AIM: India has the highest number of annual incident cases and mortality rates for cervical cancer worldwide. This study was conducted to assess the immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted cervical cancer vaccine in healthy Indian women aged 18-35 years old. METHODS: This double-blind, randomized (1:1), controlled and multicenter trial with two parallel groups, the Vaccine and Placebogroups, included 354 subjects in four centers across India. Subjects were given GlaxoSmithKline's HPV-16/18 AS04-adjuvanted cervical cancer vaccine or aluminum hydroxide placebo according to a 0, 1 and 6 month schedule and followed up until month 7. Serum samples were drawn at pre-vaccination and at month 7. Safety data were collected throughout the study. RESULTS: A total of 330 subjects completed the study. One month post-Dose 3, all initially seronegative subjects in the Vaccine group had seroconverted for HPV-16 and HPV-18 antibodies with anti-HPV-16 and anti-HPV-18 geometric mean titer levels of 10226.5 EL.U/ml (95% confidence interval: 8847.1-11821.0) and 3953.0 EL.U/ml (95% confidence interval: 3421.8-4566.8), respectively. Initially seropositive subjects also showed an increase to similar geometric mean titer levels. Six serious adverse events (two in the Vaccine group and four in the Placebo group), all unrelated to vaccination, were reported. Commonly reported solicited local (injection-site pain) and general (fatigue, headache and fever) symptoms were similar in both groups. Compliance to the three-dose vaccination course was >97%. CONCLUSIONS: The AS04-adjuvanted HPV-16/18 cervical cancer vaccine was highly immunogenic and generally well-tolerated making it a potential tool for prevention and control of cervical cancer in India.
RCT Entities:
AIM: India has the highest number of annual incident cases and mortality rates for cervical cancer worldwide. This study was conducted to assess the immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted cervical cancer vaccine in healthy Indian women aged 18-35 years old. METHODS: This double-blind, randomized (1:1), controlled and multicenter trial with two parallel groups, the Vaccine and Placebo groups, included 354 subjects in four centers across India. Subjects were given GlaxoSmithKline's HPV-16/18 AS04-adjuvanted cervical cancer vaccine or aluminum hydroxide placebo according to a 0, 1 and 6 month schedule and followed up until month 7. Serum samples were drawn at pre-vaccination and at month 7. Safety data were collected throughout the study. RESULTS: A total of 330 subjects completed the study. One month post-Dose 3, all initially seronegative subjects in the Vaccine group had seroconverted for HPV-16 and HPV-18 antibodies with anti-HPV-16 and anti-HPV-18 geometric mean titer levels of 10226.5 EL.U/ml (95% confidence interval: 8847.1-11821.0) and 3953.0 EL.U/ml (95% confidence interval: 3421.8-4566.8), respectively. Initially seropositive subjects also showed an increase to similar geometric mean titer levels. Six serious adverse events (two in the Vaccine group and four in the Placebo group), all unrelated to vaccination, were reported. Commonly reported solicited local (injection-site pain) and general (fatigue, headache and fever) symptoms were similar in both groups. Compliance to the three-dose vaccination course was >97%. CONCLUSIONS: The AS04-adjuvanted HPV-16/18 cervical cancer vaccine was highly immunogenic and generally well-tolerated making it a potential tool for prevention and control of cervical cancer in India.
Authors: Maria-Genalin Angelo; Marie-Pierre David; Julia Zima; Laurence Baril; Gary Dubin; Felix Arellano; Frank Struyf Journal: Pharmacoepidemiol Drug Saf Date: 2014-02-20 Impact factor: 2.890