ABSTRACT
Neutralization of human papillomavirus type 11 (HPV-11) has been demonstrated using serum and cervical secretions from primates vaccinated with virus-like particles (VLPs). Theoretically, neutralizing antibodies could protect women from HPV infection. The immunogenicity of a yeast-derived HPV-11 L1 VLP vaccine was tested in women. Serum specimens were evaluated for HPV-11 titer by competitive radioimmunoassay (cRIA) and for neutralization by use of the athymic mouse xenograft system. Analysis of serum from 104 subjects showed a dose response in HPV-11 cRIA titers and neutralization. Overall, 68 (82.9%) of 82 postimmunization serum specimens from VLP recipients were 100% neutralizing when used in the assay at a 1:50 dilution. Of 69 serum specimens, 63 (91.3%) with cRIA titers >200 milliMerck units per milliliter were neutralizing. Immunization with HPV VLPs elicits a vigorous serum immune response in a high percentage of women. The HPV-11 cRIA titer appears to be a surrogate marker for neutralization.
Subject(s)
Antibodies, Viral/immunology , Papillomaviridae/immunology , Papillomavirus Infections/prevention & control , Tumor Virus Infections/prevention & control , Viral Vaccines/immunology , Virion/immunology , Adolescent , Adult , Animals , Antibodies, Viral/blood , Dose-Response Relationship, Drug , Double-Blind Method , Female , Humans , Mice , Neutralization Tests , Papillomaviridae/genetics , Papillomavirus Infections/virology , Radioimmunoassay , Tumor Virus Infections/virology , Vaccination , Vaccines, Synthetic/immunology , Yeasts/geneticsABSTRACT
In vaccine trials, diary questionnaires or vaccination report cards (VRCs) are used extensively to collect complaints reported by subjects or guardians following vaccination. These have not been evaluated for accuracy or standardized to facilitate tolerability comparisons among vaccines.Objectives -(1) Develop standardized, age-specific VRCs for collecting self-reported adverse events (AEs) in trials; (2) Evaluate whether complaints elicited by nurse examinations or telephone interviews were missed by VRCs.Methods -Vaccine-trial databases, focus groups, experts and experienced nurses were used to develop paediatric and adolescent/adult VRCs. VRCs were evaluated at four sites. The primary outcome was subjects with AEs missed on the VRC and reported in nurse examinations (for injection-site reactions) or telephone interviews (for systemic complaints).Results -Of 855 subjects, 96.5% completed VRCs. For systemic complaints, 1.5% (12/812) reported both no complaint on VRCs and at least one complaint in telephone interviews. For injection-site reactions, 5.1% (53/1030) of injection sites had both no reaction reported on VRCs and had reactions noted by nurse examination. No missed AEs were rated as severe.Conclusion -The data suggest VRCs provide a practical and reasonably complete method of eliciting complaints following vaccination. Copyright (c) 2000 John Wiley & Sons, Ltd.
