Clinical trial NCT05329961: Immunogenicity of the 9vHPV Vaccination 2-dose Regimen Among Children 4 to 8 Years Old
Official title: An Open-Label Clinical Trial Evaluating the Immunogenicity of the 9vHPV Vaccination 2-dose Regimen Over a Four-year Follow up Among Children 4 to 8 Years Old, An Exploratory Immunogenicity Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Human Papilloma Virus
Keywords: Gardasil 9
Immunogenicity
Children
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2022-04-15
Enrollment: 150
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study is an open-label nonrandomized exploratory proof of concept and descriptive 4-year immunogenicity study to assess immunogenicity after administration of a 2-dose regimen of 9-valent human papillomavirus vaccine (9vHPV) vaccine separated by 12 months (months 0, 12).

Detailed description: Study participants will include 150 boys and girls aged 4-8 years (total, 75 boys and 75 girls) to receive 2 doses of the 9vHPV vaccine at 0 and 12 months. Patients will be recruited by age-group to achieve balanced enrollment of 15 girls and 15 boys per year of age. The investigators will examine the immunogenicity profile in this cohort, for which titers will be analyzed one month after dose 2 (Month 13) and at Month 60.

Though clinical efficacy cannot be assessed in young children because of limited exposure to human papillomavirus (HPV), this descriptive study will allow the investigators to understand whether the 9vHPV vaccine in younger patients provides immunogenicity similar to that shown for the 9-14 and 16-26 age groups who have received the 9vHPV vaccine.13 This study will require an IND for the use of the HPV vaccine in children younger than 9 years.

Immunogenicity will be measured by examining serum antibodies of all participants using a competitive Luminex immunoassay (cLIA).15 Month 60 serology will be by cLIA and IgG LIA assays. The antibody response testing will be performed at Merck Research Laboratory.

The goal of this study is to explore whether a 2-dose 9vHPV vaccine regimen with dosage separated by 12 months is immunogenic among children aged 4-8 years. The primary outcome will be geometric mean titers (GMT) for HPV6, HPV11, HPV16, HPV18, HPV31, HPV33, HPV45, HPV52, and HPV58 antibodies at months 13 and 60. Results will allow the investigators to qualitatively compare immunogenicity in individuals vaccinated at age 4-8 years to known immunogenicity in 9vHPV recipients vaccinated at ages 9-14.13 Knowledge of whether vaccination in this age group is sufficient to induce high-level protective antibody titers through 4 years after the second dose will support further efficacy studies in a larger randomized trial of a 2-dose 9vHPV regimen for children aged 4-8 years.

Eligibility criteria: Inclusion Criteria:

1. Children aged 4-8 years old
2. Receives care at the Boston Medical Center or one of the affiliated Community heath centers
3. Naïve to HPV Vaccine

Exclusion Criteria:

1. A history of severe allergic reaction, including known allergy to any vaccine component, specially severe allergic reaction to yeast
2. Immunocompromised/previous immunosuppressive therapy
3. Thrombocytopenia or other coagulation disorder

Primary outcomes:
measure: HPV6 antibodies at 13 months
timeFrame: 13 months
measure: HPV11 antibodies at 13 months
timeFrame: 13 months
measure: HPV16 antibodies at 13 months
timeFrame: 13 months
measure: HPV18 antibodies at 13 months
timeFrame: 13 months
measure: HPV31 antibodies at 13 months
timeFrame: 13 months
measure: HPV33 antibodies at 13 months
timeFrame: 13 months
measure: HPV45 antibodies at 13 months
timeFrame: 13 months
measure: HPV52 antibodies at 13 months
timeFrame: 13 months
measure: HPV58 antibodies at 13 months
timeFrame: 13 months
measure: HPV6 antibodies at 60 months
timeFrame: 60 months
measure: HPV11 antibodies at 60 months
timeFrame: 60 months
measure: HPV16 antibodies at 60 months
timeFrame: 60 months
measure: HPV18 antibodies at 60 months
timeFrame: 60 months
measure: HPV31 antibodies at 60 months
timeFrame: 60 months
measure: HPV33 antibodies at 60 months
timeFrame: 60 months
measure: HPV45 antibodies at 60 months
timeFrame: 60 months
measure: HPV52 antibodies at 60 months
timeFrame: 60 months
measure: HPV58 antibodies at 60 months
timeFrame: 60 months
Secondary outcomes:
measure: Injection site swelling after first injection
timeFrame: day 3 after injection
measure: Injection site swelling after second injection
timeFrame: day 3 after injection
measure: Injection site redness after first injection
timeFrame: day 3 after injection
measure: Injection site redness after second injection
timeFrame: day 3 after injection
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Natalie Pierre-Joseph, MD
role: PRINCIPAL_INVESTIGATOR
References: