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

Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05952596
• Other study ID #: LG-VGCL001
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: July 17, 2023
• Est. completion date: March 31, 2024

Study information

• Verified date: July 2023
• Source: LG Chem
• Contact: Study Lead
• Phone: +82-2-3777-1114
• Email: lgclinical[@]lgchem.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 42
• Est. completion date: March 31, 2024
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Diphtheria
• Haemophilus Infections
• Haemophilus Influenzae Type b Infection
• Hepatitis B
• Pertussis
• Poliomyelitis
• Tetanus

Intervention

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)
• 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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
LG Chem

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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]
Primary	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]
Primary	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	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)
Secondary	Proportion of the subjects who meet one of the following regarding anti-PT, anti-FHA, and anti-PRN	?If 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; ?If 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)
Secondary	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)