HPV Vaccination Study in Postpartum Women

Johns Hopkins University225 enrolled

Overview

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.

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

Allocation

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

225

Conditions

HPV Immunization Human Papilloma Virus

Eligibility

Sex: FEMALEMin age: 15 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

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.

Time frame: Up to 23 months

Secondary Outcomes

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.

Time frame: Up to 23 months

Seropositivity for HPV 16 After 1-dose

Calculate the percentage of participants that seroconverted.

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

Seropositivity for HPV 16 After 2-doses

Calculate the percentage of participants that seroconverted.

Time frame: 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.

Time frame: Baseline

Percentage of Participants Who Complete 2-dose Vaccination

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

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