Safety of and Immune Response to a Combination HIV Vaccine Regimen in HIV Uninfected Adults

Completed · Phase 1

Conditions studied: HIV Infections

In brief

To prevent HIV infection, a vaccine that produces strong HIV-specific humoral (B-cell) and cellular (T-cell) immune system responses is desirable. The purpose of this study is to test the safety of and immune response to a novel combination HIV vaccine in HIV uninfected adults. This study will also test the safety of and immune response to a protein vaccine given alone.

Key facts

Study ID

NCT00073216

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

96

Expected to finish

2007-09-01

Last updated by the study team

2021-10-14

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Understanding of vaccination procedure
• Willing to receive HIV test results and provide informed consent
• Good general health
• HIV negative
• Hepatitis B surface antigen negative
• Anti-hepatitis C virus (HCV) antibody negative, or negative for HCV PCR if the anti-HCV is positive
• Not pregnant and agrees to use acceptable forms of contraception

You may not qualify if…

• Received HIV vaccines or placebo in a prior HIV vaccine trial
• Immunosuppressive medications within 168 days prior to study
• Blood products within 120 days prior to study
• Immunoglobulin within 60 days prior to study
• Live attenuated vaccines within 30 days prior to study
• Investigational research agents within 30 days prior to study
• Medically indicated subunit or killed vaccines within 14 days prior to study
• Current anti-tuberculosis prophylaxis or therapy
• Anaphylaxis or other serious adverse reactions to vaccines; a person who had an adverse reaction to pertussis vaccine as a child is not excluded
• Autoimmune disease or immunodeficiency
• Active syphilis infection
• Unstable asthma (e.g., use of oral, orally inhaled, or intravenous corticosteroids, emergent care, urgent care, hospitalization or intubation during the past 2 years)
• Diabetes mellitus; a participant with past gestational diabetes is not excluded
• Thyroid disease, including removal of thyroid and diagnoses requiring medication
• Serious angioedema
• Uncontrolled hypertension
• Diagnosis of bleeding disorder
• Malignancy, except those with a surgical excision and subsequent observation period that in the investigator's estimate has a reasonable assurance of sustained cure and/or is unlikely to recur during the period of the study
• Seizure disorder requiring medication within the last 3 years
• Absence of the spleen
• Mental illness that would interfere with compliance with the protocol
• Breastfeeding
• Unprotected rectal or vaginal sex with a partner known to be HIV infected within 6 months of enrollment

Where it is running

• Saint Louis Univ. School of Medicine, HVTU — St Louis, Missouri, United States
• Miriam Hospital's HVTU — Providence, Rhode Island, United States
• Vanderbilt Vaccine CRS — Nashville, Tennessee, United States
• FHCRC/UW Vaccine CRS — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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