COMPARISON OF POST-LICENSURE SAFETY SURVEILLANCE OF BIVALENT AND QUADRIVALENT HUMAN PAPILLOMAVIRUS VACCINES IN HEALTHY MUMBAI WOMEN

Vikrant C. Sangar; B B Ghongane; Rajan Gupte; Rohan Kesarkar; Karthik Kalyan; Abhay Chowdhary

Authors

Vikrant C. Sangar PhD. Student, Department of Pharmacology, B. J. Govt. Medical College and Sassoon General Hospital, INDIA.
B B Ghongane Head of Department of Medical Pharmacology, B. J. Govt. Medical College and Sassoon General Hospital, Pune, INDIA
Rajan Gupte Gynaecologist, Gupte Maternity and Surgical Home, Mahim, INDIA
Rohan Kesarkar Senior research fellow, Department of Virology, Haffkine Institute for Training, Research and Testing, Mumbai, INDIA.
Karthik Kalyan Scientific Officer, Department of Virology, Haffkine Institute for Training, Research and Testing, Mumbai, INDIA.
Abhay Chowdhary Head of Dept and Director, Department of Virology, Haffkine Institute for Training, Research and Testing, Mumbai, INDIA.

Keywords:

HPV2, HPV4, Safety, Adverse drug reactions (ADRs), Injection-site pain, India

Abstract

Objective: This study is the first comprehensive effort after HPV vaccine controversy in INDIA to compare two HPV vaccines without vaccine manufacturers funding in single, randomized, well-defined population of healthy married women aged 18-25 years using identical methodology for assessment.

Methods: The study protocol was approved by an institutional ethical review committee and registered in Clinical trial registry of INDIA prior to subject recruitment. Total 77 women were screened but 69 were randomized to receive either HPV2 or HPV4 vaccines.

Results: According to the present study, both HPV vaccines were well tolerated without any serious vaccine-related adverse event. Adverse drug reactions reported for both HPV vaccinations were 22 (35.48%) after the ï¬rst dose, 7 (12.05%) after the second dose and 11 (25%) after the third dose. After bivalent and quadrivalent HPV vaccination, 29 and 11 adverse drug events were recorded within seven days after any HPV vaccine dose respectively. Most frequently reported solicited local symptom from both groups was34 injection site pain which was mild in intensity.

Conclusion: Both HPV vaccines appear to be safe, HPV4 being more cost-effective. However, large scale post-marketing studies are needed in view of amount of disease burden.

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Author Biographies

Vikrant C. Sangar, PhD. Student, Department of Pharmacology, B. J. Govt. Medical College and Sassoon General Hospital, INDIA.

PhD. Student, Department of Pharmacology,
B. J. Govt. Medical College and Sassoon General Hospital, INDIA.

B B Ghongane, Head of Department of Medical Pharmacology, B. J. Govt. Medical College and Sassoon General Hospital, Pune, INDIA

Head of Department of Medical Pharmacology, B. J. Govt. Medical College and Sassoon General Hospital, Pune, INDIA

Rajan Gupte, Gynaecologist, Gupte Maternity and Surgical Home, Mahim, INDIA

Gynaecologist, Gupte Maternity and Surgical Home, Mahim, INDIA

Rohan Kesarkar, Senior research fellow, Department of Virology, Haffkine Institute for Training, Research and Testing, Mumbai, INDIA.

Senior research fellow, Department of Virology, Haffkine Institute for Training, Research and Testing, Mumbai, INDIA.

Karthik Kalyan, Scientific Officer, Department of Virology, Haffkine Institute for Training, Research and Testing, Mumbai, INDIA.

Scientific Officer, Department of Virology, Haffkine Institute for Training, Research and Testing, Mumbai, INDIA.

Abhay Chowdhary, Head of Dept and Director, Department of Virology, Haffkine Institute for Training, Research and Testing, Mumbai, INDIA.

Head of Dept and Director, Department of Virology, Haffkine Institute for Training, Research and Testing, Mumbai, INDIA.

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