Immunogenicity of Fractional Dose of the HPV Vaccines

Study Overview
=================
Brief Summary
-----------------
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

Official Title
-----------------
Immunogenicity of Fractional Dose of the HPV Vaccines

Conditions
-----------------
HPV Infection, HPV Vaccine

Intervention / Treatment
-----------------
* Biological: HPV vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 27 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IM Bivalent HPV vaccine<br>One-fifth fractional dose (0.1 ml) of bivalent HPV vaccine administered intramuscularly | Biological: HPV vaccine<br>* One-fifth dose bivalent HPV Vaccine or One-fifth dose nonavalent HPV Vaccine<br>|
| Experimental: ID Bivalent HPV vaccine<br>One-fifth fractional dose (0.1 ml) of bivalent HPV vaccine administered subcutaneously | Biological: HPV vaccine<br>* One-fifth dose bivalent HPV Vaccine or One-fifth dose nonavalent HPV Vaccine<br>|
| Experimental: IM Nonavalent HPV vaccine<br>One-fifth fractional dose (0.1 ml) of nonavalent HPV vaccine administered intramuscularly | Biological: HPV vaccine<br>* One-fifth dose bivalent HPV Vaccine or One-fifth dose nonavalent HPV Vaccine<br>|
| Experimental: ID Nonavalent HPV vaccine<br>One-fifth fractional dose (0.1 ml) of nonavalent HPV vaccine administered subcutaneously | Biological: HPV vaccine<br>* One-fifth dose bivalent HPV Vaccine or One-fifth dose nonavalent HPV Vaccine<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HPV antibody detection after intradermal or intramuscular, fractional one-fifth dose HPV-2 or HPV-9 vaccine immunization | To describe the changes in vaccine-type HPV antibody detection measured by Luminex assay between baseline and 12 months after vaccination. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HPV, vaccines