A Phase 1/2 interventional study of Ad26.Mos.HIV and Ad26.Mos4.HIV in Healthy, sponsored by Janssen Vaccines & Prevention B.V.. Completed at 10 sites in 2 countries. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-25.
Sponsored by Janssen Vaccines & Prevention B.V. (part of Johnson & Johnson) · Phase 1/2, Interventional, and Prevention
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.
Janssen Vaccines & Prevention B.V. is the lead sponsor of 49 studies on the registry; none are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 32 (86%) have results posted.
First submitted after Janssen Vaccines & Prevention B.V. became part of Johnson & Johnson.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive Ad26.Mos.HIV vaccine at Week 0 and 12, followed by Ad26.Mos.HIV vaccine + Clade C glycoprotein 140 vaccine containing 250 micrograms (mcg) of total protein mixed with adjuvant (aluminum phosphate) at Week 24 and 48.
Biological: Ad26.Mos.HIV · Biological: Clade C gp140
Participants will receive placebo at Weeks 0, 12, 24 and 48.
Drug: Placebo
Participants will receive Ad26.Mos4.HIV vaccine at Week 0 and 12; followed by Ad26.Mos4.HIV vaccine + Clade C glycoprotein 140 vaccine containing 250 micrograms (mcg) of total protein mixed with adjuvant (aluminum phosphate) at Week 24 and 48. Participants will be included in an optional Long-term Extension (LTE) phase (3 years or 4 years Follow-up after Week 72, every 6 months visit) to assess immunogenicity and safety (serious adverse events \[SAEs\]).
Biological: Ad26.Mos4.HIV · Biological: Clade C gp140
Participants will receive placebo at Weeks 0, 12, 24 and 48.
Drug: Placebo
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.
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.
Clade C gp140 vaccine containing 250 mcg of total protein, mixed with aluminum phosphate adjuvant, per 0.5 mL injection administered intramuscularly.
Normal saline 0.9 percent (%), 0.5 mL injection administered intramuscularly.
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
| Milestone | Tetravalent Ad26.Mos4.HIV Vaccine | Trivalent Ad26.Mos.HIV Vaccine | Placebo |
|---|---|---|---|
| Started | 110 | 55 | 33 |
| Completed | 94 | 45 | 28 |
| Not completed | 16 | 10 | 5 |
| Withdrew: Adverse event | 0 | 1 | 1 |
| Withdrew: Lost to follow-up | 5 | 4 | 3 |
| Withdrew: Pregnancy | 1 | 1 | 0 |
| Withdrew: Protocol violation | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 6 | 4 | 1 |
| Withdrew: Other | 3 | 0 | 0 |
| Milestone | Tetravalent Ad26.Mos4.HIV Vaccine | Trivalent Ad26.Mos.HIV Vaccine | Placebo |
|---|---|---|---|
| Started | 77 | 0 | 0 |
| Completed | 60 | 0 | 0 |
| Not completed | 17 | 0 | 0 |
| Withdrew: Lost to follow-up | 8 | 0 | 0 |
| Withdrew: Withdrawal by subject | 8 | 0 | 0 |
| Withdrew: Other | 1 | 0 | 0 |
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 | Tetravalent Ad26.Mos4.HIV Vaccine | Trivalent Ad26.Mos.HIV Vaccine | Placebo |
|---|---|---|---|
| Percentage of Participants With Solicited Local Adverse Events (AEs) Post First Vaccination | 70.9 | 78.2 | 27.3 |
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 | Tetravalent Ad26.Mos4.HIV Vaccine | Trivalent Ad26.Mos.HIV Vaccine | Placebo |
|---|---|---|---|
| Percentage of Participants With Solicited Local AEs Post Second Vaccination | 83.3 | 76.5 | 50 |
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 | Tetravalent Ad26.Mos4.HIV Vaccine | Trivalent Ad26.Mos.HIV Vaccine | Placebo |
|---|---|---|---|
| Percentage of Participants With Solicited Local AEs Post Third Vaccination | 80.8 | 79.6 | 21.9 |
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 | Tetravalent Ad26.Mos4.HIV Vaccine | Trivalent Ad26.Mos.HIV Vaccine | Placebo |
|---|---|---|---|
| Percentage of Participants With Solicited Local AEs Post Fourth Vaccination | 84 | 68.9 | 29.6 |
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 | Tetravalent Ad26.Mos4.HIV Vaccine | Trivalent Ad26.Mos.HIV Vaccine | Placebo |
|---|---|---|---|
| Percentage of Participants With Solicited Systemic AEs Post First Vaccination | 69.1 | 83.6 | 54.5 |
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 | Tetravalent Ad26.Mos4.HIV Vaccine | Trivalent Ad26.Mos.HIV Vaccine | Placebo |
|---|---|---|---|
| Percentage of Participants With Solicited Systemic AEs Post Second Vaccination | 66.7 | 54.9 | 40.6 |
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 | Tetravalent Ad26.Mos4.HIV Vaccine | Trivalent Ad26.Mos.HIV Vaccine | Placebo |
|---|---|---|---|
| Percentage of Participants With Solicited Systemic AEs Post Third Vaccination | 59.6 | 44.9 | 34.4 |
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 | Tetravalent Ad26.Mos4.HIV Vaccine | Trivalent Ad26.Mos.HIV Vaccine | Placebo |
|---|---|---|---|
| Percentage of Participants With Solicited Systemic AEs Post Fourth Vaccination | 58.5 | 53.3 | 33.3 |
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 | Tetravalent Ad26.Mos4.HIV Vaccine | Trivalent Ad26.Mos.HIV Vaccine | Placebo |
|---|---|---|---|
| Percentage of Participants With Unsolicited AEs for 28 Days After First Vaccination | 38.2 | 41.8 | 30.3 |
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 | Tetravalent Ad26.Mos4.HIV Vaccine | Trivalent Ad26.Mos.HIV Vaccine | Placebo |
|---|---|---|---|
| Percentage of Participants With Unsolicited AEs for 28 Days After Second Vaccination | 30.4 | 23.5 | 37.5 |
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 | Tetravalent Ad26.Mos4.HIV Vaccine | Trivalent Ad26.Mos.HIV Vaccine | Placebo |
|---|---|---|---|
| Percentage of Participants With Unsolicited AEs for 28 Days After Third Vaccination | 28.3 | 20.4 | 21.9 |
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 | Tetravalent Ad26.Mos4.HIV Vaccine | Trivalent Ad26.Mos.HIV Vaccine | Placebo |
|---|---|---|---|
| Percentage of Participants With Unsolicited AEs for 28 Days After Fourth Vaccination | 36.2 | 22.2 | 40.7 |
Percentage of participants with discontinuations from vaccination due to AEs were reported.
| percentage of participants | Tetravalent Ad26.Mos4.HIV Vaccine | Trivalent Ad26.Mos.HIV Vaccine | Placebo |
|---|---|---|---|
| Percentage of Participants With Discontinuations From Vaccination Due to AEs | 0 | 1.8 | 6.1 |
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 | Tetravalent Ad26.Mos4.HIV Vaccine | Trivalent Ad26.Mos.HIV Vaccine | Placebo |
|---|---|---|---|
| Percentage of Participants With Serious Adverse Events (SAEs) During Main Study | 5.5 | 0 | 0 |
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 | Tetravalent Ad26.Mos4.HIV Vaccine |
|---|---|
| Percentage of Participants With SAEs During Long Term Extension (LTE) Period | 5.2 |
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 | Tetravalent Ad26.Mos4.HIV Vaccine | Trivalent Ad26.Mos.HIV Vaccine | Placebo |
|---|---|---|---|
| Percentage of Participants With AEs of Special Interest During Main Study | 0 | 0 | 0 |
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 participants | Tetravalent Ad26.Mos4.HIV Vaccine |
|---|---|
| Percentage of Participants With AEs of Special Interest During LTE Period | 0 |
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 | Tetravalent Ad26.Mos4.HIV Vaccine | Trivalent Ad26.Mos.HIV Vaccine | Placebo |
|---|---|---|---|
| Clade A (92UG037.1) | 100 (96.3 to 100.0) | 100 (92.6 to 100.0) | 19.4 (7.5 to 37.5) |
| Clade B (1990a) | 100 (96.3 to 100.0) | 100 (92.6 to 100.0) | 12.9 (3.6 to 29.8) |
| Clade C (Con C) | 100 (96.2 to 100) | 100 (92.6 to 100) | 12.9 (3.6 to 29.8) |
| Clade C (C97ZA.012) | 100 (96.3 to 100) | 100 (92.6 to 100) | 6.5 (0.8 to 21.4) |
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 responders | Tetravalent Ad26.Mos4.HIV Vaccine | Trivalent Ad26.Mos.HIV Vaccine | Placebo |
|---|---|---|---|
| Clade A (92UG037.1) | 100 (96.1 to 100.0) | 100 (91.2 to 100.0) | 0 (0 to 0) |
| Clade B (1990a) | 100 (96.1 to 100) | 100 (91.2 to 100) | 22.2 (8.6 to 42.3) |
| Clade C (Con C) | 100 (96.1 to 100) | 100 (91.2 to 100) | 0 (0 to 0) |
| Clade C (C97ZA.012) | 100 (96.1 to 100) | 100 (91.2 to 100) | 3.7 (0.1 to 19.0) |
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 responders | Tetravalent Ad26.Mos4.HIV Vaccine | Trivalent Ad26.Mos.HIV Vaccine | Placebo |
|---|---|---|---|
| Clade A (92UG037.1) | 100 (96.1 to 100.0) | 100 (91.8 to 100.0) | 2 (0.9 to 24.3) |
| Clade B (1990a) | 100 (96.1 to 100) | 100 (91.8 to 100) | 11.1 (2.4 to 29.2) |
| Clade C (Con C) | 100 (96 to 100) | 100 (91.8 to 100) | 0 (0 to 0) |
| Clade C (C97ZA.012) | 100 (96.1 to 100) | 100 (91.8 to 100) | 3.7 (0.1 to 19) |
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).
| percentage of responders | Tetravalent Ad26.Mos4.HIV Vaccine | Trivalent Ad26.Mos.HIV Vaccine | Placebo |
|---|---|---|---|
| Clade C (MW965.26) Week 28 | 99 (94.4 to 100.0) | 66.7 (51.6 to 79.6) | 0 (0 to 0) |
| Clade C (MW965.26) Week 52 | 100 (96.1 to 100.0) | 90 (76.3 to 97.2) | 0 (0 to 0) |
| Clade C (MW965.26) Week 72 | 98.9 (94.1 to 100.0) | 100 (85.8 to 100.0) | — |
| Clade C (C97ZA.012) Week 28 | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) |
| Clade C (C97ZA.012) Week 52 | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) |
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 | Tetravalent Ad26.Mos4.HIV Vaccine | Trivalent Ad26.Mos.HIV Vaccine | Placebo |
|---|---|---|---|
| Clade A (92UG037.1) at Week 28 | 72.4 (62.5 to 81) | 36.2 (22.7 to 51.5) | 0 (0 to 0) |
| Clade B (1990a) at Week 28 | 69.4 (59.3 to 78.3) | 57.4 (42.2 to 71.7) | 0 (0 to 0) |
| Clade C (Con C) at Week 28 | 88.8 (80.8 to 94.3) | 66 (50.7 to 79.1) | 16.1 (5.5 to 33.7) |
| Mos1 at Week 28 | 100 (96.3 to 100) | 100 (92.5 to 100) | 0 (0 to 0) |
| Clade C (C97ZA.012) at Week 28 | 98 (92.8 to 99.8) | 93.6 (82.5 to 98.7) | 3.2 (0.1 to 16.7) |
| Clade C (C97ZA.012) at Week 52 | 97.8 (92.4 to 99.7) | 82.5 (67.2 to 92.7) | 0 (0 to 0) |
| Clade C (C97ZA.012) at Week 72 | 98.9 (94.1 to 100) | 97.7 (87.7 to 99.9) | 18.5 (6.3 to 38.1) |
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 | Tetravalent Ad26.Mos4.HIV Vaccine | Trivalent Ad26.Mos.HIV Vaccine | Placebo |
|---|---|---|---|
| ENV peptide pool potential T-cell epitope (PTE) at Week 26 | 96 (90.0 to 98.9) | 79.2 (65 to 89.5) | 3.2 (0.1 to 16.7) |
| ENV peptide pool PTE at Week 52 | 95.7 (89.2 to 98.8) | 85 (70.2 to 94.3) | 3.8 (0.1 to 19.6) |
| ENV peptide pool PTE at Week 72 | 97.8 (92.1 to 99.7) | 83.3 (68.6 to 93) | 3.7 (0.1 to 19) |
| ENV peptide pool Mos1 at Week 26 | 96 (90 to 98.9) | 87.5 (74.8 to 95.3) | 6.5 (0.8 to 21.4) |
| ENV peptide pool Mos1 at Week 52 | 98.9 (94.1 to 100) | 92.5 (79.6 to 98.4) | 3.8 (0.1 to 19.6) |
| ENV peptide pool Mos1 at Week 72 | 97.8 (92.1 to 99.7) | 92.9 (80.5 to 98.5) | 18.5 (6.3 to 38.1) |
| ENV peptide pool Mos2 at Week 26 | 96 (90 to 98.9) | 58.3 (43.2 to 72.4) | 3.2 (0.1 to 16.7) |
| ENV peptide pool Mos2 at Week 52 | 93.5 (86.3 to 97.6) | 77.5 (61.5 to 89.2) | 3.8 (0.1 to 19.6) |
| ENV peptide pool Mos2 at Week 72 | 95.5 (88.9 to 98.8) | 70 (53.5 to 83.4) | 0 (0 to 0) |
| Gag peptide pool PTE at Week 26 | 58.6 (48.2 to 68.4) | 60.4 (45.3 to 74.2) | 3.2 (0.1 to 16.7) |
| Gag peptide pool PTE at Week 52 | 57.6 (46.9 to 67.9) | 70 (53.5 to 83.4) | 0 (0 to 0) |
| Gag peptide pool PTE at Week 72 | 41.6 (31.2 to 52.5) | 47.6 (32 to 63.6) | 0 (0 to 0) |
| Gag peptide pool Mos1 at Week 26 | 59.6 (49.3 to 69.3) | 54.2 (39.2 to 68.6) | 0 (0 to 0) |
| Gag peptide pool Mos1 at Week 52 | 60.9 (50.1 to 70.9) | 60 (43.3 to 75.1) | 3.8 (0.1 to 19.6) |
| Gag peptide pool Mos1 at Week 72 | 57.3 (46.4 to 67.7) | 54.8 (38.7 to 70.2) | 3.7 (0.1 to 19) |
| Gag peptide pool Mos2 at Week 26 | 69.7 (59.6 to 78.5) | 60.4 (45.3 to 74.2) | 0 (0 to 0) |
| Gag peptide pool Mos2 at Week 52 | 65.2 (54.6 to 74.9) | 62.5 (45.8 to 77.3) | 0 (0 to 0) |
| Gag peptide pool Mos2 at Week 72 | 64 (53.2 to 73.9) | 60 (43.3 to 75.1) | 0 (0 to 0) |
| Pol peptide pool PTE at Week 26 | 87.9 (79.8 to 93.6) | 91.7 (80 to 97.7) | 0 (0 to 0) |
| Pol peptide pool PTE at Week 52 | 84.8 (75.8 to 91.4) | 85 (70.2 to 94.3) | 3.8 (0.1 to 19.6) |
| Pol peptide pool PTE at Week 72 | 87.6 (79 to 93.7) | 90 (76.3 to 97.2) | 11.1 (2.4 to 29.2) |
| Pol peptide pool Mos1 at Week 26 | 88.9 (81.0 to 94.3) | 85.4 (72.2 to 93.9) | 3.2 (0.1 to 16.7) |
| Pol peptide pool Mos1 at Week 52 | 82.6 (73.3 to 89.7) | 92.5 (79.6 to 98.4) | 3.8 (0.1 to 19.6) |
| Pol peptide pool Mos1 at Week 72 | 85.4 (76.3 to 92.0) | 81 (65.9 to 91.4) | 14.8 (4.2 to 33.7) |
| Pol peptide pool Mos2 at Week 26 | 92.9 (86 to 97.1) | 93.8 (82.8 to 98.7) | 3.2 (0.1 to 16.7) |
| Pol peptide pool Mos2 at Week 52 | 89.1 (80.9 to 94.7) | 90 (76.3 to 97.2) | 3.8 (0.1 to 19.6) |
| Pol peptide pool Mos2 at Week 72 | 89.9 (81.7 to 95.3) | 92.5 (79.6 to 98.4) | 7.4 (0.9 to 24.3) |
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 | Tetravalent Ad26.Mos4.HIV Vaccine | Trivalent Ad26.Mos.HIV Vaccine | Placebo |
|---|---|---|---|
| Clade C (C97ZA.012) IgG1 at Week 28 | 72.8 (62.6 to 81.6) | 61.4 (45.5 to 75.6) | 0 (0 to 0) |
| Clade C (C97ZA.012) IgG1 at Week 52 | 73.1 (62.9 to 81.8) | 67.5 (50.9 to 81.4) | 0 (0 to 0) |
| Clade C (C97ZA.012) IgG1 at Week 72 | 67.0 (56.4 to 76.5) | 50 (34.2 to 65.8) | 0 (0 to 0) |
| Clade C (C97ZA.012) IgG3 at Week 28 | 67.4 (56.8 to 76.8) | 18.2 (8.2 to 32.7) | 0 (0 to 0) |
| Clade C (C97ZA.012) IgG3 at Week 52 | 66.3 (55.7 to 75.8) | 46.2 (30.1 to 62.8) | 0 (0 to 0) |
| Clade C (C97ZA.012) IgG3 at Week 72 | 37.1 (27.1 to 48) | 31 (17.6 to 47.1) | 0 (0 to 0) |
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 responders | Tetravalent Ad26.Mos4.HIV Vaccine | Trivalent Ad26.Mos.HIV Vaccine | Placebo |
|---|---|---|---|
| CD4+ ENV pep pool (PP) (Mos1) IFNg+ /IL2+ Wk 28 | 53.61 (43.19 to 63.80) | 41.67 (27.61 to 56.79) | 3.23 (0.08 to 16.70) |
| CD4+ ENV PP (Mos1) IFNg+ /IL2+ Wk 52 | 64.84 (54.12 to 74.56) | 50.00 (33.80 to 66.20) | — |
| CD4+ ENV PP (Mos1) IFNg+ /IL2+ Wk 72 | 53.85 (42.18 to 65.21) | 36.84 (21.81 to 54.01) | — |
| CD4+ ENV PP (Mos1 ZA PTE) IFNg+ /IL2+ Wk 28 | 56.70 (46.25 to 66.73) | 43.75 (29.48 to 58.82) | 3.23 (0.08 to 16.70) |
| CD4+ ENV PP (Mos1 ZA PTE) IFNg+ /IL2+ Wk 52 | 75.82 (65.72 to 84.19) | 55 (38.49 to 70.74) | — |
| CD4+ ENV PP (Mos1 ZA PTE) IFNg+ /IL2+ Wk 72 | 64.10 (52.44 to 74.66) | 36.84 (21.81 to 54.01) | — |
| CD4+ ENV PP clade C (ZA) IFNg+ /IL2+ Wk 28 | 46.39 (36.20 to 56.81) | 18.75 (8.95 to 32.63) | — |
