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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IM Bivalent HPV vaccine | Experimental | One-fifth fractional dose (0.1 ml) of bivalent HPV vaccine administered intramuscularly |
|
| ID Bivalent HPV vaccine | Experimental | One-fifth fractional dose (0.1 ml) of bivalent HPV vaccine administered subcutaneously |
|
| IM Nonavalent HPV vaccine | Experimental | One-fifth fractional dose (0.1 ml) of nonavalent HPV vaccine administered intramuscularly |
|
| ID Nonavalent HPV vaccine | Experimental | One-fifth fractional dose (0.1 ml) of nonavalent HPV vaccine administered subcutaneously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HPV vaccine | Biological | One-fifth dose bivalent HPV Vaccine or One-fifth dose nonavalent HPV Vaccine |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helen Stankiewicz Karita, MD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington Virology Research Clinic | Seattle | Washington | 98104 | United States |
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| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D053918 | Papillomavirus Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |