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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

Tracking Information
First Submitted Date  ICMJE February 14, 2020
First Posted Date  ICMJE February 18, 2020
Last Update Posted Date August 5, 2020
Actual Study Start Date  ICMJE August 3, 2020
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE HPV Vaccination Study in Postpartum Women
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • HPV
  • Immunization
  • Human Papilloma Virus
Intervention  ICMJE Biological: Gardasil9
Two doses of the HPV vaccine across a 12 month period (two doses of 0.5mL).
Study Arms  ICMJE 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.
Intervention: Biological: Gardasil9
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 14, 2020)
130
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2022
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
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.
Ages  ICMJE 15 Years to 45 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jenell Coleman, MD 410-614-4496 colemj@jhmi.edu
Contact: Chailee Moss, MD 410-550-0337 cmoss10@jhmi.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04274153
Other Study ID Numbers  ICMJE IRB00227941
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Merck Sharp & Dohme Corp.
Investigators  ICMJE
Principal Investigator: Jenell Coleman, MD Johns Hopkins University
Principal Investigator: Chailee Moss, MD Johns Hopkins University
Principal Investigator: Betty Chou, MD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP