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
Study Details
Study Description
Brief Summary
The purpose of this study is to assess the safety/tolerability of the 2 different vaccine regimens of priming with trivalent Ad26.Mos.HIV and boosting with trivalent Ad26.Mos.HIV and Clade C gp140 plus adjuvant or priming with tetravalent Ad26.Mos4.HIV and boosting with Ad26.Mos4.HIV and Clade C glycoprotein (gp)140 plus adjuvant. Immune responses of the different vaccine schedules will be assessed.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1/Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: 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. |
Biological: 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.
Biological: 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.
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Placebo Comparator: Group 1B: Placebo Participants will receive placebo at Weeks 0, 12, 24 and 48. |
Drug: Placebo
Normal saline 0.9 percent (%), 0.5 mL injection administered intramuscularly.
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Experimental: 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]). |
Biological: 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.
Biological: 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.
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Placebo Comparator: Group 2B: Placebo Participants will receive placebo at Weeks 0, 12, 24 and 48. |
Drug: Placebo
Normal saline 0.9 percent (%), 0.5 mL injection administered intramuscularly.
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Outcome Measures
Primary Outcome Measures
- Local And Systemic Solicited Adverse Events (AEs) for 7 Days Post-Vaccination [Baseline up to 7 days after each vaccination]
Participants will be asked to note occurrences of local reactions: pain/tenderness, erythema, swelling/induration at the injection site, and systemic events: fever (temperature measurement), fatigue, headache, nausea, myalgia and chills daily for 7 days post-vaccination.
- AEs for 28 Days After Each Vaccination [Baseline up to 28 days after each vaccination]
- Discontinuations From Vaccination/From Study Due to AEs [Baseline up to Week 72]
- Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs) During the Course of the Study, Including the Optional LTE Phase [Baseline up to Week 264]
- Envelope (Env)-specific Binding Antibody (Abs) (Titers and Breadth) [Baseline up to Week 264]
Secondary Outcome Measures
- Env-specific Neutralizing Antibody (NAbs) (Titers and Breadth) (for Tier 1 and Tier 2 Viruses) [Baseline up to Week 264]
- Env-specific Functional Abs (Phagocytosis Score and Breadth) [Baseline up to Week 264]
- Env-specific Binding Ab Isotypes (Immunoglobulin A [Iga], Igg1-4) (Titers and Breadth) [Baseline up to Week 264]
- Interferon (IFN)-gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic Peptide Pools of Env/Group-specific Antigen (Gag)/Polymerase (Pol) and Potential T-cell Epitope (PTE) [Baseline up to Week 264]
- Cluster of Differentiation (Cd)4+ and Cd8+ T-Cell Functionality (Percentage [%] Cells Producing I-alpha, Ifn-gamma, Interleukin [Il-2], Il-4, Tumor Necrosis Factor [Tnf]-alpha) [Baseline up to Week 264]
- T-Cell Development With Emphasis on Follicular Helper T-Cells and Memory Differentiation [Baseline up to Week 72]
- Available Samples From Time Points After Last Vaccination Until the Final Main Study Visit at Week 72 Will be Used for Determination of Durability of the Immune Responses [Baseline up to Week 72]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Are negative for human immunodeficiency virus (HIV) infection at screening
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Is healthy on the basis of physical examination, medical history, electrocardiogram (ECG), and vital signs measurement performed at screening
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Are willing/able to adhere to the prohibitions and restrictions specified in the protocol and study procedures
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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
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Are assessed by the clinic staff as being at low risk for HIV infection
Exclusion Criteria:
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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
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Has had a thyroidectomy or active thyroid disease requiring medication during the last 12 months (not excluded: a stable thyroid supplementation)
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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
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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
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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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Birmingham | Alabama | United States | ||
2 | San Francisco | California | United States | ||
3 | Decatur | Georgia | United States | ||
4 | Silver Spring | Maryland | United States | ||
5 | Boston | Massachusetts | United States | ||
6 | New York | New York | United States | ||
7 | Rochester | New York | United States | ||
8 | Philadelphia | Pennsylvania | United States | ||
9 | Seattle | Washington | United States | ||
10 | Kigali | Rwanda |
Sponsors and Collaborators
- Janssen Vaccines & Prevention B.V.
Investigators
- Study Director: Janssen Vaccines & Prevention B.V. Clinical Trial, Janssen Vaccines & Prevention B.V.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR108152
- VAC89220HPX2004