Recombinant gp350 vaccine for infectious mononucleosis: a phase 2, randomized, double-blind, placebo-controlled trial to evaluate the safety, immunogenicity, and efficacy of an Epstein-Barr virus vaccine in healthy young adults
- PMID: 18190254
- DOI: "VSports手机版" 10.1086/523813
Recombinant gp350 vaccine for infectious mononucleosis: a phase 2, randomized, double-blind, placebo-controlled trial to evaluate the safety, immunogenicity, and efficacy of an Epstein-Barr virus vaccine in healthy young adults (V体育平台登录)
Abstract
Background: To date, there is no commercially available vaccine to prevent infectious mononucleosis, a disease frequently induced by Epstein-Barr virus (EBV) infection in adolescents or adults devoid of preexisting immunity to the virus. VSports手机版.
Methods: A total of 181 EBV-seronegative, healthy, young adult volunteers were randomized in a double-blind fashion to receive either placebo or a recombinant EBV subunit glycoprotein 350 (gp350)/aluminum hydroxide and 3-O-desacyl-4'-monophosphoryl lipid A (AS04) candidate vaccine in a 3-dose regimen V体育安卓版. .
Results: The vaccine had demonstrable efficacy (mean efficacy rate, 78. 0% [95% confidence interval {CI}, 1. 0%-96. 0%]) in preventing the development of infectious mononucleosis induced by EBV infection, but it had no efficacy in preventing asymptomatic EBV infection V体育ios版. One month after receipt of the final dose of gp350 vaccine, 98. 7% of subjects showed seroconversion to anti-gp350 antibodies (95% CI, 85. 5%-97. 9%), and they remained anti-gp350 antibody positive for >18 months. Furthermore, there were no concerns regarding the safety or reactogenicity of the gp350/AS04 vaccine. .
Conclusion: These data support the clinical feasibility of using an EBV vaccine to prevent infectious mononucleosis VSports最新版本. .
Trial registration: ClinicalTrials V体育平台登录. gov identifier: NCT00430534. .
Comment in
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Epstein-Barr virus vaccine for the prevention of infectious mononucleosis--and what else?J Infect Dis. 2007 Dec 15;196(12):1724-6. doi: 10.1086/523815. J Infect Dis. 2007. PMID: 18190249 No abstract available.
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