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Postpartum HPV Vaccination

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ClinicalTrials.gov Identifier: NCT03451071
Recruitment Status : Not yet recruiting
First Posted : March 1, 2018
Last Update Posted : October 26, 2018
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Warner Huh, University of Alabama at Birmingham

Study Description
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Brief Summary:
Human papillomavirus (HPV)-related cancers are on the rise in the United States. Furthermore, greater than 90% of cervical cancer cases are attributable to HPV, and cervical cancer disproportionately affects women of color in both incidence and mortality. Due to low HPV vaccine uptake in the US, innovative approaches to vaccinating vulnerable populations are necessary in order to maximize the cancer prevention potential of this vaccine. The puerperium is a time period when women are engaged in the healthcare system and have almost universal access to affordable health care. Two prior studies have shown that postpartum HPV vaccination is acceptable to patients, and high rates of vaccination were achieved in these primarily Hispanic populations. However, data show that the immune response in young women is less robust than in adolescents, and no studies have examined immunogenicity in postpartum women specifically. We propose an HPV vaccination pilot study in women who receive postpartum care at University of Alabama at Birmingham (UAB) hospital. We will examine the acceptability, uptake and immunogenicity of the vaccine in the postpartum setting.

Condition or disease Intervention/treatment
HPV-Related Malignancy Drug: Gardasil9

Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Postpartum HPV Vaccination: Acceptability, Uptake and Immunogenicity
Estimated Study Start Date : November 15, 2018
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Postpartum Care

Groups and Cohorts
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Intervention Details:
  • Drug: Gardasil9
    Gardasil 9

Outcome Measures
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Primary Outcome Measures :
  1. Patient indication of willingness to accept the vaccine based on survey [ Time Frame: 1 day (at the time of initial recruitment /survey) ]

Secondary Outcome Measures :
  1. Uptake of the vaccine doses [ Time Frame: at 0, 2-3 and 6 months ]
    Uptake

  2. serum titers of vaccine-specific HPV types [ Time Frame: baseline and 7 months ]
    Immunogenicity


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 26 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
postpartum women age 16-26 who have delivered a liveborn infant at UAB hospital
Criteria

Inclusion Criteria:

  • postpartum day 0-4 after vaginal or Cesarean delivery at UAB hospital

Exclusion criteria

  • Fetal demise or miscarriage, autoimmune disorder, HIV, Hepatitis B/C, chronic steroid use, preeclampsia, non-English speaking
Contacts and Locations
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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): NCT03451071


Contacts
Contact: Sarah Dilley, MD 205-934-2749 sdilley@uabmc.edu

Sponsors and Collaborators
University of Alabama at Birmingham
Merck Sharp & Dohme Corp.
More Information
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Responsible Party: Warner Huh, Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03451071     History of Changes
Other Study ID Numbers: 000518236
First Posted: March 1, 2018    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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