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-as-married); 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. Published by Oxford University Press on behalf of the Infectious Diseases Society of America 2014. This work is written by (a) US Government employee(s) and is in the public domain in the US.
RCT Entities:
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-as-married); 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. Published by Oxford University Press on behalf of the Infectious Diseases Society of America 2014. This work is written by (a) US Government employee(s) and is in the public domain in the US.
Entities:
Keywords:
Costa Rica; HPV; HPV vaccine; vulvar human papillomavirus vaccine
Authors: Matti Lehtinen; Jorma Paavonen; Cosette M Wheeler; Unnop Jaisamrarn; Suzanne M Garland; Xavier Castellsagué; S Rachel Skinner; Dan Apter; Paulo Naud; Jorge Salmerón; Song-Nan Chow; Henry Kitchener; Júlio C Teixeira; James Hedrick; Genara Limson; Anne Szarewski; Barbara Romanowski; Fred Y Aoki; Tino F Schwarz; Willy A J Poppe; Newton S De Carvalho; Maria Julieta V Germar; Klaus Peters; Adrian Mindel; Philippe De Sutter; F Xavier Bosch; Marie-Pierre David; Dominique Descamps; Frank Struyf; Gary Dubin Journal: Lancet Oncol Date: 2011-11-08 Impact factor: 41.316
Authors: Marc Arbyn; Silvia de Sanjosé; Mona Saraiya; Mario Sideri; Joel Palefsky; Charles Lacey; Maura Gillison; Laia Bruni; Guglielmo Ronco; Nicolas Wentzensen; Julia Brotherton; You-Lin Qiao; Lynnette Denny; Jacob Bornstein; Laurent Abramowitz; Anna Giuliano; Massimo Tommasino; Joseph Monsonego Journal: Int J Cancer Date: 2012-07-02 Impact factor: 7.396
Authors: Andrew T Abalos; Robin B Harris; Alan G Nyitray; Amy Mitchell; Patricia A Thompson; Anna R Giuliano; Francisco Garcia Journal: J Low Genit Tract Dis Date: 2012-01 Impact factor: 1.925
Authors: Rebecca Howell-Jones; Natasha de Silva; Mercy Akpan; Pippa Oakeshott; Caroline Carder; Lindsay Coupland; Margaret Sillis; Harry Mallinson; Vic Ellis; David Frodsham; T Ian Robinson; O Noel Gill; Simon Beddows; Kate Soldan Journal: Vaccine Date: 2012-04-16 Impact factor: 3.641
Authors: Ahmedin Jemal; Edgar P Simard; Christina Dorell; Anne-Michelle Noone; Lauri E Markowitz; Betsy Kohler; Christie Eheman; Mona Saraiya; Priti Bandi; Debbie Saslow; Kathleen A Cronin; Meg Watson; Mark Schiffman; S Jane Henley; Maria J Schymura; Robert N Anderson; David Yankey; Brenda K Edwards Journal: J Natl Cancer Inst Date: 2013-01-07 Impact factor: 13.506
Authors: Alice R Rumbold; Sarah E Tan; John R Condon; Debbie Taylor-Thomson; Maria Nickels; Sepehr N Tabrizi; Margaret L J Davy; Margaret M O'Brien; Christine M Connors; Ibrahim Zardawi; Jim Stankovich; Suzanne M Garland Journal: BMC Infect Dis Date: 2012-10-05 Impact factor: 3.090
Authors: 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 Journal: PLoS One Date: 2013-07-17 Impact factor: 3.240
Authors: Julia M L Brotherton; Mark Jit; Patti E Gravitt; Marc Brisson; Aimée R Kreimer; Sara I Pai; Carole Fakhry; Joseph Monsonego; Silvia Franceschi Journal: Int J Cancer Date: 2016-03-22 Impact factor: 7.396
Authors: Ana Gradissimo; Viswanathan Shankar; Fanua Wiek; Lauren St Peter; Yevgeniy Studentsov; Anne Nucci-Sack; Angela Diaz; Sarah Pickering; Nicolas F Schlecht; Robert D Burk Journal: Viruses Date: 2021-08-05 Impact factor: 5.048