A Study to Evaluate the Safety and Efficacy(Immunogenicity) of GC3111 in Healthy Adults

Randomized, Double-blind, Active-controlled Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of GC3111 in Healthy Adults

The purpose of this study is to evaluate safety and efficacy (immunogenicity) of a single dose of GC3111 versus Boostrix® vaccine among healthy adults in 19-64 years of age.

Study Overview

• Status: Unknown
• Conditions: Whooping Cough; Tetanus; Diphtheria
• Intervention / Treatment: Biological: GC3111 vaccine; Biological: Boostrix® vaccine

Detailed Description

To evaluate immunogenicity of GC3111 as tetanus, diphtheria and acellular pertussis (Tdap) vaccine in healthy adults.

To evaluate safety of GC3111 in healthy adults.

• Study Type: Interventional
• Enrollment (Anticipated): 213
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Dah Yoon Kim; Phone Number: +82-31-260-0976; Email: kimdahyoon@greencross.com
• Study Contact Backup: Name: Sujin Lee; Phone Number: +82-31-260-0870

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • The Catholic Univ. of Korea Eunpyeong St. Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 64 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy adults aged above 19 and under 64 at the time of screening
2. Subject without history of administrating vaccines including diphtheria, tetanus or whooping cough antigens within 2 years prior to administration of investigational drug
3. Subject who provided informed consent and assent forms

Exclusion Criteria:

1. Subject who received vaccine within 4 weeks prior to receiving study vaccine
2. Subject who received Tdap vaccine prior to receiving study vaccine
3. Subject with chronic cough history within 12 weeks before receiving study vaccine
4. Subject who is pregnant, lactating, or of child bearing potential without using an effective method of contraception or not practicing abstinence
5. Subject who participated in any other clinical study (investigational drug/equipment) within 6 months before receiving study vaccine
6. Subject with any condition that, in the opinion of the Investigator, might interfere with the ability to comply with trial procedures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: GC3111 Vaccine Group; Participants randomized to receive a single dose of GC3111 vaccine (Biological: GC3111 vaccine).	Biological: GC3111 vaccine; 0.5mL, Intramuscular; Other Names: GC3111
ACTIVE_COMPARATOR: Boostrix® Vaccine Group; Participants randomized to receive a single dose of Boostrix® vaccine (Biological: Boostrix® vaccine).	Biological: Boostrix® vaccine; 0.5mL, Intramuscular; Other Names: Boostrix®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Solicited Adverse Events Following Vaccination with Either GC3111 or Boostrix® Vaccine		Day 0 (pre-vaccination) to Day 14 (post-vaccination)
Unsolicited Adverse Events Following Vaccination with Either GC3111 or Boostrix® Vaccine		Day 0 (pre-vaccination) to Day 28 (post-vaccination)
Serious Adverse Events Following Vaccination with Either GC3111 or Boostrix® Vaccine		Day 0 (pre-vaccination) to Day 180 (post-vaccination)
Vital Signs	Blood Pressure (systolic, diastolic) in mmHg	Day 0 (pre-vaccination), Day 28 (post-vaccination)
Vital Signs	Pulse Rate in pulses per minute	Day 0 (pre-vaccination), Day 28 (post-vaccination)
Vital Signs	Body Temperature in degrees Celcius	Day 0 (pre-vaccination), Day 28 (post-vaccination)
Laboratory Examinations	Blood Test (WBC with differential count (lymphocyte, monocyte etc.), RBC, hemoglobin, hematocrit, platelet count	Screening (pre-vaccination), Day 28 (post-vaccination)
Laboratory Examinations	Blood Chemistry Test (K, Na, Cl, P, ALT, AST etc.)	Screening (pre-vaccination), Day 28 (post-vaccination)
Laboratory Examinations	Urine Test (pH, specific gravity, bilirubin etc.)	Screening (pre-vaccination), Day 28 (post-vaccination)

Secondary Outcome Measures

Outcome Measure	Time Frame
Ratio of Participants with Antibody Responses (Seroprotection rate) to Tetanus and Diphtheria Components Following Vaccination With Either GC3111 or Boostrix® Vaccine	Day 0 (pre-vaccination) to Day 28 (post-vaccination)
Ratio of Participants With Antibody Responses (Boosting Response rate) to Tetanus and Diphtheria Components Following Vaccination With Either GC3111 or Boostrix® Vaccine	Day 0 (pre-vaccination) to Day 28 (post-vaccination)
Geometric Mean Concentrations (GMC) for Diphtheria, Tetanus and Acellular Pertussis Antigens	Day 28 (post-vaccination)
Geometric Mean Ratio (GMR) of Post-vaccination versus Pre-vaccination antibody concentrations for Diphtheria, Tetanus and Acellular Pertussis Antigens	Day 0 (pre-vaccination) to Day 28 (post-vaccination)

Other Outcome Measures

Outcome Measure	Time Frame
Functional Antibody Response of Pertussis	Day 0 (pre-vaccination) to Day 28 (post-vaccination)
Stratified Analysis of Pertussis according to Anti-Pertussis antibody titer (Positive/Negative)	Day 0 (pre-vaccination), Day 28 (post-vaccination)

Collaborators and Investigators

• Sponsor: Green Cross Corporation

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 14, 2019
• Primary Completion (ANTICIPATED): February 1, 2021
• Study Completion (ANTICIPATED): May 1, 2021

Study Registration Dates

• First Submitted: January 8, 2020
• First Submitted That Met QC Criteria: January 20, 2020
• First Posted (ACTUAL): January 23, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 23, 2020
• Last Update Submitted That Met QC Criteria: January 20, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Corynebacterium Infections; Whooping Cough; Diphtheria; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: GC3111_P2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No