HealthyPhase 1/2NCT02788045
Safety, Tolerability and Immunogenicity Study of Different Vaccine Regimens of Trivalent Ad26.Mos.HIV or Tetravalent Ad26.Mos4.HIV Along With Clade C Glycoprotein (gp)140 in Healthy Human Immunodeficiency Virus (HIV)-Uninfected Adults
A Phase 1/2 study testing Ad26.Mos.HIV, Ad26.Mos4.HIV and Clade C gp140 in people with Healthy, run by Janssen Vaccines & Prevention B.V. at 10 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ad26.Mos.HIV, Ad26.Mos4.HIV and Clade C gp140
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 201 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 8 Jul 2016to 25 Apr 2022
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States9 sites
Study site
Birmingham, Alabama
Study site
Boston, Massachusetts
Study site
Decatur, Georgia
Study site
New York, New York
Study site
Philadelphia, Pennsylvania
Study site
Rochester, New York
Study site
San Francisco, California
Study site
Seattle, Washington
Study site
Silver Spring, Maryland
About this study
Official title: A Randomized, Parallel-Group, Placebo-Controlled, Double-Blind Phase 1/2a Study in Healthy HIV Uninfected Adults to Assess the Safety/Tolerability and Immunogenicity of 2 Different Prime/Boost Regimens; 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 Tetravalent Ad26.Mos4.HIV and Clade C Gp140 Plus Adjuvant
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.
- Conditions
- Healthy
- Being tested
- Ad26.Mos.HIV, Ad26.Mos4.HIV, Clade C gp140, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ad26.Mos.HIVBiological
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.
Ad26.Mos4.HIVBiological
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 gp140Biological
Clade C gp140 vaccine containing 250 mcg of total protein, mixed with aluminum phosphate adjuvant, per 0.5 mL injection administered intramuscularly.
PlaceboDrug
Normal saline 0.9 percent (%), 0.5 mL injection administered intramuscularly.
| Study group | Role | What they receive |
|---|---|---|
| Group 1A: Ad26.Mos.HIV | Experimental | 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. Receives: Biological: Ad26.Mos.HIV; Biological: Clade C gp140 |
| Group 1B: Placebo | Placebo comparator | Participants will receive placebo at Weeks 0, 12, 24 and 48. Receives: Drug: Placebo |
| Group 2A: Ad26.Mos4.HIV | Experimental | 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]). Receives: Biological: Ad26.Mos4.HIV; Biological: Clade C gp140 |
| Group 2B: Placebo | Placebo comparator | Participants will receive placebo at Weeks 0, 12, 24 and 48. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 72
Secondary outcomes (6)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to Week 264
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2016 (estimated)
- Study start8 Jul 2016
- Primary completion25 Apr 2022
- Study completion25 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Vaccines & Prevention B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Vaccines & Prevention B.V. Clinical Trial, Study director, Janssen Vaccines & Prevention B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02788045
- Sponsor's protocol ID
- CR108152
- Other IDs
- VAC89220HPX2004
- Status last verified
- May 2025
- First submitted
- 27 May 2016
- Last updated
- 25 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated device
- No
Publications
Baden LR, Stieh DJ, Sarnecki M, Walsh SR, Tomaras GD, Kublin JG, McElrath MJ, Alter G, Ferrari G, Montefiori D, Mann P, Nijs S, Callewaert K, Goepfert P, Edupuganti S, Karita E, Langedijk JP, Wegmann F, Corey L, Pau MG, Barouch DH, Schuitemaker H, Tomaka F; Traverse/HVTN 117/HPX2004 Study Team. Safety and immunogenicity of two heterologous HIV vaccine regimens in healthy, HIV-uninfected adults (TRAVERSE): a randomised, parallel-group, placebo-controlled, double-blind, phase 1/2a study. Lancet HIV. 2020 Oct;7(10):e688-e698. doi: 10.1016/S2352-3018(20)30229-0.
