Healthy
Conditions
Brief summary
The purpose of this study is to assess the safety/tolerability of the 2 different vaccine regimens of priming with trivalent Ad26.Mos.HIV and boosting with trivalent Ad26.Mos.HIV and Clade C gp140 plus adjuvant or priming with tetravalent Ad26.Mos4.HIV and boosting with Ad26.Mos4.HIV and Clade C glycoprotein (gp)140 plus adjuvant. Immune responses of the different vaccine schedules will be assessed.
Interventions
BIOLOGICALAd26.Mos.HIV
Recombinant replication-deficient Ad26 vectored vaccine and consists of 3 Ad26 vectors, one containing a mosaic insert of envelope (Env) sequence, and 2 vectors containing mosaic inserts of Gag and Pol sequences (Ad26.Mos.1.Env + Ad26.Mos1.Gag-Pol + Ad26.Mos2.Gag-Pol). Total dose is 5\*10\^10 viral particle per 0.5 milliliter (mL) injection administered intramuscularly.
BIOLOGICALAd26.Mos4.HIV
Recombinant replication-deficient Ad26 vectored vaccine and consists of 4 Ad26 vectors, 2 containing a mosaic insert of envelope (Env) sequence, and 2 vectors containing mosaic inserts of Gag and Pol sequences (Ad26.Mos.1.Env + Ad26.Mos.2S.Env + Ad26.Mos1.Gag-Pol + Ad26.Mos2.Gag-Pol). Total dose is 5\*10\^10 viral particle per 0.5mL injection administered intramuscularly.
BIOLOGICALClade C gp140
Clade C gp140 vaccine containing 250 mcg of total protein, mixed with aluminum phosphate adjuvant, per 0.5 mL injection administered intramuscularly.
DRUGPlacebo
Normal saline 0.9 percent (%), 0.5 mL injection administered intramuscularly.
Sponsors
Janssen Vaccines & Prevention B.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Are negative for human immunodeficiency virus (HIV) infection at screening * Is healthy on the basis of physical examination, medical history, electrocardiogram (ECG), and vital signs measurement performed at screening * Are willing/able to adhere to the prohibitions and restrictions specified in the protocol and study procedures * Female participants of childbearing potential must have a negative serum pregnancy test (beta human chorionic gonadotropin \[beta hCG\]) at the Screening visit, and a negative urine pregnancy test pre-dose on Day 1 * Are assessed by the clinic staff as being at low risk for HIV infection
Exclusion criteria
* Has chronic hepatitis B (measured by hepatitis B surface antigen test) or active hepatitis C (measured by hepatitis C virus \[HCV\] Ab test; if positive, HCV ribonucleic acid \[RNA\] PCR test will be used to confirm active versus past HCV infection), active syphilis infection, chlamydia, gonorrhea, or trichomonas . Active syphilis documented by serology unless positive serology is due to past treated infection * Has had a thyroidectomy or active thyroid disease requiring medication during the last 12 months (not excluded: a stable thyroid supplementation) * Has had major psychiatric illness and/or substance abuse problems during the past 12 months (including hospitalization or periods of work disability) that in the opinion of the investigator would preclude participation * Has been in receipt of any licensed vaccine within 14 days prior to the first dose of study vaccine/placebo, plans to receive within 14 days after the first study vaccination, or plans to receive within 14 days before or after the second, third or fourth vaccination * Is a recipient of a prophylactic or therapeutic HIV vaccine candidate at any time, or a recipient of other experimental vaccine(s) within the last 12 months prior to the Day 1 visit (Vaccination 1). For participants who received an experimental vaccine (except HIV vaccine) more than 12 months prior to the Day 1 visit (Vaccination 1), documentation of the identity of the experimental vaccine must be provided to the sponsor, who will determine eligibility on a case-by-case basis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 72 | Week 72 | Percentage of responders for envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) specific binding antibody titers at Week 72 were reported. Env Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012)-specific binding antibody titers were assessed using enzyme-linked immunosorbent assay (ELISA). The response was defined as post-baseline value greater than (\>) lower limit of quantification (LLOQ) if baseline value less than (\<) LLOQ or missing or defined as post-baseline value \>3-fold increase from baseline if baseline value greater than or equal to (\>=) LLOQ. |
| Percentage of Participants With Serious Adverse Events (SAEs) During Main Study | Up to Week 72 | An AE was defined as any untoward medical event that occurred in a participant administered an investigational product, and it did not necessarily indicated only events with clear causal relationship with the relevant investigational product. SAE was defined as any AE that resulted in: death, persistent or significant disability/incapacity, required inpatient hospitalization or prolongation of existing hospitalization, was life-threatening experience, was a congenital anomaly/birth defect and would jeopardize participant and/or required medical or surgical intervention to prevent one of the outcomes listed above. |
| Percentage of Participants With SAEs During Long Term Extension (LTE) Period | From Week 96 to Week 264 | An AE was defined as any untoward medical event that occurred in a participant administered an investigational product, and it did not necessarily indicated only events with clear causal relationship with the relevant investigational product. SAE was defined as any AE that resulted in: death, persistent or significant disability/incapacity, required inpatient hospitalization or prolongation of existing hospitalization, was life-threatening experience, was a congenital anomaly/birth defect and would jeopardize participant and/or required medical or surgical intervention to prevent one of the outcomes listed above. This outcome measure was planned to be analyzed for specified arm only. |
| Percentage of Participants With AEs of Special Interest During Main Study | Up to Week 72 | Percentage of participants with AEs of special interest during main study were reported. HIV infection was considered as an AE of special interest. |
| Percentage of Participants With AEs of Special Interest During LTE Period | From Week 96 to Week 264 | Percentage of participants with AEs of special interest during LTE period were reported. HIV infection was considered as an AE of special interest. This outcome measure was planned to be analyzed for specified arm only. |
| Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 28 | Week 28 | Percentage of responders for envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) specific binding antibody titers at Week 28 were reported. Env Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012)-specific binding antibody titers were assessed using enzyme-linked immunosorbent assay (ELISA). The response was defined as post-baseline value greater than (\>) lower limit of quantification (LLOQ) if baseline value less than (\<) LLOQ or missing or defined as post-baseline value \>3-fold increase from baseline if baseline value greater than or equal to (\>=) LLOQ. |
| Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 52 | Week 52 | Percentage of responders for envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) specific binding antibody titers at Week 52 were reported. Env Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012)-specific binding antibody titers were assessed using enzyme-linked immunosorbent assay (ELISA). The response was defined as post-baseline value greater than (\>) lower limit of quantification (LLOQ) if baseline value less than (\<) LLOQ or missing or defined as post-baseline value \>3-fold increase from baseline if baseline value greater than or equal to (\>=) LLOQ. |
| Percentage of Participants With Solicited Systemic AEs Post Third Vaccination | 7 days after third vaccination on Day 169 (Day 176) | An AE was defined as any untoward medical event that occurred in a participant administered an investigational product, and it did not necessarily indicated only events with clear causal relationship with the relevant investigational product. Solicited systemic AEs including pyrexia/fever, headache, fatigue, myalgia, nausea and chills were collected within 7 days after vaccination. |
