HPV Vaccination Study in Postpartum Women

NCT04274153 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IRB00227941
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 2

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.

Conditions

HPV; Immunization; Human Papilloma Virus

Keywords

Human Papilloma Virus; HPV; Immunization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Antibody Response to the Other 8 HPV Types

  Up to 23 months

• Seropositivity for HPV 16 After 1-dose

  After the first dose, up to 7 months

• Seropositivity for HPV 16 After 2-doses

  After the second dose, up to 2 months

• Percentage of Participants With Baseline Titers Suggestive of Natural Inoculation or Prior Vaccination to HPV 16

  Baseline

• Percentage of Participants Who Complete 2-dose Vaccination

  At the end of the study, up to 2 years

Study Arms (1)

Gardasil9

EXPERIMENTAL

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.

Biological: Gardasil9

Interventions

Gardasil9 BIOLOGICAL

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

Gardasil9

Eligibility Criteria

• Age: 15 Years - 45 Years
• Gender Eligibility Details: Women seeking postpartum care at Johns Hopkins University who self-report never receiving an HPV vaccination.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Participants biologically born as females between the ages of 15 through 45 who have delivered a live born baby within the past 72 hours.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Johns Hopkins University: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (2)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Related Publications (1)

• Moss CF, Wang R, Sao S, Chou B, Perin J, Lander ME, Thaker SM, Mann M, Coleman JS. Immunogenicity of 2-Dose HPV Vaccine Series for Postpartum Women: An Open-Label, Nonrandomized, Noninferiority Trial. JAMA Netw Open. 2024 Jan 2;7(1):e2352996. doi: 10.1001/jamanetworkopen.2023.52996.

  PMID: 38285445 DERIVED

Results Point of Contact

• Title: Dr. Jenell Coleman
• Organization: Johns Hopkins SOM Department of GYN/OB

colemanj@jhmi.edu

(410)614-9178

Study Officials

• Jenell Coleman, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Chailee Moss, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Betty Chou, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: February 18, 2020
• Study Start: August 3, 2020
• Primary Completion: July 1, 2022
• Study Completion: February 1, 2023
• Last Updated: August 29, 2023
• Results First Posted: August 29, 2023

Record last verified: 2023-08

Locations

US (2)