9-valent HPV Vaccine in Postpartum Women

Phase 4

• Conditions: Human Papilloma Virus

• Registration Number: NCT04311528
• Lead Sponsor: Augusta University

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.

Study Timeline

• Status Verified: 2020-03
• Study First Submitted: 2020-03-11
• Study First Submitted QC: 2020-03-13
• Last Update Submitted: 2020-03-13
• Study First Posted: 2020-03-17
• Last Update Posted: 2020-03-17
• Study Start: 2020-04-01
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Geometric mean titer	Day 0, Month 7 and Month 12	immunogenicity testing using 9-plex competitive Luminex Immuno Assay (9-plex cLIA)