Safety and Immunogenicity of a Modified Vaccinia Ankara (MVA) HIV Vaccine in HIV Uninfected Adults

Completed · Phase 1 · Has a placebo group

Conditions studied: HIV Infection

In brief

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

Key facts

Study ID

NCT00252148

Run by

International AIDS Vaccine Initiative

People needed

48

Starts

2005-01-01

Expected to finish

2007-08-01

Last updated by the study team

2013-02-11

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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:
• Hemoglobin: <9.0 g/dL
• Absolute Neutrophil Count (ANL): ≤ 999/mm3
• Absolute Lymphocyte Count (ALC): ≤ 500/mm3
• Platelets: ≤ 90,000 ≥ 550,000/mm3
• Creatinine: > 1.4 x ULN
• AST: >3.0 x ULN
• ALT: >3.0 x ULN
• Urine dipstick: blood = 2+ or more (except in menstruating females); protein = 2+or more
• Cardiac troponin I: > ULN;
• Confirmed diagnosis of hepatitis B (surface antigen, HbsAg); hepatitis C (HCV antibodies) or active syphilis;
• If female, pregnant or planning a pregnancy within 4 months after last vaccination or lactating;
• Receipt of a live attenuated vaccine (other than influenza) within 30 days or other vaccine within 14 days of vaccination;
• Receipt of blood transfusion or blood products 6 months prior to vaccination;
• Participation in another clinical study of an investigational product currently or within past 12 weeks or expected participation during this study;
• Receipt of another experimental HIV vaccine at any time;

Where it is running

• Rockefeller University Hospital — New York, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States

Full record on ClinicalTrials.gov

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