NCT03451071

Postpartum HPV Vaccination

Postpartum HPV Vaccination: Acceptability, Uptake and Immunogenicity

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 195 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: Female
• Age: 16 Years – 26 Years
• Healthy volunteers: Not accepted

Summary

Human papillomavirus (HPV)-related cancers are on the rise in the United States. Furthermore, greater than 90% of cervical cancer cases are attributable to HPV, and cervical cancer disproportionately affects women of color in both incidence and mortality. Due to low HPV vaccine uptake in the US, innovative approaches to vaccinating vulnerable populations are necessary in order to maximize the cancer prevention potential of this vaccine. The puerperium is a time period when women are engaged in the healthcare system and have almost universal access to affordable health care. Two prior studies have shown that postpartum HPV vaccination is acceptable to patients, and high rates of vaccination were achieved in these primarily Hispanic populations. However, data show that the immune response in young women is less robust than in adolescents, and no studies have examined immunogenicity in postpartum women specifically. We propose an HPV vaccination pilot study in women who receive postpartum care at University of Alabama at Birmingham (UAB) hospital. We will examine the acceptability, uptake and immunogenicity of the vaccine in the postpartum setting.

Conditions

• HPV-Related Malignancy

Interventions

Type	Name	Description
DRUG	Gardasil9	Gardasil 9

Timeline

• Start date: 2019-04-29
• Primary completion: 2020-06-01
• Completion: 2020-12-30
• First posted: 2018-03-01
• Last updated: 2021-10-04
• Results posted: 2021-10-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study