HPV-Related Malignancy
Conditions
Brief 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.
Interventions
DRUGGardasil9
Gardasil 9
Sponsors
Merck Sharp & Dohme LLC
University of Alabama at Birmingham
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 26 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Uptake of the Vaccine Doses | at baseline | Those that actually received the vaccine and each time point. |
| Serum Titers of Vaccine-specific HPV Types | baseline and 7 months | Immunogenicity |
Countries
United States
Participant flow
Pre-assignment details
195 women consented to participate in the study. 139 consented to survey only, 56 consented to survey and Gardasil9 vaccine.
Participants by arm
| Arm | Count |
|---|---|
| Gardasil9 Gardasil9: Gardasil 9 | 56 |
| Total | 56 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Final Questionnaire and Blood Draw | Lost to Follow-up | 4 |
| First Vaccine | Withdrawal by Subject | 1 |
| Second Vaccine | Lost to Follow-up | 19 |
| Third Vaccine | Lost to Follow-up | 22 |
Baseline characteristics
| Characteristic | Gardasil9 |
|---|---|
| Age, Continuous | 21.9 years STANDARD_DEVIATION 2.8 |
| Race/Ethnicity, Customized Black | 48 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 4 Participants |
| Race/Ethnicity, Customized White | 4 Participants |
| Sex/Gender, Customized Female only | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 55 |
| other Total, other adverse events | 1 / 55 |
| serious Total, serious adverse events | 0 / 55 |
Outcome results
Primary
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)
Population: 56 patients consented to vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Gardasil9 | Patient Indication of Willingness to Accept the Vaccine Based on Survey | 56 Participants |
Secondary
Serum Titers of Vaccine-specific HPV Types
Immunogenicity
Time frame: baseline and 7 months
Population: This data was not collected
Secondary
Uptake of the Vaccine Doses
Those that actually received the vaccine and each time point.
Time frame: at 3 months
Population: 1 patient consented to vaccine and then withdrew
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Gardasil9 | Uptake of the Vaccine Doses | 36 Participants |
Secondary
Uptake of the Vaccine Doses
Those that actually received the vaccine and each time point.
Time frame: at 6 months
Population: 36 patients received the 2nd vaccine dose
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Gardasil9 | Uptake of the Vaccine Doses | 14 Participants |
Secondary
Uptake of the Vaccine Doses
Those that actually received the vaccine and each time point.
Time frame: at baseline
Population: 1 participant consented to vaccine and then subsequently withdrew
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Gardasil9 | Uptake of the Vaccine Doses | 55 Participants |