Clinical trial NCT06997627: A Phase I/II Study to Evaluate the Safety and Immunogenicity of GC3111B in Healthy Adults
Official title: An Open(Part 1), Single-arm(Part 1), Randomized(Part 2), Double-blind(Part 2), Active-controlled(Part 2) Phase I/II Clinical Trial to Evaluate the Safety and Efficacy (Immunogenicity) of GC3111B in Healthy Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Tetanus-diphtheria-acellular Pertussis (Tdap)
Lead sponsor: GC Biopharma Corp
Sponsor class: INDUSTRY
First posted: 2025-05-30
Enrollment: 120
Sex: ALL
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Solicited adverse events occurring by day 14 after administration of the investigational product
timeFrame: 14 days after administration of the IP
measure: Unsolicited adverse events occurring by day 28 after administration of the investigational product
timeFrame: 28 days after administration of the IP
measure: Acute adverse events occurring within 30 minutes after administration of the investigational product
timeFrame: 30 minutes after administration of the IP
measure: Serious adverse events (SAE) and adverse events of special interest (AESI) occurring up to 180 days after administration of the investigational product
timeFrame: 180 days after administration of the IP
measure: Clinically significant findings in vital signs, laboratory tests, 12-lead electrocardiograms, and physical examinations
timeFrame: 28 days after administration of the IP
Secondary outcomes:
measure: Antibody rates for diphtheria and tetanus on day 28 after administration of the investigational product
timeFrame: 28 days after administration of the IP
measure: Boosting response rates for diphtheria, tetanus, and pertussis on day 28 after administration of the investigational product
timeFrame: 28 days after administration of the IP
measure: 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
timeFrame: 28 days after administration of the IP
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The Catholic Univ. of Korea Eunpyeong St. Mary's Hospital
Study officials:
References: