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PLoS One. 2013 Dec 31;8(12):e83431. doi: 10.1371/journal.pone.0083431. eCollection 2013.

Long-term follow-up observation of the safety, immunogenicity, and effectiveness of Gardasil™ in adult women.

Author information

1
Instituto Nacional de Cancerologia, Bogotá, Colombia.
2
Fundacion Cardioinfantil, Bogotá, Colombia.
3
Clinica del Country, Bogotá, Colombia.
4
Fundacion Santa Fe de Bogotá, Bogotá, Colombia.
5
Cafam, Bogotá, Colombia.
6
Merck Sharp & Dohme Corp., Whitehouse Station, New Jersey, United States of America.

Abstract

BACKGROUND:

Previous analyses from a randomized trial in women aged 24-45 have shown the quadrivalent HPV vaccine to be efficacious in the prevention of infection, cervical intraepithelial neoplasia (CIN) and external genital lesions (EGL) related to HPV 6/11/16/18 through 4 years. In this report we present long term follow-up data on the efficacy, safety and immunogenicity of the quadrivalent HPV vaccine in adult women.

METHODS:

Follow-up data are from a study being conducted in 5 sites in Colombia designed to evaluate the long-term immunogenicity, effectiveness, and safety of the qHPV vaccine in women who were vaccinated at 24 to 45 years of age (in the original vaccine group during the base study [n = 684]) or 29 to 50 years of age (in the original placebo group during the base study [n = 651]). This analysis summarizes data collected as of the year 6 post-vaccination visit relative to day 1 of the base study (median follow-up of 6.26 years) from both the original base study and the Colombian follow-up.

RESULTS:

There were no cases of HPV 6/11/16/18-related CIN or EGL during the extended follow-up phase in the per-protocol population. Immunogenicity persists against vaccine-related HPV types, and no evidence of HPV type replacement has been observed. No new serious adverse experiences have been reported.

CONCLUSIONS:

Vaccination with qHPV vaccine provides generally safe and effective protection from HPV 6-, 11-, 16-, and 18-related genital warts and cervical dysplasia through 6 years following administration to 24-45 year-old women.

TRIAL REGISTRATION:

Clinicaltrials.govNCT00090220.

PMID:
24391768
PMCID:
PMC3877052
DOI:
10.1371/journal.pone.0083431
[Indexed for MEDLINE]
Free PMC Article

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