Trial Outcomes & Findings for A Clinical Trial to Evaluate the Safety and Immunogenicity of Synthetic DNAs Encoding a Native-like HIV Env Trimer and Interleukin-12 (INO-6160), Alone or in a Prime-boost Regimen With 3M-052-AF + Alum Adjuvanted VRC HIV Env Trimer 4571 in Adult Participants Without HIV (NCT NCT05828095)

Last Updated: 2025-09-02

Results Overview

Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

20 participants

Primary outcome timeframe

Measured for 14 days after each injection

Results posted on

2025-09-02

Participant Flow

Participant milestones

Participant milestones
Measure	Group T1 INO-6160 (2.0 mg) at months 0, 1, 3, 6	Group T2 INO-6160 (2.0 mg) at months 0, 1, 3, 6 + Trimer-4571 (100 mcg) + 3M-052-AF (5 mcg) + Alum (500 mcg) at months 3, 6
Overall Study STARTED	10	10
Overall Study COMPLETED	9	9
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Group T1 INO-6160 (2.0 mg) at months 0, 1, 3, 6	Group T2 INO-6160 (2.0 mg) at months 0, 1, 3, 6 + Trimer-4571 (100 mcg) + 3M-052-AF (5 mcg) + Alum (500 mcg) at months 3, 6
Overall Study Lost to Follow-up	1	0
Overall Study Reactogenicity symptom	0	1

Baseline Characteristics

A Clinical Trial to Evaluate the Safety and Immunogenicity of Synthetic DNAs Encoding a Native-like HIV Env Trimer and Interleukin-12 (INO-6160), Alone or in a Prime-boost Regimen With 3M-052-AF + Alum Adjuvanted VRC HIV Env Trimer 4571 in Adult Participants Without HIV

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group T1 n=10 Participants INO-6160 (2.0 mg) at months 0, 1, 3, 6	Group T2 n=10 Participants INO-6160 (2.0 mg) at months 0, 1, 3, 6 + Trimer-4571 (100 mcg) + 3M-052-AF (5 mcg) + Alum (500 mcg) at months 3, 6	Total n=20 Participants Total of all reporting groups
Age, Continuous	34 years n=99 Participants	30.5 years n=107 Participants	33 years n=206 Participants
Age, Customized Less than 18	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Customized 18 - 20	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Age, Customized 21 - 30	3 Participants n=99 Participants	4 Participants n=107 Participants	7 Participants n=206 Participants
Age, Customized 31 - 40	6 Participants n=99 Participants	4 Participants n=107 Participants	10 Participants n=206 Participants
Age, Customized 41 - 50	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Age, Customized Above 50	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Sex: Female, Male Female	3 Participants n=99 Participants	6 Participants n=107 Participants	9 Participants n=206 Participants
Sex: Female, Male Male	7 Participants n=99 Participants	4 Participants n=107 Participants	11 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=99 Participants	9 Participants n=107 Participants	18 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race/Ethnicity, Customized White	9 Participants n=99 Participants	7 Participants n=107 Participants	16 Participants n=206 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race/Ethnicity, Customized Asian	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race/Ethnicity, Customized Multiple Selected	0 Participants n=99 Participants	3 Participants n=107 Participants	3 Participants n=206 Participants
Race/Ethnicity, Customized Other	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment USA	10 Participants n=99 Participants	10 Participants n=107 Participants	20 Participants n=206 Participants

PRIMARY outcome

Timeframe: Measured for 14 days after each injection

Outcome measures

Outcome measures
Measure	Group T1 n=10 Participants INO-6160 (2.0 mg) at months 0, 1, 3, 6	Group T2 n=10 Participants INO-6160 (2.0 mg) at months 0, 1, 3, 6 + Trimer-4571 (100 mcg) + 3M-052-AF (5 mcg) + Alum (500 mcg) at months 3, 6
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness None	4 Participants	0 Participants
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness Mild	6 Participants	7 Participants
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness Moderate	0 Participants	3 Participants
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness Severe	0 Participants	0 Participants
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness Potentially Life-threatening	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Measured for 14 days after each injection

Outcome measures

Outcome measures
Measure	Group T1 n=10 Participants INO-6160 (2.0 mg) at months 0, 1, 3, 6	Group T2 n=10 Participants INO-6160 (2.0 mg) at months 0, 1, 3, 6 + Trimer-4571 (100 mcg) + 3M-052-AF (5 mcg) + Alum (500 mcg) at months 3, 6
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration Erythema/Redness · None	4 Participants	1 Participants
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration Erythema/Redness · Mild	4 Participants	5 Participants
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration Erythema/Redness · Moderate	1 Participants	3 Participants
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration Erythema/Redness · Severe	1 Participants	1 Participants
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration Erythema/Redness · Potentially Life-threatening	0 Participants	0 Participants
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration Induration/Swelling · None	8 Participants	3 Participants
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration Induration/Swelling · Mild	1 Participants	7 Participants
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration Induration/Swelling · Moderate	1 Participants	0 Participants
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration Induration/Swelling · Severe	0 Participants	0 Participants
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration Induration/Swelling · Potentially Life-threatening	0 Participants	0 Participants
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration Erythema and/or Induration · None	4 Participants	1 Participants
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration Erythema and/or Induration · Mild	4 Participants	5 Participants
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration Erythema and/or Induration · Moderate	1 Participants	3 Participants
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration Erythema and/or Induration · Severe	1 Participants	1 Participants
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration Erythema and/or Induration · Potentially Life-threatening	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Measured for 14 days after each injection

Outcome measures

Outcome measures
Measure	Group T1 n=10 Participants INO-6160 (2.0 mg) at months 0, 1, 3, 6	Group T2 n=10 Participants INO-6160 (2.0 mg) at months 0, 1, 3, 6 + Trimer-4571 (100 mcg) + 3M-052-AF (5 mcg) + Alum (500 mcg) at months 3, 6
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms Malaise and/or fatigue · None	4 Participants	0 Participants
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms Malaise and/or fatigue · Mild	5 Participants	5 Participants
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms Malaise and/or fatigue · Moderate	1 Participants	4 Participants
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms Malaise and/or fatigue · Severe	0 Participants	1 Participants
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms Malaise and/or fatigue · Potentially Life-threatening	0 Participants	0 Participants
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms Myalgia · None	8 Participants	2 Participants
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms Myalgia · Mild	1 Participants	4 Participants
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms Myalgia · Moderate	1 Participants	3 Participants
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms Myalgia · Severe	0 Participants	1 Participants
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms Myalgia · Potentially Life-threatening	0 Participants	0 Participants
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms Headache · None	5 Participants	0 Participants
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms Headache · Mild	4 Participants	6 Participants
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms Headache · Moderate	1 Participants	4 Participants
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms Headache · Severe	0 Participants	0 Participants
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms Headache · Potentially Life-threatening	0 Participants	0 Participants
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms Nausea · None	7 Participants	4 Participants
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms Nausea · Mild	3 Participants	2 Participants
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms Nausea · Moderate	0 Participants	4 Participants
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms Nausea · Severe	0 Participants	0 Participants
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms Nausea · Potentially Life-threatening	0 Participants	0 Participants
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms Chills · None	9 Participants	1 Participants
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms Chills · Mild	1 Participants	8 Participants
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms Chills · Moderate	0 Participants	1 Participants
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms Chills · Severe	0 Participants	0 Participants
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms Chills · Potentially Life-threatening	0 Participants	0 Participants
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms Arthralgia · None	8 Participants	5 Participants
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms Arthralgia · Mild	1 Participants	4 Participants
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms Arthralgia · Moderate	1 Participants	1 Participants
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms Arthralgia · Severe	0 Participants	0 Participants
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms Arthralgia · Potentially Life-threatening	0 Participants	0 Participants
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms Max. Systemic Symptoms · None	2 Participants	0 Participants
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms Max. Systemic Symptoms · Mild	7 Participants	1 Participants
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms Max. Systemic Symptoms · Moderate	1 Participants	8 Participants
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms Max. Systemic Symptoms · Severe	0 Participants	1 Participants
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms Max. Systemic Symptoms · Potentially Life-threatening	0 Participants	0 Participants
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms Temperature · None	10 Participants	6 Participants
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms Temperature · Mild	0 Participants	3 Participants
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms Temperature · Moderate	0 Participants	1 Participants
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms Temperature · Severe	0 Participants	0 Participants
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms Temperature · Potentially Life-threatening	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Measured for 30 days after any receipt of study vaccination.

Population: Safety population

The number (percentage) of Participants Reporting Unsolicited Adverse Events (AEs) was summarized by arm

Outcome measures

Outcome measures
Measure	Group T1 n=10 Participants INO-6160 (2.0 mg) at months 0, 1, 3, 6	Group T2 n=10 Participants INO-6160 (2.0 mg) at months 0, 1, 3, 6 + Trimer-4571 (100 mcg) + 3M-052-AF (5 mcg) + Alum (500 mcg) at months 3, 6
Number of Participants Reporting Unsolicited Adverse Events (AEs)	6 Participants	6 Participants

PRIMARY outcome

Timeframe: Measured through Month 6

Population: Safety population

The number (percentage) of participants with early discontinuation of vaccinations and reason for discontinuation was summarized by arm

Outcome measures

Outcome measures
Measure	Group T1 n=10 Participants INO-6160 (2.0 mg) at months 0, 1, 3, 6	Group T2 n=10 Participants INO-6160 (2.0 mg) at months 0, 1, 3, 6 + Trimer-4571 (100 mcg) + 3M-052-AF (5 mcg) + Alum (500 mcg) at months 3, 6
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation Lost to Follow-Up	1 Participants	0 Participants
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation Other	0 Participants	1 Participants
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation Reactogenicity Symptom	1 Participants	2 Participants
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation Did not discontinue SPA	8 Participants	7 Participants

PRIMARY outcome

Timeframe: Measured through Month 10

The number (percentage) of participants with early study termination and reason for early study termination was summarized by arm

Outcome measures

Outcome measures
Measure	Group T1 n=10 Participants INO-6160 (2.0 mg) at months 0, 1, 3, 6	Group T2 n=10 Participants INO-6160 (2.0 mg) at months 0, 1, 3, 6 + Trimer-4571 (100 mcg) + 3M-052-AF (5 mcg) + Alum (500 mcg) at months 3, 6
Number of Participants With Early Study Termination and Reason for Early Study Termination Lost to Follow-Up	1 Participants	0 Participants
Number of Participants With Early Study Termination and Reason for Early Study Termination Reactogenicity Symptom	0 Participants	1 Participants
Number of Participants With Early Study Termination and Reason for Early Study Termination Did not terminate Study	9 Participants	9 Participants

PRIMARY outcome

Timeframe: Measured at Months 1.5, 3.5, and 6.5

Population: The number of participants with available data after filtering for assay specific quality control criteria

The Binding Antibody Multiplex Assay (BAMA) assay was used to evaluate binding antibody responses of each serum specimen against BG505 SOSIP (vaccine trimer immunogen) and Trimer 4571 (vaccine matched immunogen). Positivity criteria include (1) the net Mean Fluorescence Intensity (MFI), or MFI - Blank, values are ≥ antigen-specific cutoff at the 1:50 dilution level for IgG (based on the 95th percentile of the baseline visit serum samples and at least 100 MFI minus Blank), (2) the net MFI values are greater than 3 times the baseline (day 0) net MFI, and (3) the MFI values are greater than 3 times the baseline MFI values. The AB05 antigen was used to assess binding antibody responses to the vaccine-matched trimer INO-6160. The wildtype antigen (BG505 MD39.3) captured both base and non-base specific antibodies, whereas the mutant antigen (BG505 MD39.3-BaseKO), captured only non-base specific antibodies.