| CD4+ ENV PP clade C (ZA) IFNg+ /IL2+ Wk 52 | 63.74 (52.99 to 73.56) | 35.00 (20.63 to 51.68) | — |
| CD4+ ENV PP clade C (ZA) IFNg+ /IL2+ Wk 72 | 51.28 (39.69 to 62.77) | 10.53 (2.94 to 24.80) | — |
| CD4+ ENV pol gag PP IFNg+ /IL2+ Wk 28 | 57.73 (47.28 to 67.70) | 45.83 (31.37 to 60.83) | 3.23 (0.08 to 16.70) |
| CD4+ ENV pol gag PP IFNg+ /IL2+ Wk 52 | 75.82 (65.72 to 84.19) | 55 (38.49 to 70.74) | — |
| CD4+ ENV pol gag PP IFNg+ /IL2+ Wk 72 | 64.10 (52.44 to 74.66) | 36.84 (21.81 to 54.01) | — |
| CD4+ ENV gag PP ANY IFNg+ /IL2+ Wk 28 | 8.25 (3.63 to 15.61) | 6.25 (1.31 to 17.20) | — |
| CD4+ ENV gag PP ANY IFNg+ /IL2+ Wk 52 | 3.30 (0.69 to 9.33) | 10.00 (2.79 to 23.66) | — |
| CD4+ ENV gag PP ANY IFNg+ /IL2+ Wk 72 | 2.56 (0.31 to 8.96) | 5.26 (0.64 to 17.75) | — |
| CD4+ ENV Pol PP (Mos1) IFNg+ /IL2+ Wk 28 | 8.25 (3.63 to 15.61) | 8.33 (2.32 to 19.98) | — |
| CD4+ ENV Pol PP (Mos1) IFNg+ /IL2+ Wk 52 | 6.59 (2.46 to 13.80) | 7.50 (1.57 to 20.39) | — |
| CD4+ ENV Pol PP (Mos1) IFNg+ /IL2+ Wk 72 | 6.41 (2.11 to 14.33) | 5.26 (0.64 to 17.75) | — |
| CD8+ ENV PP (Mos1) IFNg+ /IL2+ Wk 28 | 35.42 (25.92 to 45.84) | 43.75 (29.48 to 58.82) | — |
| CD8+ ENV PP (Mos1) IFNg+ /IL2+ Wk 52 | 30.77 (21.51 to 41.32) | 42.50 (27.04 to 59.11) | — |
| CD8+ ENV PP (Mos1) IFNg+ /IL2+ Wk 72 | 29.11 (19.43 to 40.42) | 26.32 (13.40 to 43.10) | — |
| CD8+ ENV PP (Mos1 ZA PTE) IFNg+ /IL2+ Wk 28 | 41.67 (31.68 to 52.18) | 45.83 (31.37 to 60.83) | — |
| CD8+ ENV PP (Mos1 ZA PTE) IFNg+ /IL2+ Wk 52 | 34.07 (24.45 to 44.75) | 45.00 (29.26 to 61.51) | — |
| CD8+ ENV PP (Mos1 ZA PTE) IFNg+ /IL2+ Wk 72 | 34.18 (23.87 to 45.71) | 28.95 (15.42 to 45.90) | — |
| CD8+ ENV PP clade C (ZA) IFNg+ /IL2+ Wk 28 | 21.88 (14.08 to 31.47) | 22.92 (12.03 to 37.31) | 0 (0 to 0) |
| CD8+ ENV PP clade C (ZA) IFNg+ /IL2+ Wk 52 | 15.38 (8.67 to 24.46) | 17.50 (7.34 to 32.78) | — |
| CD8+ ENV PP clade C (ZA) IFNg+ /IL2+ Wk 72 | 16.46 (9.06 to 26.49) | 10.53 (2.94 to 24.80) | — |
| CD8+ ENV Pol gag PP IFNg+ /IL2+ Wk 28 | 76.04 (66.25 to 84.17) | 81.25 (67.37 to 91.05) | 3.23 (0.08 to 16.70) |
| CD8+ ENV Pol gag PP IFNg+ /IL2+ Wk 52 | 71.43 (61.00 to 80.41) | 77.50 (61.55 to 89.16) | 3.70 (0.09 to 18.97) |
| CD8+ ENV Pol gag PP IFNg+ /IL2+ Wk 72 | 69.62 (58.25 to 79.47) | 65.79 (48.65 to 80.37) | 4.00 (0.10 to 20.35) |
| CD8+ ENV gag PP ANY IFNg+ /IL2+ Wk 28 | 39.58 (29.75 to 50.08) | 39.58 (25.77 to 54.73) | 3.23 (0.08 to 16.70) |
| CD8+ ENV gag PP ANY IFNg+ /IL2+ Wk 52 | 32.91 (22.75 to 44.40) | 31.58 (17.50 to 48.65) | 4.00 (0.10 to 20.35) |
| CD8+ Pol PP (Mos1) IFNg+ /IL2+ Wk 28 | 62.50 (52.03 to 72.18) | 62.50 (47.35 to 76.05) | — |
| CD8+ Pol PP (Mos1) IFNg+ /IL2+ Wk 52 | 54.95 (44.16 to 65.40) | 50.00 (33.80 to 66.20) | — |
| CD8+ Pol PP (Mos1) IFNg+ /IL2+ Wk 72 | 51.90 (40.36 to 63.29) | 36.84 (21.81 to 54.01) | — |
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.
No measurements were reported for this outcome.
Collected over Up to Week 264. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tetravalent Ad26.Mos4.HIV Vaccine | 0/110 (0%) | 9/110 (8.2%) | 37/110 (33.6%) |
| Trivalent Ad26.Mos.HIV Vaccine | 0/55 (0%) | 0/55 (0%) | 22/55 (40%) |
| Placebo | 0/33 (0%) | 0/33 (0%) | 15/33 (45.5%) |
| Event | Tetravalent Ad26.Mos4.HIV Vaccine | Trivalent Ad26.Mos.HIV Vaccine | Placebo |
|---|---|---|---|
| Angina PectorisCardiac disorders | 1/110 | 0/55 | 0/33 |
| Atrial FibrillationCardiac disorders | 1/110 | 0/55 | 0/33 |
| Covid-19 PneumoniaInfections and infestations | 1/110 | 0/55 | 0/33 |
| PneumoniaInfections and infestations | 1/110 | 0/55 | 0/33 |
| Ankle FractureInjury, poisoning and procedural complications | 1/110 | 0/55 | 0/33 |
| Rheumatoid ArthritisMusculoskeletal and connective tissue disorders | 1/110 | 0/55 | 0/33 |
| Acoustic NeuromaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/110 | 0/55 | 0/33 |
| SyncopeNervous system disorders | 1/110 | 0/55 | 0/33 |
| Abortion SpontaneousPregnancy, puerperium and perinatal conditions | 1/110 | 0/55 | 0/33 |
| Bipolar I DisorderPsychiatric disorders | 1/110 | 0/55 | 0/33 |
| Event | Tetravalent Ad26.Mos4.HIV Vaccine | Trivalent Ad26.Mos.HIV Vaccine | Placebo |
|---|---|---|---|
| Upper Respiratory Tract InfectionInfections and infestations | 17/110 | 9/55 | 10/33 |
| Alanine Aminotransferase IncreasedInvestigations | 5/110 | 2/55 | 3/33 |
| Urinary Tract InfectionInfections and infestations | 2/110 | 4/55 | 0/33 |
| Viral InfectionInfections and infestations | 7/110 | 2/55 | 0/33 |
| Muscle StrainInjury, poisoning and procedural complications | 0/110 | 0/55 | 2/33 |
| Dermatitis ContactSkin and subcutaneous tissue disorders | 1/110 | 1/55 | 2/33 |
| GastroenteritisInfections and infestations | 5/110 | 3/55 | 1/33 |
| Haemoglobin DecreasedInvestigations | 0/110 | 3/55 | 0/33 |
| ProteinuriaRenal and urinary disorders | 3/110 | 3/55 | 0/33 |
| Oropharyngeal PainRespiratory, thoracic and mediastinal disorders | 2/110 | 3/55 | 1/33 |
| Age, Continuous(years) | Tetravalent Ad26.Mos4.HIV Vaccine | Trivalent Ad26.Mos.HIV Vaccine | Placebo | Total |
|---|---|---|---|---|
| Median | 28.0 (18 to 50) | 27.0 (19 to 50) | 27.0 (18 to 44) | 27.0 (18 to 50) |
| Sex: Female, Male(Participants) | Tetravalent Ad26.Mos4.HIV Vaccine | Trivalent Ad26.Mos.HIV Vaccine | Placebo | Total |
|---|---|---|---|---|
| Female | 54 | 32 | 24 | 110 |
| Male | 56 | 23 | 9 | 88 |
| Ethnicity (NIH/OMB)(Participants) | Tetravalent Ad26.Mos4.HIV Vaccine | Trivalent Ad26.Mos.HIV Vaccine | Placebo | Total |
|---|---|---|---|---|
| Hispanic or Latino | 13 | 6 | 4 | 23 |
| Not Hispanic or Latino | 96 | 48 | 29 | 173 |
| Unknown or Not Reported | 1 | 1 | 0 | 2 |
| Race/Ethnicity, Customized(Participants) | Tetravalent Ad26.Mos4.HIV Vaccine | Trivalent Ad26.Mos.HIV Vaccine | Placebo | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 1 | 0 | 2 |
| Asian | 5 | 5 | 0 | 10 |
| Black or African American | 35 | 18 | 7 | 60 |
| White | 58 | 24 | 23 | 105 |
| More than one race | 6 | 5 | 2 | 13 |
| Unknown or Not Reported | 1 | 0 | 1 | 2 |
| Other | 4 | 2 | 0 | 6 |
| Region of Enrollment(Participants) | Tetravalent Ad26.Mos4.HIV Vaccine | Trivalent Ad26.Mos.HIV Vaccine | Placebo | Total |
|---|---|---|---|---|
| RWANDA | 10 | 5 | 2 | 17 |
| UNITED STATES | 100 | 50 | 31 | 181 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jul 2016 to primary completion in Apr 2022, 69 months.
Results were first posted in Jun 2023, 1 year 1 month after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ad26.Mos4.HIV
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