HPV Vaccination Study in Postpartum Women

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-03

Study Completion Date

2023-02-01

Brief Summary

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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.

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Detailed Description

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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

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HPV Immunization Human Papilloma Virus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Gardasil9

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.

Group Type EXPERIMENTAL

Gardasil9

Intervention Type BIOLOGICAL

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

Interventions

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Gardasil9

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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).

Minimum Eligible Age

15 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes