Safety of and Immune Response to a New HIV Vaccine: HIV CTL MEP
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.
Biological: HIV CTL MEP administered with RC529-SE adjuvant
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Primary Purpose: Prevention
|Official Title:||A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of a CTL Multi-Epitope Peptide HIV Vaccine Formulated With RC529-SE, With or Without GM-CSF, in Healthy, HIV-1 Uninfected Adult Participants|
|Study Start Date:||April 2004|
|Study Completion Date:||June 2006|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00076037
|United States, Alabama|
|Alabama Vaccine CRS|
|Birmingham, Alabama, United States, 35294-2041|
|United States, California|
|San Francisco Vaccine and Prevention CRS|
|San Francisco, California, United States|
|United States, Maryland|
|Johns Hopkins Bloomberg School of Public Health,Ctr for Immunization Research,Project SAVE-Baltimore|
|Baltimore, Maryland, United States|
|United States, Missouri|
|Saint Louis Univ. School of Medicine, HVTU|
|St. Louis, Missouri, United States, 63110-2500|
|United States, New York|
|Univ. of Rochester HVTN CRS|
|Rochester, New York, United States, 14642|
|United States, Tennessee|
|Vanderbilt Vaccine CRS|
|Nashville, Tennessee, United States, 37232|
|United States, Washington|
|FHCRC/UW Vaccine CRS|
|Seattle, Washington, United States, 98104|
|Study Chair:||Paul Spearman, MD||Vanderbilt University|
|Study Chair:||Spyros Kalams, MD||Vanderbilt University|