HPV Vaccination Study in Postpartum Women (PPV)

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

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.

Study Overview

• Status: Completed
• Conditions: HPV; Human Papilloma Virus; Immunization
• Intervention / Treatment: Biological: Gardasil9

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: Interventional
• Enrollment (Actual): 225
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins University
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins Bayview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity of a Two-dose 9-valent HPV Vaccination as Assessed by Antibody Titer	Measure the immunogenicity of a two-dose 9-valent HPV vaccination regimen in postpartum women previously unvaccinated against the HPV 16 virus. Immunogenicity will be assessed by the antibody responses. The Geometric mean titers will be measured using milli Merck units (mMU)/mL.	Up to 23 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibody Response to the Other 8 HPV Types	The antibody types that will be measured are HPV types 6, 11, 18, 31, 33, 45, 52, and 58. The milli Merck units (mMU)/mL of measure will be used to determine antibody response.	Up to 23 months
Seropositivity for HPV 16 After 1-dose	Calculate the percentage of participants that seroconverted.	After the first dose, up to 7 months
Seropositivity for HPV 16 After 2-doses	Calculate the percentage of participants that seroconverted.	After the second dose, up to 2 months
Percentage of Participants With Baseline Titers Suggestive of Natural Inoculation or Prior Vaccination to HPV 16	Running an assay to measure a participants natural inoculation or prior vaccination before administration of the 1st dose.	Baseline
Percentage of Participants Who Complete 2-dose Vaccination	Calculate the amount of participants that complete 2-dose vaccination.	At the end of the study, up to 2 years

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Jenell Coleman, MD, Johns Hopkins University; Principal Investigator: Chailee Moss, MD, Johns Hopkins University; Principal Investigator: Betty Chou, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2020
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: February 14, 2020
• First Submitted That Met QC Criteria: February 14, 2020
• First Posted (Actual): February 18, 2020

Study Record Updates

• Last Update Posted (Actual): August 29, 2023
• Last Update Submitted That Met QC Criteria: August 7, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Human Papilloma Virus; HPV; Immunization
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Papilloma
• Other Study ID Numbers: IRB00227941

Drug and device information, study documents

• 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