A phase I study to evaluate a human papillomavirus (HPV) type 18 L1 VLP vaccine

Autor: Kathrin U. Jansen, Kevin A Ault, Eliav Barr, Judith F. Smith, Gretchen M. Tamms, Anna R. Giuliano, Robert P. Edwards, Deemarie Skulsky, Lee-Lian Kim, Maria Allende, Frank J. Taddeo
Rok vydání: 2003
Předmět:
Zdroj: Vaccine. 22(23-24)
ISSN: 0264-410X
Popis: Human papillomavirus (HPV) infection can cause genital warts and cervical cancer. HPV types 6 and 11 cause >90% of genital wart cases; HPV16 and 18 cause 70% of cervical cancers. A prophylactic HPV (types 6, 11, 16, 18) L1 virus-like particle (VLP) vaccine may substantially reduce the incidence of these lesions. This report describes the results of a phase I study of the HPV18 component of such a vaccine. Forty women were randomized to receive either HPV18 L1 VLP vaccine or placebo. Anti-HPV18 responses were measured using a competitive radioimmunoassay (cRIA). Tolerability was evaluated using vaccination report cards (VRC). The study showed that the HPV18 L1 VLP vaccine was generally well-tolerated and highly immunogenic. Peak anti-HPV18 geometric mean titers (GMT) in vaccines were 60-fold greater than those observed in women following natural HPV18 infection. Further studies of a multivalent HPV L1 VLP vaccines are warranted.
Databáze: OpenAIRE