Immunogenicity Bridge Between an Investigational Monovalent Vaccine and the Equivalent Component of Gardasil (V501) a Quadrivalent Vaccine (V501-012)(COMPLETED)

Conditions

Cervical Cancer, Genital Warts

Brief summary

The purpose of the study is to determine if an investigational vaccine with a single component develops an immune response that is similar to the equivalent investigational vaccine with four components to reduce cervical disease.

Darron R. Brown, Xavier Castellsagué, Daron Ferris, Suzanne M. Garland, Warner K. Huh et al. (11 authors)

Tumour Virus Research2022-05-0413 citations

10.1016/j.tvr.2022.200236

Adjuvant-containing control arms in pivotal quadrivalent human papillomavirus vaccine trials: restoration of previously unpublished methodology

Peter Doshi, Florence T. Bourgeois, Kyungwan Hong, Mark Jones, Haeyoung Lee et al. (8 authors)

BMJ evidence-based medicine2020-03-179 citations

10.1136/bmjebm-2019-111331

The impact of quadrivalent human papillomavirus (HPV; types 6, 11, 16, and 18) L1 virus-like particle vaccine on infection and disease due to oncogenic nonvaccine HPV types in generally HPV-naive women aged 16-26 years.

Brown DR, Kjaer SK, Sigurdsson K, Iversen OE, Hernandez-Avila M, Wheeler CM, Perez G, Koutsky LA, Tay EH, Garcia P, Ault KA, Garland SM, Leodolter S, Olsson SE, Tang GW, Ferris DG, Paavonen J, Steben M, Bosch FX, Dillner J, Joura EA, Kurman RJ, Majewski S, Muñoz N, Myers ER, Villa LL, Taddeo FJ, Roberts C, Tadesse A, Bryan J, Lupinacci LC, Giacoletti KE, Sings HL, James M, Hesley TM, Barr E.

2009-04-01414 citations

10.1086/597307

The impact of quadrivalent human papillomavirus (HPV; types 6, 11, 16, and 18) L1 virus-like particle vaccine on infection and disease due to oncogenic nonvaccine HPV types in sexually active women aged 16-26 years.

Wheeler CM, Kjaer SK, Sigurdsson K, Iversen OE, Hernandez-Avila M, Perez G, Brown DR, Koutsky LA, Tay EH, García P, Ault KA, Garland SM, Leodolter S, Olsson SE, Tang GW, Ferris DG, Paavonen J, Steben M, Bosch FX, Dillner J, Joura EA, Kurman RJ, Majewski S, Muñoz N, Myers ER, Villa LL, Taddeo FJ, Roberts C, Tadesse A, Bryan J, Lupinacci LC, Giacoletti KE, James M, Vuocolo S, Hesley TM, Barr E.

2009-04-01189 citations

10.1086/597309

Interventions

BIOLOGICALV501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine / Duration of Treatment: 4 years

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

16 Years to 23 Years

Healthy volunteers

Yes

Inclusion criteria

* Female with an intact uterus with lifetime history of 0-4 sexual partners

Exclusion criteria

* Prior Human Papillomavirus Vaccine (HPV) vaccination; * Prior abnormal paps; * Prior history of genital warts

Design outcomes

Primary

Measure	Time frame
Tolerability and immune responses at week 4 post dose 3.	—

Outcome results

None listed