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Lmmunogenicity and Reactogenicity of Alternative Schedules of HPV Vaccine in Vietnam

Cervical cancer

daniel_millan
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Lmmunogenicity and Reactogenicity of Alternative Schedules of HPV Vaccine in Vietnam

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    1. lmmunogenicity and Reactogenicity of Alternative Schedules of HPV Vaccine in Vietnam KM Neuzil*, DG Canh**, VD Thiem**, A Janmohamed*, VM Huong*, Y Tang*, NTN Diep*, V Tsu*, DS LaMontagne* PATH*, Seattle, WA and Hanoi, Vietnam and National Institute of Hygiene and Epidemiology**, Hanoi, Vietnam

    2. Cervical cancer – globally and in Vietnam Each year, new cases of cervical cancer occur in approximately 529,000 women and 275,000 women die. An estimated 88 percent of deaths due to cervical cancer occur among women residing in developing countries. In Vietnam, cervical cancer is the fourth leading cause of cancer deaths among women, with significant disparities between regions.

    3. HPV Vaccines Human papillomaviruses (HPVs) are the primary cause of cervical cancer. HPV-16 and HPV-18 account for 70% of cervical cancer cases Two HPV vaccines are licensed and prequalified by the WHO: Gardasil, Merck & Co., Types 16, 18, 6, 11 Administered on 0,2,6 month schedule Cervarix, GSK, Types 16, 18 Administered on 0,1,6 month schedule Both vaccines highly efficacious in preventing cervical precancers related to HPV-16 and HPV-18 No correlate of protection identified

    4. Study Rationale Most low resource countries do not have adolescent vaccination programs Delivering vaccine on currently recommended schedule will be challenging Schedule variations will occur when vaccine used broadly Can HPV vaccines given on alternative schedules that could be more feasible and less costly?

    5. Study design School-based, cluster-randomized noninferiority trial in Hoa Binh Province, a mountainous primarily rural region in northwestern Vietnam Goal to determine immunogenicity and reactogenicity of Gardasil: Standard schedule 0,2,6 months Alternatives schedules 0,3,9 months 0,6,12 months 0,12,24 months

    6. Study design 21 schools in the province were pre-stratified to achieve 4 similar school groups Informed consent and assent obtained. Each school group randomly assigned to one of the 4 vaccine schedules Study conducted in accordance with ICH/GCP and with approvals by national and international ethics committees

    7. Study design Girls aged 11 through 13 years in grades 6 or 7 (mean age 12 years) 3 doses of Gardasil at school Blood draws before first dose, and before and one month after third dose of vaccine Monitored for immediate, serious and solicited (fever, local reactions) adverse events

    8. Study design Primary study outcome: HPV-16 and HPV-18 antibody concentrations one month after third dose of vaccine Noninferiority (alternative schedules at least as good as standard schedules) Secondary outcomes: Safety HPV-6 and HPV-11 antibody concentrations

    9. Results Between September and December 2007, 903 girls were enrolled and received at least one dose of vaccine. 809 girls (89.6%) received all 3 doses and had a post-dose 3 blood sample

    10. Results: Noninferiority of GMTs After the Third Dose of Vaccine

    11. GMT’s comparable to results from other regions

    12. Pre-dose 3 antibody concentrations were highest in yearly group

    13. Girls reporting pain on at least one day during the 7 days post-vaccination

    14. Most injection site pain was mild

    15. Other adverse events Eight girls (<1%) experienced a reaction within 30 minutes of injection (weakness, nausea, sweating, pale skin, vomiting). No episodes of fainting, allergic or anaphylactic reactions within the 30 min observation period No deaths, vaccine-related serious adverse events, or pregnancies throughout the study

    16. Conclusions Among adolescent girls in Vietnam, the HPV vaccine on standard and alternative schedules was immunogenic and well-tolerated. Antibody concentrations were robust in all dosing groups; however only the 0,3,9 and 0,6,12 group met the pre-specified non-inferiority criteria The option of delivering HPV vaccine on flexible schedules should allow countries to minimize cost and maximize feasibility according to local vaccination practices.

    17. Kathleen M. Neuzil, MD, MPH kneuzil@path.org

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