REMUNE HIV/AIDS Vaccine Phase II Pediatric Safety & Efficacy Clinical Study
HIV/AIDS
About this trial
This is an interventional treatment trial for HIV/AIDS focused on measuring HIV/AIDS, Pediatric, Vaccine, HIV-1 Immunogen
Eligibility Criteria
Inclusion Criteria:
- Children clinically diagnosed with HIV that are 3 months of age to the age 16 years old
- Subjects on any approved FDA antiviral medication except triple cocktail HAART drugs
Exclusion Criteria:
- Truvada
- Triple cocktail HAART drugs
- Healthy subjects
Sites / Locations
- Clinical Site TBA
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
REMUNE
REMUNE Low Dose
Remune vaccine consists of a suspension of killed HIV-1 virus particles that have been emulsified with Incomplete Freund's Adjuvant (IFA, a mixture of mannide mono-oleate and a highly purified mineral oil). Each dose is given by IM injection and contains 10 μg of p24 antigen in approximately 100 μg of total protein.
Remune low dose vaccine consists of a suspension of killed HIV-1 virus particles that have been emulsified with Incomplete Freund's Adjuvant (IFA, a mixture of mannide mono-oleate and a highly purified mineral oil). Each dose is given by IM injection and contains 2.5 μg of p24 antigen in approximately 25 μg of total protein.