PubMed 33010242
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel-Group, Placebo-Controlled, Double-Blind Phase 1/2a Study in Healthy HIV Uninfected Adults to Assess the Safety/Tolerability and Immunogenicity of 2 Different Prime/Boost Regimens; 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 Tetravalent Ad26.Mos4.HIV and Clade C Gp140 Plus Adjuvant
- ClinicalTrials.gov ID
- NCT02788045
- Acronym / sponsor ID
- CR108152
- Conditions
- Healthy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Janssen Vaccines & Prevention B.V.Industry (pharma, biotech, devices)
- Study start
- 8 Jul 2016 (actual)
- Primary completion
- 25 Apr 2022 (actual)
- Study completion
- 25 Apr 2022 (actual)
- First posted
- 2 Jun 2016 (estimated)
- Results
- Posted 9 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1A: Ad26.Mos.HIV | Experimental | Biological: Ad26.Mos.HIV, Biological: Clade C gp140Participants 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. |
| Group 1B: Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo at Weeks 0, 12, 24 and 48. |
| Group 2A: Ad26.Mos4.HIV | Experimental | Biological: Ad26.Mos4.HIV, Biological: Clade C gp140Participants 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]). |
| Group 2B: Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo at Weeks 0, 12, 24 and 48. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ad26.Mos.HIVRecombinant 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. | Biological | Group 1A: Ad26.Mos.HIV |
| Ad26.Mos4.HIVRecombinant 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. | Biological | Group 2A: Ad26.Mos4.HIV |
| Clade C gp140Clade C gp140 vaccine containing 250 mcg of total protein, mixed with aluminum phosphate adjuvant, per 0.5 mL injection administered intramuscularly. | Biological | Group 1A: Ad26.Mos.HIV, Group 2A: Ad26.Mos4.HIV |
| PlaceboNormal saline 0.9 percent (%), 0.5 mL injection administered intramuscularly. | Drug | Group 1B: Placebo, Group 2B: Placebo |
Primary outcome
Percentage of Participants With Solicited Local Adverse Events (AEs) Post First Vaccination
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 Third Vaccination
Time frame: 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 Systemic AEs Post Fourth Vaccination
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to Week 72
Percentage of participants with discontinuations from vaccination due to AEs were reported.
Percentage of Participants With Serious Adverse Events (SAEs) During Main Study
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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 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
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 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 for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 72
Time frame: 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.
6 secondary outcomes
Percentage of Responders for Human Immunodeficiency Virus Neutralizing Antibody (HIV nAb)
Time frame: Weeks 28, 52 and 72
Percentage of Responders for Env Antibody-dependent Cellular Phagocytosis (ADCP) gp Antibody
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)
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)
Time frame: Weeks 28, 52 and 72
Percentage of Responders for CD4+ and CD8+ T-Cell Responses
Time frame: Weeks 28, 52 and 72
Percentage of Participants With T-cell Development
Time frame: Up to Week 264
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33010242Baden LR, Stieh DJ, Sarnecki M, Walsh SR, Tomaras GD, Kublin JG, McElrath MJ, Alter G, Ferrari G, Montefiori D, Mann P, Nijs S, Callewaert K, Goepfert P, Edupuganti S, Karita E, Langedijk JP, Wegmann F, Corey L, Pau MG, Barouch DH, Schuitemaker H, Tomaka F; Traverse/HVTN 117/HPX2004 Study Team. Safety and immunogenicity of two heterologous HIV vaccine regimens in healthy, HIV-uninfected adults (TRAVERSE): a randomised, parallel-group, placebo-controlled, double-blind, phase 1/2a study. Lancet HIV. 2020 Oct;7(10):e688-e698. doi: 10.1016/S2352-3018(20)30229-0.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Vaccines & Prevention B.V. Clinical Trial study director
Janssen Vaccines & Prevention B.V.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ad26.Mos.HIV, Ad26.Mos4.HIV and Clade C gp140 in people with Healthy, run by Janssen Vaccines & Prevention B.V. at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Rwanda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Solicited Local Adverse Events (AEs) Post First Vaccination (time frame: 7 days after first vaccination on Day 1 (Day 8)). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02788045, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.