Faculty Opinions recommendation of Sustained efficacy and immunogenicity of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine: analysis of a randomised placebo-controlled trial up to 6.4 years.

2010 ◽  
Author(s):  
Robert Knobler
Keyword(s):  
Human Papillomavirus ◽  
Controlled Trial ◽  
Hpv 16 ◽  
Adjuvanted Vaccine ◽  
Sustained Efficacy

Sustained efficacy and immunogenicity of the HPV-16/18 AS04-adjuvanted vaccine up to 7.3 years in young adult women

Vaccine ◽  
2010 ◽  
Vol 28 (38) ◽  
pp. 6247-6255 ◽  
Author(s):  
N. De Carvalho ◽  
J. Teixeira ◽  
C.M. Roteli-Martins ◽  
P. Naud ◽  
P. De Borba ◽  
...  
Keyword(s):  
Young Adult ◽  
Adult Women ◽  
Young Adult Women ◽  
Hpv 16 ◽  
Adjuvanted Vaccine ◽  
Sustained Efficacy

scholarly journals Efficacy of Human Papillomavirus 16 and 18 (HPV-16/18) AS04-Adjuvanted Vaccine against Cervical Infection and Precancer in Young Women: Final Event-Driven Analysis of the Randomized, Double-Blind PATRICIA Trial

2015 ◽  
Vol 22 (4) ◽  
pp. 361-373 ◽  
Author(s):  
Dan Apter ◽  
Cosette M. Wheeler ◽  
Jorma Paavonen ◽  
Xavier Castellsagué ◽  
Suzanne M. Garland ◽  
...  
Keyword(s):  
Human Papillomavirus ◽  
Young Women ◽  
Sexual Debut ◽  
Vaccine Dose ◽  
Hpv 16 ◽  
Substantial Impact ◽  
Hpv Dna ◽  
Human Papillomavirus 16 ◽  
Adjuvanted Vaccine ◽  
Event Driven

ABSTRACTWe report final event-driven analysis data on the immunogenicity and efficacy of the human papillomavirus 16 and 18 ((HPV-16/18) AS04-adjuvanted vaccine in young women aged 15 to 25 years from the PApilloma TRIal against Cancer In young Adults (PATRICIA). The total vaccinated cohort (TVC) included all randomized participants who received at least one vaccine dose (vaccine,n= 9,319; control,n= 9,325) at months 0, 1, and/or 6. The TVC-naive (vaccine,n= 5,822; control,n= 5,819) had no evidence of high-risk HPV infection at baseline, approximating adolescent girls targeted by most HPV vaccination programs. Mean follow-up was approximately 39 months after the first vaccine dose in each cohort. At baseline, 26% of women in the TVC had evidence of past and/or current HPV-16/18 infection. HPV-16 and HPV-18 antibody titers postvaccination tended to be higher among 15- to 17-year-olds than among 18- to 25-year-olds. In the TVC, vaccine efficacy (VE) against cervical intraepithelial neoplasia grade 1 or greater (CIN1+), CIN2+, and CIN3+ associated with HPV-16/18 was 55.5% (96.1% confidence interval [CI], 43.2, 65.3), 52.8% (37.5, 64.7), and 33.6% (−1.1, 56.9). VE against CIN1+, CIN2+, and CIN3+ irrespective of HPV DNA was 21.7% (10.7, 31.4), 30.4% (16.4, 42.1), and 33.4% (9.1, 51.5) and was consistently significant only in 15- to 17-year-old women (27.4% [10.8, 40.9], 41.8% [22.3, 56.7], and 55.8% [19.2, 76.9]). In the TVC-naive, VE against CIN1+, CIN2+, and CIN3+ associated with HPV-16/18 was 96.5% (89.0, 99.4), 98.4% (90.4, 100), and 100% (64.7, 100), and irrespective of HPV DNA it was 50.1% (35.9, 61.4), 70.2% (54.7, 80.9), and 87.0% (54.9, 97.7). VE against 12-month persistent infection with HPV-16/18 was 89.9% (84.0, 94.0), and that against HPV-31/33/45/51 was 49.0% (34.7, 60.3). In conclusion, vaccinating adolescents before sexual debut has a substantial impact on the overall incidence of high-grade cervical abnormalities, and catch-up vaccination up to 18 years of age is most likely effective. (This study has been registered atClinicalTrials.govunder registration no. NCT001226810.)

scholarly journals Correlation between levels of human papillomavirus (HPV)-16 and 18 antibodies in serum and cervicovaginal secretions in girls and women vaccinated with the HPV-16/18 AS04-adjuvanted vaccine

2010 ◽  
Vol 6 (12) ◽  
pp. 1054-1061 ◽  
Author(s):  
Tino F. Schwarz ◽  
Mariëlle Kocken ◽  
Tiina Petäjä ◽  
Mark H. Einstein ◽  
Marek Spaczynski ◽  
...  
Keyword(s):  
Human Papillomavirus ◽  
Hpv 16 ◽  
Adjuvanted Vaccine

scholarly journals Efficacy of AS04-Adjuvanted Vaccine Against Human Papillomavirus (HPV) Types 16 and 18 in Clearing Incident HPV Infections: Pooled Analysis of Data From the Costa Rica Vaccine Trial and the PATRICIA Study

2020 ◽  
Author(s):  
Joseph E Tota ◽  
Frank Struyf ◽  
Allan Hildesheim ◽  
Paula Gonzalez ◽  
Martin Ryser ◽  
...  
Keyword(s):  
Human Papillomavirus ◽  
Large Scale ◽  
Sexual Debut ◽  
Vaccine Trial ◽  
Clinical Trial Data ◽  
Intraepithelial Neoplasia ◽  
Pooled Analysis ◽  
Cervical Intraepithelial Neoplasia Grade ◽  
Hpv 16 ◽  
Adjuvanted Vaccine

Abstract Clinical trial data and real-world evidence suggest that the AS04-adjuvanted vaccine targeting human papillomavirus types 16 and 18 (AS04-HPV-16/18) vaccine provides nearly 90% protection against cervical intraepithelial neoplasia grade 3 or higher irrespective of type, among women vaccinated before sexual debut. This high efficacy is not fully explained by cross-protection. Although AS04-HPV-16/18 vaccination does not affect clearance of prevalent infections, it may accelerate clearance of newly acquired infections. We pooled data from 2 large-scale randomized controlled trials to evaluate efficacy of the AS04-HPV-16/18 vaccine against clearance of nontargeted incident infections. Results of our analysis do not suggest an effect in expediting clearance of incident infections.

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