A Study to Evaluate Safety and Immunogenicity of APV006 in Healthy Adults

A Single-center, Randomized, Active-controlled, Parallel-group, Double-blind, Phase I Clinical Trial to Evaluate Safety and Immunogenicity of Hexavalent Vaccine (APV006) in Healthy Adults

This is a single-center, randomized, active-controlled, parallel-design, double-blind, phase I study to evaluate the safety and immunogenicity of a single dose of APV006 in healthy adults.

Study Overview

• Status: Not yet recruiting
• Conditions: Hepatitis B; Pertussis; Tetanus; Diphtheria; Poliomyelitis; Haemophilus Influenzae Type b Infection
• Intervention / Treatment: Biological: DTaP-HepB-IPV-Hib vaccine; Biological: DTaP-HepB-IPV-Hib vaccine

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Study Lead; Phone Number: +82-2-3777-1114; Email: lgclinical@lgchem.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy male and female adults aged 19 - 55 on Visit 1
• Those without clinically significant abnormalities on the screening test on Visit 1
• Those with a confirmed BMI of 18.5 kg/m2 to less than 30 kg/m2 on Visit 1
• Those who have heard a detailed explanation of the study and whose written consent to participate in the study was given voluntarily by themselves or their legal representatives

Exclusion Criteria:

• Those who participated in other studies and took investigational products/ investigational vaccines within 6 months from Visit 1
• Those who took tetanus toxoid (TT), tetanus-diphtheria (Td), tetanus-reduced diphtheria-acellular pertussis (Tdap) vaccine for adults, or other vaccines containing tetanus-diphtheria for adults within 5 years from Visit 1
• Those who were vaccinated within 4 weeks from Visit 1 or who plan to receive vaccines other than the investigational vaccine from the participation in this study to Visit 5
• Have had diphtheria, tetanus, pertussis, hepatitis B, polio, or invasive diseases caused by Haemophilus influenzae type b

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test group; DTaP-HepB-IPV-Hib vaccine	Biological: DTaP-HepB-IPV-Hib vaccine; Hexavalent vaccine (DTaP-HepB-IPV-Hib vaccine: Diphtheria-Tetanus-Acelluar Pertussis-Hepatitis B-Sabin Inactivated Poliovirus-Haemophilus influenzae type b vaccine); Biological: DTaP-HepB-IPV-Hib vaccine; Hexavalent vaccine (DTaP-HepB-IPV-Hib vaccine: Diphtheria-Tetanus-Acellular Pertussis-Hepatitis B-poliomyelitis(inactived)-Haemophilus influenzae type b vaccine)
Active Comparator: Control group; DTaP-HepB-IPV-Hib vaccine	Biological: DTaP-HepB-IPV-Hib vaccine; Hexavalent vaccine (DTaP-HepB-IPV-Hib vaccine: Diphtheria-Tetanus-Acelluar Pertussis-Hepatitis B-Sabin Inactivated Poliovirus-Haemophilus influenzae type b vaccine); Biological: DTaP-HepB-IPV-Hib vaccine; Hexavalent vaccine (DTaP-HepB-IPV-Hib vaccine: Diphtheria-Tetanus-Acellular Pertussis-Hepatitis B-poliomyelitis(inactived)-Haemophilus influenzae type b vaccine)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects with immediate reactions	Immediate reactions after vaccination with the study vaccine mean all the signs and symptoms occurring within 30 minutes after the vaccination.	For 30 minutes after the vaccination
Number of subjects with solicited adverse events	Solicited adverse events are classified into the local(pain, tenderness, erythema/redness, induration/swelling, pruritus) and systemic(fever, fatigue, chills/shivering, myalgia, headache, arthralgia, decreased appetite, diarrhea, nausea/vomiting, hypersensitivity) signs and symptoms.	For 7 days after the vaccination [Day 1-8]
Number of subjects with unsolicited adverse events	Unsolicited adverse events mean all the adverse events excluding the solicited adverse events that occur after the ICF is obtained until 28 days after vaccination.	For 28 days (+7 days of window period) after the vaccination [Day 1-29]
Number of subjects with serious adverse events	serious adverse events that occur after the ICF is obtained until 6 months after vaccination.	For 181 days (+7 days of window period) after the vaccination [Day 1-181]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportions of the subjects who meet seroprotection/vaccine-response to each antigen and the subjects who have shown seroconversion 28 days post-vaccination with the study vaccine (Day 29) compared to pre-vaccination.	Immunogenicity of each components (antibodies against Diphtheria, Tetanus, Acellular Pertussis, Polio, Hepatitis B, and Haemophilus influenzae type b)	Day 29 (+7 days window period)
Proportion of the subjects who meet one of the following regarding anti-PT, anti-FHA, and anti-PRN	①If the antibody concentration is < 4 X LLOQ before the administration of the investigational vaccine: The antibody concentration is ≥ 4 X LLOQ 29 days after the administration of the investigational vaccine ②If the antibody concentration is ≥ 4 X LLOQ before the administration of the investigational vaccine: The antibody concentration 29 days after the administration of the investigational vaccine is ≥ the antibody concentration before the administration	Day 29 (+7 days window period)
GMC or GMT values for each antigen prior to and 28 days post-vaccination with the study vaccine (Day 29)	Immunogenicity of each components (antibodies against Diphtheria, Tetanus, Acelluar Pertussis, Polio, Hepatitis B, and Haemophilus influenzae type b	Day 29 (+7 days window period)

Collaborators and Investigators

• Sponsor: LG Chem
• Investigators: Principal Investigator: Nam Joong Kim, Seoul National University College of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): July 17, 2023
• Primary Completion (Estimated): October 31, 2023
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: July 11, 2023
• First Submitted That Met QC Criteria: July 11, 2023
• First Posted (Actual): July 19, 2023

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 11, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Central Nervous System Diseases; Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Neuromuscular Diseases; Central Nervous System Infections; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Enterovirus Infections; Picornaviridae Infections; Spinal Cord Diseases; Corynebacterium Infections; Hepatitis; Myelitis; Pasteurellaceae Infections; Neuroinflammatory Diseases; Hepatitis B; Diphtheria; Poliomyelitis; Haemophilus Infections; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: LG-VGCL001

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