A Phase I Trial To Evaluate the Safety and Immunogenicity of the UBI HIV-1MN PND Peptide Immunogen, Given by IM Injection, in Combination With the UBI Microparticulate Monovalent HIV-1 MN Branched Peptide Given Orally, in HIV-1 Uninfected Volunteers.
To evaluate safety and immunogenicity of 2 different HIV-1 peptide candidate vaccines, the UBI HIV-1 MN PND peptide immunogen and the UBI microparticulate monovalent HIV-1 MN branched peptide when administered sequentially by 2 different routes of immunization, parental priming followed by oral boosting.
Biological: HIV-1 Peptide Vaccine, Microparticulate Monovalent
Biological: HIV-1 Peptide Immunogen, Multivalent
|Study Design:||Endpoint Classification: Safety Study
Primary Purpose: Prevention
|Official Title:||A Phase I Trial To Evaluate the Safety and Immunogenicity of the UBI HIV-1MN PND Peptide Immunogen, Given by IM Injection, in Combination With the UBI Microparticulate Monovalent HIV-1 MN Branched Peptide Given Orally, in HIV-1 Uninfected Volunteers.|
After the prescreening, volunteers will be randomized into Group I or Group II. Each group will contain 16 volunteers. At least 5 volunteers in each group must be women. At month 0 all volunteers will receive multivalent HIV-1 peptide immunogen or the placebo. Group I will receive the injection in the deltoid and Group II will receive it in the anterior thigh. At months 1, 2 and 8 all patients will receive microparticulate monovalent HIV-1 peptide or the placebo. Follow up will be conducted.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000846
|United States, Alabama|
|Univ of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294|
|United States, New York|
|Univ of Rochester Med Ctr|
|Rochester, New York, United States, 14642|
|United States, Washington|
|Univ of Washington / Pacific Med Ctr|
|Seattle, Washington, United States, 98144|
|Study Chair:||Mulligan M|