Postpartum HPV Vaccination

Postpartum HPV Vaccination: Acceptability, Uptake and Immunogenicity

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.

Study Overview

• Status: Completed
• Conditions: HPV-Related Malignancy
• Intervention / Treatment: Drug: Gardasil9

• Study Type: Interventional
• Enrollment (Actual): 195
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 26 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gardasil9	Drug: Gardasil9; Gardasil 9

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uptake of the Vaccine Doses	Those that actually received the vaccine and each time point.	at baseline
Uptake of the Vaccine Doses	Those that actually received the vaccine and each time point.	at 3 months
Uptake of the Vaccine Doses	Those that actually received the vaccine and each time point.	at 6 months
Serum Titers of Vaccine-specific HPV Types	Immunogenicity	baseline and 7 months

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2019
• Primary Completion (Actual): June 1, 2020
• Study Completion (Actual): December 30, 2020

Study Registration Dates

• First Submitted: February 23, 2018
• First Submitted That Met QC Criteria: February 28, 2018
• First Posted (Actual): March 1, 2018

Study Record Updates

• Last Update Posted (Actual): October 4, 2021
• Last Update Submitted That Met QC Criteria: September 8, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 000518236

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes