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HPV Vaccination Study in Postpartum Women (PPV)

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ClinicalTrials.gov Identifier: NCT04274153
Recruitment Status : Recruiting
First Posted : February 18, 2020
Last Update Posted : August 5, 2020
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
The human papillomavirus (HPV) is the most common sexually transmitted infection (STI) in the United States (U.S.) and is responsible for a wide range of conditions, including cancers within the anogenital tract and the oropharynx. In just the U.S. alone, it's estimated that HPV causes 330,000 cases of precancerous cervical dysplasia and 12,000 cases of cervical cancer. The investigators propose a 2-dose HPV vaccination study in women seeking postpartum care at Johns Hopkins University. The investigators will measure the immunogenicity and acceptability of the vaccine in the postpartum setting.

Condition or disease Intervention/treatment Phase
HPV Immunization Human Papilloma Virus Biological: Gardasil9 Phase 4

Detailed Description:
This is a pilot, non-inferiority clinical trial using historical controls. Participants will have whole blood drawn at 0 months, 6 months, and 7 months and receive the HPV vaccine at 0 months, 6 months, and 12 months. Each blood draw will consist of one 15mL red top tube to measure HPV serologies and hormone levels. All blood samples collected will be analyzed at the end of the study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Pilot Study of the Immunogenicity of a Two-dose Protocol for 9-valent Human Papilloma Virus Vaccination in Postpartum Girls and Women (15-45 Years Old) Previously Unvaccinated Against HPV
Actual Study Start Date : August 3, 2020
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Postpartum Care

Arm Intervention/treatment
Experimental: Gardasil9
Two doses of the 9-valent HPV vaccine to be administered to participants at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.
Biological: Gardasil9
Two doses of the HPV vaccine across a 12 month period (two doses of 0.5mL).




Primary Outcome Measures :
  1. Immunogenicity of a two-dose 9-valent HPV vaccination as assessed by antibody titer [ Time Frame: At the end of the study, up to 2 years ]
    Measure the immunogenicity of a two-dose 9-valent HPV vaccination regimen in postpartum women previously unvaccinated against the HPV virus. Immunogenicity will be assessed by the antibody responses. Antibody titers will be measured using the Geometric mean titer (GMT) ratio for each HPV type between the 2-dose and the 3-dose historical controls. The Geometric mean titers will be measured using milli Merck units (mMU)/mL.


Secondary Outcome Measures :
  1. Antibody response to the other HPV types [ Time Frame: At the end of the study, up to 2 years ]

    The antibody types that will be measured are HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58.

    The milli Merck units (mMU)/mL of measure will be used to determine antibody response.


  2. Seropositivity for each HPV type after 1-dose [ Time Frame: At the end of the study, up to 2 years ]
    Calculate the percentage of participants that seroconverted and determine if hormone levels are associated with seropositivity and GMTs. This will be measured by milli Merck units (mMU)/mL.

  3. Seropositivity for each HPV type after 2-doses [ Time Frame: At the end of the study, up to 2 years ]
    Calculate the percentage of participants that seroconverted and determine if hormone levels are associated with seropositivity and GMTs. This will be measured by milli Merck units (mMU)/mL.

  4. Percentage of participants with baseline titers suggestive of natural inoculation or prior vaccination [ Time Frame: At the end of the study, up to 2 years ]
    Running an assay to measure a participants natural inoculation or prior vaccination before administration of the 1st dose.

  5. Percentage of participants who complete 1-dose, 2-dose, or 3-dose vaccination [ Time Frame: At the end of the study, up to 2 years ]
    Calculate the amount of participants that complete 1-dose, 2-dose, or 3- dose vaccination.



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Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women seeking postpartum care at Johns Hopkins University who self-report never receiving an HPV vaccination.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participants biologically born as females between the ages of 15 through 45 who have delivered a live born baby within the past 72 hours.

Exclusion Criteria:

  • Pregnancy
  • Severe allergic reaction to vaccine components
  • Prior receipt of an HPV vaccine dose
  • Fetal demise or stillbirth
  • Allergy to latex or yeast
  • Moderate or severe acute illness (deemed by the investigator to exclude)
  • Immunosuppression (e.g., HIV, solid organ transplant).

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): NCT04274153


Contacts
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Contact: Jenell Coleman, MD 410-614-4496 colemj@jhmi.edu
Contact: Chailee Moss, MD 410-550-0337 cmoss10@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21205
Contact: Jenell Coleman, MD    410-614-4496    colemanj@jhmi.edu   
Contact: Chailee Moss, MD    410-550-0337    cmoss10@jhmi.edu   
Principal Investigator: Jenell Coleman, MD         
Principal Investigator: Chailee Moss, MD         
Sub-Investigator: Betty Chou, MD         
Johns Hopkins Bayview Medical Center Recruiting
Baltimore, Maryland, United States, 21224
Contact: Chailee Moss, MD    410-550-0337    cmoss10@jhmi.edu   
Contact: Jenell Coleman, MD    410-614-4496    colemanj@jhmi.edu   
Principal Investigator: Jenell Coleman, MD         
Sub-Investigator: Chailee Moss, MD         
Sub-Investigator: Betty Chou, MD         
Sponsors and Collaborators
Johns Hopkins University
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Jenell Coleman, MD Johns Hopkins University
Principal Investigator: Chailee Moss, MD Johns Hopkins University
Principal Investigator: Betty Chou, MD Johns Hopkins University
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT04274153    
Other Study ID Numbers: IRB00227941
First Posted: February 18, 2020    Key Record Dates
Last Update Posted: August 5, 2020
Last Verified: August 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
Keywords provided by Johns Hopkins University:
Human Papilloma Virus
HPV
Immunization
Additional relevant MeSH terms:
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Papilloma
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms