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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
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This study will assess the immunogenicity of one dose of Gardasil and one dose of Gardasil-9
This is a one group exploratory study.
The main objective of this study is to assess the persistance of anti-HPV after a single dose Gardasil and the effect of one dose of Gardasil-9 when administered 3-8 years later.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gardasil and Gardasil-9 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gardasil and Gardasil-9 | Biological | All subjects will receive one dose of Gardasil-9. Blodd samples for serological testing will be collected just before and one month post Gardasil-9 administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HPV seropositivity | Seropositivity to 9 HPV types included in Gardasil-9 vaccine will be assessed. | One month post vaccine administration. |
| Measure | Description | Time Frame |
|---|---|---|
| HPV antibody titers | Geometrical mean titers of antibodies to 9 HPV types included in Gardasil-9 vaccine will be assessed | One month post vaccine administration |
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Inclusion Criteria: Have received a single dose of Gardasil 3-8 years before recruitement.
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Exclusion Criteria: Immunossupressed or blood coagulation problems
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Based on self-representation of gender identity
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| Name | Affiliation | Role |
|---|---|---|
| Gaston DeSerres, MD, PhD | Quebec Public Health Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laval University Research Hospital Center | Québec | G1E7G9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40664165 | Derived | Guzun N, Ouakki M, Panicker G, Ionescu IG, Mayrand MH, Unger ER, Sauvageau C. Immune response after one dose of HPV vaccine among girls and boys and the impact of a second dose given after 3 or more years. Vaccine. 2025 Aug 30;62:127475. doi: 10.1016/j.vaccine.2025.127475. Epub 2025 Jul 14. | |
| 31017850 | Derived |
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| ID | Term |
|---|---|
| D000068857 | Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 |
| ID | Term |
|---|---|
| D017778 | Vaccines, Combined |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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Single group exploratory study
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| Gilca V, Sauvageau C, Panicker G, De Serres G, Schiller J, Ouakki M, Unger ER. Long intervals between two doses of HPV vaccines and magnitude of the immune response: a post hoc analysis of two clinical trials. Hum Vaccin Immunother. 2019;15(7-8):1980-1985. doi: 10.1080/21645515.2019.1605278. Epub 2019 Jun 3. |
| D053918 |
| Papillomavirus Vaccines |
| D014765 | Viral Vaccines |