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

Sponsor
Janssen Vaccines & Prevention B.V. (Industry)
Overall Status
Completed
CT.gov ID
NCT02788045
Collaborator
(none)
201
10
4
69.6
20.1
0.3

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
  • Biological: Ad26.Mos.HIV
  • Biological: Ad26.Mos4.HIV
  • Biological: Clade C gp140
  • Drug: Placebo
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
201 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Jul 8, 2016
Actual Primary Completion Date :
Apr 25, 2022
Actual Study Completion Date :
Apr 25, 2022

Arms and Interventions

Arm Intervention/Treatment
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.

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.

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.

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. AEs for 28 Days After Each Vaccination [Baseline up to 28 days after each vaccination]

  3. Discontinuations From Vaccination/From Study Due to AEs [Baseline up to Week 72]

  4. 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]

  5. Envelope (Env)-specific Binding Antibody (Abs) (Titers and Breadth) [Baseline up to Week 264]

Secondary Outcome Measures

  1. Env-specific Neutralizing Antibody (NAbs) (Titers and Breadth) (for Tier 1 and Tier 2 Viruses) [Baseline up to Week 264]

  2. Env-specific Functional Abs (Phagocytosis Score and Breadth) [Baseline up to Week 264]

  3. Env-specific Binding Ab Isotypes (Immunoglobulin A [Iga], Igg1-4) (Titers and Breadth) [Baseline up to Week 264]

  4. 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]

  5. 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]

  6. T-Cell Development With Emphasis on Follicular Helper T-Cells and Memory Differentiation [Baseline up to Week 72]

  7. 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

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 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

Exclusion Criteria:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
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.
Responsible Party:
Janssen Vaccines & Prevention B.V.
ClinicalTrials.gov Identifier:
NCT02788045
Other Study ID Numbers:
  • CR108152
  • VAC89220HPX2004
First Posted:
Jun 2, 2016
Last Update Posted:
Jul 6, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 6, 2022