HPV, Human Papilloma Virus, Immunization
Conditions
Keywords
Human Papilloma Virus, HPV, Immunization
Brief summary
The human papillomavirus (HPV) is the most common sexually transmitted infection (STI) in the United States (U.S.) and is responsible for a wide range of conditions, including cancers within the anogenital tract and the oropharynx. In just the U.S. alone, it's estimated that HPV causes 330,000 cases of precancerous cervical dysplasia and 12,000 cases of cervical cancer. The investigators propose a 2-dose HPV vaccination study in women seeking postpartum care at Johns Hopkins University. The investigators will measure the immunogenicity and acceptability of the vaccine in the postpartum setting.
Detailed description
This is a pilot, non-inferiority clinical trial using historical controls. Participants will have whole blood drawn at 0 months, 6 months, and 7 months and receive the HPV vaccine at 0 months, 6 months, and 12 months. Each blood draw will consist of one 15mL red top tube to measure HPV serologies and hormone levels. All blood samples collected will be analyzed at the end of the study.
Interventions
BIOLOGICALGardasil9
Two doses of the HPV vaccine across a 12 month period (two doses of 0.5mL).
Sponsors
Merck Sharp & Dohme LLC
Johns Hopkins University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants biologically born as females between the ages of 15 through 45 who have delivered a live born baby within the past 72 hours.
Exclusion criteria
* Pregnancy * Severe allergic reaction to vaccine components * Prior receipt of an HPV vaccine dose * Fetal demise or stillbirth * Allergy to latex or yeast * Moderate or severe acute illness (deemed by the investigator to exclude) * Immunosuppression (e.g., HIV, solid organ transplant).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity of a Two-dose 9-valent HPV Vaccination as Assessed by Antibody Titer | Up to 23 months | Measure the immunogenicity of a two-dose 9-valent HPV vaccination regimen in postpartum women previously unvaccinated against the HPV 16 virus. Immunogenicity will be assessed by the antibody responses. The Geometric mean titers will be measured using milli Merck units (mMU)/mL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antibody Response to the Other 8 HPV Types | Up to 23 months | The antibody types that will be measured are HPV types 6, 11, 18, 31, 33, 45, 52, and 58. The milli Merck units (mMU)/mL of measure will be used to determine antibody response. |
| Seropositivity for HPV 16 After 1-dose | After the first dose, up to 7 months | Calculate the percentage of participants that seroconverted. |
| Seropositivity for HPV 16 After 2-doses | After the second dose, up to 2 months | Calculate the percentage of participants that seroconverted. |
| Percentage of Participants With Baseline Titers Suggestive of Natural Inoculation or Prior Vaccination to HPV 16 | Baseline | Running an assay to measure a participants natural inoculation or prior vaccination before administration of the 1st dose. |
| Percentage of Participants Who Complete 2-dose Vaccination | At the end of the study, up to 2 years | Calculate the amount of participants that complete 2-dose vaccination. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Gardasil9 Two doses of the 9-valent HPV vaccine to be administered to participants at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.
Gardasil9: Two doses of the HPV vaccine across a 12 month period (two doses of 0.5mL). | 225 |
| Total | 225 |
Baseline characteristics
| Characteristic | Gardasil9 |
|---|---|
| Age, Continuous | 29.9 years STANDARD_DEVIATION 6.8 |
| Employed No | 151 Participants |
| Employed Yes | 74 Participants |
| Highest level of education Bachelor's degree or higher | 55 Participants |
| Highest level of education Grade 11 or less | 71 Participants |
| Highest level of education Grade 12 to some college | 99 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian | 9 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black/African American | 43 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic/Latino | 134 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Two or more races | 2 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White/Caucasian | 36 Participants |
| Region of Enrollment United States | 225 Participants |
| Sex: Female, Male Female | 225 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 225 |
| other Total, other adverse events | 1 / 225 |
| serious Total, serious adverse events | 0 / 225 |
Outcome results
Primary
Immunogenicity of a Two-dose 9-valent HPV Vaccination as Assessed by Antibody Titer
Measure the immunogenicity of a two-dose 9-valent HPV vaccination regimen in postpartum women previously unvaccinated against the HPV 16 virus. Immunogenicity will be assessed by the antibody responses. The Geometric mean titers will be measured using milli Merck units (mMU)/mL.
Time frame: Up to 23 months
Population: We excluded participants whose anti-HPV 16 titer was above the seroconversion limit and the baseline. Therefore, only 129 were included in this analysis
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Gardasil9 | Immunogenicity of a Two-dose 9-valent HPV Vaccination as Assessed by Antibody Titer | 7177.6 mMU/mL |
Secondary
Antibody Response to the Other 8 HPV Types
The antibody types that will be measured are HPV types 6, 11, 18, 31, 33, 45, 52, and 58. The milli Merck units (mMU)/mL of measure will be used to determine antibody response.
Time frame: Up to 23 months
Population: During analysis, we exclude participants who had antibodies titers above the seroconversion limit at the baseline for each HPV subtype seperately. Therefore, the number of participants analyzed are smaller than 225.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Gardasil9 | Antibody Response to the Other 8 HPV Types | 6 | 2187.2 mMU/mL |
| Gardasil9 | Antibody Response to the Other 8 HPV Types | 11 | 1492.1 mMU/mL |
| Gardasil9 | Antibody Response to the Other 8 HPV Types | 18 | 1589.8 mMU/mL |
| Gardasil9 | Antibody Response to the Other 8 HPV Types | 31 | 1077.5 mMU/mL |
| Gardasil9 | Antibody Response to the Other 8 HPV Types | 33 | 792.8 mMU/mL |
| Gardasil9 | Antibody Response to the Other 8 HPV Types | 45 | 323.2 mMU/mL |
| Gardasil9 | Antibody Response to the Other 8 HPV Types | 52 | 582.9 mMU/mL |
| Gardasil9 | Antibody Response to the Other 8 HPV Types | 58 | 802.8 mMU/mL |
Secondary
Percentage of Participants Who Complete 2-dose Vaccination
Calculate the amount of participants that complete 2-dose vaccination.
Time frame: At the end of the study, up to 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Gardasil9 | Percentage of Participants Who Complete 2-dose Vaccination | 174 Participants |
Secondary
Percentage of Participants With Baseline Titers Suggestive of Natural Inoculation or Prior Vaccination to HPV 16
Running an assay to measure a participants natural inoculation or prior vaccination before administration of the 1st dose.
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Gardasil9 | Percentage of Participants With Baseline Titers Suggestive of Natural Inoculation or Prior Vaccination to HPV 16 | 91 Participants |
Secondary
Seropositivity for HPV 16 After 1-dose
Calculate the percentage of participants that seroconverted.
Time frame: After the first dose, up to 7 months
Population: There were some participants seroconverted at the baseline so were excluded from the analysis for each type of HPV.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Gardasil9 | Seropositivity for HPV 16 After 1-dose | 118 Participants |
Secondary
Seropositivity for HPV 16 After 2-doses
Calculate the percentage of participants that seroconverted.
Time frame: After the second dose, up to 2 months
Population: Participants with anti-HPV 16 titer above the seropositivity threshold were excluded in this analysis. This is analysis among participants who received the second dose.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Gardasil9 | Seropositivity for HPV 16 After 2-doses | 128 Participants |