Outcome measures

Outcome measures
Measure	Group T1 n=10 Participants INO-6160 (2.0 mg) at months 0, 1, 3, 6	Group T2 n=10 Participants INO-6160 (2.0 mg) at months 0, 1, 3, 6 + Trimer-4571 (100 mcg) + 3M-052-AF (5 mcg) + Alum (500 mcg) at months 3, 6
Response Rate of Vaccine-matched IgG Binding Antibody (Ab) Responses as Assessed by Multiplex Assay 2 Weeks Following the Fourth Vaccination AB05, 1: 50, M1.5	1 Participants	1 Participants
Response Rate of Vaccine-matched IgG Binding Antibody (Ab) Responses as Assessed by Multiplex Assay 2 Weeks Following the Fourth Vaccination AB05, 1: 50, M3.5	5 Participants	9 Participants
Response Rate of Vaccine-matched IgG Binding Antibody (Ab) Responses as Assessed by Multiplex Assay 2 Weeks Following the Fourth Vaccination AB05, 1: 50, M6.5	5 Participants	6 Participants
Response Rate of Vaccine-matched IgG Binding Antibody (Ab) Responses as Assessed by Multiplex Assay 2 Weeks Following the Fourth Vaccination BG505 MD39.3, 1: 50, M1.5	7 Participants	5 Participants
Response Rate of Vaccine-matched IgG Binding Antibody (Ab) Responses as Assessed by Multiplex Assay 2 Weeks Following the Fourth Vaccination BG505 MD39.3, 1: 50, M3.5	8 Participants	9 Participants
Response Rate of Vaccine-matched IgG Binding Antibody (Ab) Responses as Assessed by Multiplex Assay 2 Weeks Following the Fourth Vaccination BG505 MD39.3, 1: 50, M6.5	8 Participants	6 Participants
Response Rate of Vaccine-matched IgG Binding Antibody (Ab) Responses as Assessed by Multiplex Assay 2 Weeks Following the Fourth Vaccination BG505 MD39.3-BaseKO, 1: 50, M1.5	1 Participants	0 Participants
Response Rate of Vaccine-matched IgG Binding Antibody (Ab) Responses as Assessed by Multiplex Assay 2 Weeks Following the Fourth Vaccination BG505 MD39.3-BaseKO, 1: 50, M3.5	4 Participants	4 Participants
Response Rate of Vaccine-matched IgG Binding Antibody (Ab) Responses as Assessed by Multiplex Assay 2 Weeks Following the Fourth Vaccination BG505 MD39.3-BaseKO, 1: 50, M6.5	4 Participants	6 Participants
Response Rate of Vaccine-matched IgG Binding Antibody (Ab) Responses as Assessed by Multiplex Assay 2 Weeks Following the Fourth Vaccination Trimer 4571, 1: 50, M1.5	1 Participants	1 Participants
Response Rate of Vaccine-matched IgG Binding Antibody (Ab) Responses as Assessed by Multiplex Assay 2 Weeks Following the Fourth Vaccination Trimer 4571, 1: 50, M3.5	4 Participants	9 Participants
Response Rate of Vaccine-matched IgG Binding Antibody (Ab) Responses as Assessed by Multiplex Assay 2 Weeks Following the Fourth Vaccination Trimer 4571, 1: 50, M6.5	5 Participants	6 Participants

PRIMARY outcome

Timeframe: Measured at Months 1.5, 3.5, and 6.5

Population: The number of participants with available data after filtering for assay specific quality control criteria

The Binding Antibody Multiplex Assay (BAMA) assay was used to evaluate binding antibody responses of each serum specimen against BG505 SOSIP (vaccine trimer immunogen) and Trimer 4571 (vaccine matched immunogen). Epitope specificities are assessed via wildtype-mutant pairs. The AB05 antigen was used to assess binding antibody responses to the vaccine-matched trimer INO-6160. The wildtype antigen (BG505 MD39.3) captured both base and non-base specific antibodies, whereas the mutant antigen (BG505 MD39.3-BaseKO), captured only non-base specific antibodies.

Outcome measures

Outcome measures
Measure	Group T1 n=10 Participants INO-6160 (2.0 mg) at months 0, 1, 3, 6	Group T2 n=10 Participants INO-6160 (2.0 mg) at months 0, 1, 3, 6 + Trimer-4571 (100 mcg) + 3M-052-AF (5 mcg) + Alum (500 mcg) at months 3, 6
Magnitude of Vaccine-matched IgG Binding Antibody (Ab) Responses as Assessed by Multiplex Assay 2 Weeks Following the Third and Fourth Vaccination AB05, 1: 50, M1.5	72.2 Net MFI Interval 15.8 to 167.1	20.5 Net MFI Interval 5.4 to 126.4
Magnitude of Vaccine-matched IgG Binding Antibody (Ab) Responses as Assessed by Multiplex Assay 2 Weeks Following the Third and Fourth Vaccination AB05, 1: 50, M3.5	484.6 Net MFI Interval 188.9 to 1241.4	3564.5 Net MFI Interval 1829.2 to 6158.2
Magnitude of Vaccine-matched IgG Binding Antibody (Ab) Responses as Assessed by Multiplex Assay 2 Weeks Following the Third and Fourth Vaccination AB05, 1: 50, M6.5	343.9 Net MFI Interval 196.1 to 1039.7	22000 Net MFI Interval 22000.0 to 22000.0
Magnitude of Vaccine-matched IgG Binding Antibody (Ab) Responses as Assessed by Multiplex Assay 2 Weeks Following the Third and Fourth Vaccination BG505 MD39.3, 1: 50, M1.5	9633.4 Net MFI Interval 841.6 to 14037.1	2589.8 Net MFI Interval 433.3 to 12484.8
Magnitude of Vaccine-matched IgG Binding Antibody (Ab) Responses as Assessed by Multiplex Assay 2 Weeks Following the Third and Fourth Vaccination BG505 MD39.3, 1: 50, M3.5	22000 Net MFI Interval 22000.0 to 22000.0	22000 Net MFI Interval 22000.0 to 22000.0
Magnitude of Vaccine-matched IgG Binding Antibody (Ab) Responses as Assessed by Multiplex Assay 2 Weeks Following the Third and Fourth Vaccination BG505 MD39.3, 1: 50, M6.5	22000 Net MFI Interval 12911.1 to 22000.0	22000 Net MFI Interval 22000.0 to 22000.0
Magnitude of Vaccine-matched IgG Binding Antibody (Ab) Responses as Assessed by Multiplex Assay 2 Weeks Following the Third and Fourth Vaccination BG505 MD39.3-BaseKO, 1: 50, M1.5	342.4 Net MFI Interval 127.3 to 565.6	284.5 Net MFI Interval 122.4 to 699.4
Magnitude of Vaccine-matched IgG Binding Antibody (Ab) Responses as Assessed by Multiplex Assay 2 Weeks Following the Third and Fourth Vaccination BG505 MD39.3-BaseKO, 1: 50, M3.5	1266.4 Net MFI Interval 462.2 to 2177.6	1354.5 Net MFI Interval 501.8 to 3187.5
Magnitude of Vaccine-matched IgG Binding Antibody (Ab) Responses as Assessed by Multiplex Assay 2 Weeks Following the Third and Fourth Vaccination BG505 MD39.3-BaseKO, 1: 50, M6.5	1615.9 Net MFI Interval 655.0 to 2471.1	21943.8 Net MFI Interval 17194.9 to 22000.0
Magnitude of Vaccine-matched IgG Binding Antibody (Ab) Responses as Assessed by Multiplex Assay 2 Weeks Following the Third and Fourth Vaccination Trimer 4571, 1: 50, M1.5	40.2 Net MFI Interval 24.6 to 147.6	42 Net MFI Interval 17.6 to 71.8
Magnitude of Vaccine-matched IgG Binding Antibody (Ab) Responses as Assessed by Multiplex Assay 2 Weeks Following the Third and Fourth Vaccination Trimer 4571, 1: 50, M3.5	273.5 Net MFI Interval 126.8 to 612.2	2531.8 Net MFI Interval 1057.5 to 5427.2
Magnitude of Vaccine-matched IgG Binding Antibody (Ab) Responses as Assessed by Multiplex Assay 2 Weeks Following the Third and Fourth Vaccination Trimer 4571, 1: 50, M6.5	216.8 Net MFI Interval 77.2 to 605.1	22000 Net MFI Interval 22000.0 to 22000.0

PRIMARY outcome

Timeframe: Measured at Months 3.5 and 6.5

Population: The number of participants with available data after filtering for assay specific quality control criteria

Flow cytometry is employed to examine HIV-1-specific CD4+ and CD8+ T-cell responses using a validated Intracellular Cytokine Staining (ICS) assay. To determine positivity, a one-sided Fisher's exact test is applied to a two-by-two contingency table, testing whether the number of cytokine-producing cells for the stimulated data is equal to that for the negative control data.

Outcome measures

Outcome measures
Measure	Group T1 n=8 Participants INO-6160 (2.0 mg) at months 0, 1, 3, 6	Group T2 n=9 Participants INO-6160 (2.0 mg) at months 0, 1, 3, 6 + Trimer-4571 (100 mcg) + 3M-052-AF (5 mcg) + Alum (500 mcg) at months 3, 6
Response Rate of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination Total Env, IL-4 or IL-5 or IL-13 and CD40L, M3.5	0 Participants	0 Participants
Response Rate of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination Total Env, IL-4 or IL-5 or IL-13 and CD40L, M6.5	0 Participants	0 Participants
Response Rate of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination A-AB05, IFN-g and/or IL-2, M3.5	7 Participants	7 Participants
Response Rate of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination A-AB05, IFN-g and/or IL-2, M6.5	8 Participants	5 Participants
Response Rate of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination A-AB05, IL-21, M3.5	2 Participants	2 Participants
Response Rate of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination A-AB05, IL-21, M6.5	0 Participants	1 Participants
Response Rate of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination A-AB05, IL-4 or IL-5 or IL-13 and CD40L, M3.5	0 Participants	0 Participants
Response Rate of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination A-AB05, IL-4 or IL-5 or IL-13 and CD40L, M6.5	0 Participants	0 Participants
Response Rate of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination BG505 A-AB05-gp120, IFN-g and/or IL-2, M3.5	8 Participants	9 Participants
Response Rate of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination BG505 A-AB05-gp120, IFN-g and/or IL-2, M6.5	8 Participants	6 Participants
Response Rate of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination BG505 A-AB05-gp120, IL-21, M3.5	2 Participants	4 Participants
Response Rate of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination BG505 A-AB05-gp120, IL-21, M6.5	0 Participants	1 Participants
Response Rate of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination BG505 A-AB05-gp120, IL-4 or IL-5 or IL-13 and CD40L, M3.5	0 Participants	0 Participants
Response Rate of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination BG505 A-AB05-gp120, IL-4 or IL-5 or IL-13 and CD40L, M6.5	0 Participants	0 Participants
Response Rate of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination BG505 A-AB05-gp41, IFN-g and/or IL-2, M3.5	6 Participants	9 Participants
Response Rate of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination BG505 A-AB05-gp41, IFN-g and/or IL-2, M6.5	6 Participants	6 Participants
Response Rate of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination BG505 A-AB05-gp41, IL-21, M3.5	1 Participants	0 Participants
Response Rate of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination BG505 A-AB05-gp41, IL-21, M6.5	0 Participants	0 Participants
Response Rate of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination BG505 A-AB05-gp41, IL-4 or IL-5 or IL-13 and CD40L, M3.5	0 Participants	0 Participants
Response Rate of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination BG505 A-AB05-gp41, IL-4 or IL-5 or IL-13 and CD40L, M6.5	0 Participants	0 Participants
Response Rate of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination Total Env, IFN-g and/or IL-2, M3.5	8 Participants	9 Participants
Response Rate of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination Total Env, IFN-g and/or IL-2, M6.5	8 Participants	6 Participants
Response Rate of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination Total Env, IL-21, M3.5	2 Participants	4 Participants
Response Rate of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination Total Env, IL-21, M6.5	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Measured at Months 3.5 and 6.5

Population: The number of participants with available data after filtering for assay specific quality control criteria

Flow cytometry is employed to examine HIV-1-specific CD4+ and CD8+ T-cell responses using a validated ICS assay

Outcome measures

PRIMARY outcome

Timeframe: Measured at Months 3.5 and 6.5

Population: The number of participants with available data after filtering for assay specific quality control criteria

Outcome measures

Outcome measures
Measure	Group T1 n=8 Participants INO-6160 (2.0 mg) at months 0, 1, 3, 6	Group T2 n=9 Participants INO-6160 (2.0 mg) at months 0, 1, 3, 6 + Trimer-4571 (100 mcg) + 3M-052-AF (5 mcg) + Alum (500 mcg) at months 3, 6
Response Rate of CD8+ T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination BG505 A-AB05-gp41, IFN-g and/or IL-2, M6.5	1 Participants	0 Participants
Response Rate of CD8+ T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination Total Env, IFN-g and/or IL-2, M3.5	6 Participants	3 Participants
Response Rate of CD8+ T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination Total Env, IFN-g and/or IL-2, M6.5	6 Participants	3 Participants
Response Rate of CD8+ T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination A-AB05, IFN-g and/or IL-2, M3.5	1 Participants	0 Participants
Response Rate of CD8+ T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination A-AB05, IFN-g and/or IL-2, M6.5	1 Participants	0 Participants
Response Rate of CD8+ T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination BG505 A-AB05-gp120, IFN-g and/or IL-2, M3.5	5 Participants	3 Participants
Response Rate of CD8+ T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination BG505 A-AB05-gp120, IFN-g and/or IL-2, M6.5	5 Participants	3 Participants
Response Rate of CD8+ T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination BG505 A-AB05-gp41, IFN-g and/or IL-2, M3.5	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Measured at Months 3.5 and 6.5

Population: The number of participants with available data after filtering for assay specific quality control criteria

Flow cytometry is employed to examine HIV-1-specific CD4+ and CD8+ T-cell responses using a validated ICS assay

Outcome measures

Outcome measures
Measure	Group T1 n=8 Participants INO-6160 (2.0 mg) at months 0, 1, 3, 6	Group T2 n=9 Participants INO-6160 (2.0 mg) at months 0, 1, 3, 6 + Trimer-4571 (100 mcg) + 3M-052-AF (5 mcg) + Alum (500 mcg) at months 3, 6
Magnitude of CD8+ T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination A-AB05, IFN-g and/or IL-2, M3.5	0 % CD8+ T-cells expressing cytokines Interval 0.0 to 0.0	0 % CD8+ T-cells expressing cytokines Interval 0.0 to 0.0
Magnitude of CD8+ T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination A-AB05, IFN-g and/or IL-2, M6.5	0 % CD8+ T-cells expressing cytokines Interval 0.0 to 0.01	0 % CD8+ T-cells expressing cytokines Interval 0.0 to 0.01
Magnitude of CD8+ T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination BG505 A-AB05-gp120, IFN-g and/or IL-2, M3.5	0.06 % CD8+ T-cells expressing cytokines Interval 0.01 to 0.15	0.02 % CD8+ T-cells expressing cytokines Interval 0.01 to 0.05
Magnitude of CD8+ T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination BG505 A-AB05-gp120, IFN-g and/or IL-2, M6.5	0.06 % CD8+ T-cells expressing cytokines Interval 0.02 to 0.19	0.06 % CD8+ T-cells expressing cytokines Interval 0.01 to 0.12
Magnitude of CD8+ T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination BG505 A-AB05-gp41, IFN-g and/or IL-2, M3.5	0.01 % CD8+ T-cells expressing cytokines Interval 0.0 to 0.01	0.01 % CD8+ T-cells expressing cytokines Interval 0.0 to 0.02
Magnitude of CD8+ T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination BG505 A-AB05-gp41, IFN-g and/or IL-2, M6.5	0.01 % CD8+ T-cells expressing cytokines Interval 0.0 to 0.01	0.01 % CD8+ T-cells expressing cytokines Interval 0.0 to 0.02
Magnitude of CD8+ T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination Total Env, IFN-g and/or IL-2, M3.5	0.11 % CD8+ T-cells expressing cytokines Interval 0.04 to 0.19	0.03 % CD8+ T-cells expressing cytokines Interval 0.02 to 0.06
Magnitude of CD8+ T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination Total Env, IFN-g and/or IL-2, M6.5	0.13 % CD8+ T-cells expressing cytokines Interval 0.05 to 0.24	0.08 % CD8+ T-cells expressing cytokines Interval 0.02 to 0.14

SECONDARY outcome

Timeframe: Measured at baseline (screening), Month 3.5, and Month 6.5

Population: The number of participants with available data after filtering for assay specific quality control criteria

Neutralization assays were used to measure titers in TZM-bl cells against BG505/T332N and MW965.26

Outcome measures

Outcome measures
Measure	Group T1 n=10 Participants INO-6160 (2.0 mg) at months 0, 1, 3, 6	Group T2 n=10 Participants INO-6160 (2.0 mg) at months 0, 1, 3, 6 + Trimer-4571 (100 mcg) + 3M-052-AF (5 mcg) + Alum (500 mcg) at months 3, 6
Neutralizing Ab Magnitude Against Autologous and Tier 1a HIV-1 Isolates as Assessed by TZM-bl Neutralization Assay Following the Third and Fourth Vaccinations BG505/T332N, 1: 50, Baseline	8.2 Titer Interval 5.0 to 15.0	5 Titer Interval 5.0 to 10.7
Neutralizing Ab Magnitude Against Autologous and Tier 1a HIV-1 Isolates as Assessed by TZM-bl Neutralization Assay Following the Third and Fourth Vaccinations BG505/T332N, 1: 50, M3.5	5 Titer Interval 5.0 to 15.1	12.7 Titer Interval 5.0 to 15.7
Neutralizing Ab Magnitude Against Autologous and Tier 1a HIV-1 Isolates as Assessed by TZM-bl Neutralization Assay Following the Third and Fourth Vaccinations BG505/T332N, 1: 50, M6.5	5 Titer Interval 5.0 to 5.0	12.8 Titer Interval 11.2 to 22.1
Neutralizing Ab Magnitude Against Autologous and Tier 1a HIV-1 Isolates as Assessed by TZM-bl Neutralization Assay Following the Third and Fourth Vaccinations BG505/T332N, 1: 80, Baseline	5 Titer Interval 5.0 to 5.0	5 Titer Interval 5.0 to 5.0
Neutralizing Ab Magnitude Against Autologous and Tier 1a HIV-1 Isolates as Assessed by TZM-bl Neutralization Assay Following the Third and Fourth Vaccinations BG505/T332N, 1: 80, M3.5	5 Titer Interval 5.0 to 5.0	5 Titer Interval 5.0 to 5.0
Neutralizing Ab Magnitude Against Autologous and Tier 1a HIV-1 Isolates as Assessed by TZM-bl Neutralization Assay Following the Third and Fourth Vaccinations BG505/T332N, 1: 80, M6.5	5 Titer Interval 5.0 to 5.0	5 Titer Interval 5.0 to 5.0
Neutralizing Ab Magnitude Against Autologous and Tier 1a HIV-1 Isolates as Assessed by TZM-bl Neutralization Assay Following the Third and Fourth Vaccinations MW965.26, 1: 50, Baseline	15.9 Titer Interval 13.1 to 19.9	16.2 Titer Interval 14.9 to 17.2
Neutralizing Ab Magnitude Against Autologous and Tier 1a HIV-1 Isolates as Assessed by TZM-bl Neutralization Assay Following the Third and Fourth Vaccinations MW965.26, 1: 50, M3.5	18.7 Titer Interval 15.6 to 39.3	20.1 Titer Interval 16.7 to 34.7
Neutralizing Ab Magnitude Against Autologous and Tier 1a HIV-1 Isolates as Assessed by TZM-bl Neutralization Assay Following the Third and Fourth Vaccinations MW965.26, 1: 50, M6.5	23.8 Titer Interval 20.4 to 31.9	143.4 Titer Interval 134.7 to 298.0
Neutralizing Ab Magnitude Against Autologous and Tier 1a HIV-1 Isolates as Assessed by TZM-bl Neutralization Assay Following the Third and Fourth Vaccinations MW965.26, 1: 80, Baseline	5 Titer Interval 5.0 to 5.0	5 Titer Interval 5.0 to 5.0
Neutralizing Ab Magnitude Against Autologous and Tier 1a HIV-1 Isolates as Assessed by TZM-bl Neutralization Assay Following the Third and Fourth Vaccinations MW965.26, 1: 80, M3.5	7.8 Titer Interval 5.0 to 15.7	10.9 Titer Interval 5.0 to 14.2
Neutralizing Ab Magnitude Against Autologous and Tier 1a HIV-1 Isolates as Assessed by TZM-bl Neutralization Assay Following the Third and Fourth Vaccinations MW965.26, 1: 80, M6.5	5 Titer Interval 5.0 to 10.9	47.3 Titer Interval 41.3 to 76.1
Neutralizing Ab Magnitude Against Autologous and Tier 1a HIV-1 Isolates as Assessed by TZM-bl Neutralization Assay Following the Third and Fourth Vaccinations SVA-MLV, 1: 50, Baseline	5 Titer Interval 5.0 to 5.0	5 Titer Interval 5.0 to 5.0
Neutralizing Ab Magnitude Against Autologous and Tier 1a HIV-1 Isolates as Assessed by TZM-bl Neutralization Assay Following the Third and Fourth Vaccinations SVA-MLV, 1: 50, M3.5	5 Titer Interval 5.0 to 7.8	5 Titer Interval 5.0 to 5.0
Neutralizing Ab Magnitude Against Autologous and Tier 1a HIV-1 Isolates as Assessed by TZM-bl Neutralization Assay Following the Third and Fourth Vaccinations SVA-MLV, 1: 50, M6.5	5 Titer Interval 5.0 to 5.0	5 Titer Interval 5.0 to 5.0
Neutralizing Ab Magnitude Against Autologous and Tier 1a HIV-1 Isolates as Assessed by TZM-bl Neutralization Assay Following the Third and Fourth Vaccinations SVA-MLV, 1: 80, Baseline	5 Titer Interval 5.0 to 5.0	5 Titer Interval 5.0 to 5.0
Neutralizing Ab Magnitude Against Autologous and Tier 1a HIV-1 Isolates as Assessed by TZM-bl Neutralization Assay Following the Third and Fourth Vaccinations SVA-MLV, 1: 80, M3.5	5 Titer Interval 5.0 to 5.0	5 Titer Interval 5.0 to 5.0
Neutralizing Ab Magnitude Against Autologous and Tier 1a HIV-1 Isolates as Assessed by TZM-bl Neutralization Assay Following the Third and Fourth Vaccinations SVA-MLV, 1: 80, M6.5	5 Titer Interval 5.0 to 5.0	5 Titer Interval 5.0 to 5.0

SECONDARY outcome

Timeframe: Measured at baseline (screening), Month 3.5, and Month 6.5

Population: The number of participants with available data after filtering for assay specific quality control criteria

Neutralization assays were used to measure titers in TZM-bl cells against BG505/T332N and MW965.26. Positivitity call is an unrounded titer \>= 10

Outcome measures

Outcome measures
Measure	Group T1 n=10 Participants INO-6160 (2.0 mg) at months 0, 1, 3, 6	Group T2 n=10 Participants INO-6160 (2.0 mg) at months 0, 1, 3, 6 + Trimer-4571 (100 mcg) + 3M-052-AF (5 mcg) + Alum (500 mcg) at months 3, 6
Neutralizing Ab Response Rate Against Autologous and Tier 1a HIV-1 Isolates as Assessed by TZM-bl Neutralization Assay Following the Third and Fourth Vaccinations BG505/T332N, 1: 50, Baseline	5 Participants	4 Participants
Neutralizing Ab Response Rate Against Autologous and Tier 1a HIV-1 Isolates as Assessed by TZM-bl Neutralization Assay Following the Third and Fourth Vaccinations BG505/T332N, 1: 50, M3.5	3 Participants	5 Participants
Neutralizing Ab Response Rate Against Autologous and Tier 1a HIV-1 Isolates as Assessed by TZM-bl Neutralization Assay Following the Third and Fourth Vaccinations BG505/T332N, 1: 50, M6.5	1 Participants	5 Participants
Neutralizing Ab Response Rate Against Autologous and Tier 1a HIV-1 Isolates as Assessed by TZM-bl Neutralization Assay Following the Third and Fourth Vaccinations BG505/T332N, 1: 80, Baseline	1 Participants	0 Participants
Neutralizing Ab Response Rate Against Autologous and Tier 1a HIV-1 Isolates as Assessed by TZM-bl Neutralization Assay Following the Third and Fourth Vaccinations BG505/T332N, 1: 80, M3.5	1 Participants	0 Participants
Neutralizing Ab Response Rate Against Autologous and Tier 1a HIV-1 Isolates as Assessed by TZM-bl Neutralization Assay Following the Third and Fourth Vaccinations BG505/T332N, 1: 80, M6.5	0 Participants	0 Participants
Neutralizing Ab Response Rate Against Autologous and Tier 1a HIV-1 Isolates as Assessed by TZM-bl Neutralization Assay Following the Third and Fourth Vaccinations MW965.26, 1: 50, Baseline	9 Participants	10 Participants
Neutralizing Ab Response Rate Against Autologous and Tier 1a HIV-1 Isolates as Assessed by TZM-bl Neutralization Assay Following the Third and Fourth Vaccinations MW965.26, 1: 50, M3.5	8 Participants	9 Participants
Neutralizing Ab Response Rate Against Autologous and Tier 1a HIV-1 Isolates as Assessed by TZM-bl Neutralization Assay Following the Third and Fourth Vaccinations MW965.26, 1: 50, M6.5	8 Participants	6 Participants
Neutralizing Ab Response Rate Against Autologous and Tier 1a HIV-1 Isolates as Assessed by TZM-bl Neutralization Assay Following the Third and Fourth Vaccinations MW965.26, 1: 80, Baseline	1 Participants	0 Participants
Neutralizing Ab Response Rate Against Autologous and Tier 1a HIV-1 Isolates as Assessed by TZM-bl Neutralization Assay Following the Third and Fourth Vaccinations MW965.26, 1: 80, M3.5	4 Participants	6 Participants
Neutralizing Ab Response Rate Against Autologous and Tier 1a HIV-1 Isolates as Assessed by TZM-bl Neutralization Assay Following the Third and Fourth Vaccinations MW965.26, 1: 80, M6.5	3 Participants	6 Participants
Neutralizing Ab Response Rate Against Autologous and Tier 1a HIV-1 Isolates as Assessed by TZM-bl Neutralization Assay Following the Third and Fourth Vaccinations SVA-MLV, 1: 50, Baseline	2 Participants	0 Participants
Neutralizing Ab Response Rate Against Autologous and Tier 1a HIV-1 Isolates as Assessed by TZM-bl Neutralization Assay Following the Third and Fourth Vaccinations SVA-MLV, 1: 50, M3.5	2 Participants	2 Participants
Neutralizing Ab Response Rate Against Autologous and Tier 1a HIV-1 Isolates as Assessed by TZM-bl Neutralization Assay Following the Third and Fourth Vaccinations SVA-MLV, 1: 50, M6.5	1 Participants	0 Participants
Neutralizing Ab Response Rate Against Autologous and Tier 1a HIV-1 Isolates as Assessed by TZM-bl Neutralization Assay Following the Third and Fourth Vaccinations SVA-MLV, 1: 80, Baseline	1 Participants	0 Participants
Neutralizing Ab Response Rate Against Autologous and Tier 1a HIV-1 Isolates as Assessed by TZM-bl Neutralization Assay Following the Third and Fourth Vaccinations SVA-MLV, 1: 80, M3.5	0 Participants	0 Participants
Neutralizing Ab Response Rate Against Autologous and Tier 1a HIV-1 Isolates as Assessed by TZM-bl Neutralization Assay Following the Third and Fourth Vaccinations SVA-MLV, 1: 80, M6.5	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Measured at Months 1.5, 3.5, and 6.5

Population: The number of participants with available data after filtering for assay specific quality control criteria

Epitope specificities are assessed via wildtype-mutant pairs. Serum samples from post-enrollment visits were declared to have positive differential binding responses if they met the following conditions: 1) positive direct binding response, 2) MFI ratio (wild type/mutant type) ≥ 2.5, and wild type at least 250 MFI at selected dilution, 3) net MFI ratio (wild type/mutant type) ≥ 2.5, and wild type at least 250 net MFI at selected dilution. Basespecific binding antibody Area Under the Curve (AUC) values for participants with a positive differential binding response were calculated by subtracting the AUC values of the mutant (BG505-MD39.3 Base-KO untagged) from the AUC values of the wildtype (BG505-MD39.3 untagged)

Outcome measures

Outcome measures
Measure	Group T1 n=10 Participants INO-6160 (2.0 mg) at months 0, 1, 3, 6	Group T2 n=10 Participants INO-6160 (2.0 mg) at months 0, 1, 3, 6 + Trimer-4571 (100 mcg) + 3M-052-AF (5 mcg) + Alum (500 mcg) at months 3, 6
Differential Binding Response Rates of HIV-1 Specific IgG Binding Ab Responses as Assessed by Multiplex Assay BG505_MD39.3_baseKO_1CCv4, 1: 50, M1.5	7 Participants	5 Participants
Differential Binding Response Rates of HIV-1 Specific IgG Binding Ab Responses as Assessed by Multiplex Assay BG505_MD39.3_baseKO_1CCv4, 1: 250, M3.5	8 Participants	9 Participants
Differential Binding Response Rates of HIV-1 Specific IgG Binding Ab Responses as Assessed by Multiplex Assay BG505_MD39.3_baseKO_1CCv4, 1: 250, M6.5	8 Participants	4 Participants

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Jessica Andriesen, PhD, Associate Director of HVTN SDMC Operations

Fred Hutchinson Cancer Center

Phone: 206-667-5812

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Group T1 n=8 Participants INO-6160 (2.0 mg) at months 0, 1, 3, 6	Group T2 n=9 Participants INO-6160 (2.0 mg) at months 0, 1, 3, 6 + Trimer-4571 (100 mcg) + 3M-052-AF (5 mcg) + Alum (500 mcg) at months 3, 6
Magnitude of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination A-AB05, IFN-g and/or IL-2, M3.5	0.05 % CD4+ T-cells expressing cytokines Interval 0.04 to 0.07	0.04 % CD4+ T-cells expressing cytokines Interval 0.02 to 0.08
Magnitude of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination A-AB05, IFN-g and/or IL-2, M6.5	0.04 % CD4+ T-cells expressing cytokines Interval 0.04 to 0.06	0.06 % CD4+ T-cells expressing cytokines Interval 0.03 to 0.08
Magnitude of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination A-AB05, IL-21, M3.5	0 % CD4+ T-cells expressing cytokines Interval 0.0 to 0.02	0.01 % CD4+ T-cells expressing cytokines Interval 0.0 to 0.01
Magnitude of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination A-AB05, IL-21, M6.5	0 % CD4+ T-cells expressing cytokines Interval 0.0 to 0.01	0 % CD4+ T-cells expressing cytokines Interval 0.0 to 0.01
Magnitude of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination A-AB05, IL-4 or IL-5 or IL-13 and CD40L, M3.5	0 % CD4+ T-cells expressing cytokines Interval 0.0 to 0.0	0 % CD4+ T-cells expressing cytokines Interval 0.0 to 0.0
Magnitude of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination A-AB05, IL-4 or IL-5 or IL-13 and CD40L, M6.5	0 % CD4+ T-cells expressing cytokines Interval 0.0 to 0.0	0 % CD4+ T-cells expressing cytokines Interval 0.0 to 0.0
Magnitude of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination BG505 A-AB05-gp120, IFN-g and/or IL-2, M3.5	0.14 % CD4+ T-cells expressing cytokines Interval 0.09 to 0.23	0.2 % CD4+ T-cells expressing cytokines Interval 0.14 to 0.21
Magnitude of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination BG505 A-AB05-gp120, IFN-g and/or IL-2, M6.5	0.15 % CD4+ T-cells expressing cytokines Interval 0.11 to 0.18	0.16 % CD4+ T-cells expressing cytokines Interval 0.15 to 0.17
Magnitude of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination BG505 A-AB05-gp120, IL-21, M3.5	0.02 % CD4+ T-cells expressing cytokines Interval 0.01 to 0.03	0.02 % CD4+ T-cells expressing cytokines Interval 0.02 to 0.03
Magnitude of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination BG505 A-AB05-gp120, IL-21, M6.5	0 % CD4+ T-cells expressing cytokines Interval 0.0 to 0.0	0.01 % CD4+ T-cells expressing cytokines Interval 0.0 to 0.02
Magnitude of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination BG505 A-AB05-gp120, IL-4 or IL-5 or IL-13 and CD40L, M3.5	0 % CD4+ T-cells expressing cytokines Interval 0.0 to 0.0	0 % CD4+ T-cells expressing cytokines Interval 0.0 to 0.0
Magnitude of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination BG505 A-AB05-gp120, IL-4 or IL-5 or IL-13 and CD40L, M6.5	0 % CD4+ T-cells expressing cytokines Interval 0.0 to 0.0	0 % CD4+ T-cells expressing cytokines Interval 0.0 to 0.0
Magnitude of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination BG505 A-AB05-gp41, IFN-g and/or IL-2, M3.5	0.04 % CD4+ T-cells expressing cytokines Interval 0.03 to 0.1	0.05 % CD4+ T-cells expressing cytokines Interval 0.04 to 0.07
Magnitude of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination BG505 A-AB05-gp41, IFN-g and/or IL-2, M6.5	0.04 % CD4+ T-cells expressing cytokines Interval 0.03 to 0.05	0.05 % CD4+ T-cells expressing cytokines Interval 0.04 to 0.06
Magnitude of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination BG505 A-AB05-gp41, IL-21, M3.5	0.01 % CD4+ T-cells expressing cytokines Interval 0.0 to 0.02	0.01 % CD4+ T-cells expressing cytokines Interval 0.0 to 0.01
Magnitude of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination BG505 A-AB05-gp41, IL-21, M6.5	0 % CD4+ T-cells expressing cytokines Interval 0.0 to 0.0	0 % CD4+ T-cells expressing cytokines Interval 0.0 to 0.0
Magnitude of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination BG505 A-AB05-gp41, IL-4 or IL-5 or IL-13 and CD40L, M3.5	0 % CD4+ T-cells expressing cytokines Interval 0.0 to 0.0	0 % CD4+ T-cells expressing cytokines Interval 0.0 to 0.0
Magnitude of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination BG505 A-AB05-gp41, IL-4 or IL-5 or IL-13 and CD40L, M6.5	0 % CD4+ T-cells expressing cytokines Interval 0.0 to 0.0	0 % CD4+ T-cells expressing cytokines Interval 0.0 to 0.0
Magnitude of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination Total Env, IFN-g and/or IL-2, M3.5	0.18 % CD4+ T-cells expressing cytokines Interval 0.12 to 0.34	0.24 % CD4+ T-cells expressing cytokines Interval 0.18 to 0.32
Magnitude of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination Total Env, IFN-g and/or IL-2, M6.5	0.18 % CD4+ T-cells expressing cytokines Interval 0.14 to 0.24	0.21 % CD4+ T-cells expressing cytokines Interval 0.21 to 0.22
Magnitude of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination Total Env, IL-21, M3.5	0.03 % CD4+ T-cells expressing cytokines Interval 0.01 to 0.05	0.03 % CD4+ T-cells expressing cytokines Interval 0.02 to 0.03
Magnitude of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination Total Env, IL-21, M6.5	0 % CD4+ T-cells expressing cytokines Interval 0.0 to 0.0	0.01 % CD4+ T-cells expressing cytokines Interval 0.0 to 0.02
Magnitude of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination Total Env, IL-4 or IL-5 or IL-13 and CD40L, M3.5	0 % CD4+ T-cells expressing cytokines Interval 0.0 to 0.0	0 % CD4+ T-cells expressing cytokines Interval 0.0 to 0.0
Magnitude of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination Total Env, IL-4 or IL-5 or IL-13 and CD40L, M6.5	0 % CD4+ T-cells expressing cytokines Interval 0.0 to 0.0	0 % CD4+ T-cells expressing cytokines Interval 0.0 to 0.0

Measure	Group T1 n=10 participants at risk INO-6160 (2.0 mg) at months 0, 1, 3, 6	Group T2 n=10 participants at risk INO-6160 (2.0 mg) at months 0, 1, 3, 6 + Trimer-4571 (100 mcg) + 3M-052-AF (5 mcg) + Alum (500 mcg) at months 3, 6
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/10 • Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.	10.0% 1/10 • Number of events 1 • Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.
Gastrointestinal disorders Nausea (Solicited)	30.0% 3/10 • Number of events 6 • Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.	60.0% 6/10 • Number of events 9 • Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.
Gastrointestinal disorders Vomiting	0.00% 0/10 • Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.	10.0% 1/10 • Number of events 1 • Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.
General disorders Chills (Solicited)	10.0% 1/10 • Number of events 1 • Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.	90.0% 9/10 • Number of events 14 • Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.
General disorders Fatigue (Solicited)	60.0% 6/10 • Number of events 12 • Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.	100.0% 10/10 • Number of events 25 • Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.
General disorders Injection site erythema (Solicited)	60.0% 6/10 • Number of events 17 • Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.	90.0% 9/10 • Number of events 19 • Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.
General disorders Injection site pain (Solicited)	60.0% 6/10 • Number of events 9 • Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.	100.0% 10/10 • Number of events 29 • Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.
General disorders Injection site swelling (Solicited)	20.0% 2/10 • Number of events 2 • Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.	70.0% 7/10 • Number of events 9 • Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.
General disorders Injection site vesicles	0.00% 0/10 • Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.	20.0% 2/10 • Number of events 2 • Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.
Infections and infestations Anal chlamydia infection	10.0% 1/10 • Number of events 1 • Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.	0.00% 0/10 • Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.
Infections and infestations COVID-19	10.0% 1/10 • Number of events 1 • Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.	20.0% 2/10 • Number of events 2 • Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.
Infections and infestations Chlamydial infection	10.0% 1/10 • Number of events 1 • Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.	0.00% 0/10 • Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.
Infections and infestations Herpes zoster	10.0% 1/10 • Number of events 1 • Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.	0.00% 0/10 • Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.
Infections and infestations Nasopharyngitis	10.0% 1/10 • Number of events 1 • Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.	0.00% 0/10 • Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.
Infections and infestations Pharyngitis streptococcal	0.00% 0/10 • Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.	10.0% 1/10 • Number of events 1 • Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/10 • Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.	10.0% 1/10 • Number of events 1 • Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.
Infections and infestations Sinusitis	0.00% 0/10 • Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.	10.0% 1/10 • Number of events 1 • Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.
Investigations Alanine aminotransferase increased	10.0% 1/10 • Number of events 1 • Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.	0.00% 0/10 • Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.
Investigations Blood creatinine increased	10.0% 1/10 • Number of events 1 • Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.	0.00% 0/10 • Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.
Investigations Body temperature increased (Solicited)	0.00% 0/10 • Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.	40.0% 4/10 • Number of events 5 • Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.
Investigations Haemoglobin decreased	0.00% 0/10 • Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.	10.0% 1/10 • Number of events 1 • Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.
Musculoskeletal and connective tissue disorders Arthralgia (Solicited)	20.0% 2/10 • Number of events 2 • Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.	50.0% 5/10 • Number of events 11 • Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.
Musculoskeletal and connective tissue disorders Myalgia (Solicited)	20.0% 2/10 • Number of events 2 • Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.	80.0% 8/10 • Number of events 17 • Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.
Nervous system disorders Headache (Solicited)	50.0% 5/10 • Number of events 8 • Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.	100.0% 10/10 • Number of events 27 • Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.
Nervous system disorders Syncope	10.0% 1/10 • Number of events 1 • Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.	0.00% 0/10 • Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.
Reproductive system and breast disorders Vulvovaginal ulceration	0.00% 0/10 • Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.	10.0% 1/10 • Number of events 1 • Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/10 • Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.	10.0% 1/10 • Number of events 1 • Unsolicited AEs will be collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination.