Postpartum HPV Vaccination

NCT03451071 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 000518236
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

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.

Conditions

HPV-Related Malignancy

Outcome Measures

Primary Outcomes (1)

• Patient Indication of Willingness to Accept the Vaccine Based on Survey

  This was established using a survey to indicate willingness to receive vaccine.

  1 day (at the time of initial recruitment /survey)

Secondary Outcomes (4)

• Uptake of the Vaccine Doses

  at baseline

• Uptake of the Vaccine Doses

  at 3 months

• Uptake of the Vaccine Doses

  at 6 months

• Serum Titers of Vaccine-specific HPV Types

  baseline and 7 months

Study Arms (1)

Gardasil9

EXPERIMENTAL

Drug: Gardasil9

Interventions

Gardasil9 DRUG

Gardasil 9

Gardasil9

Eligibility Criteria

• Age: 16 Years - 26 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Results Point of Contact

• Title: Haller Smith
• Organization: University of Alabama at Birmingham

hjsmith@uabmc.edu

205-934-4986

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: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 23, 2018
• First Posted: March 1, 2018
• Study Start: April 29, 2019
• Primary Completion: June 1, 2020
• Study Completion: December 30, 2020
• Last Updated: October 4, 2021
• Results First Posted: October 4, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)