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Evaluation of Long Term Immunity Following HPV Vaccination

NCT02276521 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2015-09-23

No results posted yet for this study

Summary

In Fiji, cervical cancer is the second most frequent cancer and the highest cause of cancer mortality in women. In 2008/9, the Ministry of Health in Fiji accepted a donation of 110,000 doses of quadrivalent HPV vaccine, Gardasil® based on the high cervical cancer disease burden. There was enough vaccine to vaccinate all girls aged 9-12 years (30,338 girls) with a three-dose schedule, but not all girls received three doses of the vaccine. This means those girls that received reduced doses may not be fully protected against the HPV genotypes present in the Gardasil®. While HPV vaccines are highly immunogenic and efficacious in the licensed three-dose schedule, there is limited information about the effectiveness of reduced dose schedules in terms of immunogenicity and memory. There is growing evidence from other studies that two doses of HPV vaccine may be sufficient for protection. Reduced schedules would be of benefit in Fiji due to improved costs and logistics. This study will examine whether one or two doses of HPV vaccine provide similar immunological evidence of long-term protection to the standard three-dose schedule in terms of antibody titres to the genotypes present in the Gardasil®. To compare immunological memory responses between dosage groups, a dose of Cervarix ® will be administered to all girls so that the magnitude of the memory responses can be measured.

Conditions

Interventions

BIOLOGICAL

Cervarix®

All groups will received one dose of Cervarix® vaccine

Sponsors & Collaborators

  • Department of Foregin Affairs and Trade, Australia

    collaborator OTHER_GOV

  • Ministry of Health, Fiji

    collaborator OTHER_GOV

  • The Royal Women Hospital

    collaborator UNKNOWN

  • Colonial War Memorial Hospital

    collaborator UNKNOWN

  • Murdoch Childrens Research Institute

    lead OTHER

Principal Investigators

  • Edward K Mulholland · Murdoch Childrens Research Institute

Eligibility

Min Age
15 Years
Max Age
17 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • Fiji

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02276521 on ClinicalTrials.gov