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
Status and phase
Completed
Phase 2
Phase 1
Conditions
Healthy
Treatments
Drug: Placebo
Biological: Clade C gp140
Biological: Ad26.Mos.HIV
Biological: Ad26.Mos4.HIV
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
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.
Enrollment
201 patients
Sex
All
Ages
18 to 50 years old
Volunteers
Accepts Healthy Volunteers
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
Trial design
Primary purpose
Prevention
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
201 participants in 4 patient groups, including a placebo group
Group 1A: Ad26.Mos.HIV
Experimental group
Description:
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.
Treatment:
Biological: Ad26.Mos.HIV
Biological: Clade C gp140
Group 1B: Placebo
Placebo Comparator group
Description:
Participants will receive placebo at Weeks 0, 12, 24 and 48.
Treatment:
Drug: Placebo
Group 2A: Ad26.Mos4.HIV
Experimental group
Description:
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 \[SAEs\]).
Treatment:
Biological: Ad26.Mos4.HIV
Biological: Clade C gp140
Group 2B: Placebo
Placebo Comparator group
Description:
Participants will receive placebo at Weeks 0, 12, 24 and 48.
Treatment:
Drug: Placebo
Trial contacts and locations
10
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Data sourced from clinicaltrials.gov
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