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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gardasil9 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gardasil9 | Biological | Two doses of the HPV vaccine across a 12 month period (two doses of 0.5mL). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 23 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 23 months |
| Seropositivity for HPV 16 After 1-dose |
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Inclusion Criteria:
Exclusion Criteria:
Women seeking postpartum care at Johns Hopkins University who self-report never receiving an HPV vaccination.
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| Name | Affiliation | Role |
|---|---|---|
| Jenell Coleman, MD | Johns Hopkins University | Principal Investigator |
| Chailee Moss, MD | Johns Hopkins University | Principal Investigator |
| Betty Chou, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21205 | United States | ||
| Johns Hopkins Bayview Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38285445 | Derived | Moss CF, Wang R, Sao S, Chou B, Perin J, Lander ME, Thaker SM, Mann M, Coleman JS. Immunogenicity of 2-Dose HPV Vaccine Series for Postpartum Women: An Open-Label, Nonrandomized, Noninferiority Trial. JAMA Netw Open. 2024 Jan 2;7(1):e2352996. doi: 10.1001/jamanetworkopen.2023.52996. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | We excluded participants whose anti-HPV 16 titer was above the seroconversion limit and the baseline. Therefore, only 129 were included in this analysis | Posted | Geometric Mean | 95% Confidence Interval | mMU/mL | Up to 23 months |
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Not serious adverse event due to medication | Skin and subcutaneous tissue disorders | Systematic Assessment | Participant's arm was swollen and painful for several days after receiving her second dose of the HPV vaccine |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jenell Coleman | Johns Hopkins SOM Department of GYN/OB | (410)614-9178 | colemanj@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 18, 2022 | Jul 7, 2023 | Prot_SAP_000.pdf |
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Calculate the percentage of participants that seroconverted. |
| After the first dose, up to 7 months |
| Seropositivity for HPV 16 After 2-doses | Calculate the percentage of participants that seroconverted. | After the second dose, up to 2 months |
| 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. | Baseline |
| Percentage of Participants Who Complete 2-dose Vaccination | Calculate the amount of participants that complete 2-dose vaccination. | At the end of the study, up to 2 years |
| Baltimore |
| Maryland |
| 21224 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Highest level of education | Count of Participants | Participants |
|
| Employed | Count of Participants | Participants |
|
|
|
| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | mMU/mL | Up to 23 months |
|
|
|
| Secondary | Seropositivity for HPV 16 After 1-dose | Calculate the percentage of participants that seroconverted. | There were some participants seroconverted at the baseline so were excluded from the analysis for each type of HPV. | Posted | Count of Participants | Participants | After the first dose, up to 7 months |
|
|
|
| Secondary | Seropositivity for HPV 16 After 2-doses | Calculate the percentage of participants that seroconverted. | 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. | Posted | Count of Participants | Participants | After the second dose, up to 2 months |
|
|
|
| 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. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Percentage of Participants Who Complete 2-dose Vaccination | Calculate the amount of participants that complete 2-dose vaccination. | Posted | Count of Participants | Participants | At the end of the study, up to 2 years |
|
|
|
| 0 |
| 225 |
| 0 |
| 225 |
| 1 |
| 225 |
|
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| Title | Measurements |
|---|---|
|
| 31 |
|
| 33 |
|
| 45 |
|
| 52 |
|
| 58 |
|