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This study will evaluate the immunogenicity of the 9-valent HPV vaccine in post-partum women age 16-45.
Women age 16-45 who are pregnant or who have just delivered will be eligible to participate in a study involving the 9-valent HPV vaccine. For clarification, women who are pregnant are eligible to sign consent, but the first vaccine will not occur until after delivery. Vaccine # 1 must occur within seven days of delivery.
The main objective of the study is to determine the immunogenicity of the vaccine in postpartum women. The immunogenicity results will be compared to that of non-postpartum women of the same age, 16-45.
Women will participate for approximately 12 months and will complete a total of 4 visits during that time frame.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 9-valent HPV vaccine | Biological | 9-valent HPV vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean titer | immunogenicity testing using 9-plex competitive Luminex Immuno Assay (9-plex cLIA) | Day 0, Month 7 and Month 12 |
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Inclusion Criteria:
Exclusion Criteria:
study is specifically to test the immunogenicity of postpartum women, therefore, only females will be eligible to participate
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Angela Goebel, BS | Contact | 706-721-8944 | agoebel@augusta.edu | |
| Daron Ferris, MD | Contact | 706-721-2535 | dferris@augusta.edu |
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open label; all subjects will receive the 9-valent HPV vaccine
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