Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
6
pubmed:dateCreated
2008-6-19
pubmed:abstractText
A novel prophylactic AIDS vaccine candidate, consisting of single-stranded DNA for HIV-1 subtype C gag, protease, and part of reverse transcriptase genes, enclosed within a recombinant adeno-associated virus serotype-2 protein capsid (tgAAC09) induced T cell responses and antibodies in nonhuman primates. In this randomized, dose escalation phase I trial, HIV-uninfected healthy volunteers (50 in Europe, 30 in India) received a single intramuscular injection of tgAAC09 at 3 x 10(9) DNase resistant particles (DRP) (n = 16), 3 x 10(10) DRP (n = 23), 3 x 10(11) DRP (n = 25), or placebo (n = 16). Twenty-one participants in Europe received a second (boost) dose of 3 x 10(11) DRP tgAAC09 or placebo at least 24 weeks after the first injection. The vaccine was safe and well-tolerated after initial and boost vaccination. Local and systemic reactogenicity was experienced by 13-25% of participants and was not dose related. No vaccine-related serious adverse events were reported. Modest HIV-specific T cell responses were detected in 7/64 vaccinees (40-385 SFC/10(6) PBMC), with 16% (4/25) responders in the highest dose group. All responses were to Gag epitopes. tgAAC09 appears to be safe, well-tolerated, and modestly immunogenic. Further evaluation of higher doses of tgAAC09 and boost injections is ongoing in Africa.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Jun
pubmed:issn
1931-8405
pubmed:author
pubmed:issnType
Electronic
pubmed:volume
24
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
873-80
pubmed:dateRevised
2008-11-21
pubmed:meshHeading
pubmed-meshheading:18544020-AIDS Vaccines, pubmed-meshheading:18544020-Adolescent, pubmed-meshheading:18544020-Adult, pubmed-meshheading:18544020-Antibody Formation, pubmed-meshheading:18544020-Capsid, pubmed-meshheading:18544020-DNA, Viral, pubmed-meshheading:18544020-Dependovirus, pubmed-meshheading:18544020-Double-Blind Method, pubmed-meshheading:18544020-Female, pubmed-meshheading:18544020-HIV Infections, pubmed-meshheading:18544020-HIV-1, pubmed-meshheading:18544020-Humans, pubmed-meshheading:18544020-Immunity, Cellular, pubmed-meshheading:18544020-Immunization, Secondary, pubmed-meshheading:18544020-Injections, Intramuscular, pubmed-meshheading:18544020-Interferon-gamma, pubmed-meshheading:18544020-Male, pubmed-meshheading:18544020-Middle Aged, pubmed-meshheading:18544020-Neutralization Tests, pubmed-meshheading:18544020-T-Lymphocytes, pubmed-meshheading:18544020-Vaccines, DNA, pubmed-meshheading:18544020-Vaccines, Virosome, pubmed-meshheading:18544020-gag Gene Products, Human Immunodeficiency Virus
pubmed:year
2008
pubmed:articleTitle
A phase 1 study to evaluate the safety and immunogenicity of a recombinant HIV type 1 subtype C adeno-associated virus vaccine.
pubmed:affiliation
National AIDS Research Institute, Pune, India.
pubmed:publicationType
Journal Article, Research Support, U.S. Gov't, Non-P.H.S., Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Clinical Trial, Phase I