Reduced Prevalence of Oral Human Papillomavirus (HPV) 4 Years after Bivalent HPV Vaccination in a Randomized Clinical Trial in Costa Rica

Rolando Herrero, Wim Quint, Allan Hildesheim, Paula Gonzalez, Linda Struijk, Hormuzd A. Katki, Carolina Porras, Mark Schiffman, Ana Cecilia Rodriguez, Diane Solomon, Silvia Jimenez, John T. Schiller, Douglas R. Lowy, Leen Jan van Doorn, Sholom Wacholder, Aimée R. Kreimer, Rolando Herrero, Mario Alfaro, M. Concepción Bratti, Bernal CortésAlbert Espinoza, Yenory Estrada, Paula González, Diego Guillén, Silvia E. Jiménez, Jorge Morales, Luis Villegas, Lidia Ana Morera, Carolina Porras, Mark E. Sherman, Allan Hildesheim, Aimée R. Kreimer, Douglas R. Lowy, Nora Macklin, Mark Schiffman, John T. Schiller, Mark Sherman, Diane Solomon, Sholom Wacholder, Enrique Freer, José Bonilla, Alfonso García-Piñeres, Sandra Silva, Ivannia Atmella, Margarita Ramírez, Ligia Pinto, Troy Kemp, Claire Eklund, Martha Hutchinson, Mary Sidawy, Wim Quint, Leen Jan van Doorn, Linda Struijk

Research output: Contribution to journalArticle

259 Citations (Scopus)

Abstract

Background:Human papillomavirus (HPV) infection, particularly with type 16, causes a growing fraction of oropharyngeal cancers, whose incidence is increasing, mainly in developed countries. In a double-blind controlled trial conducted to investigate vaccine efficacy (VE) of the bivalent HPV 16/18 vaccine against cervical infections and lesions, we estimated VE against prevalent oral HPV infections 4 years after vaccination.Methods and Findings:A total of 7,466 women 18-25 years old were randomized (1:1) to receive the HPV16/18 vaccine or hepatitis A vaccine as control. At the final blinded 4-year study visit, 5,840 participants provided oral specimens (91·9% of eligible women) to evaluate VE against oral infections. Our primary analysis evaluated prevalent oral HPV infection among all vaccinated women with oral and cervical HPV results. Corresponding VE against prevalent cervical HPV16/18 infection was calculated for comparison. Oral prevalence of identifiable mucosal HPV was relatively low (1·7%). Approximately four years after vaccination, there were 15 prevalent HPV16/18 infections in the control group and one in the vaccine group, for an estimated VE of 93·3% (95% CI = 63% to 100%). Corresponding efficacy against prevalent cervical HPV16/18 infection for the same cohort at the same visit was 72·0% (95% CI = 63% to 79%) (p versus oral VE = 0·04). There was no statistically significant protection against other oral HPV infections, though power was limited for these analyses.Conclusions:HPV prevalence four years after vaccination with the ASO4-adjuvanted HPV16/18 vaccine was much lower among women in the vaccine arm compared to the control arm, suggesting that the vaccine affords strong protection against oral HPV16/18 infection, with potentially important implications for prevention of increasingly common HPV-associated oropharyngeal cancer. ClinicalTrials.gov, Registry number NCT00128661.

Original languageEnglish (US)
Article numbere68329
JournalPLoS One
Volume8
Issue number7
DOIs
StatePublished - Jul 17 2013

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Human papillomavirus 4
Gammapapillomavirus
Costa Rica
randomized clinical trials
Papillomaviridae
mouth
Vaccination
Vaccines
Randomized Controlled Trials
vaccination
vaccines
Papillomavirus Infections
infection
Oropharyngeal Neoplasms
Infection
Hepatitis A Vaccines
Human papillomavirus 18
Human papillomavirus 16
hepatitis A

ASJC Scopus subject areas

  • Medicine(all)
  • Biochemistry, Genetics and Molecular Biology(all)
  • Agricultural and Biological Sciences(all)

Cite this

Reduced Prevalence of Oral Human Papillomavirus (HPV) 4 Years after Bivalent HPV Vaccination in a Randomized Clinical Trial in Costa Rica. / Herrero, Rolando; Quint, Wim; Hildesheim, Allan; Gonzalez, Paula; Struijk, Linda; Katki, Hormuzd A.; Porras, Carolina; Schiffman, Mark; Rodriguez, Ana Cecilia; Solomon, Diane; Jimenez, Silvia; Schiller, John T.; Lowy, Douglas R.; van Doorn, Leen Jan; Wacholder, Sholom; Kreimer, Aimée R.; Herrero, Rolando; Alfaro, Mario; Bratti, M. Concepción; Cortés, Bernal; Espinoza, Albert; Estrada, Yenory; González, Paula; Guillén, Diego; Jiménez, Silvia E.; Morales, Jorge; Villegas, Luis; Morera, Lidia Ana; Porras, Carolina; Sherman, Mark E.; Hildesheim, Allan; Kreimer, Aimée R.; Lowy, Douglas R.; Macklin, Nora; Schiffman, Mark; Schiller, John T.; Sherman, Mark; Solomon, Diane; Wacholder, Sholom; Freer, Enrique; Bonilla, José; García-Piñeres, Alfonso; Silva, Sandra; Atmella, Ivannia; Ramírez, Margarita; Pinto, Ligia; Kemp, Troy; Eklund, Claire; Hutchinson, Martha; Sidawy, Mary; Quint, Wim; van Doorn, Leen Jan; Struijk, Linda.

In: PLoS One, Vol. 8, No. 7, e68329, 17.07.2013.

Research output: Contribution to journalArticle

Herrero, R, Quint, W, Hildesheim, A, Gonzalez, P, Struijk, L, Katki, HA, Porras, C, Schiffman, M, Rodriguez, AC, Solomon, D, Jimenez, S, Schiller, JT, Lowy, DR, van Doorn, LJ, Wacholder, S, Kreimer, AR, Herrero, R, Alfaro, M, Bratti, MC, Cortés, B, Espinoza, A, Estrada, Y, González, P, Guillén, D, Jiménez, SE, Morales, J, Villegas, L, Morera, LA, Porras, C, Sherman, ME, Hildesheim, A, Kreimer, AR, Lowy, DR, Macklin, N, Schiffman, M, Schiller, JT, Sherman, M, Solomon, D, Wacholder, S, Freer, E, Bonilla, J, García-Piñeres, A, Silva, S, Atmella, I, Ramírez, M, Pinto, L, Kemp, T, Eklund, C, Hutchinson, M, Sidawy, M, Quint, W, van Doorn, LJ & Struijk, L 2013, 'Reduced Prevalence of Oral Human Papillomavirus (HPV) 4 Years after Bivalent HPV Vaccination in a Randomized Clinical Trial in Costa Rica', PLoS One, vol. 8, no. 7, e68329. https://doi.org/10.1371/journal.pone.0068329
Herrero, Rolando ; Quint, Wim ; Hildesheim, Allan ; Gonzalez, Paula ; Struijk, Linda ; Katki, Hormuzd A. ; Porras, Carolina ; Schiffman, Mark ; Rodriguez, Ana Cecilia ; Solomon, Diane ; Jimenez, Silvia ; Schiller, John T. ; Lowy, Douglas R. ; van Doorn, Leen Jan ; Wacholder, Sholom ; Kreimer, Aimée R. ; Herrero, Rolando ; Alfaro, Mario ; Bratti, M. Concepción ; Cortés, Bernal ; Espinoza, Albert ; Estrada, Yenory ; González, Paula ; Guillén, Diego ; Jiménez, Silvia E. ; Morales, Jorge ; Villegas, Luis ; Morera, Lidia Ana ; Porras, Carolina ; Sherman, Mark E. ; Hildesheim, Allan ; Kreimer, Aimée R. ; Lowy, Douglas R. ; Macklin, Nora ; Schiffman, Mark ; Schiller, John T. ; Sherman, Mark ; Solomon, Diane ; Wacholder, Sholom ; Freer, Enrique ; Bonilla, José ; García-Piñeres, Alfonso ; Silva, Sandra ; Atmella, Ivannia ; Ramírez, Margarita ; Pinto, Ligia ; Kemp, Troy ; Eklund, Claire ; Hutchinson, Martha ; Sidawy, Mary ; Quint, Wim ; van Doorn, Leen Jan ; Struijk, Linda. / Reduced Prevalence of Oral Human Papillomavirus (HPV) 4 Years after Bivalent HPV Vaccination in a Randomized Clinical Trial in Costa Rica. In: PLoS One. 2013 ; Vol. 8, No. 7.
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title = "Reduced Prevalence of Oral Human Papillomavirus (HPV) 4 Years after Bivalent HPV Vaccination in a Randomized Clinical Trial in Costa Rica",
abstract = "Background:Human papillomavirus (HPV) infection, particularly with type 16, causes a growing fraction of oropharyngeal cancers, whose incidence is increasing, mainly in developed countries. In a double-blind controlled trial conducted to investigate vaccine efficacy (VE) of the bivalent HPV 16/18 vaccine against cervical infections and lesions, we estimated VE against prevalent oral HPV infections 4 years after vaccination.Methods and Findings:A total of 7,466 women 18-25 years old were randomized (1:1) to receive the HPV16/18 vaccine or hepatitis A vaccine as control. At the final blinded 4-year study visit, 5,840 participants provided oral specimens (91·9{\%} of eligible women) to evaluate VE against oral infections. Our primary analysis evaluated prevalent oral HPV infection among all vaccinated women with oral and cervical HPV results. Corresponding VE against prevalent cervical HPV16/18 infection was calculated for comparison. Oral prevalence of identifiable mucosal HPV was relatively low (1·7{\%}). Approximately four years after vaccination, there were 15 prevalent HPV16/18 infections in the control group and one in the vaccine group, for an estimated VE of 93·3{\%} (95{\%} CI = 63{\%} to 100{\%}). Corresponding efficacy against prevalent cervical HPV16/18 infection for the same cohort at the same visit was 72·0{\%} (95{\%} CI = 63{\%} to 79{\%}) (p versus oral VE = 0·04). There was no statistically significant protection against other oral HPV infections, though power was limited for these analyses.Conclusions:HPV prevalence four years after vaccination with the ASO4-adjuvanted HPV16/18 vaccine was much lower among women in the vaccine arm compared to the control arm, suggesting that the vaccine affords strong protection against oral HPV16/18 infection, with potentially important implications for prevention of increasingly common HPV-associated oropharyngeal cancer. ClinicalTrials.gov, Registry number NCT00128661.",
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TY - JOUR

T1 - Reduced Prevalence of Oral Human Papillomavirus (HPV) 4 Years after Bivalent HPV Vaccination in a Randomized Clinical Trial in Costa Rica

AU - Herrero, Rolando

AU - Quint, Wim

AU - Hildesheim, Allan

AU - Gonzalez, Paula

AU - Struijk, Linda

AU - Katki, Hormuzd A.

AU - Porras, Carolina

AU - Schiffman, Mark

AU - Rodriguez, Ana Cecilia

AU - Solomon, Diane

AU - Jimenez, Silvia

AU - Schiller, John T.

AU - Lowy, Douglas R.

AU - van Doorn, Leen Jan

AU - Wacholder, Sholom

AU - Kreimer, Aimée R.

AU - Herrero, Rolando

AU - Alfaro, Mario

AU - Bratti, M. Concepción

AU - Cortés, Bernal

AU - Espinoza, Albert

AU - Estrada, Yenory

AU - González, Paula

AU - Guillén, Diego

AU - Jiménez, Silvia E.

AU - Morales, Jorge

AU - Villegas, Luis

AU - Morera, Lidia Ana

AU - Porras, Carolina

AU - Sherman, Mark E.

AU - Hildesheim, Allan

AU - Kreimer, Aimée R.

AU - Lowy, Douglas R.

AU - Macklin, Nora

AU - Schiffman, Mark

AU - Schiller, John T.

AU - Sherman, Mark

AU - Solomon, Diane

AU - Wacholder, Sholom

AU - Freer, Enrique

AU - Bonilla, José

AU - García-Piñeres, Alfonso

AU - Silva, Sandra

AU - Atmella, Ivannia

AU - Ramírez, Margarita

AU - Pinto, Ligia

AU - Kemp, Troy

AU - Eklund, Claire

AU - Hutchinson, Martha

AU - Sidawy, Mary

AU - Quint, Wim

AU - van Doorn, Leen Jan

AU - Struijk, Linda

PY - 2013/7/17

Y1 - 2013/7/17

N2 - Background:Human papillomavirus (HPV) infection, particularly with type 16, causes a growing fraction of oropharyngeal cancers, whose incidence is increasing, mainly in developed countries. In a double-blind controlled trial conducted to investigate vaccine efficacy (VE) of the bivalent HPV 16/18 vaccine against cervical infections and lesions, we estimated VE against prevalent oral HPV infections 4 years after vaccination.Methods and Findings:A total of 7,466 women 18-25 years old were randomized (1:1) to receive the HPV16/18 vaccine or hepatitis A vaccine as control. At the final blinded 4-year study visit, 5,840 participants provided oral specimens (91·9% of eligible women) to evaluate VE against oral infections. Our primary analysis evaluated prevalent oral HPV infection among all vaccinated women with oral and cervical HPV results. Corresponding VE against prevalent cervical HPV16/18 infection was calculated for comparison. Oral prevalence of identifiable mucosal HPV was relatively low (1·7%). Approximately four years after vaccination, there were 15 prevalent HPV16/18 infections in the control group and one in the vaccine group, for an estimated VE of 93·3% (95% CI = 63% to 100%). Corresponding efficacy against prevalent cervical HPV16/18 infection for the same cohort at the same visit was 72·0% (95% CI = 63% to 79%) (p versus oral VE = 0·04). There was no statistically significant protection against other oral HPV infections, though power was limited for these analyses.Conclusions:HPV prevalence four years after vaccination with the ASO4-adjuvanted HPV16/18 vaccine was much lower among women in the vaccine arm compared to the control arm, suggesting that the vaccine affords strong protection against oral HPV16/18 infection, with potentially important implications for prevention of increasingly common HPV-associated oropharyngeal cancer. ClinicalTrials.gov, Registry number NCT00128661.

AB - Background:Human papillomavirus (HPV) infection, particularly with type 16, causes a growing fraction of oropharyngeal cancers, whose incidence is increasing, mainly in developed countries. In a double-blind controlled trial conducted to investigate vaccine efficacy (VE) of the bivalent HPV 16/18 vaccine against cervical infections and lesions, we estimated VE against prevalent oral HPV infections 4 years after vaccination.Methods and Findings:A total of 7,466 women 18-25 years old were randomized (1:1) to receive the HPV16/18 vaccine or hepatitis A vaccine as control. At the final blinded 4-year study visit, 5,840 participants provided oral specimens (91·9% of eligible women) to evaluate VE against oral infections. Our primary analysis evaluated prevalent oral HPV infection among all vaccinated women with oral and cervical HPV results. Corresponding VE against prevalent cervical HPV16/18 infection was calculated for comparison. Oral prevalence of identifiable mucosal HPV was relatively low (1·7%). Approximately four years after vaccination, there were 15 prevalent HPV16/18 infections in the control group and one in the vaccine group, for an estimated VE of 93·3% (95% CI = 63% to 100%). Corresponding efficacy against prevalent cervical HPV16/18 infection for the same cohort at the same visit was 72·0% (95% CI = 63% to 79%) (p versus oral VE = 0·04). There was no statistically significant protection against other oral HPV infections, though power was limited for these analyses.Conclusions:HPV prevalence four years after vaccination with the ASO4-adjuvanted HPV16/18 vaccine was much lower among women in the vaccine arm compared to the control arm, suggesting that the vaccine affords strong protection against oral HPV16/18 infection, with potentially important implications for prevention of increasingly common HPV-associated oropharyngeal cancer. ClinicalTrials.gov, Registry number NCT00128661.

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