A Phase 4 interventional study of Gardasil9 in HPV-Related Malignancy, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to female participants aged 16 Years to 26 Years. Per ClinicalTrials.gov, last updated 2021-10-04.
Sponsored by University of Alabama at Birmingham · Phase 4, Interventional, and Health services research
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.
Exclusion criteria
Drug: Gardasil9
Gardasil 9
Patient Indication of Willingness to Accept the Vaccine Based on Survey
This was established using a survey to indicate willingness to receive vaccine.
Time frame: 1 day (at the time of initial recruitment /survey)
Uptake of the Vaccine Doses
Those that actually received the vaccine and each time point.
Time frame: at baseline
Uptake of the Vaccine Doses
Those that actually received the vaccine and each time point.
Time frame: at 3 months
Uptake of the Vaccine Doses
Those that actually received the vaccine and each time point.
Time frame: at 6 months
Serum Titers of Vaccine-specific HPV Types
Immunogenicity
Time frame: baseline and 7 months
| Milestone | Gardasil9 |
|---|---|
| Started | 56 |
| Completed | 55 |
| Not completed | 1 |
| Withdrew: Withdrawal by subject | 1 |
| Milestone | Gardasil9 |
|---|---|
| Started | 55 |
| Completed | 36 |
| Not completed | 19 |
| Withdrew: Lost to follow-up | 19 |
| Milestone | Gardasil9 |
|---|---|
| Started | 36 |
| Completed | 14 |
| Not completed | 22 |
| Withdrew: Lost to follow-up | 22 |
| Milestone | Gardasil9 |
|---|---|
| Started | 14 |
| Completed | 10 |
| Not completed | 4 |
| Withdrew: Lost to follow-up | 4 |
This was established using a survey to indicate willingness to receive vaccine.
| Participants | Gardasil9 |
|---|---|
| Patient Indication of Willingness to Accept the Vaccine Based on Survey | 56 |
Those that actually received the vaccine and each time point.
| Participants | Gardasil9 |
|---|---|
| Uptake of the Vaccine Doses | 55 |
Those that actually received the vaccine and each time point.
| Participants | Gardasil9 |
|---|---|
| Uptake of the Vaccine Doses | 36 |
Those that actually received the vaccine and each time point.
| Participants | Gardasil9 |
|---|---|
| Uptake of the Vaccine Doses | 14 |
Immunogenicity
No measurements were reported for this outcome.
Collected over 7 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Gardasil9 | 0/55 (0%) | 0/55 (0%) | 1/55 (1.8%) |
| Event | Gardasil9 |
|---|---|
| Flu-like symptomsGeneral disorders | 1/55 |
| Age, Continuous(years) | Gardasil9 |
|---|---|
| Mean | 21.9 ± 2.8 |
| Sex/Gender, Customized(Participants) | Gardasil9 |
|---|---|
| Female only | 56 |
| Race/Ethnicity, Customized(Participants) | Gardasil9 |
|---|---|
| White | 4 |
| Black | 48 |
| Hispanic/Latino | 4 |
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Plan to share: No
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University of Alabama at Birmingham