Reduced prevalence of vulvar HPV16/18 infection among women who received the HPV16/18 bivalent vaccine: A nested analysis within the Costa Rica Vaccine Trial

Krystle A Lang Kuhs, Paula Gonzalez, Ana Cecilia Rodriguez, Leen Jan Van Doorn, Mark Schiffman, Linda Struijk, Sabrina Chen, Wim Quint, Douglas R. Lowy, Carolina Porras, Corey Delvecchio, Silvia Jimenez, Mahboobeh Safaeian, John T. Schiller, Sholom Wacholder, Rolando Herrero, Allan Hildesheim, Aimée R. Kreimer, Mario Alfaro, Manuel BarrantesM. Concepción Bratti, Fernando Cárdenas, Bernal Cortés, Albert Espinoza, Yenory Estrada, Diego Guillén, Silvia E. Jiménez, Jorge Morales, Luis Villegas, Lidia Ana Morera, Elmer Pérez, Libia Rivas, Enrique Freer, José Bonilla, Alfanso García-Piñeres, Sandra Silva, Ivannia Atmella, Margarita Ramírez, Nora Macklin, Mark E. Sherman, Diane Solomon, Ligia Pinto, Troy Kemp, Claire Eklund, Martha Hutchinson, Mary Sidawy

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

Background: Vaccine efficacy (VE) against vulvar human papillomavirus (HPV) infection has not been reported and data regarding its epidemiology are sparse. Methods: Women (n = 5404) age 22-29 present at the 4-year study visit of the Costa Rica Vaccine Trial provided vulvar and cervical samples. A subset (n = 1044) was tested for HPV DNA (SPF10/LiPA25 version 1). VE against 1-time detection of vulvar HPV16/18 among HPV vaccinated versus unvaccinated women was calculated and compared to the cervix. Prevalence of and risk factors for HPV were evaluated in the control arm (n = 536). Results: Vulvar HPV16/18 VE (54.1%; 95% confidence interval [CI], 4.9%-79.1%) was comparable to cervix (45.8%; 95% CI, 6.4%-69.4%). Vulvar and cervical HPV16 prevalence within the control arm was 3.0% and 4.7%, respectively. Independent risk factors for vulvar HPV were similar to cervix and included: age (adjusted odds ratio [aOR] 0.5 [95% CI,.3-.9] ≥28 vs 22-23]); marital status (aOR 2.3 [95% CI, 1.5-3.5] single vs married/living-asmarried); and number of sexual partners (aOR 3.6 [95% CI, 1.9-7.0] ≥6 vs 1). Conclusions: In this intention-to-treat analysis, VE against vulvar and cervical HPV16/18 were comparable 4 years following vaccination. Risk factors for HPV were similar by anatomic site. Clinical Trials Registration: NCT00128661.

Original languageEnglish (US)
Pages (from-to)1890-1899
Number of pages10
JournalJournal of Infectious Diseases
Volume210
Issue number12
DOIs
StatePublished - 2014

Fingerprint

Costa Rica
Vaccines
Confidence Intervals
Cervix Uteri
Infection
Odds Ratio
Human papillomavirus 18
Intention to Treat Analysis
Papillomavirus Infections
Sexual Partners
Marital Status
Vaccination
Epidemiology
Clinical Trials
DNA

Keywords

  • Costa Rica
  • HPV
  • HPV vaccine
  • Vulvar human papillomavirus vaccine

ASJC Scopus subject areas

  • Immunology and Allergy
  • Infectious Diseases

Cite this

Reduced prevalence of vulvar HPV16/18 infection among women who received the HPV16/18 bivalent vaccine : A nested analysis within the Costa Rica Vaccine Trial. / Kuhs, Krystle A Lang; Gonzalez, Paula; Rodriguez, Ana Cecilia; Van Doorn, Leen Jan; Schiffman, Mark; Struijk, Linda; Chen, Sabrina; Quint, Wim; Lowy, Douglas R.; Porras, Carolina; Delvecchio, Corey; Jimenez, Silvia; Safaeian, Mahboobeh; Schiller, John T.; Wacholder, Sholom; Herrero, Rolando; Hildesheim, Allan; Kreimer, Aimée R.; Alfaro, Mario; Barrantes, Manuel; Concepción Bratti, M.; Cárdenas, Fernando; Cortés, Bernal; Espinoza, Albert; Estrada, Yenory; Guillén, Diego; Jiménez, Silvia E.; Morales, Jorge; Villegas, Luis; Morera, Lidia Ana; Pérez, Elmer; Rivas, Libia; Freer, Enrique; Bonilla, José; García-Piñeres, Alfanso; Silva, Sandra; Atmella, Ivannia; Ramírez, Margarita; Macklin, Nora; Sherman, Mark E.; Solomon, Diane; Pinto, Ligia; Kemp, Troy; Eklund, Claire; Hutchinson, Martha; Sidawy, Mary.

In: Journal of Infectious Diseases, Vol. 210, No. 12, 2014, p. 1890-1899.

Research output: Contribution to journalArticle

Kuhs, KAL, Gonzalez, P, Rodriguez, AC, Van Doorn, LJ, Schiffman, M, Struijk, L, Chen, S, Quint, W, Lowy, DR, Porras, C, Delvecchio, C, Jimenez, S, Safaeian, M, Schiller, JT, Wacholder, S, Herrero, R, Hildesheim, A, Kreimer, AR, Alfaro, M, Barrantes, M, Concepción Bratti, M, Cárdenas, F, Cortés, B, Espinoza, A, Estrada, Y, Guillén, D, Jiménez, SE, Morales, J, Villegas, L, Morera, LA, Pérez, E, Rivas, L, Freer, E, Bonilla, J, García-Piñeres, A, Silva, S, Atmella, I, Ramírez, M, Macklin, N, Sherman, ME, Solomon, D, Pinto, L, Kemp, T, Eklund, C, Hutchinson, M & Sidawy, M 2014, 'Reduced prevalence of vulvar HPV16/18 infection among women who received the HPV16/18 bivalent vaccine: A nested analysis within the Costa Rica Vaccine Trial', Journal of Infectious Diseases, vol. 210, no. 12, pp. 1890-1899. https://doi.org/10.1093/infdis/jiu357
Kuhs, Krystle A Lang ; Gonzalez, Paula ; Rodriguez, Ana Cecilia ; Van Doorn, Leen Jan ; Schiffman, Mark ; Struijk, Linda ; Chen, Sabrina ; Quint, Wim ; Lowy, Douglas R. ; Porras, Carolina ; Delvecchio, Corey ; Jimenez, Silvia ; Safaeian, Mahboobeh ; Schiller, John T. ; Wacholder, Sholom ; Herrero, Rolando ; Hildesheim, Allan ; Kreimer, Aimée R. ; Alfaro, Mario ; Barrantes, Manuel ; Concepción Bratti, M. ; Cárdenas, Fernando ; Cortés, Bernal ; Espinoza, Albert ; Estrada, Yenory ; Guillén, Diego ; Jiménez, Silvia E. ; Morales, Jorge ; Villegas, Luis ; Morera, Lidia Ana ; Pérez, Elmer ; Rivas, Libia ; Freer, Enrique ; Bonilla, José ; García-Piñeres, Alfanso ; Silva, Sandra ; Atmella, Ivannia ; Ramírez, Margarita ; Macklin, Nora ; Sherman, Mark E. ; Solomon, Diane ; Pinto, Ligia ; Kemp, Troy ; Eklund, Claire ; Hutchinson, Martha ; Sidawy, Mary. / Reduced prevalence of vulvar HPV16/18 infection among women who received the HPV16/18 bivalent vaccine : A nested analysis within the Costa Rica Vaccine Trial. In: Journal of Infectious Diseases. 2014 ; Vol. 210, No. 12. pp. 1890-1899.
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abstract = "Background: Vaccine efficacy (VE) against vulvar human papillomavirus (HPV) infection has not been reported and data regarding its epidemiology are sparse. Methods: Women (n = 5404) age 22-29 present at the 4-year study visit of the Costa Rica Vaccine Trial provided vulvar and cervical samples. A subset (n = 1044) was tested for HPV DNA (SPF10/LiPA25 version 1). VE against 1-time detection of vulvar HPV16/18 among HPV vaccinated versus unvaccinated women was calculated and compared to the cervix. Prevalence of and risk factors for HPV were evaluated in the control arm (n = 536). Results: Vulvar HPV16/18 VE (54.1{\%}; 95{\%} confidence interval [CI], 4.9{\%}-79.1{\%}) was comparable to cervix (45.8{\%}; 95{\%} CI, 6.4{\%}-69.4{\%}). Vulvar and cervical HPV16 prevalence within the control arm was 3.0{\%} and 4.7{\%}, respectively. Independent risk factors for vulvar HPV were similar to cervix and included: age (adjusted odds ratio [aOR] 0.5 [95{\%} CI,.3-.9] ≥28 vs 22-23]); marital status (aOR 2.3 [95{\%} CI, 1.5-3.5] single vs married/living-asmarried); and number of sexual partners (aOR 3.6 [95{\%} CI, 1.9-7.0] ≥6 vs 1). Conclusions: In this intention-to-treat analysis, VE against vulvar and cervical HPV16/18 were comparable 4 years following vaccination. Risk factors for HPV were similar by anatomic site. Clinical Trials Registration: NCT00128661.",
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TY - JOUR

T1 - Reduced prevalence of vulvar HPV16/18 infection among women who received the HPV16/18 bivalent vaccine

T2 - A nested analysis within the Costa Rica Vaccine Trial

AU - Kuhs, Krystle A Lang

AU - Gonzalez, Paula

AU - Rodriguez, Ana Cecilia

AU - Van Doorn, Leen Jan

AU - Schiffman, Mark

AU - Struijk, Linda

AU - Chen, Sabrina

AU - Quint, Wim

AU - Lowy, Douglas R.

AU - Porras, Carolina

AU - Delvecchio, Corey

AU - Jimenez, Silvia

AU - Safaeian, Mahboobeh

AU - Schiller, John T.

AU - Wacholder, Sholom

AU - Herrero, Rolando

AU - Hildesheim, Allan

AU - Kreimer, Aimée R.

AU - Alfaro, Mario

AU - Barrantes, Manuel

AU - Concepción Bratti, M.

AU - Cárdenas, Fernando

AU - Cortés, Bernal

AU - Espinoza, Albert

AU - Estrada, Yenory

AU - Guillén, Diego

AU - Jiménez, Silvia E.

AU - Morales, Jorge

AU - Villegas, Luis

AU - Morera, Lidia Ana

AU - Pérez, Elmer

AU - Rivas, Libia

AU - Freer, Enrique

AU - Bonilla, José

AU - García-Piñeres, Alfanso

AU - Silva, Sandra

AU - Atmella, Ivannia

AU - Ramírez, Margarita

AU - Macklin, Nora

AU - Sherman, Mark E.

AU - Solomon, Diane

AU - Pinto, Ligia

AU - Kemp, Troy

AU - Eklund, Claire

AU - Hutchinson, Martha

AU - Sidawy, Mary

PY - 2014

Y1 - 2014

N2 - Background: Vaccine efficacy (VE) against vulvar human papillomavirus (HPV) infection has not been reported and data regarding its epidemiology are sparse. Methods: Women (n = 5404) age 22-29 present at the 4-year study visit of the Costa Rica Vaccine Trial provided vulvar and cervical samples. A subset (n = 1044) was tested for HPV DNA (SPF10/LiPA25 version 1). VE against 1-time detection of vulvar HPV16/18 among HPV vaccinated versus unvaccinated women was calculated and compared to the cervix. Prevalence of and risk factors for HPV were evaluated in the control arm (n = 536). Results: Vulvar HPV16/18 VE (54.1%; 95% confidence interval [CI], 4.9%-79.1%) was comparable to cervix (45.8%; 95% CI, 6.4%-69.4%). Vulvar and cervical HPV16 prevalence within the control arm was 3.0% and 4.7%, respectively. Independent risk factors for vulvar HPV were similar to cervix and included: age (adjusted odds ratio [aOR] 0.5 [95% CI,.3-.9] ≥28 vs 22-23]); marital status (aOR 2.3 [95% CI, 1.5-3.5] single vs married/living-asmarried); and number of sexual partners (aOR 3.6 [95% CI, 1.9-7.0] ≥6 vs 1). Conclusions: In this intention-to-treat analysis, VE against vulvar and cervical HPV16/18 were comparable 4 years following vaccination. Risk factors for HPV were similar by anatomic site. Clinical Trials Registration: NCT00128661.

AB - Background: Vaccine efficacy (VE) against vulvar human papillomavirus (HPV) infection has not been reported and data regarding its epidemiology are sparse. Methods: Women (n = 5404) age 22-29 present at the 4-year study visit of the Costa Rica Vaccine Trial provided vulvar and cervical samples. A subset (n = 1044) was tested for HPV DNA (SPF10/LiPA25 version 1). VE against 1-time detection of vulvar HPV16/18 among HPV vaccinated versus unvaccinated women was calculated and compared to the cervix. Prevalence of and risk factors for HPV were evaluated in the control arm (n = 536). Results: Vulvar HPV16/18 VE (54.1%; 95% confidence interval [CI], 4.9%-79.1%) was comparable to cervix (45.8%; 95% CI, 6.4%-69.4%). Vulvar and cervical HPV16 prevalence within the control arm was 3.0% and 4.7%, respectively. Independent risk factors for vulvar HPV were similar to cervix and included: age (adjusted odds ratio [aOR] 0.5 [95% CI,.3-.9] ≥28 vs 22-23]); marital status (aOR 2.3 [95% CI, 1.5-3.5] single vs married/living-asmarried); and number of sexual partners (aOR 3.6 [95% CI, 1.9-7.0] ≥6 vs 1). Conclusions: In this intention-to-treat analysis, VE against vulvar and cervical HPV16/18 were comparable 4 years following vaccination. Risk factors for HPV were similar by anatomic site. Clinical Trials Registration: NCT00128661.

KW - Costa Rica

KW - HPV

KW - HPV vaccine

KW - Vulvar human papillomavirus vaccine

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