CompletedNCT03307915Updated Feb 4, 2025

A Study of 2 Different Regimens of Tetravalent Ad26.Mos4.HIV Prime Followed by Boost With Modified Vaccinia Ankara (MVA)-Mosaic OR Ad26.Mos4.HIV Plus a Combination of Mosaic and Clade C gp140 Protein in Human Immunodeficiency Virus (HIV) Type 1 Infected Adults on Suppressive Antiretroviral Treatment

A Phase 1 interventional study of Ad26.Mos4.HIV and MVA-Mosaic in Human Immunodeficiency Virus, sponsored by Janssen Vaccines & Prevention B.V.. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-02-04.

Sponsored by Janssen Vaccines & Prevention B.V. (part of Johnson & Johnson) · Phase 1, Interventional, and Other

From the registry’s dates

Primary completion was Nov 2021, 4 years 11 months ago, and no results have been posted to the registry.

Phase: Phase 1
Study type: Interventional
Enrollment: 25
Allocation: Randomized
Ages: 18 Years to 60 Years
Sex: All

Study summary

The primary purpose of this study is to assess safety/tolerability of 2 different prime/boost regimens containing adenovirus serotype 26 (Ad26).Mos4.HIV, Modified Vaccinia Ankara (MVA) -Mosaic or adjuvanted Mosaic and Clade C gp140 in Human immunodeficiency virus type 1 (HIV-1)-infected participants on suppressive antiretroviral treatment (ART).

Conditions studied

Human Immunodeficiency Virus

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Acquired Immunodeficiency Syndrome 2,099

In context

Acquired Immunodeficiency Syndrome

2,099 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 273 are open to participants now.

This study's enrollment of 25 is below the median of 104 across 1,590 interventional studies indexed under Acquired Immunodeficiency Syndrome.

Browse Acquired Immunodeficiency Syndrome studies →

Lead sponsor

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.

Browse Janssen Vaccines & Prevention B.V. studies →All Johnson & Johnson studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 60 Years
Sexes eligible: All
Accepts healthy volunteers: No

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.

Inclusion criteria

Each participant must have documented Human immunodeficiency virus type1 (HIV-1) infection
Each participant must be on suppressive antiretroviral treatment (ART) for at least 48 weeks prior to randomization and on stable suppressive ART for at least 4 weeks prior to screening. Changes in antiretrovirals (ARVs) can be made for safety/tolerability reasons only until 4 weeks prior to screening
Each participant must have started ART outside of the acute or early phase of infection
Each participant must have a plasma HIV ribonucleic acid (RNA) less than (\<) 50 copies/ milliliter (mL) at screening and at least one documented evidence of plasma HIV RNA \<50 copies/mL after the last ART change. In case of ART change within the 48 weeks prior randomization, at least one additional more recent documented plasma HIV RNA \<50 copies/mL is required. One blip of HIV RNA greater than (>)50 and \<200 copies/mL within 24 weeks prior to screening is acceptable, provided that the 2 most recent (after last ART change, tested before and/or during screening) HIV RNA results are \<50 copies/mL
Each participant must be medically stable as confirmed by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests performed at screening

Exclusion criteria

Exclusion Criteria:

Anyone who is pregnant, breastfeeding, or planning to become pregnant while enrolled in this study, or within 3 months after the last vaccination
Anyone with contraindication to intramuscular injections and blood draws example, bleeding disorders
Anyone with acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature greater than or equal to (>=) 38.0ºC (degree centigrade) within 24 hours prior to the first dose of study vaccine; enrollment at a later date is permitted
Anyone with a history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
Anyone with a history of an underlying clinically significant acute or uncontrolled chronic medical condition or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
Anyone with a history of Acquired Immunodeficiency Syndrome (AIDS)-defining illness according to Centers for Disease Control and prevention (CDC) criteria based on available medical history and assessed by the investigator as clinically relevant. A case summary for every participant with AIDS-defining illnesses assessed by the investigator as clinically irrelevant must be provided to the sponsor and Protocol Safety Review Team (PSRT), who will determine eligibility on a case-by-case basis prior to randomization
Anyone with a history of CD4+ less than (\<) 200 cells per millimeter cube (cells/mm\^3), based on available medical history and assessed by the investigator as clinically relevant. A case summary for every participant with history of CD4+ \<200 cells/mm\^3 assessed by the investigator as clinically irrelevant must be provided to the sponsor and PSRT, who will determine eligibility on a case-by-case basis prior to randomization
Anyone with chronic active hepatitis B (measured by hepatitis B surface antigen test) or active hepatitis C (measured by hepatitis C virus [HCV] antibody test; if positive, HCV RNA polymerase chain reaction test will be used to confirm active versus past HCV infection) or syphilis infection that has not been effectively treated. Positive syphilis serology due to past effectively treated infection is not exclusionary
Anyone who received or plans to receive: a) licensed live attenuated vaccines within 28 days before or after planned administration of any of the study vaccinations; b) other licensed (not live) vaccines - within 14 days before or after planned administration of any of the study vaccinations
Anyone who received an investigational drug or used an invasive investigational medical device within 30 days or received an investigational vaccine within 6 months before the planned administration of the first dose of study vaccine. Receipt of prophylactic or therapeutic HIV vaccine candidate at any time is always exclusionary. Exceptions: Participants can be included where the vaccine received was subsequently licensed. Participants with proof of having received only a placebo vaccine can also be included

Study design

Phase: Phase 1
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 25 participants (actual)

Study arms

Experimental
Group 1: Ad26.Mos4.HIV + MVA-Mosaic/Placebo
Participants will receive adenovirus serotype 26-Mosaic 4 -Human Immunodeficiency Virus (Ad26.Mos4.HIV) 5\*10\^10 virus particles (vp) as intramuscular (IM) injection at Weeks 0 and 12 (1 injection) followed by modified Vaccinia Ankara-Mosaic (MVA-Mosaic) 10\^8 Plaque-forming unit (pfu) and placebo as IM injection at Weeks 24 and 36 (2 injections).
Biological: Ad26.Mos4.HIV · Biological: MVA-Mosaic · Drug: Placebo
Experimental
Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140
Participants will receive Ad26.Mos4.HIV, 5\*10\^10 vp as IM injection at Weeks 0 and 12 (1 injection) followed by both Ad26.Mos4.HIV 5\*10\^10 vp plus Clade C gp140 (125 microgram \[mcg\]) plus Mosaic gp140 (125 mcg) with aluminum phosphate adjuvant or an equivalent dose of a bivalent vaccine that includes both Clade C gp140 and Mosaic gp140, and aluminum phosphate adjuvant in a single vial, via IM injection at Weeks 24 and 36 (2 injections).
Biological: Ad26.Mos4.HIV · Biological: Clade C gp140 + Mosaic gp140
Placebo comparator
Group 3: Placebo
Participants will receive 0.9 percent (%) saline as IM injection at Weeks 0, 12 (one injection) and at Week 24, 36 (two injections).
Drug: Placebo

Interventions

BiologicalAd26.Mos4.HIV
Participants will receive Ad26.Mos4.HIV 5\*10\^10 vp as 0.5 mL IM injection at Weeks 0, 12 in Group 1 and at Weeks 0, 12, 24, 36 in Group 2.
BiologicalMVA-Mosaic
Participants will receive MVA-Mosaic 10\^8 pfu as IM injection at Weeks 24 and 36.
BiologicalClade C gp140 + Mosaic gp140
Participants will receive both Clade C gp140 125 mcg plus Mosaic gp140 125 mcg (250 mcg coformulated with Aluminum phosphate adjuvant) OR an equivalent dose of a bivalent vaccine that includes both Clade C gp140 and Mosaic gp140, and aluminum phosphate adjuvant in a single vial, via IM injection at Weeks 24 and 36.
DrugPlacebo
Participants will receive matching placebo as IM injection at Weeks 24, 36 in Group 1 and at Weeks 0, 12, 24, 36 in Group 3.

