Clinical trial NCT04274153: HPV Vaccination Study in Postpartum Women
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HPV
Immunization
Human Papilloma Virus
Keywords: Human Papilloma Virus
HPV
Immunization
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2020-02-18
Enrollment: 225
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Immunogenicity of a Two-dose 9-valent HPV Vaccination as Assessed by Antibody Titer
timeFrame: Up to 23 months
Secondary outcomes:
measure: Antibody Response to the Other 8 HPV Types
timeFrame: Up to 23 months
measure: Seropositivity for HPV 16 After 1-dose
timeFrame: After the first dose, up to 7 months
measure: Seropositivity for HPV 16 After 2-doses
timeFrame: After the second dose, up to 2 months
measure: Percentage of Participants With Baseline Titers Suggestive of Natural Inoculation or Prior Vaccination to HPV 16
timeFrame: Baseline
measure: Percentage of Participants Who Complete 2-dose Vaccination
timeFrame: At the end of the study, up to 2 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Jenell Coleman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Chailee Moss, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Betty Chou, MD
role: PRINCIPAL_INVESTIGATOR
References: