absence of exposure. Participants received a single 0.5 mL subcutaneous injection of 10\^3.3 PFU/mL rDEN3Δ30/31-7164 vaccine formulated in Plasma-Lyte A (pH 7.4) diluent in the deltoid region on day 0.
Polytypic Dengue Virus Antibody Profile
n=13 Participants
Participants were considered dengue immune if they had a 50% plaque reduction neutralization test (PRNT50) titer of ≥10 against any dengue serotype. Among these participants, those whose highest PRNT50 titer was \<4-fold higher than the second-highest serotype were further categorized as follows: participants with PRNT50 titers ≥60 for at least two serotypes were classified as "polytypic", whereas those with PRNT50 titers between 10 and 60 were classified as "expanded polytypic". Participants received a single 0.5 mL subcutaneous injection of 10\^3.3 PFU/mL rDEN3Δ30/31-7164 vaccine formulated in Plasma-Lyte A (pH 7.4) diluent in the deltoid region on day 0.
Number of Participants With Serious Adverse Events (AEs)
Grade 4
0 Participants
0 Participants
0 Participants
Number of Participants With Serious Adverse Events (AEs)
Grade 5
0 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: Day 28 and day 0

Population: The 'per protocol subset', which is based on participants assignment determined by day 0 dengue antibody profile.

The dengue virus (DENV) geometric mean titer (GMT) is a measure of average humoral immunity against all four dengue virus (DENV1-4) serotypes before and after vaccination obtained using plaque reduction neutralization tests (PRNT). The fold change in the DENV1-4 neutralizing antibody GMT between days 0 and 28 was analyzed as GMT Day 28/GMT Day 0.

Outcome measures

Outcome measures
Measure
Primary Heterotypic Dengue Virus Antibody Profile
n=18 Participants
Participants where the highest plaque reduction neutralization test (PRNT50) titer is ≥4-fold higher than the second highest serotype (or one serotype ≥10 and others \<10) were considered monotypic. Of these, participants with their highest titer to DENV3 were excluded, and all others were included in the heterotypic group. Participants received a single 0.5 mL subcutaneous injection of 10\^3.3 PFU/mL rDEN3Δ30/31-7164 vaccine formulated in Plasma-Lyte A (pH 7.4) diluent in the deltoid region on day 0.
Flavivirus naïve
n=14 Participants
Participants were classified as flavivirus-naive if they met any of the following criteria: a 50% plaque reduction neutralization test (PRNT50) titer \<10 for all dengue serotypes, no history of flavivirus vaccination, or no travel history associated with an increased risk of other flavivirus infections. If there was any concern regarding prior flavivirus exposure, antibody testing was performed to confirm the absence of exposure. Participants received a single 0.5 mL subcutaneous injection of 10\^3.3 PFU/mL rDEN3Δ30/31-7164 vaccine formulated in Plasma-Lyte A (pH 7.4) diluent in the deltoid region on day 0.
Polytypic Dengue Virus Antibody Profile
n=13 Participants
Participants were considered dengue immune if they had a 50% plaque reduction neutralization test (PRNT50) titer of ≥10 against any dengue serotype. Among these participants, those whose highest PRNT50 titer was \<4-fold higher than the second-highest serotype were further categorized as follows: participants with PRNT50 titers ≥60 for at least two serotypes were classified as "polytypic", whereas those with PRNT50 titers between 10 and 60 were classified as "expanded polytypic". Participants received a single 0.5 mL subcutaneous injection of 10\^3.3 PFU/mL rDEN3Δ30/31-7164 vaccine formulated in Plasma-Lyte A (pH 7.4) diluent in the deltoid region on day 0.
Mean Fold-change in Dengue virus1-4 Neutralizing Antibody Mean Titer Between Days 0 and 28
40.2 Ratio
Interval 22.2 to 72.5
7.2 Ratio
Interval 4.3 to 12.0
5.3 Ratio
Interval 1.6 to 17.0

PRIMARY outcome

Timeframe: Day 3 through day 15

Population: The 'per protocol subset', which is based on participants assignment determined by day 0 dengue antibody profile.

The mean peak viremia was measured by viral quantitative reverse transcription polymerase chain reaction (qRT-PCR) for days 3, 6, 9, 12, and 15. Analysis was done as the average of the log mean of the peak value for each participant.

Outcome measures

Outcome measures
Measure
Primary Heterotypic Dengue Virus Antibody Profile
n=18 Participants
Participants where the highest plaque reduction neutralization test (PRNT50) titer is ≥4-fold higher than the second highest serotype (or one serotype ≥10 and others \<10) were considered monotypic. Of these, participants with their highest titer to DENV3 were excluded, and all others were included in the heterotypic group. Participants received a single 0.5 mL subcutaneous injection of 10\^3.3 PFU/mL rDEN3Δ30/31-7164 vaccine formulated in Plasma-Lyte A (pH 7.4) diluent in the deltoid region on day 0.
Flavivirus naïve
n=14 Participants
Participants were classified as flavivirus-naive if they met any of the following criteria: a 50% plaque reduction neutralization test (PRNT50) titer \<10 for all dengue serotypes, no history of flavivirus vaccination, or no travel history associated with an increased risk of other flavivirus infections. If there was any concern regarding prior flavivirus exposure, antibody testing was performed to confirm the absence of exposure. Participants received a single 0.5 mL subcutaneous injection of 10\^3.3 PFU/mL rDEN3Δ30/31-7164 vaccine formulated in Plasma-Lyte A (pH 7.4) diluent in the deltoid region on day 0.
Polytypic Dengue Virus Antibody Profile
n=13 Participants
Participants were considered dengue immune if they had a 50% plaque reduction neutralization test (PRNT50) titer of ≥10 against any dengue serotype. Among these participants, those whose highest PRNT50 titer was \<4-fold higher than the second-highest serotype were further categorized as follows: participants with PRNT50 titers ≥60 for at least two serotypes were classified as "polytypic", whereas those with PRNT50 titers between 10 and 60 were classified as "expanded polytypic". Participants received a single 0.5 mL subcutaneous injection of 10\^3.3 PFU/mL rDEN3Δ30/31-7164 vaccine formulated in Plasma-Lyte A (pH 7.4) diluent in the deltoid region on day 0.
Mean Peak Viremia
4.3 log copies/mL
Interval 4.1 to 4.5
3.5 log copies/mL
Interval 3.3 to 3.6
3.5 log copies/mL
Interval 3.1 to 3.8

SECONDARY outcome

Timeframe: Day 57 and day 0

Population: The 'per protocol subset', which is based on participants assignment determined by day 0 dengue antibody profile.

The dengue virus (DENV) geometric mean titer (GMT) is a measure of average humoral immunity against all four dengue virus (DENV1-4) serotypes before and after vaccination obtained using plaque reduction neutralization tests (PRNT). The fold change in the DENV1-4 neutralizing antibody GMT between days 0 and 57 was analyzed as GMT Day 57/GMT Day 0.

Outcome measures

Outcome measures
Measure
Primary Heterotypic Dengue Virus Antibody Profile
n=18 Participants
Participants where the highest plaque reduction neutralization test (PRNT50) titer is ≥4-fold higher than the second highest serotype (or one serotype ≥10 and others \<10) were considered monotypic. Of these, participants with their highest titer to DENV3 were excluded, and all others were included in the heterotypic group. Participants received a single 0.5 mL subcutaneous injection of 10\^3.3 PFU/mL rDEN3Δ30/31-7164 vaccine formulated in Plasma-Lyte A (pH 7.4) diluent in the deltoid region on day 0.
Flavivirus naïve
n=14 Participants
Participants were classified as flavivirus-naive if they met any of the following criteria: a 50% plaque reduction neutralization test (PRNT50) titer \<10 for all dengue serotypes, no history of flavivirus vaccination, or no travel history associated with an increased risk of other flavivirus infections. If there was any concern regarding prior flavivirus exposure, antibody testing was performed to confirm the absence of exposure. Participants received a single 0.5 mL subcutaneous injection of 10\^3.3 PFU/mL rDEN3Δ30/31-7164 vaccine formulated in Plasma-Lyte A (pH 7.4) diluent in the deltoid region on day 0.
Polytypic Dengue Virus Antibody Profile
n=13 Participants
Participants were considered dengue immune if they had a 50% plaque reduction neutralization test (PRNT50) titer of ≥10 against any dengue serotype. Among these participants, those whose highest PRNT50 titer was \<4-fold higher than the second-highest serotype were further categorized as follows: participants with PRNT50 titers ≥60 for at least two serotypes were classified as "polytypic", whereas those with PRNT50 titers between 10 and 60 were classified as "expanded polytypic". Participants received a single 0.5 mL subcutaneous injection of 10\^3.3 PFU/mL rDEN3Δ30/31-7164 vaccine formulated in Plasma-Lyte A (pH 7.4) diluent in the deltoid region on day 0.
Mean Fold-change in Dengue virus1-4 Neutralizing Antibody Mean Titer Between Days 0 and 57
25 Ratio
Interval 15.0 to 41.9
3.9 Ratio
Interval 2.4 to 6.2
5 Ratio
Interval 1.8 to 13.7

SECONDARY outcome

Timeframe: Day 0, Day 28, and Day 57

Population: The 'per protocol subset', which is based on participants assignment determined by day 0 dengue antibody profile.

The dengue virus (DENV) geometric mean titer (GMT) is a measure of average humoral immunity against all four dengue virus (DENV1-4) serotypes. GMT for the DENV1-4 neutralizing antibody titer was assessed for days 0, 28, and 57.

Outcome measures

Outcome measures
Measure
Primary Heterotypic Dengue Virus Antibody Profile
n=18 Participants
Participants where the highest plaque reduction neutralization test (PRNT50) titer is ≥4-fold higher than the second highest serotype (or one serotype ≥10 and others \<10) were considered monotypic. Of these, participants with their highest titer to DENV3 were excluded, and all others were included in the heterotypic group. Participants received a single 0.5 mL subcutaneous injection of 10\^3.3 PFU/mL rDEN3Δ30/31-7164 vaccine formulated in Plasma-Lyte A (pH 7.4) diluent in the deltoid region on day 0.
Flavivirus naïve
n=14 Participants
Participants were classified as flavivirus-naive if they met any of the following criteria: a 50% plaque reduction neutralization test (PRNT50) titer \<10 for all dengue serotypes, no history of flavivirus vaccination, or no travel history associated with an increased risk of other flavivirus infections. If there was any concern regarding prior flavivirus exposure, antibody testing was performed to confirm the absence of exposure. Participants received a single 0.5 mL subcutaneous injection of 10\^3.3 PFU/mL rDEN3Δ30/31-7164 vaccine formulated in Plasma-Lyte A (pH 7.4) diluent in the deltoid region on day 0.
Polytypic Dengue Virus Antibody Profile
n=13 Participants
Participants were considered dengue immune if they had a 50% plaque reduction neutralization test (PRNT50) titer of ≥10 against any dengue serotype. Among these participants, those whose highest PRNT50 titer was \<4-fold higher than the second-highest serotype were further categorized as follows: participants with PRNT50 titers ≥60 for at least two serotypes were classified as "polytypic", whereas those with PRNT50 titers between 10 and 60 were classified as "expanded polytypic". Participants received a single 0.5 mL subcutaneous injection of 10\^3.3 PFU/mL rDEN3Δ30/31-7164 vaccine formulated in Plasma-Lyte A (pH 7.4) diluent in the deltoid region on day 0.
Mean Titer for Dengue Virus Neutralizing Antibody
Day 0
28.5 titer
Interval 16.5 to 49.2
5 titer
Interval 5.0 to 5.0
62.3 titer
Interval 33.7 to 115.1
Mean Titer for Dengue Virus Neutralizing Antibody
Day 28
1144.6 titer
Interval 804.0 to 1629.4
35.9 titer
Interval 21.4 to 60.1
328.8 titer
Interval 133.8 to 807.9
Mean Titer for Dengue Virus Neutralizing Antibody
Day 57
713.3 titer
Interval 485.2 to 1048.8
19.5 titer
Interval 12.2 to 31.2
310.4 titer
Interval 154.0 to 625.6

SECONDARY outcome

Timeframe: Day 15

Population: The 'per protocol subset', which is based on participants assignment determined by day 0 dengue antibody profile.

Percent dengue virus (DENV)-specific CD8+ T-cells among total CD8+ T-cells at day 15 was measured through flow cytometric analyses using the Activation-Induced Marker (AIM) assays.

Outcome measures

Outcome measures
Measure
Primary Heterotypic Dengue Virus Antibody Profile
n=18 Participants
Participants where the highest plaque reduction neutralization test (PRNT50) titer is ≥4-fold higher than the second highest serotype (or one serotype ≥10 and others \<10) were considered monotypic. Of these, participants with their highest titer to DENV3 were excluded, and all others were included in the heterotypic group. Participants received a single 0.5 mL subcutaneous injection of 10\^3.3 PFU/mL rDEN3Δ30/31-7164 vaccine formulated in Plasma-Lyte A (pH 7.4) diluent in the deltoid region on day 0.
Flavivirus naïve
n=14 Participants
Participants were classified as flavivirus-naive if they met any of the following criteria: a 50% plaque reduction neutralization test (PRNT50) titer \<10 for all dengue serotypes, no history of flavivirus vaccination, or no travel history associated with an increased risk of other flavivirus infections. If there was any concern regarding prior flavivirus exposure, antibody testing was performed to confirm the absence of exposure. Participants received a single 0.5 mL subcutaneous injection of 10\^3.3 PFU/mL rDEN3Δ30/31-7164 vaccine formulated in Plasma-Lyte A (pH 7.4) diluent in the deltoid region on day 0.
Polytypic Dengue Virus Antibody Profile
n=13 Participants
Participants were considered dengue immune if they had a 50% plaque reduction neutralization test (PRNT50) titer of ≥10 against any dengue serotype. Among these participants, those whose highest PRNT50 titer was \<4-fold higher than the second-highest serotype were further categorized as follows: participants with PRNT50 titers ≥60 for at least two serotypes were classified as "polytypic", whereas those with PRNT50 titers between 10 and 60 were classified as "expanded polytypic". Participants received a single 0.5 mL subcutaneous injection of 10\^3.3 PFU/mL rDEN3Δ30/31-7164 vaccine formulated in Plasma-Lyte A (pH 7.4) diluent in the deltoid region on day 0.
Percent Dengue-specific CD8+ T-cells
1.4 percentage of dengue-specific CD8+ cells
Interval 0.5 to 3.4
0.3 percentage of dengue-specific CD8+ cells
Interval 0.1 to 0.8
0.3 percentage of dengue-specific CD8+ cells
Interval 0.1 to 0.9

Adverse Events

Flavivirus naïve

Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths

Polytypic Dengue Virus Antibody Profile

Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths

Primary Heterotypic Dengue Virus Antibody Profile

Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Flavivirus naïve
n=14 participants at risk
Participants were classified as flavivirus-naive if they met any of the following criteria: a 50% plaque reduction neutralization test (PRNT50) titer \<10 for all dengue serotypes, no history of flavivirus vaccination, or no travel history associated with an increased risk of other flavivirus infections. If there was any concern regarding prior flavivirus exposure, antibody testing was performed to confirm the absence of exposure. Participants received a single 0.5 mL subcutaneous injection of 10\^3.3 PFU/mL rDEN3Δ30/31-7164 vaccine formulated in Plasma-Lyte A (pH 7.4) diluent in the deltoid region on day 0.
Polytypic Dengue Virus Antibody Profile
n=13 participants at risk
Participants were considered dengue immune if they had a 50% plaque reduction neutralization test (PRNT50) titer of ≥10 against any dengue serotype. Among these participants, those whose highest PRNT50 titer was \<4-fold higher than the second-highest serotype were further categorized as follows: participants with PRNT50 titers ≥60 for at least two serotypes were classified as "polytypic", whereas those with PRNT50 titers between 10 and 60 were classified as "expanded polytypic". Participants received a single 0.5 mL subcutaneous injection of 10\^3.3 PFU/mL rDEN3Δ30/31-7164 vaccine formulated in Plasma-Lyte A (pH 7.4) diluent in the deltoid region on day 0.
Primary Heterotypic Dengue Virus Antibody Profile
n=18 participants at risk
Participants where the highest plaque reduction neutralization test (PRNT50) titer is ≥4-fold higher than the second highest serotype (or one serotype ≥10 and others \<10) were considered monotypic. Of these, participants with their highest titer to DENV3 were excluded, and all others were included in the heterotypic group. Participants received a single 0.5 mL subcutaneous injection of 10\^3.3 PFU/mL rDEN3Δ30/31-7164 vaccine formulated in Plasma-Lyte A (pH 7.4) diluent in the deltoid region on day 0.
Infections and infestations
Skin infection
7.1%
1/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.

Other adverse events

Other adverse events
Measure
Flavivirus naïve
n=14 participants at risk
Participants were classified as flavivirus-naive if they met any of the following criteria: a 50% plaque reduction neutralization test (PRNT50) titer \<10 for all dengue serotypes, no history of flavivirus vaccination, or no travel history associated with an increased risk of other flavivirus infections. If there was any concern regarding prior flavivirus exposure, antibody testing was performed to confirm the absence of exposure. Participants received a single 0.5 mL subcutaneous injection of 10\^3.3 PFU/mL rDEN3Δ30/31-7164 vaccine formulated in Plasma-Lyte A (pH 7.4) diluent in the deltoid region on day 0.
Polytypic Dengue Virus Antibody Profile
n=13 participants at risk
Participants were considered dengue immune if they had a 50% plaque reduction neutralization test (PRNT50) titer of ≥10 against any dengue serotype. Among these participants, those whose highest PRNT50 titer was \<4-fold higher than the second-highest serotype were further categorized as follows: participants with PRNT50 titers ≥60 for at least two serotypes were classified as "polytypic", whereas those with PRNT50 titers between 10 and 60 were classified as "expanded polytypic". Participants received a single 0.5 mL subcutaneous injection of 10\^3.3 PFU/mL rDEN3Δ30/31-7164 vaccine formulated in Plasma-Lyte A (pH 7.4) diluent in the deltoid region on day 0.
Primary Heterotypic Dengue Virus Antibody Profile
n=18 participants at risk
Participants where the highest plaque reduction neutralization test (PRNT50) titer is ≥4-fold higher than the second highest serotype (or one serotype ≥10 and others \<10) were considered monotypic. Of these, participants with their highest titer to DENV3 were excluded, and all others were included in the heterotypic group. Participants received a single 0.5 mL subcutaneous injection of 10\^3.3 PFU/mL rDEN3Δ30/31-7164 vaccine formulated in Plasma-Lyte A (pH 7.4) diluent in the deltoid region on day 0.
General disorders and administration site conditions
Malaise
7.1%
1/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
7.7%
1/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
22.2%
4/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
General disorders and administration site conditions
Pain
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
5.6%
1/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
General disorders and administration site conditions
Pyrexia
7.1%
1/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
23.1%
3/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
General disorders and administration site conditions
Tenderness
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
7.7%
1/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
General disorders and administration site conditions
Thirst
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
11.1%
2/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
General disorders and administration site conditions
Vessel puncture site bruise
14.3%
2/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Injury, poisoning and procedural complications
Fall
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
5.6%
1/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Injury, poisoning and procedural complications
Injury
7.1%
1/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Injury, poisoning and procedural complications
Post procedural contusion
21.4%
3/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
22.2%
4/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
General disorders and administration site conditions
Vessel puncture site pain
7.1%
1/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Immune system disorders
Hypersensitivity
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
7.7%
1/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Infections and infestations
Acute sinusitis
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
5.6%
1/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Infections and infestations
Bronchitis
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
7.7%
1/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Infections and infestations
COVID-19
7.1%
1/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
15.4%
2/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
11.1%
2/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Infections and infestations
Gastroenteritis
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
7.7%
1/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Infections and infestations
Herpes simplex
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
5.6%
1/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Infections and infestations
Influenza
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
15.4%
2/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
5.6%
1/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Infections and infestations
Lower respiratory tract infection
7.1%
1/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Infections and infestations
Oral herpes
7.1%
1/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Infections and infestations
Pneumonia
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
5.6%
1/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Infections and infestations
Rhinovirus infection
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
5.6%
1/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Infections and infestations
Upper respiratory tract infection
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
16.7%
3/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Infections and infestations
Urinary tract infection
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
5.6%
1/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Infections and infestations
Viral infection
21.4%
3/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
7.7%
1/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
11.1%
2/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Injury, poisoning and procedural complications
Arthropod bite
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
7.7%
1/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Injury, poisoning and procedural complications
Contusion
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
7.7%
1/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
16.7%
3/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Injury, poisoning and procedural complications
Epicondylitis
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
5.6%
1/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
General disorders and administration site conditions
Injection site pain
7.1%
1/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
22.2%
4/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Injury, poisoning and procedural complications
Procedural pain
50.0%
7/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
38.5%
5/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
38.9%
7/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Injury, poisoning and procedural complications
Procedural site reaction
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
5.6%
1/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Investigations
Activated partial thromboplastin time prolonged
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
5.6%
1/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Investigations
Alanine aminotransferase increased
7.1%
1/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
5.6%
1/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Investigations
Aspartate aminotransferase increased
14.3%
2/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
7.7%
1/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
5.6%
1/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Investigations
Blood bilirubin increased
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
7.7%
1/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Investigations
Blood creatine phosphokinase increased
7.1%
1/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Investigations
Blood fibrinogen decreased
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
5.6%
1/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Investigations
Blood fibrinogen increased
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
23.1%
3/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
5.6%
1/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Investigations
Blood urea increased
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
7.7%
1/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Investigations
C-reactive protein increased
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
7.7%
1/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Investigations
Haemoglobin decreased
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
7.7%
1/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
16.7%
3/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Investigations
Hepatic enzyme increased
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
7.7%
1/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Investigations
Respiratory rate
21.4%
3/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
33.3%
6/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Metabolism and nutrition disorders
Decreased appetite
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
5.6%
1/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Metabolism and nutrition disorders
Hyperglycaemia
64.3%
9/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
53.8%
7/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
38.9%
7/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Metabolism and nutrition disorders
Hyperkalaemia
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
5.6%
1/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Metabolism and nutrition disorders
Hypoglycaemia
14.3%
2/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
7.7%
1/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
16.7%
3/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Metabolism and nutrition disorders
Hypokalaemia
35.7%
5/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
30.8%
4/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
11.1%
2/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Metabolism and nutrition disorders
Hyponatraemia
14.3%
2/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
7.7%
1/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
5.6%
1/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Metabolism and nutrition disorders
Polydipsia
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
7.7%
1/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Metabolism and nutrition disorders
Vitamin D deficiency
7.1%
1/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Musculoskeletal and connective tissue disorders
Arthralgia
7.1%
1/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
15.4%
2/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
22.2%
4/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
11.1%
2/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Musculoskeletal and connective tissue disorders
Myalgia
21.4%
3/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
15.4%
2/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
38.9%
7/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Musculoskeletal and connective tissue disorders
Pain in extremity
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
5.6%
1/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Nervous system disorders
Cluster headache
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
5.6%
1/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Nervous system disorders
Dizziness
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
5.6%
1/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Nervous system disorders
Headache
57.1%
8/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
30.8%
4/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
33.3%
6/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Nervous system disorders
Paraesthesia
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
7.7%
1/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Nervous system disorders
Presyncope
14.3%
2/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
11.1%
2/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Psychiatric disorders
Anxiety
7.1%
1/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
7.7%
1/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Psychiatric disorders
Attention deficit hyperactivity disorder
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
5.6%
1/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Psychiatric disorders
Insomnia
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
5.6%
1/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Renal and urinary disorders
Dysuria
7.1%
1/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Renal and urinary disorders
Pollakiuria
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
5.6%
1/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Reproductive system and breast disorders
Menorrhagia
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
5.6%
1/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Respiratory, thoracic and mediastinal disorders
Cough
7.1%
1/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Respiratory, thoracic and mediastinal disorders
Dysphonia
7.1%
1/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
7.7%
1/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Respiratory, thoracic and mediastinal disorders
Nasal congestion
7.1%
1/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
7.7%
1/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
7.7%
1/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Respiratory, thoracic and mediastinal disorders
Sinus congestion
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
5.6%
1/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Respiratory, thoracic and mediastinal disorders
Throat irritation
21.4%
3/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
7.7%
1/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
5.6%
1/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Skin and subcutaneous tissue disorders
Dermatitis contact
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
7.7%
1/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Skin and subcutaneous tissue disorders
Dry skin
7.1%
1/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Skin and subcutaneous tissue disorders
Hyperhidrosis
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
5.6%
1/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Skin and subcutaneous tissue disorders
Keloid scar
7.1%
1/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Skin and subcutaneous tissue disorders
Night sweats
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
5.6%
1/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Skin and subcutaneous tissue disorders
Pruritus
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
5.6%
1/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Skin and subcutaneous tissue disorders
Rash
21.4%
3/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
7.7%
1/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
27.8%
5/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Skin and subcutaneous tissue disorders
Rash erythematous
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
7.7%
1/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Skin and subcutaneous tissue disorders
Rash maculo-papular
78.6%
11/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
23.1%
3/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
44.4%
8/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Vascular disorders
Systolic hypertension
7.1%
1/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
7.7%
1/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Blood and lymphatic system disorders
Anaemia
28.6%
4/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
46.2%
6/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
55.6%
10/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Blood and lymphatic system disorders
Leukopenia
21.4%
3/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
30.8%
4/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
38.9%
7/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Blood and lymphatic system disorders
Lymphadenopathy
14.3%
2/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
7.7%
1/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
11.1%
2/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Blood and lymphatic system disorders
Lymphopenia
7.1%
1/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
7.7%
1/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
22.2%
4/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Blood and lymphatic system disorders
Neutropenia
21.4%
3/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
30.8%
4/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
44.4%
8/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Cardiac disorders
Bradycardia
14.3%
2/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
15.4%
2/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
16.7%
3/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Cardiac disorders
Tachycardia
21.4%
3/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
16.7%
3/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Eye disorders
Chalazion
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
5.6%
1/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Eye disorders
Dry eye
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
7.7%
1/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Eye disorders
Eye pain
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
7.7%
1/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
16.7%
3/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Eye disorders
Periorbital oedema
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
5.6%
1/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Eye disorders
Photophobia
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
11.1%
2/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Gastrointestinal disorders
Abdominal pain
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
5.6%
1/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Gastrointestinal disorders
Constipation
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
5.6%
1/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Gastrointestinal disorders
Diarrhoea
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
7.7%
1/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
22.2%
4/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
5.6%
1/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Vascular disorders
Diastolic hypertension
14.3%
2/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
23.1%
3/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
5.6%
1/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Vascular disorders
Hypotension
7.1%
1/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
5.6%
1/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Gastrointestinal disorders
Gastrooesophageal reflux disease
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
11.1%
2/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Gastrointestinal disorders
Large intestine polyp
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
7.7%
1/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
5.6%
1/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Gastrointestinal disorders
Nausea
14.3%
2/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
15.4%
2/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
16.7%
3/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
Gastrointestinal disorders
Toothache
0.00%
0/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
7.7%
1/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
General disorders and administration site conditions
Injection site erythema
7.1%
1/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
0.00%
0/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
11.1%
2/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
General disorders and administration site conditions
Fatigue
57.1%
8/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
46.2%
6/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
50.0%
9/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
General disorders and administration site conditions
Chills
7.1%
1/14 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
7.7%
1/13 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.
16.7%
3/18 • Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.

Additional Information

Dr. Camila Odio

National Institute of Allergy and Infectious Diseases

Phone: +1 240 338 4945

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place