What researchers measure

Primary outcomes

Percentage of Participants With Solicited Local Adverse Events (AEs) as a Measure of Safety and Tolerability
Solicited local AEs: erythema, swelling/induration, and pain/tenderness will be assessed.
Time frame: 7 days post-vaccination (approximately up to 37 weeks)
Percentage of Participants With Solicited Systemic AEs as a Measure of Safety and Tolerability
Solicited systemic AEs: fever (temperature measurement), fatigue, headache, nausea, myalgia, and chills will be assessed.
Time frame: 7 days post-vaccination (approximately up to 37 weeks)
Percentage of Participants With AEs as a Measure of Safety and Tolerability
An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Time frame: Approximately up to 96 weeks

Secondary outcomes

Total IgG and Subclass Specific Antibody Titer
Total immunoglobulin G (IgG) and subclass (IgG1-4) specific antibody titers (binding antibody) to envelope (Env) proteins representing Clades A, B, and C, as well as Mosaic antigens.
Time frame: Up to post-vaccination follow-up period until Week 96
Antibody Functionality Assessment by Antibody-dependent Cell-mediated Phagocytosis (ADCP)
Antibody functionality assessment will be assessed by antibody-dependent cell-mediated phagocytosis (ADCP) assay.
Time frame: Up to post-vaccination follow-up period until Week 96
Magnitude of T-cell Responses as Measured by Intracellular Cytokine Staining (ICS) Assay
Intracellular cytokine staining (ICS) assays with Env, group-specific antigen (Gag), and/or polymerase (Pol)-peptide pools will be used to determine the magnitude of T-cell responses elicited.
Time frame: Up to post-vaccination follow-up period until Week 96
Functionality of T-cell Responses as Measured by ICS Assay
ICS assays with Env, Gag, and/or Pol-peptide pools will be used to determine the functionality of T-cell responses elicited.
Time frame: Up to post-vaccination follow-up period until Week 96
Phenotype of T-cell Responses as Measured by ICS Assay
ICS assays with Env, Gag, and/or Pol-peptide pools will be used to determine the phenotype of T-cell responses elicited.
Time frame: Up to post-vaccination follow-up period until Week 96
Frequency of Epitope Recognition by Enzyme-Linked Immunospot (ELISPOT)
Assays of peptide pool sets covering the Gag, Env or Pol will be evaluated by standard enzyme linked immunospot assay (ELISPOT).
Time frame: Up to post-vaccination follow-up period until Week 96

Study locations

1 site

Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215, United States

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2018 to primary completion in Nov 2021, 44 months.

Of 62 industry-sponsored phase 1 interventional studies under Acquired Immunodeficiency Syndrome, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 18. This study's 44 months is above that.

Counting every sponsor, half of 108 studies reached it within 15 months; a quarter within 3 and three quarters within 29.

How these figures are worked out, and which studies are left out of them.

Registered: Sep 25, 2017
First posted: Oct 12, 2017
StartActual: Mar 5, 2018
Primary completionActual: Nov 5, 2021
CompletionActual: Nov 5, 2021
Last update: Feb 4, 2025

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Feb 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03307915
Lead sponsor: Janssen Vaccines & Prevention B.V.
Collaborators: Beth Israel Deaconess Medical Center, Ragon Institute of MGH, MIT and Harvard, US Military HIV Research Program
Responsible party: Sponsor
First posted: Oct 12, 2017
Start date: Mar 5, 2018
Primary completion: Nov 5, 2021
Completion: Nov 5, 2021
Last update: Feb 4, 2025

Study contacts

Janssen Vaccines & Prevention B.V. Clinical Trial

study director · Janssen Vaccines & Prevention B.V.

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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