A Study of LIPO-5 and ALVAC-HIV (vCP1452) as Possible HIV Vaccines
HIV Infections

About this trial
This is an interventional prevention trial for HIV Infections focused on measuring HIV Seronegativity, ALVAC-HIV vCP1452, ALVAC Vaccine, HIV-1, Normal Values, HIV Preventive Vaccine
Eligibility Criteria
Inclusion Criteria: HIV uninfected Willing to receive HIV test results Good general health Acceptable methods of contraception for females of reproductive potential Access to participating site and available for follow-up during the 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 Hypersensitivity to neomycin or egg products Uveitis, chronic Lyme disease, active mycobacterial diseases, or sarcoidosis Serious adverse reaction to a vaccine. A person who had an adverse reaction to pertussis vaccine as a child is not excluded. 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
Sites / Locations
- Alabama Vaccine CRS
- Johns Hopkins Bloomberg School of Public Health,Ctr for Immunization Research,Project SAVE-Baltimore
- Project Brave HIV Vaccine CRS
- Brigham and Women's Hosp. CRS
- Fenway Community Health Clinical Research Site (FCHCRS)
- Saint Louis Univ. School of Medicine, HVTU
- NY Blood Ctr./Bronx CRS
- Univ. of Rochester HVTN CRS
- Miriam Hospital's HVTU
- Vanderbilt Vaccine CRS
- FHCRC/UW Vaccine CRS
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Experimental
A
B
C
D
E
Participants in Groups A will receive four injections over 6 months of either LIPO-5 or a placebo.
Participants in Group B will receive four injections over 6 months of either the ALVAC-HIV (vCP1452) or a placebo.
Participants in Groups C will receive six injections over 6 months. Participants in this group will receive either ALVAC-HIV (vCP1452) and LIPO-5 or a placebo. Participants who receive the vaccine combination will receive four injections of the same dose of ALVAC-HIV (vCP1452) and two injections of LIPO-5. The dose of LIPO-5 will be different for participants in Groups C, D, and E.
Participants in Group D will receive six injections over 6 months. Participants in this group will receive either ALVAC-HIV (vCP1452) and LIPO-5 or a placebo. Participants who receive the vaccine combination will receive four injections of the same dose of ALVAC-HIV (vCP1452) and two injections of LIPO-5. The dose of LIPO-5 will be different for participants in Groups C, D, and E.
Participants in Group E will receive six injections over 6 months. Participants in this group will receive either ALVAC-HIV (vCP1452) and LIPO-5 or a placebo. Participants who receive the vaccine combination will receive four injections of the same dose of ALVAC-HIV (vCP1452) and two injections of LIPO-5. The dose of LIPO-5 will be different for participants in Groups C, D, and E.