Randomized, Placebo-Controlled, Dose-Escalating, Double-Blinded Phase 1 Safety and Immunogenicity Study of a Modified Vaccinia Ankara (MVA) Vectored HIV-1 (ADMVA) Vaccine Administered Intramuscularly to HIV-Uninfected, Healthy Volunteers

International AIDS Vaccine Initiative2 sites in 1 country48 target enrollmentJanuary 2005

ConditionsHIV Infection

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: HIV Infection
Sponsor: International AIDS Vaccine Initiative
Enrollment: 48
Locations: 2
Primary Endpoint: safety and tolerability of AMVA
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine the safety of an immune response to an investigational HIV vaccine, ADMVA, at three different dosage levels, in adults who are not infected with HIV

Detailed Description

This is a dose escalation trial. Study site staff and volunteers will be blinded. Blinding will not apply to the assignment of dose levels (low, middle or high). Volunteers will be screened up to 42 days before enrolment and will be followed for 18 months after the first vaccination. 16 volunteers will be randomized in a 3:1 ratio of active vaccine to placebo. Safety and tolerability of the ADMVA vaccine/placebo will be evaluated at least 14 days after the 12th volunteer in the low dose group receives the second injection before proceeding to the middle dose group.

Registry

clinicaltrials.gov

Start Date

January 2005

End Date

August 2007

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

•Healthy adult males and females, as assessed by a medical history, physical exam, and laboratory tests;
•Age of at least 18 years of age on the day of screening and no greater than 40 years on the day of first vaccination;
•Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study (screening plus 18 months);
•In the opinion of the principal investigator or designee has understood the information provided. Written informed consent needs to be given before any study-related procedures are performed;
•Willing to undergo HIV Testing and counseling, and receive HIV test results;
•If sexually active female, using an effective method of contraception from screening until at least 4 months after last vaccination. All female volunteers must be willing to undergo urine pregnancy tests.
•If sexually active male, willing to use an effective method of contraception from screening until 4 months after the last vaccination and will be advised not to get his partner pregnant.

Exclusion Criteria

•Confirmed HIV-1 or HIV-2 infection;
•Reported high-risk behavior for HIV infection defined as:
•Within 6 months before vaccination, the volunteer has:
•Had unprotected vaginal or anal sex with a known HIV infected person or with a casual partner.
•Engaged in sex work for money or drugs
•Used injection drugs (illicit), or
•Acquired an STD;
•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 trial physician within the last 6 months;
•Any clinically significant acute or chronic medical condition requiring care of a physician (e.g., diabetes, coronary artery disease, rheumatologic illness, malignancy, substance abuse) that in the opinion of the investigator would preclude participation;
•Any of the following abnormal laboratory parameters listed below: