HPV Vaccination Study in Postpartum Women

Human Papilloma Virus Clinical Trial

— PPV  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04274153
• Other study ID #: IRB00227941
• Status: Completed
• Phase: Phase 4
• Start date: August 3, 2020
• Est. completion date: February 1, 2023

Study information

• Verified date: August 2023
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: February 1, 2023
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 45 Years

Eligibility

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).

Related Conditions & MeSH terms

• HPV
• Human Papilloma Virus
• Immunization
• Papilloma

Intervention

Biological:
• Gardasil9
Two doses of the HPV vaccine across a 12 month period (two doses of 0.5mL).

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 23 months
Secondary	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.	Up to 23 months
Secondary	Seropositivity for HPV 16 After 1-dose	Calculate the percentage of participants that seroconverted.	After the first dose, up to 7 months
Secondary	Seropositivity for HPV 16 After 2-doses	Calculate the percentage of participants that seroconverted.	After the second dose, up to 2 months
Secondary	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.	Baseline
Secondary	Percentage of Participants Who Complete 2-dose Vaccination	Calculate the amount of participants that complete 2-dose vaccination.	At the end of the study, up to 2 years