Clinical trial NCT02788045: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthy
Lead sponsor: Janssen Vaccines & Prevention B.V.
Sponsor class: INDUSTRY
First posted: 2016-06-02
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Percentage of Participants With Solicited Local Adverse Events (AEs) Post First Vaccination
timeFrame: 7 days after first vaccination on Day 1 (Day 8)
measure: Percentage of Participants With Solicited Local AEs Post Second Vaccination
timeFrame: 7 days after second vaccination on Day 85 (Day 92)
measure: Percentage of Participants With Solicited Local AEs Post Third Vaccination
timeFrame: 7 days after third vaccination on Day 169 (Day 176)
measure: Percentage of Participants With Solicited Local AEs Post Fourth Vaccination
timeFrame: 7 days after fourth vaccination on Day 337 (Day 344)
measure: Percentage of Participants With Solicited Systemic AEs Post First Vaccination
timeFrame: 7 days after first vaccination on Day 1 (Day 8)
measure: Percentage of Participants With Solicited Systemic AEs Post Second Vaccination
timeFrame: 7 days after second vaccination on Day 85 (Day 92)
measure: Percentage of Participants With Solicited Systemic AEs Post Third Vaccination
timeFrame: 7 days after third vaccination on Day 169 (Day 176)
measure: Percentage of Participants With Solicited Systemic AEs Post Fourth Vaccination
timeFrame: 7 days after fourth vaccination on Day 337 (Day 344)
measure: Percentage of Participants With Unsolicited AEs for 28 Days After First Vaccination
timeFrame: 28 days after first vaccination on Day 1 (Day 29)
measure: Percentage of Participants With Unsolicited AEs for 28 Days After Second Vaccination
timeFrame: 28 days after second vaccination on Day 85 (Day 113)
measure: Percentage of Participants With Unsolicited AEs for 28 Days After Third Vaccination
timeFrame: 28 days after third vaccination on Day 169 (Day 197)
measure: Percentage of Participants With Unsolicited AEs for 28 Days After Fourth Vaccination
timeFrame: 28 days after fourth vaccination on Day 334 (Day 362)
measure: Percentage of Participants With Discontinuations From Vaccination Due to AEs
timeFrame: Up to Week 72
measure: Percentage of Participants With Serious Adverse Events (SAEs) During Main Study
timeFrame: Up to Week 72
measure: Percentage of Participants With SAEs During Long Term Extension (LTE) Period
timeFrame: From Week 96 to Week 264
measure: Percentage of Participants With AEs of Special Interest During Main Study
timeFrame: Up to Week 72
measure: Percentage of Participants With AEs of Special Interest During LTE Period
timeFrame: From Week 96 to Week 264
measure: 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
timeFrame: Week 28
measure: 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
timeFrame: Week 52
measure: 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
timeFrame: Week 72
Secondary outcomes:
measure: Percentage of Responders for Human Immunodeficiency Virus Neutralizing Antibody (HIV nAb)
timeFrame: Weeks 28, 52 and 72
measure: Percentage of Responders for Env Antibody-dependent Cellular Phagocytosis (ADCP) gp Antibody
timeFrame: Weeks 28, 52 and 72
measure: Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot)
timeFrame: Weeks 26, 52 and 72
measure: 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)
timeFrame: Weeks 28, 52 and 72
measure: Percentage of Responders for CD4+ and CD8+ T-Cell Responses
timeFrame: Weeks 28, 52 and 72
measure: Percentage of Participants With T-cell Development
timeFrame: Up to Week 264
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: San Francisco
country: United States
state: California
city: Decatur
country: United States
state: Georgia
city: Silver Spring
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Philadelphia
country: United States
state: Pennsylvania
city: Seattle
country: United States
state: Washington
city: Kigali
country: Rwanda
Study officials:
affiliation: Janssen Vaccines & Prevention B.V.
name: Janssen Vaccines & Prevention B.V. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.