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9-valent HPV Vaccine in Postpartum Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04311528
Recruitment Status : Not yet recruiting
First Posted : March 17, 2020
Last Update Posted : March 17, 2020
Sponsor:
Information provided by (Responsible Party):
Augusta University

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

Condition or disease Intervention/treatment Phase
Human Papilloma Virus Biological: 9-valent HPV vaccine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: open label; all subjects will receive the 9-valent HPV vaccine
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Immunogenicity, Compliance, Knowledge and Attitudes in Postpartum Women During a Two Dose 9-valent HPV Vaccination Series
Estimated Study Start Date : April 1, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Postpartum Care


Intervention Details:
  • Biological: 9-valent HPV vaccine
    9-valent HPV vaccine


Primary Outcome Measures :
  1. Geometric mean titer [ Time Frame: Day 0, Month 7 and Month 12 ]
    immunogenicity testing using 9-plex competitive Luminex Immuno Assay (9-plex cLIA)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   study is specifically to test the immunogenicity of postpartum women, therefore, only females will be eligible to participate
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04311528


Contacts
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Contact: Angela Goebel, BS 706-721-8944 agoebel@augusta.edu
Contact: Daron Ferris, MD 706-721-2535 dferris@augusta.edu

Sponsors and Collaborators
Augusta University
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Responsible Party: Augusta University
ClinicalTrials.gov Identifier: NCT04311528    
Other Study ID Numbers: PP-HPV
First Posted: March 17, 2020    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020

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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
Additional relevant MeSH terms:
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Papilloma
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms