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Evaluation of Immunogenicity Levels in Women With HPV Vaccine in Mexico

This study has been completed.
Sponsor:
Collaborator:
Secretaria de Salud, Mexico
Information provided by (Responsible Party):
Eduardo Cesar Lazcano Ponce, Instituto Nacional de Salud Publica, Mexico
ClinicalTrials.gov Identifier:
NCT01717118
First received: October 26, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
  Purpose

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 objective is to monitor immunity levels induced by the anti-HPV vaccine with two vaccination schemes: amplified (0, 6, 60 months) and traditional (0, 1 and/or 2, 6). The study design consists in making a sentinel cohort of women vaccinated against HPV in three comparison groups:

  • 9-year-old females with an extended vaccination scheme (0-6-60)
  • 9-year-old females with a traditional vaccination scheme (0-1/2-6)

  • Women 18 to 24 years of age with a traditional vaccination scheme (0-1/2-6)

    1. The direct Elisa test and Elisa inhibition test with pseudovirion-based neutralization assay will be used for HPV 16 and 18 and for the Cervarix vaccine
    2. For the Gardasil vaccine a test will be used to determine antibodies by luminometry (cLIA) for VPH 6, 11, 16 and 18 suited for measurement of specific epitopes and total IgG

Condition Intervention Phase
Human Papillomavirus 16
Human Papillomavirus 18
Vaccines
 Biological: Bivalent Vaccines
Biological: Tetravalent Vaccine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Evaluation of Immunogenicity Levels in Women With HPV Vaccine in Mexico

Further study details as provided by Instituto Nacional de Salud Publica, Mexico:

Primary Outcome Measures:
  • To monitor immunogenicity levels induced by anti/HPV vaccine in traditional squeme [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

    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 Outcome Measures:
  • To monitor immunogenicity levels induced by anti/HPV vaccine in extended squeme [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]

    BIVALENT VACCINE: This group will consist of a total of 2000 women. Two thirds of them will be 9 to 10 years of age, and 500 will be 18 to 24 years of age. In the first age group, 1000 of them will be administered the vaccine in the amplified scheme of 0, 6, 60 months.

    TETRAVALENT VACCINE: the group of 9- to 10-year-olds, 150 of them will be administered the vaccine in the amplified scheme of 0, 6, 60 months



Enrollment: 2000
Study Start Date: November 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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
 Biological: Tetravalent Vaccine
Other Name: Gardasil
Active Comparator: 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
 Biological: Bivalent Vaccines
Other Name: CERVARIX

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   9 Years to 24 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01717118

Locations
Mexico
Centro Médico Cuauhtemoc
Cuernavaca, Morelos, Mexico, 1299
Sponsors and Collaborators
Instituto Nacional de Salud Publica, Mexico
Secretaria de Salud, Mexico
Investigators
Principal Investigator: Eduardo C Lazcano, Phd, MD National Institute of Public Health Mexico
Study Director: Aurelio Cruz, Valdez National Institute of Public Health Mexico
Study Chair: Janet L. Pacheco National Institute of Public Health
  More Information

No publications provided

Responsible Party: Eduardo Cesar Lazcano Ponce, Executive Director of the Center of Research in population health, Instituto Nacional de Salud Publica, Mexico
ClinicalTrials.gov Identifier: NCT01717118     History of Changes
Other Study ID Numbers: 883
Study First Received: October 26, 2012
Last Updated: October 26, 2012
Health Authority: Mexico: Federal Commission for Sanitary Risks Protection

Keywords provided by Instituto Nacional de Salud Publica, Mexico:
Evaluation
Immunogenicity
Levels
Women
 HPV
Vaccine
Mexico

ClinicalTrials.gov processed this record on May 23, 2013