Postpartum HPV Vaccination

Phase 4

Completed

• Conditions: HPV-Related Malignancy
• Interventions: Drug: Gardasil9

• Registration Number: NCT03451071
• Lead Sponsor: University of Alabama at Birmingham

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-23
• Study First Submitted QC: 2018-02-28
• Study First Posted: 2018-03-01
• Study Start: 2019-04-29
• Primary Completion: 2020-06-01
• Study Completion: 2020-12-30
• Status Verified: 2021-09
• Results First Submitted: 2021-09-08
• Results First Submitted QC: 2021-09-08
• Last Update Submitted: 2021-09-08
• Results First Posted: 2021-10-04
• Last Update Posted: 2021-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 195

Inclusion Criteria

• postpartum day 0-4 after vaginal or Cesarean delivery at UAB hospital

Exclusion criteria

• Fetal demise or miscarriage, autoimmune disorder, HIV, Hepatitis B/C, chronic steroid use, preeclampsia, non-English speaking

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gardasil9	Gardasil9	-

Primary Outcome Measures

Name	Time	Method
Patient Indication of Willingness to Accept the Vaccine Based on Survey	1 day (at the time of initial recruitment /survey)	This was established using a survey to indicate willingness to receive vaccine.

Secondary Outcome Measures

Name	Time	Method
Serum Titers of Vaccine-specific HPV Types	baseline and 7 months	Immunogenicity
Uptake of the Vaccine Doses	at 6 months	Those that actually received the vaccine and each time point.

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States