Human Papilloma Virus
Conditions
Brief summary
This study will evaluate the immunogenicity of the 9-valent HPV vaccine in post-partum women age 16-45.
Detailed description
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.
Interventions
BIOLOGICAL9-valent HPV vaccine
9-valent HPV vaccine
Sponsors
Augusta University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
open label; all subjects will receive the 9-valent HPV vaccine
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Female between the ages of 16 and 45 years of age at enrollment * Postpartum (Day 1 vaccination to occur within 1 week of delivery) * Judged to be in good health on the basis of medical history and physical examination * Able to fully understand study procedures, alternative treatments available, the risks involved in the study and voluntarily agrees to participate by giving written informed consent * Able to read, understand, and complete the questionnaires
Exclusion criteria
* Has a known allergy to any vaccine component, including aluminum, yeast, or BENZONASE™ * Has thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections * Is currently immunocompromised or has been diagnosed as having a congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition. * Is receiving or has received in the year prior to enrollment the following immunosuppressive therapies: radiation therapy, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin, leflunomide, TNF-α antagonists, monoclonal antibody therapies (including rituximab), intravenous gamma globulin (IVIG), antilymphocyte sera, or other therapy known to interfere with the immune response. With regard to systemic corticosteroids, a subject will be excluded if she is currently receiving steroid therapy, has recently (within 2 weeks of enrollment) received such therapy, or has received 2 or more courses of high dose corticosteroids (orally or parenterally) lasting at least 1 week in duration in the year prior to enrollment. The use of inhaled, nasal, or topical steroids are considered eligible for the study * Has received any immune globulin product (including RhoGAM™) or other blood- derived product within 3 months prior to Day 1 vaccination or plans to receive such product during the study * Has received a marketed HPV vaccine * Has had a fever of \> 100° within 24-hour period prior to the Day 1 vaccination
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric mean titer | Day 0, Month 7 and Month 12 | immunogenicity testing using 9-plex competitive Luminex Immuno Assay (9-plex cLIA) |
Contacts
Primary ContactAngela Goebel, BS
Backup ContactDaron Ferris, MD
Outcome results
None listed