Long-term study of a quadrivalent human papillomavirus vaccine
ABCD PBi
Long-term study of a quadrivalent human papillomavirus vaccine
Autor:
Ferris, Daron
;
Samakoses, Rudiwilai
;
Block, Stan L
;
Lazcano-Ponce, Eduardo
;
Restrepo, Jaime Alberto
;
Reisinger, Keith S
;
Mehlsen, Jesper
;
Chatterjee, Archana
;
Iversen, Ole-Erik
;
Sings, Heather L
;
Shou, Qiong
;
Sausser, Timothy A
;
Saah, Alfred
Assuntos:
Adolescent
;
Child
;
Double-Blind Method
;
Female
;
Follow-Up Studies
;
Human papillomavirus
;
Human papillomavirus 11 - drug effects
;
Human papillomavirus 11 - physiology
;
Human papillomavirus 16 - drug effects
;
Human papillomavirus 16 - physiology
;
Human papillomavirus 18 - drug effects
;
Human papillomavirus 18 - physiology
;
Human papillomavirus 6 - drug effects
;
Human papillomavirus 6 - physiology
;
Humans
;
Immunization
;
Male
;
Papillomavirus Infections - blood
;
Papillomavirus Infections - epidemiology
;
Papillomavirus Infections - prevention & control
;
Papillomavirus Vaccines - administration & dosage
;
Papillomavirus Vaccines - blood
;
Pediatrics
;
Time Factors
;
Treatment Outcome
;
Vaccination - trends
;
Vaccines
É parte de:
Pediatrics (Evanston), 2014-09, Vol.134 (3), p.e657-e665
Notas:
ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-News-2
ObjectType-Feature-3
content type line 23
ObjectType-Feature-2
Descrição:
We present a long-term safety, immunogenicity, and effectiveness study of a quadrivalent human papillomavirus (HPV4) vaccine. Sexually naive boys and girls aged 9 to 15 years (N = 1781) were assigned (2:1) to receive HPV4 vaccine or saline placebo at day 1 and months 2 and 6. At month 30, the placebo group (n = 482) received HPV4 vaccine following the same regimen and both cohorts were followed through month 96. Subjects ≥ 16 years were eligible for effectiveness evaluations. The primary objective was to evaluate the long-term anti-HPV6/11/16/18 serological levels. The secondary objective was to estimate vaccine effectiveness against HPV6/11/16/18-related persistent infection or disease. For each of the HPV4 vaccine types, vaccination-induced anti-HPV response persisted through month 96. Among 429 subjects who received HPV4 vaccine at a mean age of 12, none developed HPV6/11/16/18-related disease or persistent infection of ≥ 12 months' duration. Acquisition of new sexual partners (among those ≥ 16 years) was ∼1 per year. Subjects receiving HPV4 vaccine at month 30 (mean age 15 years) had a similar baseline rate of seropositivity to ≥ 1 of the 4 HPV types to those vaccinated at day 1 (mean age 12 years; 1.9% [9 of 474] vs 1.7% [20 of 1157]); however, 4 of the 9 subjects vaccinated at the later age were seropositive to 3 vaccine types, indicating previous HPV exposure. No new significant serious adverse events were observed for 8 years postvaccination in both genders. When administered to adolescents, the HPV4 vaccine demonstrated durability in clinically effective protection and sustained antibody titers over 8 years.
Editor:
United States: American Academy of Pediatrics
Idioma:
Inglês