NCT04274153

HPV Vaccination Study in Postpartum Women

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 225 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: Female
• Age: 15 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• HPV
• Immunization
• Human Papilloma Virus

Interventions

Type	Name	Description
BIOLOGICAL	Gardasil9	Two doses of the HPV vaccine across a 12 month period (two doses of 0.5mL).

Timeline

• Start date: 2020-08-03
• Primary completion: 2022-07-01
• Completion: 2023-02-01
• First posted: 2020-02-18
• Last updated: 2023-08-29
• Results posted: 2023-08-29

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study