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

• Register: ClinicalTrials.gov
• Last refreshed on: 10 July 2023
• Main ID: NCT02788045
• Date of registration: 27/05/2016
• Prospective Registration: Yes
• Primary sponsor: Janssen Vaccines & Prevention B.V.
• Public title: 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
• Scientific 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
• Date of first enrolment: July 8, 2016
• Target sample size: 201
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02788045
• 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

Rwanda, United States

Contacts

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

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 50 Years
Gender: All

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: Placebo

Biological: Clade C gp140

Biological: Ad26.Mos.HIV

Biological: Ad26.Mos4.HIV

Primary Outcome(s)

Percentage of Participants With Solicited Local AEs Post Third Vaccination [Time Frame: 7 days after third vaccination on Day 169 (Day 176)]

Percentage of Participants With Unsolicited AEs for 28 Days After First Vaccination [Time Frame: 28 days after first vaccination on Day 1 (Day 29)]

Percentage of Participants With Unsolicited AEs for 28 Days After Third Vaccination [Time Frame: 28 days after third vaccination on Day 169 (Day 197)]

Percentage of Participants With SAEs During Long Term Extension (LTE) Period [Time Frame: From Week 96 to Week 264]

Percentage of Participants With Solicited Systemic AEs Post First Vaccination [Time Frame: 7 days after first vaccination on Day 1 (Day 8)]

Percentage of Participants With Solicited Systemic AEs Post Second Vaccination [Time Frame: 7 days after second vaccination on Day 85 (Day 92)]

Percentage of Participants With Solicited Local Adverse Events (AEs) Post First Vaccination [Time Frame: 7 days after first vaccination on Day 1 (Day 8)]

Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 72 [Time Frame: Week 72]

Percentage of Participants With AEs of Special Interest During Main Study [Time Frame: Up to Week 72]

Percentage of Participants With Solicited Systemic AEs Post Third Vaccination [Time Frame: 7 days after third vaccination on Day 169 (Day 176)]

Percentage of Participants With Discontinuations From Vaccination Due to AEs [Time Frame: Up to Week 72]

Percentage of Participants With Solicited Local AEs Post Fourth Vaccination [Time Frame: 7 days after fourth vaccination on Day 337 (Day 344)]

Percentage of Participants With Unsolicited AEs for 28 Days After Second Vaccination [Time Frame: 28 days after second vaccination on Day 85 (Day 113)]

Percentage of Participants With Unsolicited AEs for 28 Days After Fourth Vaccination [Time Frame: 28 days after fourth vaccination on Day 334 (Day 362)]

Percentage of Participants With Solicited Systemic AEs Post Fourth Vaccination [Time Frame: 7 days after fourth vaccination on Day 337 (Day 344)]

Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 28 [Time Frame: Week 28]

Percentage of Participants With Serious Adverse Events (SAEs) During Main Study [Time Frame: Up to Week 72]

Percentage of Participants With Solicited Local AEs Post Second Vaccination [Time Frame: 7 days after second vaccination on Day 85 (Day 92)]

Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 52 [Time Frame: Week 52]

Percentage of Participants With AEs of Special Interest During LTE Period [Time Frame: From Week 96 to Week 264]

Secondary Outcome(s)

Percentage of Responders for Human Immunodeficiency Virus Neutralizing Antibody (HIV nAb) [Time Frame: Weeks 28, 52 and 72]

Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) [Time Frame: Weeks 26, 52 and 72]

Percentage of Participants With T-cell Development [Time Frame: Up to Week 264]

Percentage of Responders for Env Antibody-dependent Cellular Phagocytosis (ADCP) gp Antibody [Time Frame: Weeks 28, 52 and 72]

Percentage of Responders for CD4+ and CD8+ T-Cell Responses [Time Frame: Weeks 28, 52 and 72]

Percentage of Responders for Immunoglobulin G1 (IgG1) and IgG3 Gylcoprotein (gp) 140 Binding Antibody Assessed Using Clade C (C97ZA.012) Env Enzyme-linked Immunosorbent Assay (ELISA) [Time Frame: Weeks 28, 52 and 72]

Secondary ID(s)

CR108152

VAC89220HPX2004

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 09/06/2023
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02788045