Title:Development of Human Papillomavirus (HPV) Vaccines: A Review of Literature and Clinical Update
VOLUME: 11 ISSUE: 4
Author(s):Vikrant Chadrakant Sangar, Balasaheb Ghongane and Gaurav Mathur
Affiliation:Department of Pharmacology, B.J. Govt. Medical College and Sassoon General Hospital, Pune-411001, India.
Keywords:Clinical development of HPV vaccines, Clinical Phases of HPV vaccines, HPV2, HPV4, Prophylactic Human
papillomavirus Vaccines (HPV).
Abstract:The casual relationship concerning Human papillomaviruses (HPV) and
cervical cancer is already established. Therefore, such HPV-associated malignancies
might be prevented by prophylactic HPV vaccines. From 2009, two prophylactic
HPV L1 Virus-Like Particle vaccines namely, Gardasil® - quadrivalent (Merck) and
Cervarix™ - bivalent (GlaxoSmithKline) are widely commercially available. By
Aug 2014, 58 countries had introduced HPV vaccination in their national immunization
program; this has led to numerous publications on safety and real world effectiveness.
We have also seen long-term immunogenicity and efficacy data emerging.
Data on cross-protection has also evolved. In clinical trials, it is observed that vaccinating
adolescents results in higher immunological response than young adults hence
to achieve best HPV vaccine efficacy it is advisable to immunize before the onset of sexual activity. Recently
we have seen development of 2 dose vaccine schedule for adolescent, and emerging evidences
even point that single dose of HPV vaccines can result in high efficacy, this observation is currently under
consideration but if accepted will greatly impact vaccination coverage. In terms of safety, pregnancy
registry did not find any unexpected patterns in fetal or maternal outcomes. This review only focuses on
the efficacy and safety data of both Food and Drug Administration approved vaccines from clinical
phase I to phase IV.
