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Immunogenicity of 2 Doses of HPV Vaccine in Younger Adolescents vs 3 Doses in Young Women: A Randomized Clinical Trial

Dobson, Simon R. M ; McNeil, Shelly ; Dionne, Marc ; Dawar, Meena ; Ogilvie, Gina ; Krajden, Mel ; Sauvageau, Chantal ; Scheifele, David W ; Kollmann, Tobias R ; Halperin, Scott A ; Langley, Joanne M ; Bettinger, Julie A ; Singer, Joel ; Money, Deborah ; Miller, Dianne ; Naus, Monika ; Marra, Fawziah ; Young, Eric

JAMA : the journal of the American Medical Association, 2013-05, Vol.309 (17), p.1793-1802 [Periódico revisado por pares]

Chicago, IL: American Medical Association

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Título:
Immunogenicity of 2 Doses of HPV Vaccine in Younger Adolescents vs 3 Doses in Young Women: A Randomized Clinical Trial
Autor: Dobson, Simon R. M ; McNeil, Shelly ; Dionne, Marc ; Dawar, Meena ; Ogilvie, Gina ; Krajden, Mel ; Sauvageau, Chantal ; Scheifele, David W ; Kollmann, Tobias R ; Halperin, Scott A ; Langley, Joanne M ; Bettinger, Julie A ; Singer, Joel ; Money, Deborah ; Miller, Dianne ; Naus, Monika ; Marra, Fawziah ; Young, Eric
Assuntos: Adolescent ; Adult ; Antibody Formation ; Biological and medical sciences ; Child ; Clinical trials ; Drug dosages ; Drug therapy ; Female ; General aspects ; Genotype ; Health aspects ; Human papillomavirus ; Human papillomavirus 16 - genetics ; Human papillomavirus 16 - immunology ; Human papillomavirus 18 - genetics ; Human papillomavirus 18 - immunology ; Humans ; Immunization Schedule ; Immunogenetics ; Medical sciences ; Papillomavirus Infections - complications ; Papillomavirus Infections - immunology ; Papillomavirus Infections - prevention & control ; Papillomavirus Vaccines - administration & dosage ; Papillomavirus Vaccines - immunology ; Papillomaviruses ; Teenagers ; Treatment Outcome ; Uterine Cervical Neoplasms - prevention & control ; Uterine Cervical Neoplasms - virology ; Vaccines ; Women ; Young Adult
É parte de: JAMA : the journal of the American Medical Association, 2013-05, Vol.309 (17), p.1793-1802
Notas: ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
ObjectType-News-3
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Descrição: IMPORTANCE Global use of human papillomavirus (HPV) vaccines to prevent cervical cancer is impeded by cost. A 2-dose schedule for girls may be possible. OBJECTIVE To determine whether mean antibody levels to HPV-16 and HPV-18 among girls receiving 2 doses was noninferior to women receiving 3 doses. DESIGN, SETTING, AND PATIENTS Randomized, phase 3, postlicensure, multicenter, age-stratified, noninferiority immunogenicity study of 830 Canadian females from August 2007 through February 2011. Follow-up blood samples were provided by 675 participants (81%). INTERVENTION Girls (9-13 years) were randomized 1:1 to receive 3 doses of quadrivalent HPV vaccine at 0, 2, and 6 months (n = 261) or 2 doses at 0 and 6 months (n = 259). Young women (16-26 years) received 3 doses at 0, 2, and 6 months (n = 310). Antibody levels were measured at 0, 7, 18, 24, and 36 months. MAIN OUTCOMES AND MEASURES Primary outcome was noninferiority (95% CI, lower bound >0.5) of geometric mean titer (GMT) ratios for HPV-16 and HPV-18 for girls (2 doses) compared with young women (3 doses) 1 month after last dose. Secondary outcomes were noninferiority of GMT ratios of girls receiving 2 vs 3 doses of vaccine; and durability of noninferiority to 36 months. RESULTS The GMT ratios were noninferior for girls (2 doses) to women (3 doses): 2.07 (95% CI, 1.62-2.65) for HPV-16 and 1.76 (95% CI, 1.41-2.19) for HPV-18. Girls (3 doses) had GMT responses 1 month after last vaccination for HPV-16 of 7736 milli-Merck units per mL (mMU/mL) (95% CI, 6651-8999) and HPV-18 of 1730 mMU/mL (95% CI, 1512-1980). The GMT ratios were noninferior for girls (2 doses) to girls (3 doses): 0.95 (95% CI, 0.73-1.23) for HPV-16 and 0.68 (95% CI, 0.54-0.85) for HPV-18. The GMT ratios for girls (2 doses) to women (3 doses) remained noninferior for all genotypes to 36 months. Antibody responses in girls were noninferior after 2 doses vs 3 doses for all 4 vaccine genotypes at month 7, but not for HPV-18 by month 24 or HPV-6 by month 36. CONCLUSIONS AND RELEVANCE Among girls who received 2 doses of HPV vaccine 6 months apart, responses to HPV-16 and HPV-18 one month after the last dose were noninferior to those among young women who received 3 doses of the vaccine within 6 months. Because of the loss of noninferiority to some genotypes at 24 to 36 months in girls given 2 doses vs 3 doses, more data on the duration of protection are needed before reduced-dose schedules can be recommended. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00501137
Editor: Chicago, IL: American Medical Association
Idioma: Inglês

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Immunogenicity of 2 Doses of HPV Vaccine in Younger Adolescents vs 3 Doses in Young Women: A Randomized Clinical Trial

Chicago, IL: American Medical Association

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