Prevention of persistent human papillomavirus infection by an HPV16/18 vaccine: A community-based randomized clinical trial in guanacaste, Costa Rica

Rolando Herrero, Sholom Wacholder, Ana C. Rodríguez, Diane Solomon, Paula González, Aimee R. Kreimer, Carolina Porras, John Schussler, Silvia Jiménez, Mark E. Sherman, Wim Quint, John T. Schiller, Douglas R. Lowy, Mark Schiffman

Research output: Contribution to journalArticle

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Abstract

Target groups for human papillomavirus (HPV) vaccination are controversial. We evaluated vaccine efficacy (VE) against 1-year persistent infection, stratified by age and sexual behavior, among young women in Costa Rica. We randomized 7,466 healthy women 18 to 25 years of age to HPV16/18 or hepatitis A vaccine (follow-up, 50.4 months). According-to-protocol (ATP) cohorts included compliant HPV-negative women; intention-to-treat (ITT) included all randomized women. ATP VE was 90.9% (95% CI, 82.0-95.9) against HPV16/18 infections, 44.5% against HPV31/33/45 (95% CI, 17.5-63.1), and 12.4% (95% CI, -3.2 to 25.6) against any oncogenic infection. Overall ITT VE against HPV16/18 infections was 49.0%, but ATP and ITT VE almost reached 100% in year 4 of follow-up. ATP efficacy against HPV16/18 was similar by age, but ITT VE was greatest among youngest women (68.9% among those 18-19 years of age; 21.8% among those 24-25 years of age) and 79.8% among virgins. Among previously unexposed women, vaccination is highly efficacious against HPV16/18 and partially against HPV31/33/45. Vaccination is most effective in women and girls before they initiate sexual activity, with programmatic and individual decision implications. Significance: In an independent trial of the bivalent ASO4-adjuvanted HPV16/18 vaccine (Cervarix) conducted among young women in Costa Rica, we confirmed the high efficacy against HPV16/18 persistent infection and partial cross-protection against HPV31/33/45. Furthermore, efficacy data suggest that the benefit of HPV vaccination is maximal when the vaccine is given to young women before they initiate sexual activity.

Original languageEnglish (US)
Pages (from-to)408-419
Number of pages12
JournalCancer Discovery
Volume1
Issue number5
DOIs
StatePublished - Oct 2011

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Costa Rica
Papillomavirus Infections
Vaccines
Randomized Controlled Trials
Vaccination
Sexual Behavior
Infection
Hepatitis A Vaccines
Cross Protection

ASJC Scopus subject areas

  • Oncology

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Prevention of persistent human papillomavirus infection by an HPV16/18 vaccine : A community-based randomized clinical trial in guanacaste, Costa Rica. / Herrero, Rolando; Wacholder, Sholom; Rodríguez, Ana C.; Solomon, Diane; González, Paula; Kreimer, Aimee R.; Porras, Carolina; Schussler, John; Jiménez, Silvia; Sherman, Mark E.; Quint, Wim; Schiller, John T.; Lowy, Douglas R.; Schiffman, Mark.

In: Cancer Discovery, Vol. 1, No. 5, 10.2011, p. 408-419.

Research output: Contribution to journalArticle

Herrero, R, Wacholder, S, Rodríguez, AC, Solomon, D, González, P, Kreimer, AR, Porras, C, Schussler, J, Jiménez, S, Sherman, ME, Quint, W, Schiller, JT, Lowy, DR & Schiffman, M 2011, 'Prevention of persistent human papillomavirus infection by an HPV16/18 vaccine: A community-based randomized clinical trial in guanacaste, Costa Rica', Cancer Discovery, vol. 1, no. 5, pp. 408-419. https://doi.org/10.1158/2159-8290.CD-11-0131
Herrero, Rolando ; Wacholder, Sholom ; Rodríguez, Ana C. ; Solomon, Diane ; González, Paula ; Kreimer, Aimee R. ; Porras, Carolina ; Schussler, John ; Jiménez, Silvia ; Sherman, Mark E. ; Quint, Wim ; Schiller, John T. ; Lowy, Douglas R. ; Schiffman, Mark. / Prevention of persistent human papillomavirus infection by an HPV16/18 vaccine : A community-based randomized clinical trial in guanacaste, Costa Rica. In: Cancer Discovery. 2011 ; Vol. 1, No. 5. pp. 408-419.
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abstract = "Target groups for human papillomavirus (HPV) vaccination are controversial. We evaluated vaccine efficacy (VE) against 1-year persistent infection, stratified by age and sexual behavior, among young women in Costa Rica. We randomized 7,466 healthy women 18 to 25 years of age to HPV16/18 or hepatitis A vaccine (follow-up, 50.4 months). According-to-protocol (ATP) cohorts included compliant HPV-negative women; intention-to-treat (ITT) included all randomized women. ATP VE was 90.9{\%} (95{\%} CI, 82.0-95.9) against HPV16/18 infections, 44.5{\%} against HPV31/33/45 (95{\%} CI, 17.5-63.1), and 12.4{\%} (95{\%} CI, -3.2 to 25.6) against any oncogenic infection. Overall ITT VE against HPV16/18 infections was 49.0{\%}, but ATP and ITT VE almost reached 100{\%} in year 4 of follow-up. ATP efficacy against HPV16/18 was similar by age, but ITT VE was greatest among youngest women (68.9{\%} among those 18-19 years of age; 21.8{\%} among those 24-25 years of age) and 79.8{\%} among virgins. Among previously unexposed women, vaccination is highly efficacious against HPV16/18 and partially against HPV31/33/45. Vaccination is most effective in women and girls before they initiate sexual activity, with programmatic and individual decision implications. Significance: In an independent trial of the bivalent ASO4-adjuvanted HPV16/18 vaccine (Cervarix) conducted among young women in Costa Rica, we confirmed the high efficacy against HPV16/18 persistent infection and partial cross-protection against HPV31/33/45. Furthermore, efficacy data suggest that the benefit of HPV vaccination is maximal when the vaccine is given to young women before they initiate sexual activity.",
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