Back to results9-valent HPV Vaccine in Postpartum Women
Primary Purpose
Human Papilloma Virus
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
9-valent HPV vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Human Papilloma Virus
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Geometric mean titer
immunogenicity testing using 9-plex competitive Luminex Immuno Assay (9-plex cLIA)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04311528
Brief Title
9-valent HPV Vaccine in Postpartum Women
Official Title
Immunogenicity, Compliance, Knowledge and Attitudes in Postpartum Women During a Two Dose 9-valent HPV Vaccination Series
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2020 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Augusta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Papilloma Virus
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
open label; all subjects will receive the 9-valent HPV vaccine
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
9-valent HPV vaccine
Intervention Description
9-valent HPV vaccine
Primary Outcome Measure Information:
Title
Geometric mean titer
Description
immunogenicity testing using 9-plex competitive Luminex Immuno Assay (9-plex cLIA)
Time Frame
Day 0, Month 7 and Month 12
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
study is specifically to test the immunogenicity of postpartum women, therefore, only females will be eligible to participate
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angela Goebel, BS
Phone
706-721-8944
Email
agoebel@augusta.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Daron Ferris, MD
Phone
706-721-2535
Email
dferris@augusta.edu
12. IPD Sharing Statement
Learn more about this trial
9-valent HPV Vaccine in Postpartum Women
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