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Safety and immunogenicity of a bivalent cytomegalovirus DNA vaccine in healthy adult subjects.

Wloch, Mary K and Smith, Larry R and Boutsaboualoy, Souphaphone and Reyes, Luane and Han, Christina and Kehler, Jackie and Smith, Heather D and Selk, Linda and Nakamura, Ryotaro and Brown, Janice M and Marbury, Thomas and Wald, Anna and Rolland, Alain and Kaslow, David and Evans, Thomas and Boeckh, Michael (2008) Safety and immunogenicity of a bivalent cytomegalovirus DNA vaccine in healthy adult subjects. The Journal of infectious diseases, 197 (12). pp. 1634-1642. ISSN 0022-1899

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Abstract

BACKGROUND: VCL-CB01, a candidate cytomegalovirus (CMV) DNA vaccine that contains plasmids encoding CMV phosphoprotein 65 (pp65) and glycoprotein B (gB) to induce cellular and humoral immune responses and that is formulated with poloxamer CRL1005 and benzalkonium chloride to enhance immune responses, was evaluated in a phase 1 clinical trial. METHODS: VCL-CB01 was evaluated in 44 healthy adult subjects (22 CMV seronegative and 22 CMV seropositive) 18-43 years old. Thirty-two subjects received 1- or 5-mg doses of vaccine on a 0-, 2-, and 8-week schedule, and 12 subjects received 5-mg doses of vaccine on a 0-, 3-, 7-, and 28-day schedule. RESULTS: Overall, the vaccine was well tolerated, with no serious adverse events. Local reactions included mild to moderate injection site pain and tenderness, induration, and erythema. Systemic reactions included mild to moderate malaise and myalgia. All reactions resolved without sequelae. Through week 16 of the study, immunogenicity, as measured by enzyme-linked immunosorbant assay and/or ex vivo interferon (IFN)-gamma enzyme-linked immunospot assay, was documented in 45.5% of CMV-seronegative subjects and in 25.0% of CMV-seropositive subjects who received the full vaccine series, and 68.1% of CMV-seronegative subjects had memory IFN-gamma T cell responses at week 32. CONCLUSION: The safety and immunogenicity data from this trial support further evaluation of VCL-CB01.

Item Type: Article
Additional Information: © 2008 by Chicago Journals
DOI: 10.1086/588385
PubMed ID: 18444883
NIHMSID: NIHMS124250
PMCID: PMC2956065
Grant Numbers: R01 AI060159-02, R44 AI058386-04
Keywords or MeSH Headings: Adolescent; Adult; Antibodies, Viral/blood; Cytomegalovirus/immunology; Cytomegalovirus Vaccines/adverse effects/immunology; Dose-Response Relationship, Immunologic; Female; Humans; Immunologic Memory; Kinetics; Male; T-Lymphocytes/physiology; Time Factors; Vaccines, DNA/adverse effects/immunology;
Depositing User: Library Staff
Date Deposited: 12 Jun 2009 23:29
Last Modified: 14 Feb 2012 14:42
URI: http://authors.fhcrc.org/id/eprint/299

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