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OpenTrials
Completed

NCT Number: NCT03451071

Postpartum HPV Vaccination

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.

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Key information

Age range

16 year–26 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gardasil9

Drug

Gardasil 9

Primary outcomes

  1. 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

  1. Uptake of the Vaccine Doses

    Time frame: at baseline

    Those that actually received the vaccine and each time point.

  2. Uptake of the Vaccine Doses

    Time frame: at 3 months

    Those that actually received the vaccine and each time point.

  3. Uptake of the Vaccine Doses

    Time frame: at 6 months

    Those that actually received the vaccine and each time point.

  4. Serum Titers of Vaccine-specific HPV Types

    Time frame: baseline and 7 months

    Immunogenicity

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

Postpartum HPV Vaccination: Acceptability, Uptake and Immunogenicity

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 1, 2018
Registry last updated
Oct 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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