| Percentage of Participants With Solicited Local Adverse Events (AEs) Post First Vaccination | 7 days after first vaccination on Day 1 (Day 8) | Solicited local AEs were predefined local events (at the injection site: erythema, induration, swelling, itching and warmth) that were by definition considered as related to the study vaccine and collected within 7 days after vaccination. |
| Percentage of Participants With Solicited Local AEs Post Second Vaccination | 7 days after second vaccination on Day 85 (Day 92) | Solicited local AEs were predefined local events (at the injection site: erythema, induration, swelling, itching and warmth) that were by definition considered as related to the study vaccine and collected within 7 days after vaccination. |
| Percentage of Participants With Solicited Local AEs Post Third Vaccination | 7 days after third vaccination on Day 169 (Day 176) | Solicited local AEs were predefined local events (at the injection site: erythema, induration, swelling, itching and warmth) that were by definition considered as related to the study vaccine and collected within 7 days after vaccination. |
| Percentage of Participants With Solicited Local AEs Post Fourth Vaccination | 7 days after fourth vaccination on Day 337 (Day 344) | Solicited local AEs were predefined local events (at the injection site: erythema, induration, swelling, itching and warmth) that were by definition considered as related to the study vaccine and collected within 7 days after vaccination. |
| Percentage of Participants With Solicited Systemic AEs Post First Vaccination | 7 days after first vaccination on Day 1 (Day 8) | An AE was defined as any untoward medical event that occurred in a participant administered an investigational product, and it did not necessarily indicated only events with clear causal relationship with the relevant investigational product. Solicited systemic AEs including pyrexia/fever, headache, fatigue, myalgia, nausea and chills were collected within 7 days after vaccination. |
| Percentage of Participants With Solicited Systemic AEs Post Second Vaccination | 7 days after second vaccination on Day 85 (Day 92) | An AE was defined as any untoward medical event that occurred in a participant administered an investigational product, and it did not necessarily indicated only events with clear causal relationship with the relevant investigational product. Solicited systemic AEs including pyrexia/fever, headache, fatigue, myalgia, nausea and chills were collected within 7 days after vaccination. |
| Percentage of Participants With Solicited Systemic AEs Post Fourth Vaccination | 7 days after fourth vaccination on Day 337 (Day 344) | An AE was defined as any untoward medical event that occurred in a participant administered an investigational product, and it did not necessarily indicated only events with clear causal relationship with the relevant investigational product. Solicited systemic AEs including pyrexia/fever, headache, fatigue, myalgia, nausea and chills were collected within 7 days after vaccination. |
| Percentage of Participants With Unsolicited AEs for 28 Days After First Vaccination | 28 days after first vaccination on Day 1 (Day 29) | An AE was defined as any untoward medical event that occurred in a participant administered an investigational product, and it did not necessarily indicated only events with clear causal relationship with the relevant investigational product. Unsolicited AEs were defined as the AEs other than those categorized as solicited AEs and were required to be collected for any events that occurred from the time of vaccination and through the subsequent 28 days. |
| Percentage of Participants With Unsolicited AEs for 28 Days After Second Vaccination | 28 days after second vaccination on Day 85 (Day 113) | An AE was defined as any untoward medical event that occurred in a participant administered an investigational product, and it did not necessarily indicated only events with clear causal relationship with the relevant investigational product. Unsolicited AEs were defined as the AEs other than those categorized as solicited AEs and were required to be collected for any events that occurred from the time of vaccination and through the subsequent 28 days. |
| Percentage of Participants With Unsolicited AEs for 28 Days After Third Vaccination | 28 days after third vaccination on Day 169 (Day 197) | An AE was defined as any untoward medical event that occurred in a participant administered an investigational product, and it did not necessarily indicated only events with clear causal relationship with the relevant investigational product. Unsolicited AEs were defined as the AEs other than those categorized as solicited AEs and were required to be collected for any events that occurred from the time of vaccination and through the subsequent 28 days. |
| Percentage of Participants With Unsolicited AEs for 28 Days After Fourth Vaccination | 28 days after fourth vaccination on Day 334 (Day 362) | An AE was defined as any untoward medical event that occurred in a participant administered an investigational product, and it did not necessarily indicated only events with clear causal relationship with the relevant investigational product. Unsolicited AEs were defined as the AEs other than those categorized as solicited AEs and were required to be collected for any events that occurred from the time of vaccination and through the subsequent 28 days. |
| Percentage of Participants With Discontinuations From Vaccination Due to AEs | Up to Week 72 | Percentage of participants with discontinuations from vaccination due to AEs were reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Responders for Env Antibody-dependent Cellular Phagocytosis (ADCP) gp Antibody | Weeks 28, 52 and 72 | The functionality of vaccine-induced antibody responses was investigated by the determination of ADCP. The response was defined as post-baseline value \> limit of detection (LOD) if baseline value \<LOD or missing or defined as post-baseline value \>3-fold increase from baseline if baseline value \>=LOD. The lower limits of detection (LODs) for this assay were 5.16, 6.43, 6.49, 4.32 and 4.28 (phagocytic score) for Clade A (92UG037.1), Clade B (1990a), Clade C (Con C), Clade C (C97ZA.012), and Mos1, respectively. |
| Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Weeks 26, 52 and 72 | Frozen peripheral blood mononuclear cell (PBMCs) were analyzed by interferon-gamma (IFN-gamma) (ELISpot). The response was defined as post-baseline value \>P95 if baseline \<P95 or missing or defined as post-baseline value \>3-fold increase from baseline if baseline \>=P95. |
| Percentage of Responders for Immunoglobulin G1 (IgG1) and IgG3 Gylcoprotein (gp) 140 Binding Antibody Assessed Using Clade C (C97ZA.012) Env Enzyme-linked Immunosorbent Assay (ELISA) | Weeks 28, 52 and 72 | Vaccine-induced binding antibody IgG1 and IgG3 subclass responses were investigated using Clade C (C97ZA.012) specific ELISAs. The response was defined as post-baseline value \>LLOQ if baseline \<LLOQ or missing or defined as post-baseline value \>3-fold increase from baseline if baseline \>=LLOQ. The LLOQs for this assay were 12.3 and 12.4 for IgG1 and IgG3, respectively. |
| Percentage of Responders for CD4+ and CD8+ T-Cell Responses | Weeks 28, 52 and 72 | Intracellular cytokine staining (ICS) was performed to examine the type of T-cell responding to vaccination. Responder definition was based on the Fisher's exact text between cytokine producing cells and non-producing cells in stimulated versus non-stimulated conditions. |
| Percentage of Participants With T-cell Development | Up to Week 264 | As per change in planned analysis, this outcome measure was not performed since it was no longer considered relevant to interpret the immunogenicity of the vaccines. |
| Percentage of Responders for Human Immunodeficiency Virus Neutralizing Antibody (HIV nAb) | Weeks 28, 52 and 72 | The functionality of vaccine-induced antibody responses was investigated by the determination of nAb activity in a virus neutralization assay (VNA) using TZM-bl cells and Env-pseudotyped viruses. The response was defined as post-baseline value \>LLOQ. The LLOQ for this assay was an inhibitory concentration (IC50) of 20 (fold-dilution). The data was collected for the responses against Tier 1 HIV strain Clade C (MW965.26 and C97ZA.012). |
Countries
Rwanda, United States
Participant flow
Pre-assignment details
A total of 201 participants were enrolled, out of which 198 participants were randomized and vaccinated; 3 participants were not vaccinated and hence were not included in analyses.
Participants by arm
| Arm | Count |
|---|---|
| Tetravalent Ad26.Mos4.HIV Vaccine Participants received adenovirus serotype 26-Mosaic-Human Immunodeficiency Virus (Ad26.Mos4.HIV) vaccine 5\*10\^10 virus particles (vp) via Intramuscular (IM) injection at Weeks (Wks) 0 and 12. At Weeks 24 and 48, participants received 5\*10\^10 vp Ad26.Mos4.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 micrograms (mcg) of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72. Participants who had received all 4 vaccinations and were negative for HIV infection at Week 72 were included in an optional Long-term Extension (LTE) phase (up to Week 264). | 110 |
| Trivalent Ad26.Mos.HIV Vaccine Participants received Ad26.Mos4.HIV vaccine 5\*10\^10 vp via IM injection at Weeks 0 and 12. At Weeks 24 and 48 participants received 5\*10\^10 vp Ad26.Mos.HIV vaccine and HIV Clade C glycoprotein 140 (gp140) vaccine containing 250 mcg of total protein mixed with adjuvant (aluminum phosphate) as an IM injection. Participants were followed up till Week 72. | 55 |
| Placebo Participants received placebo matching to either Ad26.Mos4.HIV or Ad26.Mos.HIV as 0.5 mL via IM injection at Weeks 0 and 12, and placebo matching to Clade C gp 140/aluminum phosphate adjuvant as 0.5 mL via IM injection at Weeks 24 and 48. The placebo arms were pooled as there were no differences in the individuals randomized to either of the placebo groups. Participants were followed up till Week 72. | 33 |
| Total | 198 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Long Term Extension (From Wk 72 to 264) | Lost to Follow-up | 8 | 0 | 0 |
| Long Term Extension (From Wk 72 to 264) | Other | 1 | 0 | 0 |
| Long Term Extension (From Wk 72 to 264) | Withdrawal by Subject | 8 | 0 | 0 |
| Main Study (Up to Week 72) | Adverse Event | 0 | 1 | 1 |
| Main Study (Up to Week 72) | Lost to Follow-up | 5 | 4 | 3 |
| Main Study (Up to Week 72) | Other | 3 | 0 | 0 |
| Main Study (Up to Week 72) | Pregnancy | 1 | 1 | 0 |
| Main Study (Up to Week 72) | Protocol Violation | 1 | 0 | 0 |
| Main Study (Up to Week 72) | Withdrawal by Subject | 6 | 4 | 1 |
Baseline characteristics
| Characteristic | Tetravalent Ad26.Mos4.HIV Vaccine | Total | Placebo | Trivalent Ad26.Mos.HIV Vaccine |
|---|---|---|---|---|
| Age, Continuous | 28.0 years | 27.0 years | 27.0 years | 27.0 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants | 23 Participants | 4 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 96 Participants | 173 Participants | 29 Participants | 48 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 2 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 5 Participants | 10 Participants | 0 Participants | 5 Participants |
| Race/Ethnicity, Customized Black or African American | 35 Participants | 60 Participants | 7 Participants | 18 Participants |
| Race/Ethnicity, Customized More than one race | 6 Participants | 13 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized Other | 4 Participants | 6 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 58 Participants | 105 Participants | 23 Participants | 24 Participants |
| Region of Enrollment RWANDA | 10 Participants | 17 Participants | 2 Participants | 5 Participants |
| Region of Enrollment UNITED STATES | 100 Participants | 181 Participants | 31 Participants | 50 Participants |
| Sex: Female, Male Female | 54 Participants | 110 Participants | 24 Participants | 32 Participants |
| Sex: Female, Male Male | 56 Participants | 88 Participants | 9 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 110 | 0 / 55 | 0 / 33 |
| other Total, other adverse events | 37 / 110 | 22 / 55 | 15 / 33 |
| serious Total, serious adverse events | 9 / 110 | 0 / 55 | 0 / 33 |
Outcome results
Primary
Percentage of Participants With AEs of Special Interest During LTE Period
Percentage of participants with AEs of special interest during LTE period were reported. HIV infection was considered as an AE of special interest. This outcome measure was planned to be analyzed for specified arm only.
Time frame: From Week 96 to Week 264
Population: The FAS included all participants those were all the participants from the Tetravalent Ad26.Mos4.HIV group who had received all 4 vaccinations and were negative for HIV infections at Week 72.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Participants With AEs of Special Interest During LTE Period | 0 percentage of participants |
Primary
Percentage of Participants With AEs of Special Interest During Main Study
Percentage of participants with AEs of special interest during main study were reported. HIV infection was considered as an AE of special interest.
Time frame: Up to Week 72
Population: The FAS included all participants who were randomized and who received at least one dose of study vaccine.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Participants With AEs of Special Interest During Main Study | 0 percentage of participants |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Participants With AEs of Special Interest During Main Study | 0 percentage of participants |
| Placebo | Percentage of Participants With AEs of Special Interest During Main Study | 0 percentage of participants |
Primary
Percentage of Participants With Discontinuations From Vaccination Due to AEs
Percentage of participants with discontinuations from vaccination due to AEs were reported.
Time frame: Up to Week 72
Population: The FAS included all participants who were randomized and who received at least one dose of study vaccine.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Participants With Discontinuations From Vaccination Due to AEs | 0 percentage of participants |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Participants With Discontinuations From Vaccination Due to AEs | 1.8 percentage of participants |
| Placebo | Percentage of Participants With Discontinuations From Vaccination Due to AEs | 6.1 percentage of participants |
Primary
Percentage of Participants With SAEs During Long Term Extension (LTE) Period
An AE was defined as any untoward medical event that occurred in a participant administered an investigational product, and it did not necessarily indicated only events with clear causal relationship with the relevant investigational product. SAE was defined as any AE that resulted in: death, persistent or significant disability/incapacity, required inpatient hospitalization or prolongation of existing hospitalization, was life-threatening experience, was a congenital anomaly/birth defect and would jeopardize participant and/or required medical or surgical intervention to prevent one of the outcomes listed above. This outcome measure was planned to be analyzed for specified arm only.
Time frame: From Week 96 to Week 264
Population: The FAS included all participants those were all the participants from the Tetravalent Ad26.Mos4.HIV group who had received all 4 vaccinations and were negative for HIV infections at Week 72.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Participants With SAEs During Long Term Extension (LTE) Period | 5.2 percentage of participants |
Primary
Percentage of Participants With Serious Adverse Events (SAEs) During Main Study
An AE was defined as any untoward medical event that occurred in a participant administered an investigational product, and it did not necessarily indicated only events with clear causal relationship with the relevant investigational product. SAE was defined as any AE that resulted in: death, persistent or significant disability/incapacity, required inpatient hospitalization or prolongation of existing hospitalization, was life-threatening experience, was a congenital anomaly/birth defect and would jeopardize participant and/or required medical or surgical intervention to prevent one of the outcomes listed above.
Time frame: Up to Week 72
Population: The FAS included all participants who were randomized and who received at least one dose of study vaccine.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Participants With Serious Adverse Events (SAEs) During Main Study | 5.5 percentage of participants |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Participants With Serious Adverse Events (SAEs) During Main Study | 0 percentage of participants |
| Placebo | Percentage of Participants With Serious Adverse Events (SAEs) During Main Study | 0 percentage of participants |
Primary
Percentage of Participants With Solicited Local Adverse Events (AEs) Post First Vaccination
Solicited local AEs were predefined local events (at the injection site: erythema, induration, swelling, itching and warmth) that were by definition considered as related to the study vaccine and collected within 7 days after vaccination.
Time frame: 7 days after first vaccination on Day 1 (Day 8)
Population: The full analysis set (FAS) included all participants who were randomized and who received at least one dose of study vaccine.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Participants With Solicited Local Adverse Events (AEs) Post First Vaccination | 70.9 percentage of participants |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Participants With Solicited Local Adverse Events (AEs) Post First Vaccination | 78.2 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local Adverse Events (AEs) Post First Vaccination | 27.3 percentage of participants |
Primary
Percentage of Participants With Solicited Local AEs Post Fourth Vaccination
Solicited local AEs were predefined local events (at the injection site: erythema, induration, swelling, itching and warmth) that were by definition considered as related to the study vaccine and collected within 7 days after vaccination.
Time frame: 7 days after fourth vaccination on Day 337 (Day 344)
Population: The FAS included all participants who were randomized and who received at least one dose of study vaccine. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Participants With Solicited Local AEs Post Fourth Vaccination | 84 percentage of participants |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Participants With Solicited Local AEs Post Fourth Vaccination | 68.9 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local AEs Post Fourth Vaccination | 29.6 percentage of participants |
Primary
Percentage of Participants With Solicited Local AEs Post Second Vaccination
Solicited local AEs were predefined local events (at the injection site: erythema, induration, swelling, itching and warmth) that were by definition considered as related to the study vaccine and collected within 7 days after vaccination.
Time frame: 7 days after second vaccination on Day 85 (Day 92)
Population: The FAS included all participants who were randomized and who received at least one dose of study vaccine. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Participants With Solicited Local AEs Post Second Vaccination | 83.3 percentage of participants |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Participants With Solicited Local AEs Post Second Vaccination | 76.5 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local AEs Post Second Vaccination | 50 percentage of participants |
Primary
Percentage of Participants With Solicited Local AEs Post Third Vaccination
Solicited local AEs were predefined local events (at the injection site: erythema, induration, swelling, itching and warmth) that were by definition considered as related to the study vaccine and collected within 7 days after vaccination.
Time frame: 7 days after third vaccination on Day 169 (Day 176)
Population: The FAS included all participants who were randomized and who received at least one dose of study vaccine. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Participants With Solicited Local AEs Post Third Vaccination | 80.8 percentage of participants |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Participants With Solicited Local AEs Post Third Vaccination | 79.6 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local AEs Post Third Vaccination | 21.9 percentage of participants |
Primary
Percentage of Participants With Solicited Systemic AEs Post First Vaccination
An AE was defined as any untoward medical event that occurred in a participant administered an investigational product, and it did not necessarily indicated only events with clear causal relationship with the relevant investigational product. Solicited systemic AEs including pyrexia/fever, headache, fatigue, myalgia, nausea and chills were collected within 7 days after vaccination.
