Abstract
Two double-blind randomised controlled studies (phase I and I/II) were performed to assess for the first time the safety and immunogenicity of a recombinant subunit gp350 Epstein-Barr virus (EBV) vaccine in 148 healthy adult volunteers. All candidate vaccine formulations had a good safety profile and were well tolerated, with the incidence of solicited and unsolicited symptoms within a clinically acceptable range. One serious adverse event was reported in the phase I trial which was considered to be of suspected relationship to vaccination. The gp350 vaccine formulations were immunogenic and induced gp350-specific antibody responses (including neutralising antibodies).
Publication types
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Clinical Trial, Phase I
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Clinical Trial, Phase II
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Randomized Controlled Trial
MeSH terms
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Adolescent
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Adult
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Antibodies, Viral / blood
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Antigens, Viral / immunology*
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Double-Blind Method
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Enzyme-Linked Immunosorbent Assay
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Epstein-Barr Virus Infections / prevention & control*
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Female
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Herpesvirus 4, Human / immunology*
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Herpesvirus Vaccines / adverse effects*
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Herpesvirus Vaccines / immunology*
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Humans
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Male
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Neutralization Tests
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Vaccines, Subunit / adverse effects
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Vaccines, Subunit / immunology
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Vaccines, Synthetic / adverse effects
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Vaccines, Synthetic / immunology
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Viral Matrix Proteins / immunology*
Substances
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Antibodies, Viral
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Antigens, Viral
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EBV-associated membrane antigen, Epstein-Barr virus
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Herpesvirus Vaccines
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Vaccines, Subunit
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Vaccines, Synthetic
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Viral Matrix Proteins