A Phase I/II Study to Evaluate the Safety and Immunogenicity of GC3111B in Healthy Adults

Phase 2RecruitingNCT06997627

GC Biopharma Corp120 enrolled

Overview

This clinical trial consists of two parts: Part 1, which explores safety, and Part 2, which examines both safety and efficacy (immunogenicity). Part 1 is a single-center, open-label, single-group study, while Part 2 is designed as a multicenter, double-blind, randomized, active-controlled trial.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

120

Conditions

Tetanus-diphtheria-acellular Pertussis (Tdap)

Interventions

GC3111BBIOLOGICAL

0.5 mL, Intramuscular injection

Boostrix®BIOLOGICAL

0.5 mL, Intramuscular injection

Eligibility

Sex: ALLMin age: 19 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy adults aged 19 to 64 years old as of the date of written consent. * Individuals with no history of vaccination with a vaccine containing diphtheria, tetanus, or pertussis antigens within the past 2 years prior to administration of the investigational product. Exclusion Criteria: * Individuals who have received a vaccine within 4 weeks prior to administration of the investigational product. * Individuals with a history of Tdap vaccination prior to administration of the investigational product. * Pregnant and breastfeeding women. * Individuals who have participated in other clinical trials involving investigational products/devices within 6 months prior to administration of the investigational product.

Locations (1)

The Catholic Univ. of Korea Eunpyeong St. Mary's Hospital

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

Solicited adverse events occurring by day 14 after administration of the investigational product

Time frame: 14 days after administration of the IP

Unsolicited adverse events occurring by day 28 after administration of the investigational product

Time frame: 28 days after administration of the IP

Acute adverse events occurring within 30 minutes after administration of the investigational product

Time frame: 30 minutes after administration of the IP

Serious adverse events (SAE) and adverse events of special interest (AESI) occurring up to 180 days after administration of the investigational product

Time frame: 180 days after administration of the IP

Clinically significant findings in vital signs, laboratory tests, 12-lead electrocardiograms, and physical examinations

Time frame: 28 days after administration of the IP

Secondary Outcomes

Antibody rates for diphtheria and tetanus on day 28 after administration of the investigational product

Time frame: 28 days after administration of the IP

Boosting response rates for diphtheria, tetanus, and pertussis on day 28 after administration of the investigational product

Boosting response rate: 1) If less than 0.1 IU/ml before vaccination, it should be 0.4 IU/ml or higher after the vaccination, or 2) if not less than 0.1 IU/ml before vaccination, it should be 4 times or higher after the vaccination.

Time frame: 28 days after administration of the IP

Geometric mean concentrations (GMC) of antibodies against diphtheria, tetanus, and pertussis antitoxins (anti-PT, anti-FHA, anti-PRN) on day 28 after administration of the investigational product

Central Contacts

Minji Ko

CONTACT

+82-31-260-9143 minji.ko@gccorp.com

Sujin Lee

CONTACT

Data from ClinicalTrials.gov

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