9-valent HPV Vaccine in Postpartum Women

NCT04311528 | Unknown Phase 4 FDA Drug

• 1 other identifier: PP-HPV
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will evaluate the immunogenicity of the 9-valent HPV vaccine in post-partum women age 16-45.

Conditions

Human Papilloma Virus

Outcome Measures

Primary Outcomes (1)

• Geometric mean titer

  immunogenicity testing using 9-plex competitive Luminex Immuno Assay (9-plex cLIA)

  Day 0, Month 7 and Month 12

Interventions

9-valent HPV vaccine BIOLOGICAL

9-valent HPV vaccine

Eligibility Criteria

• Age: 16 Years - 45 Years
• Gender Eligibility Details: study is specifically to test the immunogenicity of postpartum women, therefore, only females will be eligible to participate
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Augusta University: lead

Central Study Contacts

Angela Goebel, BS

CONTACT

706-721-8944; agoebel@augusta.edu

Daron Ferris, MD

CONTACT

706-721-2535; dferris@augusta.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: open label; all subjects will receive the 9-valent HPV vaccine

Study Record Dates

• First Submitted: March 11, 2020
• First Posted: March 17, 2020
• Study Start: April 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: March 17, 2020

Record last verified: 2020-03