A Safety, Tolerability and Immunogenicity Study of 2 Different Regimens of Tetravalent Ad26.Mos4.HIV Prime Followed by Boost With Tetravalent Ad26.Mos4.HIV Along With Either Clade C gp140 Plus Adjuvant OR With a Combination of Mosaic and Clade C gp140 Plus Adjuvant in Healthy HIV Uninfected Adults

• Register: ClinicalTrials.gov
• Last refreshed on: 6 May 2024
• Main ID: NCT02935686
• Date of registration: 14/10/2016
• Prospective Registration: Yes
• Primary sponsor: Janssen Vaccines & Prevention B.V.
• Public title: A Safety, Tolerability and Immunogenicity Study of 2 Different Regimens of Tetravalent Ad26.Mos4.HIV Prime Followed by Boost With Tetravalent Ad26.Mos4.HIV Along With Either Clade C gp140 Plus Adjuvant OR With a Combination of Mosaic and Clade C gp140 Plus Adjuvant in Healthy HIV Uninfected Adults IPCAVD-012
• Scientific title: A Randomized, Parallel-group, Placebo-controlled, Double-blind Phase 1/2a Study in Healthy HIV Uninfected Adults to Assess Safety/Tolerability and Immunogenicity of 2 Different Prime/Boost Regimens: Priming With Tetravalent Ad26.Mos4.HIV and Boosting With Tetravalent Ad26.Mos4.HIV and Either Clade C gp140 Plus Adjuvant OR a Combination of Mosaic and Clade C gp140 Plus Adjuvant
• Date of first enrolment: March 31, 2017
• Target sample size: 155
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02935686
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator).
• Phase: Phase 1/Phase 2

Countries of recruitment

Kenya, Rwanda, United States

Contacts

• Name: Janssen Vaccines & Prevention B.V. Clinical Trial
• Affiliation: Janssen Vaccines & Prevention B.V.

Key inclusion & exclusion criteria

Inclusion Criteria:

- Participant must be healthy on the basis of medical history, physical examination, and
vital signs measurement performed at screening

- Participants are negative for human immunodeficiency virus (HIV) infection at
screening

- Participants are amenable to HIV-risk reduction counseling and committed to
maintaining behavior consistent with low risk of HIV exposure through the last
required protocol clinic visit

- All female participants of childbearing potential must have a negative serum
(beta-human chorionic gonadotropin [beta-hCG]) at the screening visit, and a negative
urine pregnancy test pre-dose on Day 1

- Participants are willing/able to adhere to the prohibitions and restrictions specified
in the protocol and study procedures

- Participant must be enrolled in the LTE phase to receive the late boost vaccination

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] polymerase chain reaction (PCR) test will be used to confirm active versus
past HCV infection), active syphilis infection, chlamydia, gonorrhea, or trichomonas

- In the 12 months prior to randomization, participant has a history of newly acquired
herpes simplex virus type 2 (HSV-2), syphilis, gonorrhea, non-gonococcal urethritis,
chlamydia, pelvic inflammatory disease, trichomonas, mucopurulent cervicitis,
epididymitis, proctitis, lymphogranulomavenereum, chancroid, or hepatitis B

- Participant has had major surgery (eg, requiring general anesthesia) within the 4
weeks before screening, or will not have fully recovered from surgery, or has surgery
planned through the course of the study

- Participant has had a thyroidectomy or active thyroid disease requiring medication
during the last 12 months (not excluded: a stable thyroid supplementation)

- Current or past drug/alcohol use that investigator assesses poses any more than a
remotely increased risk of the ability of the participant to comply with the protocol
requirements

- Has been in receipt of any licensed vaccine within 14 days prior to the first dose of
study vaccine or 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Biological: gp140 HIV Bivalent Vaccine

Other: Placebo

Biological: Clade C gp140 plus adjuvant

Biological: Clade C gp140/Mosaic gp140 plus adjuvant

Biological: Ad26.Mos4.HIV

Primary Outcome(s)

Discontinuations From Vaccination/From Study due to AEs [Time Frame: Baseline up to Week 72]

Envelope (Env)-specific Binding Antibody (Abs) (Titers and Breadth) [Time Frame: Baseline up to Week 216]

Number of Participants With Adverse events (AEs) [Time Frame: Baseline up to 28 days after each vaccination]

Number of Participants with AESIs of Thrombosis With Thrombocytopenia Syndrome (TTS) [Time Frame: Baseline up to Week 216]

Number of Participants With Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs) of Confirmed Human Immunodeficiency Virus (HIV) Infection [Time Frame: Baseline up to Week 288]

Number of Participants With Solicited Local and Systemic Adverse Events (AEs) [Time Frame: Baseline up to 7 days after each vaccination]

Secondary Outcome(s)

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) [Time Frame: Baseline up to Week 288]

Env-specific Neutralizing Antibody (nAbs) (Titers and Breadth) (for Tier 1 and Tier 2 Viruses) [Time Frame: Baseline up to Week 288]

Env-specific Functional Abs (Phagocytosis Score and Breadth) [Time Frame: Baseline up to Week 288]

T-Cell Development With Emphasis on Follicular Helper T-Cells and Memory Differentiation [Time Frame: Baseline up to Week 288]

Interferon (IFN)-gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) peptide pools of Env/Group-specific Antigen (Gag)/ Polymerase (Pol) [Time Frame: Baseline up to Week 288]

Env-specific Binding Ab Isotypes (Immunoglobulin A [IgA], IgG1-4) (Titers and Breadth) [Time Frame: Baseline up to Week 288]

Secondary ID(s)

CR108207

VAC89220HPX2003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors