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Clinical Trials/NCT03451071
NCT03451071CompletedPhase 4

Postpartum HPV Vaccination: Acceptability, Uptake and Immunogenicity

University of Alabama at Birmingham1 site in 1 country195 target enrollmentStarted: April 29, 2019Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
195
Locations
1
Primary Endpoint
Patient Indication of Willingness to Accept the Vaccine Based on Survey

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
16 Years to 26 Years (Child, Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Exclusion Criteria

  • Not provided

Arms & Interventions

Gardasil9

Experimental

Intervention: Gardasil9 (Drug)

Outcomes

Primary Outcomes

Patient Indication of Willingness to Accept the Vaccine Based on Survey

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

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

Secondary Outcomes

  • Serum Titers of Vaccine-specific HPV Types(baseline and 7 months)
  • Uptake of the Vaccine Doses(at 6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Haller Smith

Professor

University of Alabama at Birmingham

Study Sites (1)

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