Clinical trial · Interventional
Intradermal, Fractional Dose of HPV Vaccines:
Immunogenicity of Fractional Dose of the Bivalent and Nonavalent Intradermal HPV Vaccines.
NCT04235257CI-TRIAL-00110480active not recruitingPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This randomized phase IV trial compares fractional dose of bivalent HPV vaccine to fractional dose of nonavalent HPV vaccine among men and women aged 27-45 years in Seattle, Washington. Participants will have immune response assessed at baseline, 4 weeks, 6 months, 12 months, and 24 months.
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 |
|---|---|---|---|
| HPV Infection | — | UNRESOLVED | — |
| HPV Vaccine | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HPV vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Bivalent HPV vaccine
- description
- One-fifth fractional dose (0.1 ml) of bivalent HPV vaccine administered subcutaneously
- interventionNames
- Biological: HPV vaccine
- type
- EXPERIMENTAL
- label
- Nonavalent HPV vaccine
- description
- One-fifth fractional dose (0.1 ml) of nonavalent HPV vaccine administered subcutaneously
- interventionNames
- Biological: HPV vaccine
Primary outcomes (1)
- measure
- HPV antibody detection after fractional HPV vaccination
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 27 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Age 27-45 years at enrollment * Not intending to receive the HPV vaccine series for the duration of the study participation * Willing and able to provide written informed consent, undergo clinical evaluation, and adhere to follow-up schedule Exclusion Criteria: * Prior immunization with HPV-vaccine (Cervarix, Gardasil-4, Gardasil-9) * Currently pregnant or breastfeeding * Immune deficiency or other immune disorder * HIV infection or continued high risk for HIV; patients at risk for HIV who do not have a negative HIV test in the last 6 months will be excluded * Cancer or chemotherapy (current, within 6 months, or anticipated in the future) except for fully excised non-melanoma skin cancer) * Unstable medical condition (e.g., malignant hypertension, poorly controlled diabetes, * Known allergy to vaccine components * Prior history of HPV-associated cancer
References
Publications (0)
Data not yet available
No reference posted for this study.