Status:
COMPLETED
Safety of and Immune Response to a Combination HIV Vaccine Regimen in HIV Uninfected Adults
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
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 an...
Detailed Description
The development of a vaccine eliciting HIV-specific humoral and cellular immune responses is desirable for the prevention of HIV infection. This study will investigate a combination vaccine regimen co...
Eligibility Criteria
Inclusion
- Note: As of 07/01/05, Group 5 will begin enrollment after enrollment into Groups 1, 2, 3, and 4 is completed.
- Inclusion Criteria
- 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
- Exclusion Criteria
- 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
Exclusion
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00073216
End Date
September 1 2007
Last Update
October 14 2021
Active Locations (4)
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1
Saint Louis Univ. School of Medicine, HVTU
St Louis, Missouri, United States
2
Miriam Hospital's HVTU
Providence, Rhode Island, United States, 02906
3
Vanderbilt Vaccine CRS
Nashville, Tennessee, United States, 37232
4
FHCRC/UW Vaccine CRS
Seattle, Washington, United States, 98104