Trial Outcomes & Findings for Trial of a Falciparum Malaria Protein (FMP012), E. Coli-expressed PfCelTOS, in Healthy Malaria-Naive Adults (NCT NCT01540474)
NCT ID: NCT01540474
Last Updated: 2021-06-08
Results Overview
Number of participants for each dose (1 through 3) that experienced any symptom, general solicited symptoms, and local solicited symptoms
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
36 participants
Primary outcome timeframe
From vaccination day through 7 days post vaccination (for all three doses)
Results posted on
2021-06-08
Participant Flow
Participant milestones
| Measure |
Group 1: 10 ug FMP012 With 2 ug GLA-SE
Single center, non-randomized, open label, dose escalation Phase 1 study with sporozoite challenge. The antigen FMP012 will be adjuvanted with Glucopyranosyl lipd A stable emulsion. This is a first-in-human study of FMP012. 30 subjects, divided into 3 groups, will receive 3 doses of the FMP012/GLA-SE vaccine. Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant
Group 1: 10 ug FMP012 with 2 ug GLA-SE: Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant
|
Group 2: 10 ug FMP012 With 5 ug GLA-SE
Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant
Group 2: 10 ug FMP012 with 5 ug GLA-SE: E-coli expressed antigen FMP012 will be adjuvanted with Glucopyranosyl lipd A stable emulsion (GLA-SE), a proprietary adjuvant
|
Group 3: 50 ug FMP012 With 5 ug GLA-SE or 2 ug GLA-SE
Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant
50 ug FMP012 with 5 ug GLA-SE or 2 ug GLA-SE: E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipd A stable emulsion (GLA-SE), a proprietary adjuvant
|
Control Group
Infectivity Controls participating in the study at the challenge stage; no vaccinations received or placebos prior to the challenge
|
|---|---|---|---|---|
|
Vaccination Period
STARTED
|
10
|
10
|
10
|
0
|
|
Vaccination Period
COMPLETED
|
10
|
9
|
10
|
0
|
|
Vaccination Period
NOT COMPLETED
|
0
|
1
|
0
|
0
|
|
Malaria Challenge
STARTED
|
10
|
9
|
10
|
6
|
|
Malaria Challenge
COMPLETED
|
10
|
9
|
10
|
5
|
|
Malaria Challenge
NOT COMPLETED
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Group 1: 10 ug FMP012 With 2 ug GLA-SE
Single center, non-randomized, open label, dose escalation Phase 1 study with sporozoite challenge. The antigen FMP012 will be adjuvanted with Glucopyranosyl lipd A stable emulsion. This is a first-in-human study of FMP012. 30 subjects, divided into 3 groups, will receive 3 doses of the FMP012/GLA-SE vaccine. Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant
Group 1: 10 ug FMP012 with 2 ug GLA-SE: Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant
|
Group 2: 10 ug FMP012 With 5 ug GLA-SE
Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant
Group 2: 10 ug FMP012 with 5 ug GLA-SE: E-coli expressed antigen FMP012 will be adjuvanted with Glucopyranosyl lipd A stable emulsion (GLA-SE), a proprietary adjuvant
|
Group 3: 50 ug FMP012 With 5 ug GLA-SE or 2 ug GLA-SE
Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant
50 ug FMP012 with 5 ug GLA-SE or 2 ug GLA-SE: E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipd A stable emulsion (GLA-SE), a proprietary adjuvant
|
Control Group
Infectivity Controls participating in the study at the challenge stage; no vaccinations received or placebos prior to the challenge
|
|---|---|---|---|---|
|
Vaccination Period
Lost to Follow-up
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Trial of a Falciparum Malaria Protein (FMP012), E. Coli-expressed PfCelTOS, in Healthy Malaria-Naive Adults
Baseline characteristics by cohort
| Measure |
Group 1: 10 ug FMP012 With 2 ug GLA-SE
n=10 Participants
Single center, non-randomized, open label, dose escalation Phase 1 study with sporozoite challenge. The antigen FMP012 will be adjuvanted with Glucopyranosyl lipd A stable emulsion. This is a first-in-human study of FMP012. 30 subjects, divided into 3 groups, will receive 3 doses of the FMP012/GLA-SE vaccine. Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant
Group 1: 10 ug FMP012 with 2 ug GLA-SE: Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant
|
Group 2: 10 ug FMP012 With 5 ug GLA-SE
n=10 Participants
Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant
Group 2: 10 ug FMP012 with 5 ug GLA-SE: E-coli expressed antigen FMP012 will be adjuvanted with Glucopyranosyl lipd A stable emulsion (GLA-SE), a proprietary adjuvant
|
Group 3: 50 ug FMP012 With 5 ug GLA-SE or 2 ug GLA-SE
n=10 Participants
Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant
50 ug FMP012 with 5 ug GLA-SE or 2 ug GLA-SE: E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipd A stable emulsion (GLA-SE), a proprietary adjuvant
|
Control Group
n=6 Participants
Infectivity Controls participating in the study at the challenge stage; no vaccinations received or placebos prior to the challenge
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
34.1 years
STANDARD_DEVIATION 8.37 • n=99 Participants
|
31.1 years
STANDARD_DEVIATION 10.17 • n=107 Participants
|
34.3 years
STANDARD_DEVIATION 10.88 • n=206 Participants
|
28.3 years
STANDARD_DEVIATION 8.41 • n=7 Participants
|
32.4 years
STANDARD_DEVIATION 9.51 • n=31 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
13 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
23 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
35 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
21 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Active Duty
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: From vaccination day through 7 days post vaccination (for all three doses)Population: Three dosing groups vaccinated with three doses of vaccine at varying intervals + an infectivity control group (malaria challenge phase only)
Number of participants for each dose (1 through 3) that experienced any symptom, general solicited symptoms, and local solicited symptoms
Outcome measures
| Measure |
Group 1: 10 ug FMP012 With 2 ug GLA-SE
n=10 Participants
Single center, non-randomized, open label, dose escalation Phase 1 study with sporozoite challenge. The antigen FMP012 will be adjuvanted with Glucopyranosyl lipd A stable emulsion. This is a first-in-human study of FMP012. 30 subjects, divided into 3 groups, will receive 3 doses of the FMP012/GLA-SE vaccine. Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant
Group 1: 10 ug FMP012 with 2 ug GLA-SE: Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant
|
Group 2: 10 ug FMP012 With 5 ug GLA-SE
n=10 Participants
Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant
Group 2: 10 ug FMP012 with 5 ug GLA-SE: E-coli expressed antigen FMP012 will be adjuvanted with Glucopyranosyl lipd A stable emulsion (GLA-SE), a proprietary adjuvant
|
Group 3: 50 ug FMP012 With 5 ug GLA-SE or 2 ug GLA-SE
n=10 Participants
Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant
50 ug FMP012 with 5 ug GLA-SE or 2 ug GLA-SE: E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipd A stable emulsion (GLA-SE), a proprietary adjuvant
|
Control Group
Infectivity Controls participating in the study at the challenge stage; no vaccinations received or placebos prior to the challenge
|
|---|---|---|---|---|
|
Number of Participants With Solicited or Unsolicited Symptoms Reporting During the Post-vaccination Period
Any Symptoms Dose 1
|
10 participants
|
10 participants
|
9 participants
|
—
|
|
Number of Participants With Solicited or Unsolicited Symptoms Reporting During the Post-vaccination Period
Any Symptom Dose 2
|
10 participants
|
10 participants
|
9 participants
|
—
|
|
Number of Participants With Solicited or Unsolicited Symptoms Reporting During the Post-vaccination Period
Any Symptom Dose 3
|
8 participants
|
9 participants
|
4 participants
|
—
|
|
Number of Participants With Solicited or Unsolicited Symptoms Reporting During the Post-vaccination Period
General Solicited Symptoms Dose 1
|
3 participants
|
5 participants
|
1 participants
|
—
|
|
Number of Participants With Solicited or Unsolicited Symptoms Reporting During the Post-vaccination Period
General Solicited Symptoms Dose 2
|
3 participants
|
3 participants
|
3 participants
|
—
|
|
Number of Participants With Solicited or Unsolicited Symptoms Reporting During the Post-vaccination Period
General Solicited Symptoms Dose 3
|
0 participants
|
1 participants
|
0 participants
|
—
|
|
Number of Participants With Solicited or Unsolicited Symptoms Reporting During the Post-vaccination Period
Local Solicited Symptoms Dose 1
|
9 participants
|
10 participants
|
9 participants
|
—
|
|
Number of Participants With Solicited or Unsolicited Symptoms Reporting During the Post-vaccination Period
Local Solicited Symptoms Dose 2
|
8 participants
|
9 participants
|
9 participants
|
—
|
|
Number of Participants With Solicited or Unsolicited Symptoms Reporting During the Post-vaccination Period
Local Solicitied Symptoms Dose 3
|
10 participants
|
9 participants
|
10 participants
|
—
|
|
Number of Participants With Solicited or Unsolicited Symptoms Reporting During the Post-vaccination Period
Overall/Dose Any Symptom
|
28 participants
|
29 participants
|
22 participants
|
—
|
|
Number of Participants With Solicited or Unsolicited Symptoms Reporting During the Post-vaccination Period
Overall/Dose General Solicited Symptoms
|
6 participants
|
9 participants
|
4 participants
|
—
|
|
Number of Participants With Solicited or Unsolicited Symptoms Reporting During the Post-vaccination Period
Overall/Dose Local Solicited Symptoms
|
25 participants
|
28 participants
|
22 participants
|
—
|
|
Number of Participants With Solicited or Unsolicited Symptoms Reporting During the Post-vaccination Period
Overall/Subject Any Symptom
|
10 participants
|
10 participants
|
9 participants
|
—
|
|
Number of Participants With Solicited or Unsolicited Symptoms Reporting During the Post-vaccination Period
Overall/Subject General Solicited Symptoms
|
5 participants
|
5 participants
|
3 participants
|
—
|
|
Number of Participants With Solicited or Unsolicited Symptoms Reporting During the Post-vaccination Period
Overall/Subject Local Solicited Symptoms
|
9 participants
|
10 participants
|
9 participants
|
—
|
PRIMARY outcome
Timeframe: From vaccination day through 7 days post vaccination for each does (1-3)Population: Vaccination group only; control group participated in malaria challenge only
Incidence of erythema and pain (solicited local symptoms) reported after each dose (1-3) of vaccination. Results for groups 1, 2 and 3 only as control group did not receive any vaccinations and only participated in the malaria challenge portion of the study.
Outcome measures
| Measure |
Group 1: 10 ug FMP012 With 2 ug GLA-SE
n=10 Participants
Single center, non-randomized, open label, dose escalation Phase 1 study with sporozoite challenge. The antigen FMP012 will be adjuvanted with Glucopyranosyl lipd A stable emulsion. This is a first-in-human study of FMP012. 30 subjects, divided into 3 groups, will receive 3 doses of the FMP012/GLA-SE vaccine. Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant
Group 1: 10 ug FMP012 with 2 ug GLA-SE: Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant
|
Group 2: 10 ug FMP012 With 5 ug GLA-SE
n=10 Participants
Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant
Group 2: 10 ug FMP012 with 5 ug GLA-SE: E-coli expressed antigen FMP012 will be adjuvanted with Glucopyranosyl lipd A stable emulsion (GLA-SE), a proprietary adjuvant
|
Group 3: 50 ug FMP012 With 5 ug GLA-SE or 2 ug GLA-SE
n=10 Participants
Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant
50 ug FMP012 with 5 ug GLA-SE or 2 ug GLA-SE: E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipd A stable emulsion (GLA-SE), a proprietary adjuvant
