HIV Infections Clinical Trial
Official title:
A Phase 1 Placebo-controlled, Double-blind, Randomized Trial to Evaluate the Safety and Immunogenicity of Ad26-ENVA and Ad35-ENV HIV Vaccines in Healthy HIV-uninfected Adult Volunteers
The purpose of this study is to evaluate the safety and tolerability of Ad26.ENVA.01 and Ad35-ENV in low-risk for HIV-uninfected healthy adults administered in heterologous and homologous prime-boost regimens at different time intervals.
The study is a randomized, double-blind placebo-controlled trial assessing the order of
vector priming and boosting (Ad26 versus Ad35), the timing of boost (3 versus 6 months) and
the homologous versus heterologous regimen at the 3-month time interval. Groups A-D will be
enrolled in Boston, MA, USA, Groups E-H will be enrolled at the East African Clinical
Research Centres and Groups I-L will be enrolled at the South African Clinical Research
Centres.
Volunteers will be screened up to 56 days before vaccination and will be followed for 12
months after the second vaccination.
Approximately 212 volunteers will be randomized to receive either vaccine or placebo within
a group (A-L); Groups A-D, Groups E-H and Groups I-L will be randomized separately. Up to 7%
over-enrolment (approximately 15 volunteers) will be allowed to facilitate enrolment.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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