HPV Vaccination Study in Postpartum Women

Phase 4

Completed

• Conditions: HPV; Immunization; Human Papilloma Virus
• Interventions: Biological: Gardasil9

• Registration Number: NCT04274153
• Lead Sponsor: Johns Hopkins University

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.

Study Timeline

• Study First Submitted: 2020-02-14
• Study First Submitted QC: 2020-02-14
• Study First Posted: 2020-02-18
• Study Start: 2020-08-03
• Primary Completion: 2022-07-01
• Study Completion: 2023-02-01
• Disposition First Submitted: 2023-06-02
• Results First Submitted: 2023-07-12
• Status Verified: 2023-08
• Results First Submitted QC: 2023-08-07
• Last Update Submitted: 2023-08-07
• Results First Posted: 2023-08-29
• Disposition First Posted: 2023-08-29
• Last Update Posted: 2023-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 225

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gardasil9	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.

Primary Outcome Measures

Name	Time	Method
Immunogenicity of a Two-dose 9-valent HPV Vaccination as Assessed by Antibody Titer	Up to 23 months	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.

Secondary Outcome Measures

Name	Time	Method
Seropositivity for HPV 16 After 1-dose	After the first dose, up to 7 months	Calculate the percentage of participants that seroconverted.
Antibody Response to the Other 8 HPV Types	Up to 23 months	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.
Percentage of Participants Who Complete 2-dose Vaccination	At the end of the study, up to 2 years	Calculate the amount of participants that complete 2-dose vaccination.
Seropositivity for HPV 16 After 2-doses	After the second dose, up to 2 months	Calculate the percentage of participants that seroconverted.
Percentage of Participants With Baseline Titers Suggestive of Natural Inoculation or Prior Vaccination to HPV 16	Baseline	Running an assay to measure a participants natural inoculation or prior vaccination before administration of the 1st dose.

Trial Locations

Locations (2)

Johns Hopkins Bayview Medical Center; 🇺🇸 Baltimore, Maryland, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States