Evaluation of Immunogenicity Levels in Women With HPV Vaccine in Mexico
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 2,000
- Locations
- 2
- Primary Endpoint
- To monitor immunogenicity levels induced by anti/HPV vaccine in traditional squeme
Study Overview
Brief Summary
In September 2009 the National Vaccination Council approved the policy for anti-HPV vaccination in 9-year-old girls with an extended scheme of 0, 6, and 60 months, under the following justification:
- Antibody induction due to the vaccine is greater than that produced by natural exposure to the virus
- Immune response in girls 9 to 11 years of age is similar to the response obtained after three doses in women 16 to 26 years of age
- The third dose will be administered at the time when maximum protection is required, near the onset of sexual activity Thus the National Institute of Public Health was commissioned to monitor anti-HPV antibody levels in women who received the anti-HPV vaccine to determine non-inferiority of the extended scheme in 9-year-old girls compared with the traditional scheme of 3 doses in women 18 to 24 years of age. To this end, a sentinel cohort will be formed to evaluate immunogenicity levels in 3 age groups, and stratified by vaccine type. The hypothesis is that in 9-year-old girls who are administered the amplified HPV vaccination scheme (0-6-60) show immunogenicity levels that are not lower than those of adult women who have been administered the traditional scheme (0-1/2-6).
The main objectives are to monitor the levels of immunity induced by vaccination against HPV with two vaccination schemes with the quadrivalent vaccine: Traditional Extended (0-6-60 months) and traditional (0-2-6); Monitoring levels of immunity induced by vaccination against HPV with three vaccine schemes with bivalent vaccine: Extended (0-6-60 months), traditional (0-1-6) and two doses (0- 6); as well as evaluating the interchangeability of the bivalent and quadrivalent vaccines in the third dose of extended scheme. The study design is to create a sentinel cohort of women vaccinated against HPV in the following comparison groups:
- Women of nine years with extended vaccination scheme with three doses of quadrivalent vaccine (0-6-60)
- Women of nine years with extended vaccination scheme with two doses of the quadrivalent vaccine and the third dose with bivalent (0-6-60)
- Women of nine years with traditional vaccination scheme with the quadrivalent HPV vaccine (0-2-6)
- Women between 18 and 24 years with traditional vaccination scheme with the quadrivalent HPV vaccine (0-2-6)
- Women of nine years with extended vaccination scheme with three doses of bivalent vaccine (0-6-60)
- Women of nine years with extended vaccination scheme with two doses of bivalent vaccine and the third tetravalent dose
- Women of nine years with two vaccine doses scheme with the bivalent HPV vaccine (0-6)
- Women of nine years with traditional vaccination scheme with bivalent HPV vaccine (0-1-6)
- Women between 18 and 24 years with traditional vaccination scheme with bivalent HPV vaccine (0-1-6)
- To monitoring HPV infections, at month 61 of follow-up, a group of 400 women aged 14-15 years, who have not been vaccinated against HPV, will be invited , in order to make the monitoring of occurrence of HPV infections in urine per month 61, 72, 96 and 120 post dose 0 in vaccinated groups
Detailed Description
Hypothesis Girls 9 and 10 years of age who are administered the amplified anti/HPV vaccination scheme (0-6-60), show immunogenicity levels against HPV antibodies that are not lower than those of 9-year-old girls and adult women who have been administered the traditional scheme (0-1/2-6).
The vaccination schemes for HPV traditional (0-1 / 2-6) and extended (0-6-60), are equivalent from the immunologically perspective and therefore the number of memory B and T lymphocytes as well as the structure of repertoire will be not different between schemes.
Objectives The main objectives are to monitor the levels of immunity induced by vaccination against HPV with two vaccination schemes with the quadrivalent vaccine: Traditional Extended (0-6-60 months) and traditional (0-2-6); Monitoring levels of immunity induced by vaccination against HPV with three vaccine schemes with bivalent vaccine: Extended (0-6-60 months), traditional (0-1-6) and two doses (0- 6); as well as evaluating the interchangeability of the bivalent and quadrivalent vaccines in the third dose of extended scheme. The study design is to create a sentinel cohort of women vaccinated against HPV in the following comparison groups:
- Women of nine years with extended vaccination scheme with three doses of quadrivalent vaccine (0-6-60)
- Women of nine years with extended vaccination scheme with two doses of the quadrivalent vaccine and the third dose with bivalent (0-6-60)
- Women of nine years with traditional vaccination scheme with the quadrivalent HPV vaccine (0-2-6)
- Women between 18 and 24 years with traditional vaccination scheme with the quadrivalent HPV vaccine (0-2-6)
- Women of nine years with extended vaccination scheme with three doses of bivalent vaccine (0-6-60)
- Women of nine years with extended vaccination scheme with two doses of bivalent vaccine and the third tetravalent dose
- Women of nine years with two vaccine doses scheme with the bivalent HPV vaccine (0-6)
- Women of nine years with traditional vaccination scheme with bivalent HPV vaccine (0-1-6)
- Women between 18 and 24 years with traditional vaccination scheme with bivalent HPV vaccine (0-1-6)
- To monitoring HPV infections, at month 61 of follow-up, a group of 400 women aged 14-15 years, who have not been vaccinated against HPV, will be invited , in order to make the monitoring of occurrence of HPV infections in urine per month 61, 72, 96 and 120 post dose 0 in vaccinated groups
Methodology
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 9 Years to 24 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •• Women 18 to 24 years of age who agree to participate by signing an informed consent form prior to recruitment.
- •Girls 9 and 10 years of age whose father/mother/guardian signs the informed consent form to participate in the study.
Exclusion Criteria
- •• Prior administration of an anti-HPV vaccine
- •Pregnant women or women planning to get pregnant in the next 8 months.
- •Auto-immune diseases
- •Women with a history of Guillain Barré syndrome.
- •Prior administration of immunoglobulins and/or any blood product in the past 6 months before the study's first vaccine dose.
Arms & Interventions
Tetravalent Vaccine
- Month 2 visit: May be scheduled on the appropriate month +/- 3 weeks.
- Month 6, 21, 60 and 61 visit (vaccination scheme 0, 2, 6): May be programmed on the appropriate month +/- 4 weeks.
- Month 7 and 61 visit (vaccination scheme 0, 6, 60): The time interval between the month 6/60 visit and the month 7/61 visit must be at least 3 weeks and maximum 7 weeks from the previous vaccination
Intervention: Tetravalent Vaccine (Biological)
Bivalent Vaccine
- Month 1 visit: May be scheduled 21 to 62 days after the Day 0 visit.
- Month 6 visit: May be scheduled 161 to 216 days after the Day 0 visit.
- Month 6 visit: The time interval between the month 6 visit and the month 7 visit must be at least 3 weeks and maximum 7 weeks from the previous vaccination.
- Month 21, 60 and 61 visit (vaccination scheme 0, 1, 6): May be scheduled on the appropriate month +/- 4 weeks.
- Month 61 (vaccination scheme 0, 6, 60) The time interval between the month 60 visit and the month 61 visit must be at least 3 weeks and maximum 7 weeks from the previous vaccination
Intervention: Bivalent Vaccines (Biological)
Outcomes
Primary Outcomes
To monitor immunogenicity levels induced by anti/HPV vaccine in traditional squeme
Time Frame: 6 months
Bivalent Vaccine: Five hundred females from this age group will be administered the vaccine according to the traditional scheme of 0, 1, 6 months. All females from the 18 to 24 age group will be administered the traditional scheme of 0, 1, 6 months. Tetravalent Vaccine: 150 will receive the vaccine under the traditional scheme of 0, 2, 6 months. The group of 18- to 24-year-old women will be conducted under the traditional scheme of 0, 2 and 6 months.
Secondary Outcomes
- To monitor immunogenicity levels induced by anti/HPV vaccine in extended squeme(60 months)
Investigators
Eduardo Cesar Lazcano Ponce
Executive Director of the Center of Research in population health
Instituto Nacional de Salud Publica, Mexico