Skip to main content
OpenTrials
Completed

NCT Number: NCT04274153

HPV Vaccination Study in Postpartum Women

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HPV Human Papilloma Virus Immunization

Age range

15 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Johns Hopkins Bayview Medical Center, Baltimore, Maryland, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Gardasil9

Biological

Two doses of the HPV vaccine across a 12 month period (two doses of 0.5mL).

Primary outcomes

  1. Immunogenicity of a Two-dose 9-valent HPV Vaccination as Assessed by Antibody Titer

    Time frame: Up to 23 months

    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.

Secondary outcomes

  1. Antibody Response to the Other 8 HPV Types

    Time frame: Up to 23 months

    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.

  2. Seropositivity for HPV 16 After 1-dose

    Time frame: After the first dose, up to 7 months

    Calculate the percentage of participants that seroconverted.

  3. Seropositivity for HPV 16 After 2-doses

    Time frame: After the second dose, up to 2 months

    Calculate the percentage of participants that seroconverted.

  4. Percentage of Participants With Baseline Titers Suggestive of Natural Inoculation or Prior Vaccination to HPV 16

    Time frame: Baseline

    Running an assay to measure a participants natural inoculation or prior vaccination before administration of the 1st dose.

  5. Percentage of Participants Who Complete 2-dose Vaccination

    Time frame: At the end of the study, up to 2 years

    Calculate the amount of participants that complete 2-dose vaccination.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study 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

Acronym: PPV

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Feb 18, 2020
Registry last updated
Aug 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.