Cervarix is a vaccine for use from the age of 9 years for the prevention of premalignant ano-genital lesions (cervical, vulvar, vaginal and anal) and cervical and anal cancers causally related to certain oncogenic Human Papillomavirus (HPV) types. 1
Cervarix is an adjuvanted non-infectious recombinant vaccine prepared from the highly purified virus-like particles (VLPs) of the major capsid L1 protein of oncogenic HPV types 16 and 18. Since the VLPs contain no viral DNA, they cannot infect cells, reproduce or cause disease. 1
Cervarix Efficacy Data
Cervarix efficacy has been studied in various studies of which the pivotal trial was PATRICIA. This phase III study was a randomised controlled trial that enrolled 18,729 healthy women aged 15–25 years; it is the largest phase III study with a licensed HPV vaccine. 2-5Enrolled women were actively followed up to detect cervical lesions and HPV infections for, on average, 43.7 months after vaccination. CIN3+* efficacy data from the PATRICIA study is presented below. Data on prevention of CIN3+, the last stage before invasive cancer, are considered to be the most robust indicator of cervical cancer protection. 2
In the Patricia study, HPV 16/18 were the HPV types most commonly associated with CIN3+, accounting for approximately 60% of these lesions.* Showing 100% efficacy against those 2 HPV types could therefore prevent 6 out of 10 CIN3+ cases 2,† However, 93.2% CIN3+ efficacy irrespective of type suggests that Cervarix may prevent 9 out of 10 CIN3+ cases that occur in HPV-naïve girls and women, demonstrating significant efficacy against lesions where HPV 16 or 18 were not detected 2,‡
§ In an analysis of CIN3+* lesions related to HPV 16 and/or 18 Cervarix showed 100% efficacy (95% CI 85,5–100) (TVC-naїve) based on 0 cases among 5466 Cervarix-vaccinated women and 27 cases among 5452 women in the control group.**
† In the control group of the PATRICIA study (TVC-naїve), 61,3% (approximately 6/10) of CIN3+* lesions were associated with HPV 16/18, and 38,7% (approximately 4/10) of CIN3+ lesions were not associated with HPV 16/18.**
‡ In an analysis of CIN3+* lesions, conducted irrespective of HPV type, Cervarix showed 93,2% efficacy (95% CI: 78.9–98.7) (TVC-naїve), based on 3 cases among 5466 Cervarix-vaccinated women and 44 cases among 5452 women in the control group. This can be translated, in the context of the PATRICIA trial, to a potential overall prevention of 9/10 CIN3+ lesions**
*CIN: cervical intraepithelial neoplasia.
**TVC-naïve: total vaccinated cohort of women who received ≥one vaccine dose, with negative cytology, HPV DNA-negative for all 14 high-risk cancer-causing HPV types and HPV 16/18 seronegative.
At 34.9 months, vaccine efficacy against HPV 16/18-associated CIN2+ was 92.9% (96.1% CI: 79.9–98.3) in the according-to-protocol cohort for efficacy (ATP-E), the primary endpoint based on 4 cases among 7344 Cervarix-vaccinated women and 56 cases among 7312 women in the control group 6
- GSK Cervarix SmPC. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000721/WC500024632.pdf . Last accessed May 2017.
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- Lehtinen M, Paavonen J, Wheeler CM, et al. Overall efficacy of HPV-16/18 AS04-adjuvanted vaccine against grade 3 or greater cervical intraepithelial neoplasia: 4-year end-of-study analysis of the randomised, double-blind PATRICIA trial. Lancet Oncol 2012;13:89–99.
- ClinicalTrials.gov (2013). Human papilloma virus (HPV) vaccine efficacy trial against cervical pre-cancer in young adults with GlaxoSmithKline (GSK) Biologicals HPV-16/18. Available from: http://clinicaltrials.gov/ct2/show/study/NCT00122681?term=580299%2F008&rank=5. Last accessed May 2017.
- ClinicalTrials.gov (2014a). Cervical intraepithelial neoplasm (CIN)-warts efficacy trial in women (Gardasil)(V501-013)(COMPLETED). Available from http://clinicaltrials.gov/ct2/show/NCT00092521?term=HPV+Merck&rank=38 . Last accessed May 2017.
- ClinicalTrials.gov (2014b). Cervical intraepithelial neoplasm (CIN) in women (Gardasil)(V501-015). Available from: http://clinicaltrials.gov/ct2/show/NCT00092534?term=HPV+Merck&rank=26. Last accessed May 2017.
- Paavonen J, Naud P, Salmerón J, et al. Efficacy of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by oncogenic HPV types (PATRICIA): final analysis of a double-blind, randomised study in young women. Lancet 2009;374(9686):301–314.