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

• Sponsor: LG Chem (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05952596
• Collaborator: (none)
• Enrollment: 42
• Arms: 2
• Anticipated Duration (Months): 8.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Diphtheria; Tetanus; Pertussis; Poliomyelitis; Hepatitis B; Haemophilus Influenzae Type b Infection	Biological: DTaP-HepB-IPV-Hib vaccine; Biological: DTaP-HepB-IPV-Hib vaccine	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: active-controlled modelactive-controlled model
• Masking: Double (Participant, Investigator)
• Masking Description: The study pharmacist and study staff who administer the investigational vaccine (e.g., medication nurse) will not be blinded in this study since a control vaccine that can be visually distinguished from the study vaccine will be used. The study staff including the investigator will remain blinded, except the unblinded staff.
• Primary Purpose: Prevention
• Official Title: 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
• Anticipated Study Start Date: Jul 17, 2023
• Anticipated Primary Completion Date: Oct 31, 2023
• Anticipated Study Completion Date: Mar 31, 2024

Arms and Interventions

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)
Active Comparator: Control group DTaP-HepB-IPV-Hib 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)

Outcome Measures

Primary Outcome Measures

1. Number of subjects with immediate reactions [For 30 minutes after the vaccination]

   Immediate reactions after vaccination with the study vaccine mean all the signs and symptoms occurring within 30 minutes after the vaccination.

2. Number of subjects with solicited adverse events [For 7 days after the vaccination [Day 1-8]]

   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.

3. Number of subjects with unsolicited adverse events [For 28 days (+7 days of window period) after the vaccination [Day 1-29]]

   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.

4. Number of subjects with serious adverse events [For 181 days (+7 days of window period) after the vaccination [Day 1-181]]

   serious adverse events that occur after the ICF is obtained until 6 months after vaccination.

Secondary Outcome Measures

1. 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. [Day 29 (+7 days window period)]

   Immunogenicity of each components (antibodies against Diphtheria, Tetanus, Acellular Pertussis, Polio, Hepatitis B, and Haemophilus influenzae type b)

2. Proportion of the subjects who meet one of the following regarding anti-PT, anti-FHA, and anti-PRN [Day 29 (+7 days window period)]

   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

3. GMC or GMT values for each antigen prior to and 28 days post-vaccination with the study vaccine (Day 29) [Day 29 (+7 days window period)]

   Immunogenicity of each components (antibodies against Diphtheria, Tetanus, Acelluar Pertussis, Polio, Hepatitis B, and Haemophilus influenzae type b

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• LG Chem

Investigators

• Principal Investigator: Nam Joong Kim, Seoul National University College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: LG Chem
• ClinicalTrials.gov Identifier: NCT05952596
• Other Study ID Numbers: LG-VGCL001
• First Posted: Jul 19, 2023
• Last Update Posted: Jul 19, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hepatitis B; Diphtheria; Poliomyelitis; Haemophilus Infections; Vaccines

Study Results

No Results Posted as of Jul 19, 2023