Immunogenicity of the 9vHPV Vaccination 2-dose Regimen Among Children 4 to 8 Years Old

NCT05329961 | Active Not Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: H-41686
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

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).

Conditions

Human Papilloma Virus

Keywords

Gardasil 9; Immunogenicity; Children

Outcome Measures

Primary Outcomes (18)

• HPV6 antibodies at 13 months

  A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV6 if it is \>30mMu.

  13 months

• HPV11 antibodies at 13 months

  A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV11 if it is \>16mMu.

  13 months

• HPV16 antibodies at 13 months

  A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV16 if it is \>20mMu.

  13 months

• HPV18 antibodies at 13 months

  A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV18 if it is \>24 mMU.

  13 months

• HPV31 antibodies at 13 months

  A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV31 if it is \>10 mMU.

  13 months

• HPV33 antibodies at 13 months

  A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV33 if it is \>8 mMU.

  13 months

• HPV45 antibodies at 13 months

  A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV45 if it is \>8 mMU.

  13 months

• HPV52 antibodies at 13 months

  A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV52 if it is \>8 mMU.

  13 months

• HPV58 antibodies at 13 months

  A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV58 if it is \>8 mMU.

  13 months

• HPV6 antibodies at 60 months

  A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV6 if it is \>30mMU.

  60 months

• HPV11 antibodies at 60 months

  A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV11 if it is \>16 mMU.

  60 months

• HPV16 antibodies at 60 months

  A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV16 if it is \>20 mMU.

  60 months

• HPV18 antibodies at 60 months

  A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV18 if it is \>24mMU.

  60 months

• HPV31 antibodies at 60 months

  A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV31 if it is \>10 mMU.

  60 months

• HPV33 antibodies at 60 months

  A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV33 if it is \>8 mMU.

  60 months

• HPV45 antibodies at 60 months

  A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV45 if it is \>8 mMU.

  60 months

• HPV52 antibodies at 60 months

  A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV52 if it is \>8 mMU.

  60 months

• HPV58 antibodies at 60 months

  A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV58 if it is \>8 mMU.

  60 months

Secondary Outcomes (4)

• Injection site swelling after first injection

  day 3 after injection

• Injection site swelling after second injection

  day 3 after injection

• Injection site redness after first injection

  day 3 after injection

• Injection site redness after second injection

  day 3 after injection

Study Arms (1)

Single Arm

EXPERIMENTAL

HPV 9-valent human papillomavirus vaccine (Gardasil 9) - 0.5mL intramuscular dose - 2 doses (Month 0, 12)

Drug: Gardasil9

Interventions

Gardasil9 DRUG

The Gardasil 9 vaccine is a recombinant L 1 VLP vaccine containing HPV types 6, 11,16,18, 31, 33, 45, 52 and 58 VLP. The vaccine is not currently licensed for children under 9 years of age but it is licensed in the USA for males and females ages 9 to 45 years old.

Also known as: GARDASIL®

Single Arm

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Boston Medical Center: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Interventions

Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Intervention Hierarchy (Ancestors)

Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Papillomavirus Vaccines; Viral Vaccines

Study Officials

• Elisha Wachman, MD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics, Vice Chair for Research

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: April 15, 2022
• Study Start: September 26, 2022
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)