A Randomized Single-blind Placebo-controlled Study to Evaluate the Safety and Immunogenicity of Three Candidate HIV-1 Vaccines, pSG2.HIVconsv DNA, ChAdV63.HIVconsv and MVA.HIVconsv, Administered in Combination to Healthy HIV 1 Uninfected Adults

University of Oxford1 site in 1 country32 target enrollmentOctober 2010

Overview

This is a randomised, placebo-controlled, single-blind study designed to evaluate the safety and immunogenicity of three novel HIV vaccines.

Registry

clinicaltrials.gov

Start Date

October 2010

End Date

April 2014

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

•Healthy males or females, as assessed by a medical history, physical examination and laboratory tests.
•Aged at least 18 years on the day of screening and no greater than 50 years on the day of the first vaccination.
•Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study.
•In the opinion of the principal investigator or designee, the volunteer has understood the information provided. Written informed consent must be given before any study-related procedures are performed.
•Willing to undergo HIV-1 testing, HIV-1 counselling and receive HIV-1 test results.
•If heterosexually active female; using an effective method of contraception (e.g. hormonal contraception, diaphragm, intra-uterine device (IUD), condoms, anatomical sterility in self or partner) from 14 days prior to the first vaccination until at least 6 weeks after the last vaccination; all female volunteers must be willing to undergo urine pregnancy tests at time points specified in the protocol.
•If heterosexually active male; willing to use an effective method of contraception (condoms; anatomical sterility in self or partner) from the day of the first vaccination until 6 weeks after the last vaccination.
•Willing to forgo donations of blood during the study.

•Any clinically significant acute or chronic medical condition that is considered progressive or, in the opinion of the principal investigator or designee, would make the volunteer unsuitable for the study.
•Any of the following abnormal laboratory parameters listed below:
•Haematology
•Haemoglobin \< 10.0 g/dl
•Absolute Neutrophil Count (ANC) ≤ 1000 /mm3 (≤ 1 x 109 /l)
•Absolute Lymphocyte Count (ALC) ≤ 600 /mm3 (≤ 1 x 109 /l)
•Platelets ≤100,000 /mm3, ≥ 550,000 /mm3 (≤ 90 /l, ≥ 550 /l) Biochemistry
•Creatinine \> 1.3 x ULN
•Aspartate aminotransferase (AST) \> 2.5 x ULN
•Alanine aminotransferase (ALT) \> 2.5 x ULN Urinalysis

Safety

Time Frame: Actively collected data throughout the study until 6 months after the last vaccination

Proportion of volunteers who develop a grade 3 or 4 local reaction.

Immunogenicity(Stage 1; screen, 0, 1, 2, 4, 8, 16, 28 wk. Stage 2; screen, 0, 1, 2, 4, 8, 9, 12, 20, 28 wk. Stage 3; screen, 1, 8, 12, 13, 14, 20, 21, 22, 28 wk. Stage 4; screen, 0, 8, 12, 13, 16, 17, 18, 24, 28 wk post vac. Stage 2 & 3: 6,12,24 mth after last vaccine)