Safety of and Immune Response to a New HIV Vaccine: HIV CTL MEP
Completed · Phase 1
Conditions studied: HIV Infections
In brief
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 the administration of another type vaccine (the booster). An adjuvant is a substance that can enhance the immune response when given at the same time as a vaccine. This study will evaluate the safety of and immune response to a vaccine designed to be used as part of a prime boost strategy. The study will also evaluate the vaccine when given with an adjuvant. The vaccine in this study is not produced from live HIV or from infected cells. It does not contain HIV, and it cannot cause HIV infection.
Key facts
- Study ID
- NCT00076037
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 96
- Starts
- 2004-04-01
- Expected to finish
- 2006-06-01
- Last updated by the study team
- 2021-10-14
Who can join
Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Alabama Vaccine CRS — Birmingham, Alabama, United States
- San Francisco Vaccine and Prevention CRS — San Francisco, California, United States
- Johns Hopkins Bloomberg School of Public Health,Ctr for Immunization Research,Project SAVE-Baltimore — Baltimore, Maryland, United States
- Saint Louis Univ. School of Medicine, HVTU — St Louis, Missouri, United States
- Univ. of Rochester HVTN CRS — Rochester, New York, 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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