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Postpartum HPV Vaccination

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: NCT03451071
Recruitment Status : Recruiting
First Posted : March 1, 2018
Last Update Posted : March 26, 2020
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Warner Huh, University of Alabama at Birmingham

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 Phase
HPV-Related Malignancy Drug: Gardasil9 Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Postpartum HPV Vaccination: Acceptability, Uptake and Immunogenicity
Actual Study Start Date : April 29, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Postpartum Care

Arm Intervention/treatment
Experimental: Gardasil9 Drug: Gardasil9
Gardasil 9




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



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Ages Eligible for Study:   16 Years to 26 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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
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Contact: Haller Smith, MD 2059344986 hjsmith@uabmc.edu
Contact: Sarah Dilley, MD sdilley@uabmc.edu

Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Haller Smith, MD    205-934-4986    hjsmith@uab.edu   
Sponsors and Collaborators
University of Alabama at Birmingham
Merck Sharp & Dohme Corp.
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Responsible Party: Warner Huh, Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03451071    
Other Study ID Numbers: 000518236
First Posted: March 1, 2018    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Neoplasms