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HPV Vaccines : Evidence from Clinical S tudies in India

HPV Vaccines : Evidence from Clinical S tudies in India. Dr Neerja Bhatla MBBS, MD, FIMSA, FICOG, FNAMS Professor, Dept of Ob-Gyn, AIIMS Member , FIGO Gyn Oncology Committee President-Elect, AOGIN Founder-President, AOGIN-India Vice President, AOGD & AGOI. Indian Scenario.

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HPV Vaccines : Evidence from Clinical S tudies in India

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  1. HPV Vaccines : Evidence from Clinical Studies in India Dr Neerja Bhatla MBBS, MD, FIMSA, FICOG, FNAMS Professor, Dept of Ob-Gyn, AIIMS Member, FIGO Gyn Oncology Committee President-Elect, AOGIN Founder-President, AOGIN-India Vice President, AOGD & AGOI

  2. Indian Scenario Ten most frequent HPV types among women with and without cervical lesions in India • India has a population of 366.58 million women ages 15 years and older who are at risk of developing cervical cancer • Current estimates indicate that every year 134420 women are diagnosed with cervical cancer and 72825 die from the disease • Cervical cancer ranks as the 1st most frequent cancer among women in India

  3. 0 20 40 60 80 100 120 HPV infections in invasive cervical cancer in India: A meta-analysis HPV 16 63.26 78.86 15.6 HPV 18 6.02 84.88 HPV 45 5.38 90.26 HPV 33 5.02 95.28 HPV 35 3.58 98.86 HPV 58 HPV 59 1.97 100.83 1.94 102.77 HPV 31 1.75 104.52 HPV 56 HPV Type 1.31 105.83 HPV 51 1.31 107.14 HPV 52 1.09 108.23 HPV 73 HPV 62 0.75 108.98 0.75 109.73 HPV 64 0.66 110.39 HPV 39 0.44 110.83 HPV 61 0.44 111.27 HPV 68 0.44 111.71 HPV 82 Cumulative HPV Prevalence (%) Bhatla et al, Vaccine.2008;26(23):2811-7

  4. Meta-analysis - Overall HPV prevalence in India(n=3723) Bhatla N et al, Vaccine.2008;26(23):2811-7

  5. Indian statistics Data sources: Bhatla N, Int J GynecolPathol 2006;25:398; Franceschi S, Int J Cancer 2003;107:127; Gheit T, Vaccine 2009;27:636; Munirajan AK, GynecolOncol 1998;69:205; Nagpal JK, Eur J Clin Invest 2002;32:943; Peedicayil A, Int J Gynecol Cancer 2006;16:1591; Sowjanya AP, MBC Infect Dis 2005;5:116. http://apps.who.int/hpvcentre/statistics/dynamic/ico/country_pdf/IND, p 28. Accessed on Sep 30, 2012

  6. Cervical cancer continues to be a major problem in India • No effective national programme has been implemented for cervical cancer screening and prevention • Screening coverage among women aged 18-69 years screened every 3 years is 2.6% • 4.9% urban • 2.3% rural Key point 1 http://apps.who.int/hpvcentre/statistics/dynamic/ico/country_pdf/IND, p 28. Accessed on Sep 30, 2012

  7. Results: Anti-HPV-16 and -18 antibody levels one month post-dose 3 (N=124) (N=117) • 100% seroconversion / seropositivity of vaccine group with comparable titers and safety Bhatla N, et al. J ObstetGynaecol Res. 2010;36(1):123–132

  8. Both the HPV vaccines are available in the private market in India • Infrastructure for vaccine administration is already in place with the EPI vaccines • Indian HPV epidemiology data suggest a greater fraction (82.5%) of cervical cancer can be prevented by these vaccines • Immunobridgingstudies show good safety and immunogenicity in Indian women Key point 2

  9. Major barriers to implementation of HPV vaccination in India • Lack of awareness • Misinformation on its safety and efficacy • Cost • Logistics of cold chain • Logistic difficulties in accessing pre-adolescent and adolescent girls • Challenges in compliance to a multiple-dose regime • Socio-cultural barriers

  10. Banner What lessons have been learned from HPV vaccine implementation trials in India?  Is vaccine acceptable, what are the barriers?

  11. PATH HPV Vaccine Project: June 2006 - May 2011 Objective: Generate critical data & experience for evidence-based decision making about WHETHER & HOW to introduce HPV vaccines into India’s public –sector immunization program as part of broader cervical cancer prevention & control strategy. Collaborators: Indian Council of Medical Research, State Governments India Vietnam Peru Uganda Slide courtesy: Dr Martha Jacob

  12. HPV vaccine delivery strategies in demonstration projects, India(Vaccination year 2009-2010)

  13. HPV vaccination coverage survey, survey respondents and age of girls eligible for vaccination, India, 2009-10

  14. Parents’ and guardians’ reasons for accepting HPV vaccination, India

  15. Parents’ and guardians’ reasons for accepting HPV vaccination, India

  16. Parents’ and guardians’ reasons for not accepting HPV vaccination, India

  17. Parents’ and guardians’ reasons for not accepting HPV vaccination, India

  18. There was a positive acceptance of HPV vaccination with the understanding that they protect against cervical cancer • Non-acceptance was mainly for programmatic reasons • A large proportion of girls completed the vaccine schedule • The HPV vaccine is now a GAVI-eligible vaccine. Efforts are underway to implement demonstration and national upscaling in eligible countries Key point 3

  19. New Delhi Sikkim Ahmedabad Mizoram Mumbai Pune Barshi Hyderabad Ambillikai Randomised Trial of 2 versus 3 doses of HPV vaccination in India World Health Organization (WHO)International Agency for Research on Cancer (IARC), Lyon, France In collaboration with AIIMS-New Delhi GCRI-Ahmedabad TMH-Mumbai JCDC-Pune NDMCH-Barshi MNJ Institute of Oncology and RCC, Hyderabad CFCHC-Ambillikai Cancer Foundation of India, Kolkata Supported by the Bill & Melinda Gates Foundation

  20. 20,000 girlsaged 10-18 years 10,000 girls3 doses / 6 months 10,000 girls2 doses / 6 months • 20+ years follow up for: • Sero-conversion • Immune response • HPV infection rates • Incidence of CIN • Incidence of cervical cancer Randomised Trial of 2 versus 3 doses of qHPVvaccination in India

  21. Randomised Trial of 2 versus 3 doses of HPV vaccination in India Potential benefits • Decrease costs • Improve compliance • Improve logistics • Provide first efficacy data for India • Set up facilities for testing antibody levels in India And then the trial was suspended!

  22. Randomised Trial of 2 versus 3 doses of HPV vaccination in India Situation of the different vaccination regimens All study sites (N=17,729) (as of June 2012) 2-dose group 3-dose group N=9188 N=8541 Received 3 doses (day 1-60-180) N= 2061 Received 1 dose (day 1) N= 4268 Received 2 doses (day 1-180) N= 1421 Received 1 dose (day 1) N= 687 Received 2 doses (day 1-60) N= 3963 Received 2 doses (day 1-180) N= 14 Received 2 doses (day 1-445/675) N= 40 Received 3 doses (day 1-472/574 -567/676) N= 56 Received 3 doses (day 1-60- 344/955) N= 2220 Received 2 doses (day 1-315/877) N= 3499 Start: 09/07/2009 Start: 02/09/2009

  23. Randomised Trial of 2 versus 3 doses of HPV vaccination in India Mean GMT values of HPV 16, 18, 6 and 11 L1 antibodies in the 2- and 3-dose groups at day 1 and month 7 (1 month after the last dose) (Analysis done at Rajiv Gandhi Centre for Biotechnology, Trivandrum, India)

  24. Randomised Trial of 2 versus 3 doses of HPV vaccination in India Mean GMT values for HPV 6, 11, 16 and 18 L1 antibodies at different time points among girls who completed vaccination per protocol [vaccination at day 1, 60, 180 (3-dose group) or day 1, 180 (2-dose group)]

  25. Randomised Trial of 2 versus 3 doses of HPV vaccination in India Mean GMT values for HPV 6, 11, 16 and 18 L1 antibodies at different time points among girls with incomplete vaccine schedules

  26. The 2-dose vaccination regime is very promising with comparable immunogenicity to the 3-dose regime • Further evaluation is required to determine • Age based stratification of titers • Long-term comparison of titers • Efficacy • HPV trials must continue alongside implementation Key point 4

  27. New Vaccine Development • Indian vaccine development in research • HPV 16/18 VLP vaccines • HPV 16 vaccine • Chimera : Prophylactic + Therapeutic • L2 vaccine

  28. Conclusions • Secondary prevention has not yielded desired results in India • HPV vaccination is an important complementary strategy to reduce the cervical cancer burden • Formative studies in demonstration projects have documented acceptability and feasibility • Two-dose regimes have great potential to decrease cost and improve compliance in low resource settings • Misconceptions must be cleared and awareness improved among the population at large

  29. “Screen every woman by age 40, Vaccinate every girl by age 14” The All India Institute of Medical Sciences

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