HPV Vaccination Study in Postpartum Women

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Pilot Study of the Immunogenicity of a Two-dose Protocol for 9-valent Human Papilloma Virus Vaccination in Postpartum Girls and Women (15-45 Years Old) Previously Unvaccinated Against HPV

Conditions
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HPV, Immunization, Human Papilloma Virus

Intervention / Treatment
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* Biological: Gardasil9


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gardasil9<br>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. | Biological: Gardasil9<br>* Two doses of the HPV vaccine across a 12 month period (two doses of 0.5mL).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human Papilloma Virus, HPV, Immunization