Evaluation of Immunogenicity Levels in Women With HPV Vaccine in Mexico

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

Conditions

• Healthy

Interventions

BIOLOGICAL

Bivalent Vaccines

BIOLOGICAL

Tetravalent Vaccine

Sponsors & Collaborators

• Secretaria de Salud, Mexico

  collaborator OTHER_GOV

• Instituto Nacional de Salud Publica, Mexico

  lead OTHER

Principal Investigators

• Eduardo C Lazcano, Phd, MD · National Institute of Public Health Mexico

• Aurelio Cruz, Valdez · National Institute of Public Health Mexico

• Janet L. Pacheco · National Institute of public Health

Study Design

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

9 Years

Max Age

24 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2009-11-30

Primary Completion

2015-02-28

Completion

2018-08-31

Countries

• Mexico

Study Locations