Abstract
The preventive effect of HPV vaccines against anogenital and oropharyngeal cancers has been proven in both clinical trials and real-world data. We reviewed the published evidence about the long-term efficacy and effectiveness of the HPV vaccine in available papers of clinical trials and real-world data. As far as we searched, the longest period of preventive effect for the bivalent, 4-valent, and 9-valent vaccine were 11 years in the Costa Rica trial, 14 years in the FUTURE II, and 8 years in the LTFU extension study of V503-002 and the Scandinavian study, respectively. The sustained clinical effect during the observation period was longest for the 4-valent vaccine. In real-world data, the longest observation period of the vaccine effectiveness was 12 years in an Australian study for the 4-valent vaccine. On the other hand, the longest period of long-term persistence of HPV vaccine-induced seropositivity was 14 years in FUTURE II for the 4-valent vaccine. For the bivalent vaccine, additional long-term follow-up studies may not have been planned due to the launch of the 4-valent and 9-valent vaccines. In some studies of the 9-valent vaccine, the results have not yet been published because of the short observation period. The additional results are expected in the future. In a national immunization program, most girls and boys are inoculated with HPV vaccine by the time puberty begins; thus, it is important to monitor the vaccine effect at least until the sexually active period in their 20s and 30s.
Highlights
Human papillomavirus (HPV) is mainly transmitted through sexual activity
This study showed the efficacy of the 4-valent vaccine in the prevention of HPV 6/11 (LR-HPV) and HPV 16/18 (HR-HPV) infection, cervical intraepithelial neoplasia (CIN), and external genital lesions (EGL) related to HPV 6/11/16/18 for 4 years
The results showed that the 9-valent vaccine prevented approximately 97% of high-grade cervical, vulvar, and vaginal diseases associated with HPV 31/33/45/52/58, and the increase in antibody titer against HPV 6/11 (LR-HPV) and HPV 16/18 (HR-HPV) was not inferior to that of the
Summary
Human papillomavirus (HPV) is mainly transmitted through sexual activity. HPV sequences have been identified in chorionic villi tissues from pregnant females and other districts of the reproductive tract [1,2]. HPV infection is the most common viral infection of the genital tract and persistent infection with high-risk HPV types (HR-HPV) can cause changes from normal cells to precancerous and cancerous lesions [3] in both men and women. The onco-proteins E6 and E7 are expressed, causing the degradation of p53 and pRb, respectively This is followed by the alteration of many cellular processes such as DNA repair, angiogenesis, apoptosis, etc., which lead to carcinogenesis [4]. HPV vaccination can prevent 33,000 of these cancers by preventing the infections that cause them [6]. Since the risk of HPV infection persists throughout the period of sexual activity in women, it is important to confirm the long-term preventive effect of the HPV vaccine [23]
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