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Home > "S" Clinical Trials Conditions > Safety of and Immune Response to a New HIV Vaccine: HIV CTL MEP  Safety of and Immune Response to a New HIV Vaccine: HIV CTL MEP
Safety of and Immune Response to a New HIV Vaccine: HIV CTL MEP
For Condition: HIV Seronegativity,HIV Infections
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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 trial will evaluate the safety and immunogenicity of an HIV multi-epitope peptide cytotoxic T lymphocyte (HIV CTL MEP) vaccine developed as part of a prime-boost strategy and designed to be administered in combination with an HIV DNA vaccine. The HIV CTL MEP vaccine is a mixture of four synthetic peptides, each containing one of three different HIV CTL epitopes derived from env or gag. The use of multiple conserved CTL epitopes will address the extraordinary diversity found among HIV strains. The vaccine is administered with RC529-SE, an analogue of monophosphoryl lipid A. The vaccine/adjuvant combination will be evaluated with or without coadministration of granulocyte-macrophage colony-stimulating factor (GM-CSF). Participants will be randomly assigned to receive either the vaccine with the RC529-SE adjuvant, the vaccine with both adjuvants (RC529-SE and GM-CSF), or a placebo. The vaccine, adjuvants, and placebo will all be given as an injection into the upper arm. Participants will have 11 study visits. Study visits will include a physical exam, medical interview, and blood and urine tests. Participants will receive an injection at three of these visits: study entry and Months 1 and 3. Participants will be followed for 1 year after the last injection.
Eligibility:
Study Type: Interventional, Prevention, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/40 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - HIV uninfected - Willing to receive HIV test results - Good general health - One of the following major histocompatability (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 Criteria: - 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
Total Enrollment: 96
Location and Contact Information:
Overall Study Official:
SpyrosKalams, Study Chair, Vanderbilt University
Mt. Zion Hospital *Not yet recruiting*
San Francisco, California, 94102-6033
United States
Not yet recruiting Rose Quinones 415-544-9014
Vanderbilt University *Recruiting*
Nashville, Tennessee, 37232
United States
Recruiting Kyle Rybczyk 615-322-5641
St. Louis University - New Hope Bldg. *Recruiting*
St. Louis, Missouri, 63110-2500
United States
Recruiting Heidi Israel 314-268-5448
JHU-CIR/DC *Not yet recruiting*
Baltimore, Maryland, 21205-1901
United States
Not yet recruiting Eric Zimmerman 410-955-7283
San Francisco Department of Public Health *Not yet recruiting*
San Francisco, California, 94102-6033
United States
Not yet recruiting Rose Quinones 415-544-9014
Johns Hopkins University *Not yet recruiting*
Baltimore, Maryland, 21205-1901
United States
Not yet recruiting Eric Zimmerman 410-955-7283
Additional Information:
Study ID Numbers: HVTN 056;
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00076037
Other Hiv Seronegativity Studies:
1. A Randomized, Open-Label Study of 800 mg Lopinavir/200 mg Ritonavir QD in Combination with Tenofovir and Emtricitabine vs. 400 mg Lopinavir /100 mg Ritonavir BID in Combination with Tenofovir and Emtricitabine in HIV-Infected Antiretroviral Naïve Subjects
2. Safety and Effectiveness of Adding Adefovir Dipivoxil and Nelfinavir to the Anti-HIV Therapy of HIV-Infected Children
3. Using Nevirapine to Prevent Mother-to-Child HIV Transmission During Breastfeeding
4. Evaluation of the Interaction Between High Dose Sulfamethoxazole/Trimethoprim and Zidovudine
5. Effect of Interleukin-2 on HIV Treatment Interruption
Related Studies:
Other HIV Seronegativity Clinical Trials
Other Missouri Clinical Trials
Other St. Louis Clinical Trials
Safety of and Immune Response to a New HIV Vaccine: HIV CTL MEP
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