Who is sponsoring NCT05329961?

NCT05329961 is sponsored by Boston Medical Center.

What condition does NCT05329961 study?

NCT05329961 studies Human Papilloma Virus.

What is the status of NCT05329961?

NCT05329961 is currently ACTIVE_NOT_RECRUITING.

Last reviewed 2025-06-28 · How we verify

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

NCT05329961 EARLY_PHASE1 ACTIVE_NOT_RECRUITING

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).

Details

Lead sponsor	Boston Medical Center
Phase	EARLY_PHASE1
Status	ACTIVE_NOT_RECRUITING
Enrolment	155
Start date	2022-09-26
Completion	2028-12

Conditions

Human Papilloma Virus

Interventions

Gardasil9

Primary outcomes

HPV6 antibodies at 13 months — 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.
HPV11 antibodies at 13 months — 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.
HPV16 antibodies at 13 months — 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.
HPV18 antibodies at 13 months — 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.
HPV31 antibodies at 13 months — 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.
HPV33 antibodies at 13 months — 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.

Countries

United States