Postpartum HPV Vaccination

The University of Alabama at Birmingham

Status and phase: Completed; Phase 4

Conditions: HPV-Related Malignancy

Treatments: Drug: Gardasil9

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03451071

000518236

Details and patient eligibility

About

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.

Enrollment: 195 patients

Sex: Female

Ages: 16 to 26 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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195 participants in 1 patient group

Gardasil9

Experimental group

Treatment:

Drug: Gardasil9