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 Barrantes; M. 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 Sherman; Diane Solomon; Ligia Pinto; Troy Kemp; Claire Eklund; Martha Hutchinson; Mary Sidawy

doi:10.1093/infdis/jiu357

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 Sherman, Diane Solomon, Ligia Pinto, Troy Kemp, Claire Eklund, Martha Hutchinson, Mary Sidawy

Quantitative Health Sciences

Research output: Contribution to journal › Article › peer-review

13 Scopus citations

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 language	English (US)
Pages (from-to)	1890-1899
Number of pages	10
Journal	Journal of Infectious Diseases
Volume	210
Issue number	12
DOIs	https://doi.org/10.1093/infdis/jiu357
State	Published - Dec 2014

Keywords

Costa Rica
HPV
HPV vaccine
Vulvar human papillomavirus vaccine

ASJC Scopus subject areas

General Medicine

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10.1093/infdis/jiu357

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Kuhs, K. A. L., Gonzalez, P., Rodriguez, A. C., Van Doorn, L. J., Schiffman, M., Struijk, L., Chen, S., Quint, W., Lowy, D. R., Porras, C., Delvecchio, C., Jimenez, S., Safaeian, M., Schiller, J. T., Wacholder, S., Herrero, R., Hildesheim, A., Kreimer, A. R., Alfaro, 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, 210(12), 1890-1899. https://doi.org/10.1093/infdis/jiu357

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 et al.
In: Journal of Infectious Diseases, Vol. 210, No. 12, 12.2014, p. 1890-1899.

Research output: Contribution to journal › Article › peer-review

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, M, 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

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title = "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",

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.",

keywords = "Costa Rica, HPV, HPV vaccine, Vulvar human papillomavirus vaccine",

author = "Kuhs, {Krystle A.Lang} and Paula Gonzalez and Rodriguez, {Ana Cecilia} and {Van Doorn}, {Leen Jan} and Mark Schiffman and Linda Struijk and Sabrina Chen and Wim Quint and Lowy, {Douglas R.} and Carolina Porras and Corey Delvecchio and Silvia Jimenez and Mahboobeh Safaeian and Schiller, {John T.} and Sholom Wacholder and Rolando Herrero and Allan Hildesheim and Kreimer, {Aim{\'e}e R.} and Mario Alfaro and Manuel Barrantes and {Concepci{\'o}n Bratti}, M. and Fernando C{\'a}rdenas and Bernal Cort{\'e}s and Albert Espinoza and Yenory Estrada and Diego Guill{\'e}n and Jim{\'e}nez, {Silvia E.} and Jorge Morales and Luis Villegas and Morera, {Lidia Ana} and Elmer P{\'e}rez and Libia Rivas and Enrique Freer and Jos{\'e} Bonilla and Alfanso Garc{\'i}a-Pi{\~n}eres and Sandra Silva and Ivannia Atmella and Margarita Ram{\'i}rez and Nora Macklin and Mark Sherman and Diane Solomon and Ligia Pinto and Troy Kemp and Claire Eklund and Martha Hutchinson and Mary Sidawy",

note = "Publisher Copyright: {\textcopyright} The Author 2014.",

year = "2014",

month = dec,

doi = "10.1093/infdis/jiu357",

language = "English (US)",

volume = "210",

pages = "1890--1899",

journal = "Journal of Infectious Diseases",

issn = "0022-1899",

publisher = "Oxford University Press",

number = "12",

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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

AU - Solomon, Diane

AU - Pinto, Ligia

AU - Kemp, Troy

AU - Eklund, Claire

AU - Hutchinson, Martha

AU - Sidawy, Mary

PY - 2014/12

Y1 - 2014/12

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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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

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