Clinical trial · Observational
Evaluation of Long Term Immunity Following HPV Vaccination
Evaluation of Long-term Immunological Responses Following Reduced Dose Quadrivalent Human Papillomavirus (HPV) Vaccine Schedules: A Phase II/III Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anogenital Warts | — | UNRESOLVED | — |
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cervarix® | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- Zero dose group
- description
- Participants that did not received any HPV vaccine previously.
- interventionNames
- Biological: Cervarix®
- label
- One dose group
- description
- Participants that received one dose of Gardasil® vaccine 5-6 years ago from a vaccination campaign.
- interventionNames
- Biological: Cervarix®
- label
- Two dose group
- description
- Participants that received two dose of Gardasil® vaccine 5-6 years ago from a vaccination campaign.
- interventionNames
- Biological: Cervarix®
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 15 Years
- Maximum age
- 17 Years
Show eligibility criteria text
Inclusion Criteria: * Girls who live in Suva and were previously vaccinated with one, two or three Gardasil® doses or were eligible but did not receive Gardasil® vaccine in the 2008/9 campaign will be eligible for the study. Exclusion Criteria: * Any participant who had anaphylaxis following a previous dose of the vaccine, anaphylaxis to any vaccine component, or possible pregnancy will be excluded from this study. * In addition, any participant whose dates of previous Gardasil® vaccination are uncertain, or has received Cervarix® vaccine previously, or has an axillary temperature greater than 38°C will be excluded from this study.
References
Publications (35)
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