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

Phase 1

Not yet recruiting

• Conditions: Tetanus; Diphtheria; Pertussis; Hepatitis B; Poliomyelitis; Haemophilus Influenzae Type b Infection

• Registration Number: NCT05952596
• Lead Sponsor: LG Chem

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-11
• Study First Submitted QC: 2023-07-11
• Last Update Submitted: 2023-07-11
• Study Start: 2023-07-17
• Study First Posted: 2023-07-19
• Last Update Posted: 2023-07-19
• Primary Completion: 2023-10-31
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.
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.
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.
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

Name	Time	Method
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
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)
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