A phase I study of HGP-30, a 30 amino acid subunit of the human immunodeficiency virus (HIV) p17 synthetic peptide analogue sub-unit vaccine in seronegative subjects.

Abstract:

:HGP-30-KLH vaccine in alum at doses of 10, 25, 50, and 100 micrograms/kg administered intramuscularly at weeks 0, 4, and 10 appear well-tolerated clinically. Local pain at the injection site, appears to be the main clinical toxicity. Laboratory parameters are not affected by administration of the vaccine candidate except for perhaps mild urinalysis abnormalities at the highest dose. This vaccine candidate has no apparent immunotoxicity and does not appear to affect lymphocyte populations or T-cell functional studies. Low levels and transient antibodies develop in a minority of subjects early after immunization with the vaccine candidate. These responses were observed in the lowest dose range. Higher doses, and longer follow-up will be needed to confirm this observation. T-cell proliferative responses to KLH and KLH-HGP-30 are consistent and may not be dose dependent, but the proliferative responses are variable and more data need to be accumulated. Preliminary, there appears to be an HGP-30-induced CTL response of HGP-30-coated EBV-transformed autologous B cell lines. This study was approved under an IND for the California Department of Health Services' Food and Drug Branch. They have provided excellent support and regulatory guidelines for this project. Future work will extend and confirm these initial observations.

authors

Kahn JO,Stites DP,Scillian J,Murcar N,Stryker R,Volberding PA,Naylor PH,Goldstein AL,Sarin PS,Simmon VF

doi

10.1089/aid.1992.8.1321

subject

Has Abstract,Author List Incomplete

pub_date

1992-08-01 00:00:00

pages

1321-5

issue

8

eissn

0889-2229

issn

1931-8405

journal_volume

8

pub_type

临床试验,杂志文章,多中心研究
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    pub_type: 临床试验,杂志文章,随机对照试验

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