Status:
COMPLETED
Safety of and Immune Response to a New HIV Vaccine: HIV CTL MEP
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
Brief Summary
The effectiveness of a vaccine can be improved by using a "prime boost strategy" or by using an adjuvant. A prime boost strategy is the administration of one type of vaccine (the primer) followed by t...
Detailed Description
Prime-boost vaccine strategies are aimed at inducing different types of immune responses and enhancing the overall immune response, a result that may not occur with a single type of vaccine. This tria...
Eligibility Criteria
Inclusion
- HIV uninfected
- Willing to receive HIV test results
- Good general health
- One of the following major histocompatibility (MHC) alleles: HLA A3, B7, or B8
- Acceptable methods of contraception for females of reproductive potential
- Hepatitis B surface antigen negative
- Anti-hepatitis C virus antibody (anti-HCV) negative or negative HCV PCR if anti-HCV is positive
- Access to participating site and available for follow-up during the 15 month study
Exclusion
- HIV vaccines or placebos in prior HIV vaccine trial
- Immunosuppressive medications within 168 days prior to first study vaccine administration
- Blood products within 120 days prior to first study vaccine administration
- Immunoglobulin within 60 days prior to first study vaccine administration
- Live attenuated vaccines within 30 days prior to first study vaccine administration
- Investigational research agents within 30 days prior to first study vaccine administration
- Subunit or killed vaccines within 14 days prior to first study vaccine administration
- Current tuberculosis prophylaxis or therapy
- Serious adverse reaction to a vaccine. A person who had an adverse reaction to pertussis vaccine as a child is not excluded.
- Hypersensitivity to egg products or yeast-derived products
- Autoimmune disease or immunodeficiency
- Active syphilis
- Unstable asthma
- Type 1 or Type 2 diabetes mellitus
- Thyroid disease requiring treatment in the past 12 months
- Serious angioedema within the past 3 years
- Uncontrolled hypertension
- Bleeding disorder
- Malignancy unless it has been surgically removed and, in the opinion of the investigator, is not likely to recur during the study period
- Seizure disorder requiring medication within the past 3 years
- Asplenia
- Mental illness that would interfere with compliance with the protocol
- Other conditions that, in the judgment of the investigator, would interfere with the study
- Pregnant or breast-feeding
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00076037
Start Date
April 1 2004
End Date
June 1 2006
Last Update
October 14 2021
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Alabama Vaccine CRS
Birmingham, Alabama, United States, 35294-2041
2
San Francisco Vaccine and Prevention CRS
San Francisco, California, United States
3
Johns Hopkins Bloomberg School of Public Health,Ctr for Immunization Research,Project SAVE-Baltimore
Baltimore, Maryland, United States
4
Saint Louis Univ. School of Medicine, HVTU
St Louis, Missouri, United States, 63110-2500