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
NCT ID: NCT02788045
Last Updated: 2025-05-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
201 participants
INTERVENTIONAL
2016-07-08
2022-04-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Group 1A: Ad26.Mos.HIV
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.
Ad26.Mos.HIV
Recombinant replication-deficient Ad26 vectored vaccine and consists of 3 Ad26 vectors, one containing a mosaic insert of envelope (Env) sequence, and 2 vectors containing mosaic inserts of Gag and Pol sequences (Ad26.Mos.1.Env + Ad26.Mos1.Gag-Pol + Ad26.Mos2.Gag-Pol). Total dose is 5\*10\^10 viral particle per 0.5 milliliter (mL) injection administered intramuscularly.
Clade C gp140
Clade C gp140 vaccine containing 250 mcg of total protein, mixed with aluminum phosphate adjuvant, per 0.5 mL injection administered intramuscularly.
Group 1B: Placebo
Participants will receive placebo at Weeks 0, 12, 24 and 48.
Placebo
Normal saline 0.9 percent (%), 0.5 mL injection administered intramuscularly.
Group 2A: Ad26.Mos4.HIV
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 \[SAEs\]).
Ad26.Mos4.HIV
Recombinant replication-deficient Ad26 vectored vaccine and consists of 4 Ad26 vectors, 2 containing a mosaic insert of envelope (Env) sequence, and 2 vectors containing mosaic inserts of Gag and Pol sequences (Ad26.Mos.1.Env + Ad26.Mos.2S.Env + Ad26.Mos1.Gag-Pol + Ad26.Mos2.Gag-Pol). Total dose is 5\*10\^10 viral particle per 0.5mL injection administered intramuscularly.
Clade C gp140
Clade C gp140 vaccine containing 250 mcg of total protein, mixed with aluminum phosphate adjuvant, per 0.5 mL injection administered intramuscularly.
Group 2B: Placebo
Participants will receive placebo at Weeks 0, 12, 24 and 48.
Placebo
Normal saline 0.9 percent (%), 0.5 mL injection administered intramuscularly.
Interventions
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Ad26.Mos.HIV
Recombinant replication-deficient Ad26 vectored vaccine and consists of 3 Ad26 vectors, one containing a mosaic insert of envelope (Env) sequence, and 2 vectors containing mosaic inserts of Gag and Pol sequences (Ad26.Mos.1.Env + Ad26.Mos1.Gag-Pol + Ad26.Mos2.Gag-Pol). Total dose is 5\*10\^10 viral particle per 0.5 milliliter (mL) injection administered intramuscularly.
Ad26.Mos4.HIV
Recombinant replication-deficient Ad26 vectored vaccine and consists of 4 Ad26 vectors, 2 containing a mosaic insert of envelope (Env) sequence, and 2 vectors containing mosaic inserts of Gag and Pol sequences (Ad26.Mos.1.Env + Ad26.Mos.2S.Env + Ad26.Mos1.Gag-Pol + Ad26.Mos2.Gag-Pol). Total dose is 5\*10\^10 viral particle per 0.5mL injection administered intramuscularly.
Clade C gp140
Clade C gp140 vaccine containing 250 mcg of total protein, mixed with aluminum phosphate adjuvant, per 0.5 mL injection administered intramuscularly.
Placebo
Normal saline 0.9 percent (%), 0.5 mL injection administered intramuscularly.
Eligibility Criteria
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Inclusion Criteria
* Is healthy on the basis of physical examination, medical history, electrocardiogram (ECG), and vital signs measurement performed at screening
* Are willing/able to adhere to the prohibitions and restrictions specified in the protocol and study procedures
* Female participants of childbearing potential must have a negative serum pregnancy test (beta human chorionic gonadotropin \[beta hCG\]) at the Screening visit, and a negative urine pregnancy test pre-dose on Day 1
* Are assessed by the clinic staff as being at low risk for HIV infection
Exclusion Criteria
* Has 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
18 Years
50 Years
ALL
Yes
Sponsors
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Janssen Vaccines & Prevention B.V.
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Vaccines & Prevention B.V. Clinical Trial
Role: STUDY_DIRECTOR
Janssen Vaccines & Prevention B.V.
Locations
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Birmingham, Alabama, United States
San Francisco, California, United States
Decatur, Georgia, United States
Silver Spring, Maryland, United States
Boston, Massachusetts, United States
New York, New York, United States
Rochester, New York, United States
Philadelphia, Pennsylvania, United States
Seattle, Washington, United States
Kigali, , Rwanda
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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VAC89220HPX2004
Identifier Type: OTHER
Identifier Source: secondary_id
CR108152
Identifier Type: -
Identifier Source: org_study_id
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