Phase I Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of TBC-M4 (MVA Based HIV Vaccine) Alone or in a Prime-Boost Regimen With ADVAX, DNA HIV Vaccine

International AIDS Vaccine Initiative1 site in 1 country32 target enrollmentNovember 2008

ConditionsHIV Infections

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: HIV Infections
Sponsor: International AIDS Vaccine Initiative
Enrollment: 32
Locations: 1
Primary Endpoint: Safety of TBC-M4 alone or in a prime-boost regimen with ADVAX
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This trial will study a prime-boost vaccine approach designed mainly to induce cell-mediated immune (CTL) responses.

Detailed Description

Two vaccine candidates will be used in two different prime-boost regimens: ADVAX (DNA) + TBC-M4 (MVA) and TBC-M4 (MVA) alone. Both these vaccines have already been tested in humans and both were found to be well tolerated and immunogenic. Approximately 32 volunteers (24 vaccine /8 placebo recipients) will be included in the study.

Registry

clinicaltrials.gov

Start Date

November 2008

End Date

April 2010

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

International AIDS Vaccine Initiative

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•Confirmed HIV-1 or HIV-2 infection;
•High-risk behaviour for HIV infection which is defined as (Within 6 months before vaccination, the volunteer has):
•Had unprotected vaginal or anal sex with a known HIV infected person or a casual partner (i.e., no continuing established relationship)
•Engaged in sex work for money or drugs
•Substance abuse/use injection drugs
•Acquired a sexually transmitted disease (STD) (e.g., gonorrhoea, chlamydia, syphilis, Trichomonas vaginalis, and symptomatic herpes genitalis)
•Having a high-risk partner either currently or within the previous 6 months
•Any clinically significant abnormality on history or examination including history of immunodeficiency or autoimmune disease; use of systemic corticosteroids, immunosuppressive, antiviral, anticancer, or other medications considered significant by the investigator within the previous 6 months; (Note: use of inhaled steroids for asthma and use of topical steroids for localized skin conditions will not exclude a volunteer from participation.)
•Any clinically significant acute or chronic medical condition that is considered progressive or in the opinion of the investigator would make the volunteer unsuitable for the study;
•Any of the following abnormal laboratory parameters listed below: