Postpartum HPV Vaccination

HPV-Related Malignancy Clinical Trial

Official title:

Postpartum HPV Vaccination: Acceptability, Uptake and Immunogenicity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03451071
• Other study ID #: 000518236
• Status: Completed
• Phase: Phase 4
• Start date: April 29, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: September 2021
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 195
• Est. completion date: December 30, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 26 Years

Eligibility

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

Related Conditions & MeSH terms

• HPV-Related Malignancy
• Neoplasms

Intervention

Drug:
• Gardasil9
Gardasil 9

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Uptake of the Vaccine Doses	Those that actually received the vaccine and each time point.	at baseline
Secondary	Uptake of the Vaccine Doses	Those that actually received the vaccine and each time point.	at 3 months
Secondary	Uptake of the Vaccine Doses	Those that actually received the vaccine and each time point.	at 6 months
Secondary	Serum Titers of Vaccine-specific HPV Types	Immunogenicity	baseline and 7 months