HPV Vaccination Study in Postpartum Women (PPV)

Johns Hopkins University

Status and phase: Completed; Phase 4

Conditions: HPV; Human Papilloma Virus; Immunization

Treatments: Biological: Gardasil9

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04274153

IRB00227941

Details and patient eligibility

About

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.

Full 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.

Enrollment: 225 patients

Sex: Female

Ages: 15 to 45 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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225 participants in 1 patient group

Gardasil9

Experimental group

Description:

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.

Treatment:

Biological: Gardasil9