Postpartum HPV Vaccination: Acceptability, Uptake and Immunogenicity
| Registry | NCT03451071 |
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| Status | Completed |
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| Phase | Phase 4 |
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| Study type | Interventional; na, single group, masking: none, health services research |
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| Enrollment | 195 (Actual) |
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| Sponsor | University of Alabama at Birmingham (Other); collaborators: Merck Sharp & Dohme LLC |
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| Conditions | HPV-Related Malignancy |
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| Interventions | Gardasil9 (Drug) |
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| Dates | start 2019-04-29, primary completion 2020-06-01, completion 2020-12-30, first posted 2018-03-01, last updated 2021-10-04 |
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| Locations | 1 site in United States |
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-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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Gardasil9 | Experimental | Drug: Gardasil9 | |
- Gardasil9 (Drug): Gardasil 9
+Outcome measures
Primary outcomes
- Patient Indication of Willingness to Accept the Vaccine Based on Survey [1 day (at the time of initial recruitment /survey)]: This was established using a survey to indicate willingness to receive vaccine.
Secondary outcomes
- Uptake of the Vaccine Doses [at baseline]: Those that actually received the vaccine and each time point.
- Uptake of the Vaccine Doses [at 3 months]: Those that actually received the vaccine and each time point.
- Uptake of the Vaccine Doses [at 6 months]: Those that actually received the vaccine and each time point.
- Serum Titers of Vaccine-specific HPV Types [baseline and 7 months]: Immunogenicity
+Eligibility
Sex: Female, ages: 16 Years to 26 Years
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
+Posted results
Participant flow
| Milestone | Gardasil9 |
|---|
| Started | 56 |
| Completed | 55 |
| Not completed | 1 |
Outcome results
- Patient Indication of Willingness to Accept the Vaccine Based on Survey (Primary), Count of participants, Participants: Gardasil9 56
- Uptake of the Vaccine Doses (Secondary), Count of participants, Participants: Gardasil9 55
- Uptake of the Vaccine Doses (Secondary), Count of participants, Participants: Gardasil9 36
- Uptake of the Vaccine Doses (Secondary), Count of participants, Participants: Gardasil9 14
- Serum Titers of Vaccine-specific HPV Types (Secondary)
Adverse events
Time frame: 7 months
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|
| Gardasil9 | 0/55 (0.0%) | 0/55 (0.0%) | 1/55 (1.8%) |
Other adverse events by term
| Term | Organ system | Gardasil9 |
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| Flu-like symptoms | General disorders | 1/55 |
+Locations (1)
| Facility | City | Country | Status |
|---|
| University of Alabama at Birmingham | Birmingham, Alabama | United States | |
+Study documents