Immunogenicity of Fractional Dose of the HPV Vaccines

University of Washington

Status and phase: Active, not recruiting; Phase 4

Conditions: HPV Infection; HPV Vaccine

Treatments: Biological: HPV vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT05291871

STUDY00014983

Details and patient eligibility

About

This randomized phase IV trial compares intramuscular and intradermal 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, and 12 months

Enrollment: 92 patients

Sex: All

Ages: 27 to 45 years old

Volunteers: Accepts Healthy Volunteers

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, adhere to follow-up schedule

Exclusion criteria

• Prior immunization with HPV-vaccine (Cervarix, Gardasil-4, Gardasil-9)
• Currently pregnant or breastfeeding
• Immunedeficiency disease/condition or cancer that causes clinically significant immunosuppression
• Known HIV infection
• Chemotherapy (current or within 12 months) or currently taking a medication that causes clinically significant immunosuppression.
• Unstable medical condition (e.g., malignant hypertension, poorly controlled diabetes)
• Known allergy to vaccine components
• Prior history of HPV-associated cancer
• Any medical condition which, in the opinion of the investigator, may compromise the subject's ability to safely complete the study.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

92 participants in 4 patient groups

IM Bivalent HPV vaccine

Experimental group

Description:

One-fifth fractional dose (0.1 ml) of bivalent HPV vaccine administered intramuscularly

Treatment:

Biological: HPV vaccine

ID Bivalent HPV vaccine

Experimental group

Description:

One-fifth fractional dose (0.1 ml) of bivalent HPV vaccine administered subcutaneously

Treatment:

Biological: HPV vaccine

IM Nonavalent HPV vaccine

Experimental group

Description:

One-fifth fractional dose (0.1 ml) of nonavalent HPV vaccine administered intramuscularly

Treatment:

Biological: HPV vaccine

ID Nonavalent HPV vaccine

Experimental group

Description:

One-fifth fractional dose (0.1 ml) of nonavalent HPV vaccine administered subcutaneously

Treatment:

Biological: HPV vaccine