HPV Vaccination Study in Postpartum Women

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.

Timeline

Start

2020-08-03

Primary completion

2022-07-01

Completion

2023-02-01

Outcome

Met primary endpoint

paper Relative to historical controls, the HPV-16 GMT ratio was 2.29 (90% CI, 2.03-2.58). PMID 38285445 ↗

paper This study suggests that immunogenicity of a 2-dose HPV vaccination regimen given 6 months apart among postpartum women was noninferior to a 3-dose regimen among young historical controls. PMID 38285445 ↗

Publications

• 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gardasil 9	Vaccine	0.5 ml	—

Indications