Time frame: 7 days after first vaccination on Day 1 (Day 8)
Population: FAS included all participants who were randomized and who received at least one dose of study vaccine.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Participants With Solicited Systemic AEs Post First Vaccination | 69.1 percentage of participants |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Participants With Solicited Systemic AEs Post First Vaccination | 83.6 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic AEs Post First Vaccination | 54.5 percentage of participants |
Primary
Percentage of Participants With Solicited Systemic AEs Post Fourth Vaccination
An AE was defined as any untoward medical event that occurred in a participant administered an investigational product, and it did not necessarily indicated only events with clear causal relationship with the relevant investigational product. Solicited systemic AEs including pyrexia/fever, headache, fatigue, myalgia, nausea and chills were collected within 7 days after vaccination.
Time frame: 7 days after fourth vaccination on Day 337 (Day 344)
Population: FAS included all participants who were randomized and who received at least one dose of study vaccine. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Participants With Solicited Systemic AEs Post Fourth Vaccination | 58.5 percentage of participants |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Participants With Solicited Systemic AEs Post Fourth Vaccination | 53.3 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic AEs Post Fourth Vaccination | 33.3 percentage of participants |
Primary
Percentage of Participants With Solicited Systemic AEs Post Second Vaccination
An AE was defined as any untoward medical event that occurred in a participant administered an investigational product, and it did not necessarily indicated only events with clear causal relationship with the relevant investigational product. Solicited systemic AEs including pyrexia/fever, headache, fatigue, myalgia, nausea and chills were collected within 7 days after vaccination.
Time frame: 7 days after second vaccination on Day 85 (Day 92)
Population: FAS included all participants who were randomized and who received at least one dose of study vaccine. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Participants With Solicited Systemic AEs Post Second Vaccination | 66.7 percentage of participants |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Participants With Solicited Systemic AEs Post Second Vaccination | 54.9 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic AEs Post Second Vaccination | 40.6 percentage of participants |
Primary
Percentage of Participants With Solicited Systemic AEs Post Third Vaccination
An AE was defined as any untoward medical event that occurred in a participant administered an investigational product, and it did not necessarily indicated only events with clear causal relationship with the relevant investigational product. Solicited systemic AEs including pyrexia/fever, headache, fatigue, myalgia, nausea and chills were collected within 7 days after vaccination.
Time frame: 7 days after third vaccination on Day 169 (Day 176)
Population: FAS included all participants who were randomized and who received at least one dose of study vaccine. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Participants With Solicited Systemic AEs Post Third Vaccination | 59.6 percentage of participants |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Participants With Solicited Systemic AEs Post Third Vaccination | 44.9 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic AEs Post Third Vaccination | 34.4 percentage of participants |
Primary
Percentage of Participants With Unsolicited AEs for 28 Days After First Vaccination
An AE was defined as any untoward medical event that occurred in a participant administered an investigational product, and it did not necessarily indicated only events with clear causal relationship with the relevant investigational product. Unsolicited AEs were defined as the AEs other than those categorized as solicited AEs and were required to be collected for any events that occurred from the time of vaccination and through the subsequent 28 days.
Time frame: 28 days after first vaccination on Day 1 (Day 29)
Population: The FAS included all participants who were randomized and who received at least one dose of study vaccine.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Participants With Unsolicited AEs for 28 Days After First Vaccination | 38.2 percentage of participants |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Participants With Unsolicited AEs for 28 Days After First Vaccination | 41.8 percentage of participants |
| Placebo | Percentage of Participants With Unsolicited AEs for 28 Days After First Vaccination | 30.3 percentage of participants |
Primary
Percentage of Participants With Unsolicited AEs for 28 Days After Fourth Vaccination
An AE was defined as any untoward medical event that occurred in a participant administered an investigational product, and it did not necessarily indicated only events with clear causal relationship with the relevant investigational product. Unsolicited AEs were defined as the AEs other than those categorized as solicited AEs and were required to be collected for any events that occurred from the time of vaccination and through the subsequent 28 days.
Time frame: 28 days after fourth vaccination on Day 334 (Day 362)
Population: The FAS included all participants who were randomized and who received at least one dose of study vaccine. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Participants With Unsolicited AEs for 28 Days After Fourth Vaccination | 36.2 percentage of participants |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Participants With Unsolicited AEs for 28 Days After Fourth Vaccination | 22.2 percentage of participants |
| Placebo | Percentage of Participants With Unsolicited AEs for 28 Days After Fourth Vaccination | 40.7 percentage of participants |
Primary
Percentage of Participants With Unsolicited AEs for 28 Days After Second Vaccination
An AE was defined as any untoward medical event that occurred in a participant administered an investigational product, and it did not necessarily indicated only events with clear causal relationship with the relevant investigational product. Unsolicited AEs were defined as the AEs other than those categorized as solicited AEs and were required to be collected for any events that occurred from the time of vaccination and through the subsequent 28 days.
Time frame: 28 days after second vaccination on Day 85 (Day 113)
Population: The FAS included all participants who were randomized and who received at least one dose of study vaccine. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Participants With Unsolicited AEs for 28 Days After Second Vaccination | 30.4 percentage of participants |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Participants With Unsolicited AEs for 28 Days After Second Vaccination | 23.5 percentage of participants |
| Placebo | Percentage of Participants With Unsolicited AEs for 28 Days After Second Vaccination | 37.5 percentage of participants |
Primary
Percentage of Participants With Unsolicited AEs for 28 Days After Third Vaccination
An AE was defined as any untoward medical event that occurred in a participant administered an investigational product, and it did not necessarily indicated only events with clear causal relationship with the relevant investigational product. Unsolicited AEs were defined as the AEs other than those categorized as solicited AEs and were required to be collected for any events that occurred from the time of vaccination and through the subsequent 28 days.
Time frame: 28 days after third vaccination on Day 169 (Day 197)
Population: The FAS included all participants who were randomized and who received at least one dose of study vaccine. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Participants With Unsolicited AEs for 28 Days After Third Vaccination | 28.3 percentage of participants |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Participants With Unsolicited AEs for 28 Days After Third Vaccination | 20.4 percentage of participants |
| Placebo | Percentage of Participants With Unsolicited AEs for 28 Days After Third Vaccination | 21.9 percentage of participants |
Primary
Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 28
Percentage of responders for envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) specific binding antibody titers at Week 28 were reported. Env Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012)-specific binding antibody titers were assessed using enzyme-linked immunosorbent assay (ELISA). The response was defined as post-baseline value greater than (\>) lower limit of quantification (LLOQ) if baseline value less than (\<) LLOQ or missing or defined as post-baseline value \>3-fold increase from baseline if baseline value greater than or equal to (\>=) LLOQ.
Time frame: Week 28
Population: The PPI analysis set included all participants who had received at least first three vaccinations, according to protocol-specified vaccination schedule (+/- 2 weeks), had at least 1 measured post-dose blood sample collected and were not diagnosed with HIV infection during the study. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure; 'n' (number analyzed) signifies number of participants evaluable for specified categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 28 | Clade A (92UG037.1) | 100 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 28 | Clade B (1990a) | 100 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 28 | Clade C (Con C) | 100 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 28 | Clade C (C97ZA.012) | 100 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 28 | Clade C (C97ZA.012) | 100 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 28 | Clade A (92UG037.1) | 100 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 28 | Clade C (Con C) | 100 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 28 | Clade B (1990a) | 100 percentage of responders |
| Placebo | Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 28 | Clade C (C97ZA.012) | 6.5 percentage of responders |
| Placebo | Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 28 | Clade B (1990a) | 12.9 percentage of responders |
| Placebo | Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 28 | Clade C (Con C) | 12.9 percentage of responders |
| Placebo | Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 28 | Clade A (92UG037.1) | 19.4 percentage of responders |
Primary
Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 52
Percentage of responders for envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) specific binding antibody titers at Week 52 were reported. Env Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012)-specific binding antibody titers were assessed using enzyme-linked immunosorbent assay (ELISA). The response was defined as post-baseline value greater than (\>) lower limit of quantification (LLOQ) if baseline value less than (\<) LLOQ or missing or defined as post-baseline value \>3-fold increase from baseline if baseline value greater than or equal to (\>=) LLOQ.
Time frame: Week 52
Population: The PPI analysis set included all participants who had received at least first three vaccinations, according to protocol-specified vaccination schedule (+/- 2 weeks), had at least 1 measured post-dose blood sample collected and were not diagnosed with HIV infection during the study. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure; 'n' (number analyzed) signifies number of participants evaluable for specified categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 52 | Clade A (92UG037.1) | 100 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 52 | Clade B (1990a) | 100 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 52 | Clade C (Con C) | 100 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 52 | Clade C (C97ZA.012) | 100 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 52 | Clade C (C97ZA.012) | 100 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 52 | Clade A (92UG037.1) | 100 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 52 | Clade C (Con C) | 100 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 52 | Clade B (1990a) | 100 percentage of responders |
| Placebo | Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 52 | Clade C (C97ZA.012) | 3.7 percentage of responders |
| Placebo | Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 52 | Clade B (1990a) | 22.2 percentage of responders |
| Placebo | Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 52 | Clade C (Con C) | 0 percentage of responders |
| Placebo | Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 52 | Clade A (92UG037.1) | 0 percentage of responders |
Primary
Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 72
Percentage of responders for envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) specific binding antibody titers at Week 72 were reported. Env Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012)-specific binding antibody titers were assessed using enzyme-linked immunosorbent assay (ELISA). The response was defined as post-baseline value greater than (\>) lower limit of quantification (LLOQ) if baseline value less than (\<) LLOQ or missing or defined as post-baseline value \>3-fold increase from baseline if baseline value greater than or equal to (\>=) LLOQ.
Time frame: Week 72
Population: The PPI analysis set included all participants who had received at least first three vaccinations, according to protocol-specified vaccination schedule (+/- 2 weeks), had at least 1 measured post-dose blood sample collected and were not diagnosed with HIV infection during the study. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure; 'n' (number analyzed) signifies number of participants evaluable for specified categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 72 | Clade A (92UG037.1) | 100 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 72 | Clade B (1990a) | 100 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 72 | Clade C (Con C) | 100 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 72 | Clade C (C97ZA.012) | 100 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 72 | Clade C (C97ZA.012) | 100 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 72 | Clade A (92UG037.1) | 100 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 72 | Clade C (Con C) | 100 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 72 | Clade B (1990a) | 100 percentage of responders |
| Placebo | Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 72 | Clade C (C97ZA.012) | 3.7 percentage of responders |
| Placebo | Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 72 | Clade B (1990a) | 11.1 percentage of responders |
| Placebo | Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 72 | Clade C (Con C) | 0 percentage of responders |
| Placebo | Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 72 | Clade A (92UG037.1) | 2 percentage of responders |
Secondary
Percentage of Participants With T-cell Development
As per change in planned analysis, this outcome measure was not performed since it was no longer considered relevant to interpret the immunogenicity of the vaccines.
Time frame: Up to Week 264
Population: The PPI analysis set included all participants who had received at least first three vaccinations, according to protocol-specified vaccination schedule (+/- 2 weeks), had at least 1 measured post-dose blood sample collected and were not diagnosed with HIV infection during the study.
Secondary
Percentage of Responders for CD4+ and CD8+ T-Cell Responses
Intracellular cytokine staining (ICS) was performed to examine the type of T-cell responding to vaccination. Responder definition was based on the Fisher's exact text between cytokine producing cells and non-producing cells in stimulated versus non-stimulated conditions.
Time frame: Weeks 28, 52 and 72
Population: The PPI analysis set included all participants who had received at least first three vaccinations, according to protocol-specified vaccination schedule (+/- 2 weeks), had at least 1 measured post-dose blood sample collected and were not diagnosed with HIV during the study. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure; 'n' (number analyzed) signifies number of participants evaluable at specified categories
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD4+ ENV Pol PP (Mos1) IFNg+ /IL2+ Wk 52 | 6.59 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD8+ Pol PP (Mos1) IFNg+ /IL2+ Wk 72 | 51.90 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD4+ ENV Pol PP (Mos1) IFNg+ /IL2+ Wk 72 | 6.41 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD4+ ENV PP clade C (ZA) IFNg+ /IL2+ Wk 52 | 63.74 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD8+ ENV PP (Mos1) IFNg+ /IL2+ Wk 28 | 35.42 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD4+ ENV PP (Mos1 ZA PTE) IFNg+ /IL2+ Wk 28 | 56.70 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD8+ ENV PP (Mos1) IFNg+ /IL2+ Wk 52 | 30.77 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD4+ ENV PP clade C (ZA) IFNg+ /IL2+ Wk 72 | 51.28 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD8+ ENV PP (Mos1) IFNg+ /IL2+ Wk 72 | 29.11 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD4+ ENV PP (Mos1) IFNg+ /IL2+ Wk 52 | 64.84 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD8+ ENV PP (Mos1 ZA PTE) IFNg+ /IL2+ Wk 28 | 41.67 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD4+ ENV pol gag PP IFNg+ /IL2+ Wk 28 | 57.73 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD8+ ENV PP (Mos1 ZA PTE) IFNg+ /IL2+ Wk 52 | 34.07 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD8+ Pol PP (Mos1) IFNg+ /IL2+ Wk 52 | 54.95 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD8+ ENV PP (Mos1 ZA PTE) IFNg+ /IL2+ Wk 72 | 34.18 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD8+ Pol PP (Mos1) IFNg+ /IL2+ Wk 28 | 62.50 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD8+ ENV PP clade C (ZA) IFNg+ /IL2+ Wk 28 | 21.88 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD4+ ENV pol gag PP IFNg+ /IL2+ Wk 52 | 75.82 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD8+ ENV gag PP ANY IFNg+ /IL2+ Wk 52 | 32.91 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD8+ ENV PP clade C (ZA) IFNg+ /IL2+ Wk 52 | 15.38 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD4+ ENV PP (Mos1 ZA PTE) IFNg+ /IL2+ Wk 52 | 75.82 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD8+ ENV PP clade C (ZA) IFNg+ /IL2+ Wk 72 | 16.46 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD4+ ENV pol gag PP IFNg+ /IL2+ Wk 72 | 64.10 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD8+ ENV Pol gag PP IFNg+ /IL2+ Wk 28 | 76.04 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD4+ ENV pep pool (PP) (Mos1) IFNg+ /IL2+ Wk 28 | 53.61 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD8+ ENV gag PP ANY IFNg+ /IL2+ Wk 28 | 39.58 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD8+ ENV Pol gag PP IFNg+ /IL2+ Wk 52 | 71.43 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD4+ ENV gag PP ANY IFNg+ /IL2+ Wk 28 | 8.25 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD8+ ENV Pol gag PP IFNg+ /IL2+ Wk 72 | 69.62 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD4+ ENV PP (Mos1 ZA PTE) IFNg+ /IL2+ Wk 72 | 64.10 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD4+ ENV gag PP ANY IFNg+ /IL2+ Wk 52 | 3.30 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD4+ ENV PP (Mos1) IFNg+ /IL2+ Wk 72 | 53.85 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD4+ ENV gag PP ANY IFNg+ /IL2+ Wk 72 | 2.56 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD4+ ENV Pol PP (Mos1) IFNg+ /IL2+ Wk 28 | 8.25 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD4+ ENV PP clade C (ZA) IFNg+ /IL2+ Wk 28 | 46.39 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD4+ ENV PP clade C (ZA) IFNg+ /IL2+ Wk 52 | 35.00 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD4+ ENV pep pool (PP) (Mos1) IFNg+ /IL2+ Wk 28 | 41.67 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD4+ ENV PP (Mos1) IFNg+ /IL2+ Wk 52 | 50.00 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD4+ ENV PP (Mos1) IFNg+ /IL2+ Wk 72 | 36.84 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD4+ ENV PP (Mos1 ZA PTE) IFNg+ /IL2+ Wk 28 | 43.75 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD4+ ENV PP (Mos1 ZA PTE) IFNg+ /IL2+ Wk 52 | 55 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD4+ ENV PP (Mos1 ZA PTE) IFNg+ /IL2+ Wk 72 | 36.84 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD4+ ENV PP clade C (ZA) IFNg+ /IL2+ Wk 28 | 18.75 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD4+ ENV gag PP ANY IFNg+ /IL2+ Wk 72 | 5.26 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD4+ ENV PP clade C (ZA) IFNg+ /IL2+ Wk 72 | 10.53 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD4+ ENV pol gag PP IFNg+ /IL2+ Wk 28 | 45.83 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD4+ ENV pol gag PP IFNg+ /IL2+ Wk 52 | 55 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD4+ ENV pol gag PP IFNg+ /IL2+ Wk 72 | 36.84 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD4+ ENV gag PP ANY IFNg+ /IL2+ Wk 28 | 6.25 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD4+ ENV gag PP ANY IFNg+ /IL2+ Wk 52 | 10.00 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD4+ ENV Pol PP (Mos1) IFNg+ /IL2+ Wk 28 | 8.33 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD4+ ENV Pol PP (Mos1) IFNg+ /IL2+ Wk 52 | 7.50 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD4+ ENV Pol PP (Mos1) IFNg+ /IL2+ Wk 72 | 5.26 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD8+ ENV PP (Mos1) IFNg+ /IL2+ Wk 28 | 43.75 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD8+ ENV PP (Mos1) IFNg+ /IL2+ Wk 52 | 42.50 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD8+ ENV PP (Mos1) IFNg+ /IL2+ Wk 72 | 26.32 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD8+ ENV PP (Mos1 ZA PTE) IFNg+ /IL2+ Wk 28 | 45.83 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD8+ ENV PP (Mos1 ZA PTE) IFNg+ /IL2+ Wk 52 | 45.00 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD8+ ENV PP (Mos1 ZA PTE) IFNg+ /IL2+ Wk 72 | 28.95 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD8+ ENV PP clade C (ZA) IFNg+ /IL2+ Wk 28 | 22.92 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD8+ ENV PP clade C (ZA) IFNg+ /IL2+ Wk 52 | 17.50 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD8+ ENV PP clade C (ZA) IFNg+ /IL2+ Wk 72 | 10.53 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD8+ ENV Pol gag PP IFNg+ /IL2+ Wk 28 | 81.25 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD8+ ENV Pol gag PP IFNg+ /IL2+ Wk 52 | 77.50 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD8+ ENV Pol gag PP IFNg+ /IL2+ Wk 72 | 65.79 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD8+ ENV gag PP ANY IFNg+ /IL2+ Wk 28 | 39.58 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD8+ ENV gag PP ANY IFNg+ /IL2+ Wk 52 | 31.58 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD8+ Pol PP (Mos1) IFNg+ /IL2+ Wk 28 | 62.50 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD8+ Pol PP (Mos1) IFNg+ /IL2+ Wk 52 | 50.00 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD8+ Pol PP (Mos1) IFNg+ /IL2+ Wk 72 | 36.84 percentage of responders |
| Placebo | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD8+ ENV PP clade C (ZA) IFNg+ /IL2+ Wk 28 | 0 percentage of responders |
| Placebo | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD4+ ENV PP (Mos1 ZA PTE) IFNg+ /IL2+ Wk 28 | 3.23 percentage of responders |
| Placebo | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD8+ ENV gag PP ANY IFNg+ /IL2+ Wk 52 | 4.00 percentage of responders |
| Placebo | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD8+ ENV Pol gag PP IFNg+ /IL2+ Wk 52 | 3.70 percentage of responders |
| Placebo | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD4+ ENV pol gag PP IFNg+ /IL2+ Wk 28 | 3.23 percentage of responders |
| Placebo | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD8+ ENV Pol gag PP IFNg+ /IL2+ Wk 72 | 4.00 percentage of responders |
| Placebo | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD8+ ENV Pol gag PP IFNg+ /IL2+ Wk 28 | 3.23 percentage of responders |
| Placebo | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD4+ ENV pep pool (PP) (Mos1) IFNg+ /IL2+ Wk 28 | 3.23 percentage of responders |
| Placebo | Percentage of Responders for CD4+ and CD8+ T-Cell Responses | CD8+ ENV gag PP ANY IFNg+ /IL2+ Wk 28 | 3.23 percentage of responders |
Secondary
Percentage of Responders for Env Antibody-dependent Cellular Phagocytosis (ADCP) gp Antibody
The functionality of vaccine-induced antibody responses was investigated by the determination of ADCP. The response was defined as post-baseline value \> limit of detection (LOD) if baseline value \<LOD or missing or defined as post-baseline value \>3-fold increase from baseline if baseline value \>=LOD. The lower limits of detection (LODs) for this assay were 5.16, 6.43, 6.49, 4.32 and 4.28 (phagocytic score) for Clade A (92UG037.1), Clade B (1990a), Clade C (Con C), Clade C (C97ZA.012), and Mos1, respectively.
Time frame: Weeks 28, 52 and 72
Population: The PPI analysis set included all participants who had received at least first three vaccinations, according to protocol-specified vaccination schedule (+/- 2 weeks), had at least 1 measured post-dose blood sample collected and were not diagnosed with HIV infection during the study. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure; 'n' (number analyzed) signifies number of participants evaluable for specified categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for Env Antibody-dependent Cellular Phagocytosis (ADCP) gp Antibody | Clade B (1990a) at Week 28 | 69.4 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for Env Antibody-dependent Cellular Phagocytosis (ADCP) gp Antibody | Clade C (C97ZA.012) at Week 28 | 98 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for Env Antibody-dependent Cellular Phagocytosis (ADCP) gp Antibody | Mos1 at Week 28 | 100 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for Env Antibody-dependent Cellular Phagocytosis (ADCP) gp Antibody | Clade A (92UG037.1) at Week 28 | 72.4 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for Env Antibody-dependent Cellular Phagocytosis (ADCP) gp Antibody | Clade C (C97ZA.012) at Week 72 | 98.9 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for Env Antibody-dependent Cellular Phagocytosis (ADCP) gp Antibody | Clade C (C97ZA.012) at Week 52 | 97.8 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for Env Antibody-dependent Cellular Phagocytosis (ADCP) gp Antibody | Clade C (Con C) at Week 28 | 88.8 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for Env Antibody-dependent Cellular Phagocytosis (ADCP) gp Antibody | Mos1 at Week 28 | 100 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for Env Antibody-dependent Cellular Phagocytosis (ADCP) gp Antibody | Clade A (92UG037.1) at Week 28 | 36.2 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for Env Antibody-dependent Cellular Phagocytosis (ADCP) gp Antibody | Clade B (1990a) at Week 28 | 57.4 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for Env Antibody-dependent Cellular Phagocytosis (ADCP) gp Antibody | Clade C (Con C) at Week 28 | 66 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for Env Antibody-dependent Cellular Phagocytosis (ADCP) gp Antibody | Clade C (C97ZA.012) at Week 28 | 93.6 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for Env Antibody-dependent Cellular Phagocytosis (ADCP) gp Antibody | Clade C (C97ZA.012) at Week 52 | 82.5 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for Env Antibody-dependent Cellular Phagocytosis (ADCP) gp Antibody | Clade C (C97ZA.012) at Week 72 | 97.7 percentage of responders |
| Placebo | Percentage of Responders for Env Antibody-dependent Cellular Phagocytosis (ADCP) gp Antibody | Clade C (C97ZA.012) at Week 28 | 3.2 percentage of responders |
| Placebo | Percentage of Responders for Env Antibody-dependent Cellular Phagocytosis (ADCP) gp Antibody | Clade B (1990a) at Week 28 | 0 percentage of responders |
| Placebo | Percentage of Responders for Env Antibody-dependent Cellular Phagocytosis (ADCP) gp Antibody | Clade C (C97ZA.012) at Week 72 | 18.5 percentage of responders |
| Placebo | Percentage of Responders for Env Antibody-dependent Cellular Phagocytosis (ADCP) gp Antibody | Clade C (C97ZA.012) at Week 52 | 0 percentage of responders |
| Placebo | Percentage of Responders for Env Antibody-dependent Cellular Phagocytosis (ADCP) gp Antibody | Mos1 at Week 28 | 0 percentage of responders |
| Placebo | Percentage of Responders for Env Antibody-dependent Cellular Phagocytosis (ADCP) gp Antibody | Clade C (Con C) at Week 28 | 16.1 percentage of responders |
| Placebo | Percentage of Responders for Env Antibody-dependent Cellular Phagocytosis (ADCP) gp Antibody | Clade A (92UG037.1) at Week 28 | 0 percentage of responders |
Secondary
Percentage of Responders for Human Immunodeficiency Virus Neutralizing Antibody (HIV nAb)
The functionality of vaccine-induced antibody responses was investigated by the determination of nAb activity in a virus neutralization assay (VNA) using TZM-bl cells and Env-pseudotyped viruses. The response was defined as post-baseline value \>LLOQ. The LLOQ for this assay was an inhibitory concentration (IC50) of 20 (fold-dilution). The data was collected for the responses against Tier 1 HIV strain Clade C (MW965.26 and C97ZA.012).
