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Phase 4 N=56 Health Services Research

Postpartum HPV Vaccination

HPV-Related Malignancy

Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcome: Primary: Patient Indication of Willingness to Accept the Vaccine Based on Survey — 56 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Gardasil9 (Drug)
Age
Pediatric, Adult · 16+ yrs
Sex
Female
Sponsor
University of Alabama at Birmingham
Primary completion
Jun 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
Patient Indication of Willingness to Accept the Vaccine Based on Survey
56
SECONDARY
Uptake of the Vaccine Doses
14
SECONDARY
Uptake of the Vaccine Doses
14
SECONDARY
Uptake of the Vaccine Doses
14
SECONDARY
Serum Titers of Vaccine-specific HPV Types

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03451071). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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