A phase I study to evaluate a human papillomavirus (HPV) type 18 L1 VLP vaccine.
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.
Ault
Kevin A
KA
Department of Obstetrics and Gynecology, University of Iowa Hospitals and Clinics, 200 Hawkins Drive, Iowa City, IA 52242, USA. kevin-ault@uiowa.edu
Giuliano
Anna R
AR
Edwards
Robert P
RP
Tamms
Gretchen
G
Kim
Lee-Lian
LL
Smith
Judith F
JF
Jansen
Kathrin U
KU
Allende
Maria
M
Taddeo
Frank J
FJ
Skulsky
DeeMarie
D
Barr
Eliav
E
D000293:Adolescent; D000328:Adult; D000914:Antibodies, Viral / Q000032:analysis / Q000096:biosynthesis; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D027383:Papillomaviridae / Q000276:immunology*; D030361:Papillomavirus Infections / Q000276:immunology* / Q000517:prevention & control*; D053918:Papillomavirus Vaccines; D013997:Time Factors; D014765:Viral Vaccines / Q000009:adverse effects / Q000276:immunology* / Q000627:therapeutic use
D000914:Antibodies, Viral; D053918:Papillomavirus Vaccines; D014765:Viral Vaccines; C492959:human papillomavirus type 18 L1 VLP vaccine