Time frame: Weeks 28, 52 and 72
Population: The PPI analysis set included all participants who had received at least first three vaccinations, according to protocol-specified vaccination schedule (+/- 2 weeks), had at least 1 measured post-dose blood sample collected and were not diagnosed with HIV infection during the study. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure; 'n' (number analyzed) signifies number of participants evaluable for specified categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for Human Immunodeficiency Virus Neutralizing Antibody (HIV nAb) | Clade C (C97ZA.012) Week 28 | 0 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for Human Immunodeficiency Virus Neutralizing Antibody (HIV nAb) | Clade C (MW965.26) Week 72 | 98.9 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for Human Immunodeficiency Virus Neutralizing Antibody (HIV nAb) | Clade C (MW965.26) Week 28 | 99 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for Human Immunodeficiency Virus Neutralizing Antibody (HIV nAb) | Clade C (MW965.26) Week 52 | 100 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for Human Immunodeficiency Virus Neutralizing Antibody (HIV nAb) | Clade C (C97ZA.012) Week 52 | 0 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for Human Immunodeficiency Virus Neutralizing Antibody (HIV nAb) | Clade C (MW965.26) Week 72 | 100 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for Human Immunodeficiency Virus Neutralizing Antibody (HIV nAb) | Clade C (MW965.26) Week 28 | 66.7 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for Human Immunodeficiency Virus Neutralizing Antibody (HIV nAb) | Clade C (MW965.26) Week 52 | 90 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for Human Immunodeficiency Virus Neutralizing Antibody (HIV nAb) | Clade C (C97ZA.012) Week 28 | 0 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for Human Immunodeficiency Virus Neutralizing Antibody (HIV nAb) | Clade C (C97ZA.012) Week 52 | 0 percentage of responders |
| Placebo | Percentage of Responders for Human Immunodeficiency Virus Neutralizing Antibody (HIV nAb) | Clade C (C97ZA.012) Week 28 | 0 percentage of responders |
| Placebo | Percentage of Responders for Human Immunodeficiency Virus Neutralizing Antibody (HIV nAb) | Clade C (MW965.26) Week 28 | 0 percentage of responders |
| Placebo | Percentage of Responders for Human Immunodeficiency Virus Neutralizing Antibody (HIV nAb) | Clade C (MW965.26) Week 52 | 0 percentage of responders |
| Placebo | Percentage of Responders for Human Immunodeficiency Virus Neutralizing Antibody (HIV nAb) | Clade C (C97ZA.012) Week 52 | 0 percentage of responders |
Secondary
Percentage of Responders for Immunoglobulin G1 (IgG1) and IgG3 Gylcoprotein (gp) 140 Binding Antibody Assessed Using Clade C (C97ZA.012) Env Enzyme-linked Immunosorbent Assay (ELISA)
Vaccine-induced binding antibody IgG1 and IgG3 subclass responses were investigated using Clade C (C97ZA.012) specific ELISAs. The response was defined as post-baseline value \>LLOQ if baseline \<LLOQ or missing or defined as post-baseline value \>3-fold increase from baseline if baseline \>=LLOQ. The LLOQs for this assay were 12.3 and 12.4 for IgG1 and IgG3, respectively.
Time frame: Weeks 28, 52 and 72
Population: The PPI analysis set included all participants who had received at least first three vaccinations, according to protocol-specified vaccination schedule (+/- 2 weeks), had at least 1 measured post-dose blood sample collected and were not diagnosed with HIV infection during the study. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure; 'n' (number analyzed) signifies number of participants evaluable for specified categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for Immunoglobulin G1 (IgG1) and IgG3 Gylcoprotein (gp) 140 Binding Antibody Assessed Using Clade C (C97ZA.012) Env Enzyme-linked Immunosorbent Assay (ELISA) | Clade C (C97ZA.012) IgG1 at Week 28 | 72.8 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for Immunoglobulin G1 (IgG1) and IgG3 Gylcoprotein (gp) 140 Binding Antibody Assessed Using Clade C (C97ZA.012) Env Enzyme-linked Immunosorbent Assay (ELISA) | Clade C (C97ZA.012) IgG1 at Week 52 | 73.1 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for Immunoglobulin G1 (IgG1) and IgG3 Gylcoprotein (gp) 140 Binding Antibody Assessed Using Clade C (C97ZA.012) Env Enzyme-linked Immunosorbent Assay (ELISA) | Clade C (C97ZA.012) IgG1 at Week 72 | 67.0 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for Immunoglobulin G1 (IgG1) and IgG3 Gylcoprotein (gp) 140 Binding Antibody Assessed Using Clade C (C97ZA.012) Env Enzyme-linked Immunosorbent Assay (ELISA) | Clade C (C97ZA.012) IgG3 at Week 28 | 67.4 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for Immunoglobulin G1 (IgG1) and IgG3 Gylcoprotein (gp) 140 Binding Antibody Assessed Using Clade C (C97ZA.012) Env Enzyme-linked Immunosorbent Assay (ELISA) | Clade C (C97ZA.012) IgG3 at Week 52 | 66.3 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders for Immunoglobulin G1 (IgG1) and IgG3 Gylcoprotein (gp) 140 Binding Antibody Assessed Using Clade C (C97ZA.012) Env Enzyme-linked Immunosorbent Assay (ELISA) | Clade C (C97ZA.012) IgG3 at Week 72 | 37.1 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for Immunoglobulin G1 (IgG1) and IgG3 Gylcoprotein (gp) 140 Binding Antibody Assessed Using Clade C (C97ZA.012) Env Enzyme-linked Immunosorbent Assay (ELISA) | Clade C (C97ZA.012) IgG3 at Week 72 | 31 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for Immunoglobulin G1 (IgG1) and IgG3 Gylcoprotein (gp) 140 Binding Antibody Assessed Using Clade C (C97ZA.012) Env Enzyme-linked Immunosorbent Assay (ELISA) | Clade C (C97ZA.012) IgG1 at Week 28 | 61.4 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for Immunoglobulin G1 (IgG1) and IgG3 Gylcoprotein (gp) 140 Binding Antibody Assessed Using Clade C (C97ZA.012) Env Enzyme-linked Immunosorbent Assay (ELISA) | Clade C (C97ZA.012) IgG3 at Week 28 | 18.2 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for Immunoglobulin G1 (IgG1) and IgG3 Gylcoprotein (gp) 140 Binding Antibody Assessed Using Clade C (C97ZA.012) Env Enzyme-linked Immunosorbent Assay (ELISA) | Clade C (C97ZA.012) IgG3 at Week 52 | 46.2 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for Immunoglobulin G1 (IgG1) and IgG3 Gylcoprotein (gp) 140 Binding Antibody Assessed Using Clade C (C97ZA.012) Env Enzyme-linked Immunosorbent Assay (ELISA) | Clade C (C97ZA.012) IgG1 at Week 52 | 67.5 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders for Immunoglobulin G1 (IgG1) and IgG3 Gylcoprotein (gp) 140 Binding Antibody Assessed Using Clade C (C97ZA.012) Env Enzyme-linked Immunosorbent Assay (ELISA) | Clade C (C97ZA.012) IgG1 at Week 72 | 50 percentage of responders |
| Placebo | Percentage of Responders for Immunoglobulin G1 (IgG1) and IgG3 Gylcoprotein (gp) 140 Binding Antibody Assessed Using Clade C (C97ZA.012) Env Enzyme-linked Immunosorbent Assay (ELISA) | Clade C (C97ZA.012) IgG1 at Week 52 | 0 percentage of responders |
| Placebo | Percentage of Responders for Immunoglobulin G1 (IgG1) and IgG3 Gylcoprotein (gp) 140 Binding Antibody Assessed Using Clade C (C97ZA.012) Env Enzyme-linked Immunosorbent Assay (ELISA) | Clade C (C97ZA.012) IgG1 at Week 72 | 0 percentage of responders |
| Placebo | Percentage of Responders for Immunoglobulin G1 (IgG1) and IgG3 Gylcoprotein (gp) 140 Binding Antibody Assessed Using Clade C (C97ZA.012) Env Enzyme-linked Immunosorbent Assay (ELISA) | Clade C (C97ZA.012) IgG3 at Week 72 | 0 percentage of responders |
| Placebo | Percentage of Responders for Immunoglobulin G1 (IgG1) and IgG3 Gylcoprotein (gp) 140 Binding Antibody Assessed Using Clade C (C97ZA.012) Env Enzyme-linked Immunosorbent Assay (ELISA) | Clade C (C97ZA.012) IgG3 at Week 28 | 0 percentage of responders |
| Placebo | Percentage of Responders for Immunoglobulin G1 (IgG1) and IgG3 Gylcoprotein (gp) 140 Binding Antibody Assessed Using Clade C (C97ZA.012) Env Enzyme-linked Immunosorbent Assay (ELISA) | Clade C (C97ZA.012) IgG1 at Week 28 | 0 percentage of responders |
| Placebo | Percentage of Responders for Immunoglobulin G1 (IgG1) and IgG3 Gylcoprotein (gp) 140 Binding Antibody Assessed Using Clade C (C97ZA.012) Env Enzyme-linked Immunosorbent Assay (ELISA) | Clade C (C97ZA.012) IgG3 at Week 52 | 0 percentage of responders |
Secondary
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot)
Frozen peripheral blood mononuclear cell (PBMCs) were analyzed by interferon-gamma (IFN-gamma) (ELISpot). The response was defined as post-baseline value \>P95 if baseline \<P95 or missing or defined as post-baseline value \>3-fold increase from baseline if baseline \>=P95.
Time frame: Weeks 26, 52 and 72
Population: The PPI analysis set included all participants who had received at least first three vaccinations, according to protocol-specified vaccination schedule (+/- 2 weeks), had at least 1 measured post-dose blood sample collected and were not diagnosed with HIV infection during the study. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure; 'n' (number analyzed) signifies number of participants evaluable for specified categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Gag peptide pool PTE at Week 26 | 58.6 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Pol peptide pool Mos2 at Week 72 | 89.9 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Pol peptide pool PTE at Week 26 | 87.9 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Gag peptide pool PTE at Week 52 | 57.6 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | ENV peptide pool potential T-cell epitope (PTE) at Week 26 | 96 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Gag peptide pool Mos2 at Week 72 | 64 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Gag peptide pool PTE at Week 72 | 41.6 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | ENV peptide pool Mos1 at Week 52 | 98.9 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Gag peptide pool Mos2 at Week 52 | 65.2 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Gag peptide pool Mos1 at Week 26 | 59.6 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Pol peptide pool Mos2 at Week 52 | 89.1 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Gag peptide pool Mos2 at Week 26 | 69.7 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Gag peptide pool Mos1 at Week 52 | 60.9 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Pol peptide pool Mos1 at Week 72 | 85.4 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Gag peptide pool Mos1 at Week 72 | 57.3 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | ENV peptide pool Mos1 at Week 72 | 97.8 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | ENV peptide pool PTE at Week 72 | 97.8 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Pol peptide pool Mos1 at Week 52 | 82.6 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | ENV peptide pool Mos2 at Week 26 | 96 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | ENV peptide pool PTE at Week 52 | 95.7 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Pol peptide pool Mos1 at Week 26 | 88.9 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | ENV peptide pool Mos2 at Week 52 | 93.5 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Pol peptide pool Mos2 at Week 26 | 92.9 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Pol peptide pool PTE at Week 72 | 87.6 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | ENV peptide pool Mos2 at Week 72 | 95.5 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | ENV peptide pool Mos1 at Week 26 | 96 percentage of responders |
| Tetravalent Ad26.Mos4.HIV Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Pol peptide pool PTE at Week 52 | 84.8 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Pol peptide pool Mos1 at Week 72 | 81 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | ENV peptide pool potential T-cell epitope (PTE) at Week 26 | 79.2 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | ENV peptide pool PTE at Week 52 | 85 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | ENV peptide pool PTE at Week 72 | 83.3 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | ENV peptide pool Mos1 at Week 26 | 87.5 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | ENV peptide pool Mos1 at Week 52 | 92.5 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | ENV peptide pool Mos1 at Week 72 | 92.9 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | ENV peptide pool Mos2 at Week 26 | 58.3 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | ENV peptide pool Mos2 at Week 52 | 77.5 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | ENV peptide pool Mos2 at Week 72 | 70 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Gag peptide pool PTE at Week 26 | 60.4 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Gag peptide pool PTE at Week 52 | 70 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Gag peptide pool PTE at Week 72 | 47.6 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Gag peptide pool Mos1 at Week 26 | 54.2 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Gag peptide pool Mos1 at Week 52 | 60 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Gag peptide pool Mos1 at Week 72 | 54.8 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Gag peptide pool Mos2 at Week 26 | 60.4 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Gag peptide pool Mos2 at Week 52 | 62.5 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Gag peptide pool Mos2 at Week 72 | 60 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Pol peptide pool PTE at Week 26 | 91.7 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Pol peptide pool PTE at Week 52 | 85 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Pol peptide pool PTE at Week 72 | 90 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Pol peptide pool Mos1 at Week 26 | 85.4 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Pol peptide pool Mos1 at Week 52 | 92.5 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Pol peptide pool Mos2 at Week 26 | 93.8 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Pol peptide pool Mos2 at Week 52 | 90 percentage of responders |
| Trivalent Ad26.Mos.HIV Vaccine | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Pol peptide pool Mos2 at Week 72 | 92.5 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Gag peptide pool PTE at Week 26 | 3.2 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | ENV peptide pool potential T-cell epitope (PTE) at Week 26 | 3.2 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Pol peptide pool PTE at Week 26 | 0 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | ENV peptide pool Mos2 at Week 72 | 0 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Pol peptide pool Mos2 at Week 26 | 3.2 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Pol peptide pool PTE at Week 52 | 3.8 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | ENV peptide pool Mos2 at Week 52 | 3.8 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | ENV peptide pool PTE at Week 52 | 3.8 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Pol peptide pool PTE at Week 72 | 11.1 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | ENV peptide pool Mos2 at Week 26 | 3.2 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Pol peptide pool Mos2 at Week 72 | 7.4 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Pol peptide pool Mos1 at Week 26 | 3.2 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | ENV peptide pool Mos1 at Week 72 | 18.5 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Pol peptide pool Mos2 at Week 52 | 3.8 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Pol peptide pool Mos1 at Week 52 | 3.8 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Gag peptide pool Mos1 at Week 52 | 3.8 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | ENV peptide pool Mos1 at Week 52 | 3.8 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Gag peptide pool Mos1 at Week 72 | 3.7 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Gag peptide pool Mos1 at Week 26 | 0 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | ENV peptide pool Mos1 at Week 26 | 6.5 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Gag peptide pool Mos2 at Week 26 | 0 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Gag peptide pool PTE at Week 72 | 0 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Pol peptide pool Mos1 at Week 72 | 14.8 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Gag peptide pool Mos2 at Week 52 | 0 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Gag peptide pool PTE at Week 52 | 0 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | ENV peptide pool PTE at Week 72 | 3.7 percentage of responders |
| Placebo | Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) | Gag peptide pool Mos2 at Week 72 | 0 percentage of responders |