|
Control Group
Infectivity Controls participating in the study at the challenge stage; no vaccinations received or placebos prior to the challenge
|
|---|---|---|---|---|
|
Number of Participants With Solicited or Unsolicited Symptoms Reporting During the Post-vaccination Period
Overall/Dose Pain All
|
24 participants
|
28 participants
|
22 participants
|
—
|
|
Number of Participants With Solicited or Unsolicited Symptoms Reporting During the Post-vaccination Period
Overall/Dose Pain Grade 3
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants With Solicited or Unsolicited Symptoms Reporting During the Post-vaccination Period
Dose 1 : Erythema All
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants With Solicited or Unsolicited Symptoms Reporting During the Post-vaccination Period
Dose 1 : Erythema > 100mm
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants With Solicited or Unsolicited Symptoms Reporting During the Post-vaccination Period
Dose 1 : Pain All
|
9 participants
|
10 participants
|
9 participants
|
—
|
|
Number of Participants With Solicited or Unsolicited Symptoms Reporting During the Post-vaccination Period
Dose 1 : Pain Grade 3
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants With Solicited or Unsolicited Symptoms Reporting During the Post-vaccination Period
Dose 2 : Erythema All
|
1 participants
|
1 participants
|
0 participants
|
—
|
|
Number of Participants With Solicited or Unsolicited Symptoms Reporting During the Post-vaccination Period
Dose 2 : Erythema > 100mm
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants With Solicited or Unsolicited Symptoms Reporting During the Post-vaccination Period
Dose 2 : Pain All
|
7 participants
|
9 participants
|
9 participants
|
—
|
|
Number of Participants With Solicited or Unsolicited Symptoms Reporting During the Post-vaccination Period
Dose 2 : Pain Grade 3
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants With Solicited or Unsolicited Symptoms Reporting During the Post-vaccination Period
Dose 3 : Erythema All
|
1 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants With Solicited or Unsolicited Symptoms Reporting During the Post-vaccination Period
Dose 3 : Erythema > 100mm
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants With Solicited or Unsolicited Symptoms Reporting During the Post-vaccination Period
Dose 3 : Pain All
|
8 participants
|
9 participants
|
4 participants
|
—
|
|
Number of Participants With Solicited or Unsolicited Symptoms Reporting During the Post-vaccination Period
Dose 3 : Pain Grade 3
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants With Solicited or Unsolicited Symptoms Reporting During the Post-vaccination Period
Overall/Dose Erythema All
|
2 participants
|
1 participants
|
0 participants
|
—
|
|
Number of Participants With Solicited or Unsolicited Symptoms Reporting During the Post-vaccination Period
Overall/dose Erythema >100mm
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants With Solicited or Unsolicited Symptoms Reporting During the Post-vaccination Period
Overall/Subject Erythema All
|
2 participants
|
1 participants
|
0 participants
|
—
|
|
Number of Participants With Solicited or Unsolicited Symptoms Reporting During the Post-vaccination Period
Overall/Subject Erythema >100mm
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants With Solicited or Unsolicited Symptoms Reporting During the Post-vaccination Period
Overall/Subject Pain All
|
9 participants
|
10 participants
|
9 participants
|
—
|
|
Number of Participants With Solicited or Unsolicited Symptoms Reporting During the Post-vaccination Period
Overall/Subject Pain Grade 3
|
0 participants
|
0 participants
|
0 participants
|
—
|
PRIMARY outcome
Timeframe: 28 days after each vaccinationPopulation: Three dosing groups. Control group only participated in the malaria challenge portion of the study and was not vaccinated.
Number of participants with at lease one administered dose presenting with at least one specified symptom within 28 days after vaccination
Outcome measures
| Measure |
Group 1: 10 ug FMP012 With 2 ug GLA-SE
n=10 Participants
Single center, non-randomized, open label, dose escalation Phase 1 study with sporozoite challenge. The antigen FMP012 will be adjuvanted with Glucopyranosyl lipd A stable emulsion. This is a first-in-human study of FMP012. 30 subjects, divided into 3 groups, will receive 3 doses of the FMP012/GLA-SE vaccine. Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant
Group 1: 10 ug FMP012 with 2 ug GLA-SE: Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant
|
Group 2: 10 ug FMP012 With 5 ug GLA-SE
n=10 Participants
Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant
Group 2: 10 ug FMP012 with 5 ug GLA-SE: E-coli expressed antigen FMP012 will be adjuvanted with Glucopyranosyl lipd A stable emulsion (GLA-SE), a proprietary adjuvant
|
Group 3: 50 ug FMP012 With 5 ug GLA-SE or 2 ug GLA-SE
n=10 Participants
Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant
50 ug FMP012 with 5 ug GLA-SE or 2 ug GLA-SE: E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipd A stable emulsion (GLA-SE), a proprietary adjuvant
|
Control Group
Infectivity Controls participating in the study at the challenge stage; no vaccinations received or placebos prior to the challenge
|
|---|---|---|---|---|
|
Subjects Reporting the Occurrence of Unsolicited Adverse Events Related to Vaccination
At Least 1 Symptom
|
2 participants
|
2 participants
|
1 participants
|
—
|
|
Subjects Reporting the Occurrence of Unsolicited Adverse Events Related to Vaccination
General Disorders and Admin. Site Conditio
|
2 participants
|
1 participants
|
1 participants
|
—
|
|
Subjects Reporting the Occurrence of Unsolicited Adverse Events Related to Vaccination
Injection Site Haemorrhage
|
1 participants
|
0 participants
|
1 participants
|
—
|
|
Subjects Reporting the Occurrence of Unsolicited Adverse Events Related to Vaccination
Injection Site Haematoma
|
0 participants
|
1 participants
|
0 participants
|
—
|
|
Subjects Reporting the Occurrence of Unsolicited Adverse Events Related to Vaccination
Injection Site Pruritus
|
1 participants
|
0 participants
|
0 participants
|
—
|
|
Subjects Reporting the Occurrence of Unsolicited Adverse Events Related to Vaccination
Nervous System Disorders
|
0 participants
|
1 participants
|
0 participants
|
—
|
|
Subjects Reporting the Occurrence of Unsolicited Adverse Events Related to Vaccination
Dizziness
|
0 participants
|
1 participants
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Only subjects who received vaccinations or were challenged were included in the analysis of immunogenicity. Subjects who withdrew from the study had data collected to the point of withdraw.
Seroconversion was defined as a post-second vaccination titer (serum dilution of 1:100) that is 3 standard deviations higher than the average of the negative or pre-vaccination serum measured using enzyme-linked immunosorbent assay (ELISA). Values reported as "below the detection limit" were given a value of 50 units. The safety population was used for immunogenicity analysis. Only subjects who received vaccinations or were challenged were included in the analysis of immunogenicity. Subjects who withdrew from the study had data collected to the point of withdraw. Geometric mean titers (GMT) were obtained by first calculating the mean and 95% confidence intervals for log-transformed values of the ELISA results, followed by exponentiation of the values. Among those vaccinated, all values were below the detection limit until post-dose II.
Outcome measures
| Measure |
Group 1: 10 ug FMP012 With 2 ug GLA-SE
n=10 Participants
Single center, non-randomized, open label, dose escalation Phase 1 study with sporozoite challenge. The antigen FMP012 will be adjuvanted with Glucopyranosyl lipd A stable emulsion. This is a first-in-human study of FMP012. 30 subjects, divided into 3 groups, will receive 3 doses of the FMP012/GLA-SE vaccine. Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant
Group 1: 10 ug FMP012 with 2 ug GLA-SE: Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant
|
Group 2: 10 ug FMP012 With 5 ug GLA-SE
n=10 Participants
Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant
Group 2: 10 ug FMP012 with 5 ug GLA-SE: E-coli expressed antigen FMP012 will be adjuvanted with Glucopyranosyl lipd A stable emulsion (GLA-SE), a proprietary adjuvant
|
Group 3: 50 ug FMP012 With 5 ug GLA-SE or 2 ug GLA-SE
n=10 Participants
Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant
50 ug FMP012 with 5 ug GLA-SE or 2 ug GLA-SE: E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipd A stable emulsion (GLA-SE), a proprietary adjuvant
|
Control Group
n=6 Participants
Infectivity Controls participating in the study at the challenge stage; no vaccinations received or placebos prior to the challenge
|
|---|---|---|---|---|
|
Humoral Immune Response to FMP012/GLA-SE
Post Dose II
|
1780.1 antibody titer
Interval 685.8 to 4620.7
|
2755.5 antibody titer
Interval 1041.1 to 7292.7
|
3846.6 antibody titer
Interval 1352.0 to 10943.7
|
—
|
|
Humoral Immune Response to FMP012/GLA-SE
Pre Dose III
|
362.9 antibody titer
Interval 145.8 to 903.4
|
518.9 antibody titer
Interval 180.9 to 1488.9
|
2151.9 antibody titer
Interval 609.4 to 7598.9
|
—
|
|
Humoral Immune Response to FMP012/GLA-SE
Post Dose III
|
9503.1 antibody titer
Interval 4420.9 to 20427.4
|
11110.2 antibody titer
Interval 5681.6 to 21725.4
|
6744.3 antibody titer
Interval 2337.7 to 19457.2
|
—
|
|
Humoral Immune Response to FMP012/GLA-SE
Post Challenge
|
6440.0 antibody titer
Interval 2715.8 to 15271.4
|
4289.4 antibody titer
Interval 2027.7 to 9074.1
|
3566.8 antibody titer
Interval 1214.1 to 10478.4
|
65.2 antibody titer
Interval 33.0 to 128.7
|
|
Humoral Immune Response to FMP012/GLA-SE
Final Visit
|
3077.4 antibody titer
Interval 1202.6 to 7874.9
|
2099.8 antibody titer
Interval 823.4 to 5354.8
|
1483.6 antibody titer
Interval 499.0 to 4410.8
|
67.4 antibody titer
Interval 31.3 to 145.2
|
SECONDARY outcome
Timeframe: Up to 1 yearProtective Efficacy of FMP012/GLA-SE Measured against a P falciparum sporozoite challenge. Vaccinated subjects were compared to infectivity controls to assess for delayed onset of parasitemia. Time of onset of parasitemia was based on the date of sporozoite challenge to the date of first positive blood smear detection.
Outcome measures
| Measure |
Group 1: 10 ug FMP012 With 2 ug GLA-SE
n=10 Participants
Single center, non-randomized, open label, dose escalation Phase 1 study with sporozoite challenge. The antigen FMP012 will be adjuvanted with Glucopyranosyl lipd A stable emulsion. This is a first-in-human study of FMP012. 30 subjects, divided into 3 groups, will receive 3 doses of the FMP012/GLA-SE vaccine. Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant
Group 1: 10 ug FMP012 with 2 ug GLA-SE: Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant
|
Group 2: 10 ug FMP012 With 5 ug GLA-SE
n=9 Participants
Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant
Group 2: 10 ug FMP012 with 5 ug GLA-SE: E-coli expressed antigen FMP012 will be adjuvanted with Glucopyranosyl lipd A stable emulsion (GLA-SE), a proprietary adjuvant
|
Group 3: 50 ug FMP012 With 5 ug GLA-SE or 2 ug GLA-SE
n=10 Participants
Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant
50 ug FMP012 with 5 ug GLA-SE or 2 ug GLA-SE: E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipd A stable emulsion (GLA-SE), a proprietary adjuvant
|
Control Group
n=6 Participants
Infectivity Controls participating in the study at the challenge stage; no vaccinations received or placebos prior to the challenge
|
|---|---|---|---|---|
|
Time to Onset of Parasitemia Following Sporozoite Challenge
|
13.0 days
Standard Deviation 0.82
|
14.6 days
Standard Deviation 2.30
|
13.5 days
Standard Deviation 0.85
|
14.0 days
Standard Deviation 1.00
|
Adverse Events
Group 1: 10 ug FMP012 With 2 ug GLA-SE
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Group 2: 10 ug FMP012 With 5 ug GLA-SE
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Group 3: 50 ug FMP012 With 5 ug GLA-SE or 2 ug GLA-SE
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1: 10 ug FMP012 With 2 ug GLA-SE
n=10 participants at risk
Single center, non-randomized, open label, dose escalation Phase 1 study with sporozoite challenge. The antigen FMP012 will be adjuvanted with Glucopyranosyl lipd A stable emulsion. This is a first-in-human study of FMP012. 30 subjects, divided into 3 groups, will receive 3 doses of the FMP012/GLA-SE vaccine. Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant
Group 1: 10 ug FMP012 with 2 ug GLA-SE: Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant
|
Group 2: 10 ug FMP012 With 5 ug GLA-SE
n=10 participants at risk
Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant
Group 2: 10 ug FMP012 with 5 ug GLA-SE: E-coli expressed antigen FMP012 will be adjuvanted with Glucopyranosyl lipd A stable emulsion (GLA-SE), a proprietary adjuvant
|
Group 3: 50 ug FMP012 With 5 ug GLA-SE or 2 ug GLA-SE
n=10 participants at risk
Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant
50 ug FMP012 with 5 ug GLA-SE or 2 ug GLA-SE: E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipd A stable emulsion (GLA-SE), a proprietary adjuvant
|
Control Group
n=6 participants at risk
Infectivity Controls participating in the study at the challenge stage; no vaccinations received or placebos prior to the challenge
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Investigations
Alanine Aminotransferase Increased
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
30.0%
3/10 • Number of events 3 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
30.0%
3/10 • Number of events 3 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
16.7%
1/6 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
20.0%
2/10 • Number of events 2 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Investigations
Aspartate Aminotransferase Increased
|
40.0%
4/10 • Number of events 4 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
40.0%
4/10 • Number of events 4 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
30.0%
3/10 • Number of events 3 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
33.3%
2/6 • Number of events 2 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
20.0%
2/10 • Number of events 2 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
16.7%
1/6 • Number of events 2 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Investigations
Blood Creatinine Increased
|
10.0%
1/10 • Number of events 2 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
20.0%
2/10 • Number of events 2 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
16.7%
1/6 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Investigations
Blood Pressure Systolic Increased
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
20.0%
2/10 • Number of events 5 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
10.0%
1/10 • Number of events 2 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
33.3%
2/6 • Number of events 4 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
General disorders
Chest Pain
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
General disorders
Chills
|
10.0%
1/10 • Number of events 2 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
16.7%
1/6 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Gastrointestinal disorders
Constipation
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
20.0%
2/10 • Number of events 2 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
33.3%
2/6 • Number of events 4 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
50.0%
5/10 • Number of events 5 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
20.0%
2/10 • Number of events 2 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Immune system disorders
Drug Hypersensitivity
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
General disorders
Fatigue
|
20.0%
2/10 • Number of events 2 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
30.0%
3/10 • Number of events 3 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
66.7%
4/6 • Number of events 4 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
General disorders
Feeling Hot
|
10.0%
1/10 • Number of events 2 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
20.0%
2/10 • Number of events 5 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
33.3%
2/6 • Number of events 3 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Infections and infestations
Food Poisening
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
20.0%
2/10 • Number of events 3 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
16.7%
1/6 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Investigations
Haemoglobin Decreased
|
30.0%
3/10 • Number of events 4 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
10.0%
1/10 • Number of events 3 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
30.0%
3/10 • Number of events 4 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
33.3%
2/6 • Number of events 3 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Nervous system disorders
Headache
|
60.0%
6/10 • Number of events 8 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
60.0%
6/10 • Number of events 25 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
40.0%
4/10 • Number of events 5 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
33.3%
2/6 • Number of events 6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Vascular disorders
Hot Flush
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Vascular disorders
Hypertension
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
General disorders
Inflammation
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
General disorders
Injection Site Haemorrhage
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
General disorders
Injection site Pain
|
90.0%
9/10 • Number of events 24 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
100.0%
10/10 • Number of events 28 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
90.0%
9/10 • Number of events 22 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
General disorders
Malaise
|
30.0%
3/10 • Number of events 4 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
40.0%
4/10 • Number of events 7 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
10.0%
1/10 • Number of events 3 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Infections and infestations
Malaria
|
100.0%
10/10 • Number of events 10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
90.0%
9/10 • Number of events 9 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
100.0%
10/10 • Number of events 10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
83.3%
5/6 • Number of events 5 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Respiratory, thoracic and mediastinal disorders
Upper Airway Cough Syndrome
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
30.0%
3/10 • Number of events 5 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
20.0%
2/10 • Number of events 3 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
16.7%
1/6 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Cardiac disorders
Palpitations
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
10.0%
1/10 • Number of events 3 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Investigations
Platelet Count Decreased
|
80.0%
8/10 • Number of events 9 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
30.0%
3/10 • Number of events 3 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
40.0%
4/10 • Number of events 4 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
33.3%
2/6 • Number of events 2 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Injury, poisoning and procedural complications
Post-Traumatic Pain
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Nervous system disorders
Presyncope
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
70.0%
7/10 • Number of events 8 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
40.0%
4/10 • Number of events 4 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
20.0%
2/10 • Number of events 3 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
33.3%
2/6 • Number of events 3 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
General disorders
Pyrexia
|
50.0%
5/10 • Number of events 5 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
70.0%
7/10 • Number of events 7 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
80.0%
8/10 • Number of events 8 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
66.7%
4/6 • Number of events 4 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Gastrointestinal disorders
Rectal fissure
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Infections and infestations
Sinusitis
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Cardiac disorders
Tachycardia
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
30.0%
3/10 • Number of events 13 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Infections and infestations
Tooth Abscess
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
10.0%
1/10 • Number of events 2 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Injury, poisoning and procedural complications
Tooth Injury
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Infections and infestations
Upper Respiratory Infection
|
10.0%
1/10 • Number of events 2 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
40.0%
4/10 • Number of events 5 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
30.0%
3/10 • Number of events 3 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
16.7%
1/6 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Infections and infestations
Vaginitis Bacterial
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Infections and infestations
Viral Infection
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Investigations
Vulvovaginal Candidiasis
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Investigations
White Blood Cell Count Decreased
|
20.0%
2/10 • Number of events 2 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
20.0%
2/10 • Number of events 2 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
20.0%
2/10 • Number of events 2 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
16.7%
1/6 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Investigations
White Blood Cell Count Increased
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
16.7%
1/6 • Number of events 2 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.0%
1/10 • Number of events 2 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Gastrointestinal disorders
Apthous Stomatitis
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Investigations
Blood Pressure Diastolic Increased
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Infections and infestations
Bronchitis
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Skin and subcutaneous tissue disorders
Campbell de Morgan Spots
|
10.0%
1/10 • Number of events 2 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
General disorders
Chest Discomfort
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
16.7%
1/6 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Eye disorders
Eye Pain
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Gastrointestinal disorders
Gastroenteritis Viral
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
20.0%
2/10 • Number of events 4 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
33.3%
2/6 • Number of events 3 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
General disorders
Injection Site Erythema
|
20.0%
2/10 • Number of events 2 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
General disorders
Injection Site Hematoma
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
20.0%
2/10 • Number of events 3 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
General disorders
Injection Site Pruritus
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Musculoskeletal and connective tissue disorders
Joint Stiffness
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
10.0%
1/10 • Number of events 2 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Skin and subcutaneous tissue disorders
Melanoicytic Naevus
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Nervous system disorders
Migraine
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
20.0%
2/10 • Number of events 3 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
10.0%
1/10 • Number of events 1 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/6 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
40.0%
4/10 • Number of events 4 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
20.0%
2/10 • Number of events 5 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
0.00%
0/10 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
16.7%
1/6 • Number of events 3 • Unsolicited AEs collected through day 28 after each vaccination; SAEs collected from Day 0 through Day 225
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place