Spots Global Cancer Trial Database for HPV Vaccination Study in Postpartum Women

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Trial Identification

Brief Title: HPV Vaccination Study in Postpartum Women

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

Study ID: NCT04274153

Conditions

HPV

Immunization

Human Papilloma Virus

Interventions

Gardasil9

Study Description

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.