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The DOI matches its Crossref record; 2 of the 2 references it cites were found in a registry or an index.

Safety and Immunogenicity of a Replication‐Incompetent Adenovirus Type 5 HIV‐1 Clade B gag/pol/nef Vaccine in Healthy Adults

Priddy, Frances H., Brown, Deborah, Kublin, James, Monahan, Kathleen, Wright, David P., Lalezari, Jacob, Santiago, Steven, Marmor, Michael, Lally, Michelle, Novak, Richard M., Brown, Stephen J., Kulkarni, Priya, Dubey, Sheri A., Kierstead, Lisa S., Casimiro, Danilo R., Mogg, Robin, DiNubile, Mark J., Shiver, John W., Leavitt, Randi Y., Robertson, Michael N., Mehrotra, Devan V., Quirk, Erin, Merck V520‐016 Study Group·2008·Clinical Infectious Diseases

Abstract

BACKGROUND: The safety and immunogenicity of the MRK adenovirus type 5 human immunodeficiency virus type 1 clade B gag/pol/nef vaccine, a replication-incompetent adenovirus type 5-vectored vaccine designed to elicit cell-mediated immunity against conserved human immunodeficiency virus proteins, was assessed in a phase 1 trial. METHODS: Healthy adults not infected with human immunodeficiency virus were enrolled in a multicenter, dose-escalating, blind, placebo-controlled study to evaluate a 3-dose homologous prime-boost regimen of the trivalent MRK adenovirus type 5 human immunodeficiency virus type 1 vaccine containing from 3 x 10(6) to 1 x 10(11) viral particles per 1-mL dose administered on day 1, during week 4 and during week 26. Adverse events were recorded for 29 days after each intradeltoid injection. The primary immunogenicity end point was the proportion of study participants with a positive unfractionated Gag-, Pol-, or Nef-specific interferon-gamma enzyme-linked immunosorbent spot response measured 4 weeks after administration of the last dose. RESULTS: Of 259 randomized individuals, 257 (99%) received > or = 1 dose of vaccine or placebo and were included in the safety analyses. Enzyme-linked immunosorbent spot results were available for 217 study participants (84%) at week 30. No serious vaccine-related adverse events occurred. No study participant discontinued participation because of vaccine-related adverse events. The frequency of injection-site reactions was dose dependent. Vaccine doses of > or = 3 x 10(9) viral particles elicited positive enzyme-linked immunosorbent spot responses to > or = 1 vaccine component in > 60% of recipients. High baseline antibody titers against adenovirus type 5 diminished enzyme-linked immunosorbent spot responses at all doses except the 3 x 10(10) viral particle dose. CONCLUSIONS: The vaccine was generally well tolerated and induced cell-mediated immune responses against human immunodeficiency virus type 1 peptides in most healthy adults. Despite these findings, vaccination in a proof-of-concept trial with use of this vaccine was discontinued because of lack of efficacy.

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Crossref · 10.1086/587993

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Metadata

Authors
Priddy, F. H., Brown, D., Kublin, J., Monahan, K., Wright, D. P., Lalezari, J., Santiago, S., Marmor, M., Lally, M., Novak, R. M., Brown, S. J., Kulkarni, P., Dubey, S. A., Kierstead, L. S., Casimiro, D. R., Mogg, R., DiNubile, M. J., Shiver, J. W., Leavitt, R. Y., Robertson, M. N., Mehrotra, D. V., Quirk, E., & Merck V520‐016 Study Group
Venue
Clinical Infectious Diseases
Published
2008-06
Volume
46
Issue
11
Pages
1769-1781
ISSN
  • 1058-4838 (ISSN-L)
  • 1537-6591
OpenAlex
W2158973015
Cited by
253
References
2
FWCI
11.72
Type
journal article
Language
en
Open access
closed

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