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

ConditionTetanus-diphtheria-acellular Pertussis (Tdap)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age19-64
SponsorGC Biopharma Corp

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • GC3111B

    Biological/Vaccine

    0.5 mL, Intramuscular injection

  • Boostrix®

    Biological/Vaccine

    0.5 mL, Intramuscular injection

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: GC3111BExperimental treatment 1 intervention
Group B: Boostrix®Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
14 days after administration of the IP
2

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

Time frame
28 days after administration of the IP
3

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

Time frame
30 minutes after administration of the IP
4

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

Secondary outcomes

1

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

Time frame
28 days after administration of the IP
2

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
3

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

Time frame
28 days after administration of the IP

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

GC Biopharma Corp

Lead sponsor

Source ClinicalTrials.gov
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