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

Primary Purpose

Diphtheria, Tetanus, Pertussis

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
DTaP-HepB-IPV-Hib vaccine
DTaP-HepB-IPV-Hib vaccine
Sponsored by
LG Chem
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diphtheria

Eligibility Criteria

19 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Test group

    Control group

    Arm Description

    DTaP-HepB-IPV-Hib vaccine

    DTaP-HepB-IPV-Hib vaccine

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    Number of subjects with serious adverse events
    serious adverse events that occur after the ICF is obtained until 6 months after vaccination.

    Secondary Outcome Measures

    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)
    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
    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

    Full Information

    First Posted
    July 11, 2023
    Last Updated
    July 11, 2023
    Sponsor
    LG Chem
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05952596
    Brief Title
    A Study to Evaluate Safety and Immunogenicity of APV006 in Healthy Adults
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 17, 2023 (Anticipated)
    Primary Completion Date
    October 31, 2023 (Anticipated)
    Study Completion Date
    March 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    LG Chem

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diphtheria, Tetanus, Pertussis, Poliomyelitis, Hepatitis B, Haemophilus Influenzae Type b Infection

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Model Description
    active-controlled model
    Masking
    ParticipantInvestigator
    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.
    Allocation
    Randomized
    Enrollment
    42 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Test group
    Arm Type
    Experimental
    Arm Description
    DTaP-HepB-IPV-Hib vaccine
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    DTaP-HepB-IPV-Hib vaccine
    Intervention Type
    Biological
    Intervention Name(s)
    DTaP-HepB-IPV-Hib vaccine
    Intervention Description
    Hexavalent vaccine (DTaP-HepB-IPV-Hib vaccine: Diphtheria-Tetanus-Acelluar Pertussis-Hepatitis B-Sabin Inactivated Poliovirus-Haemophilus influenzae type b vaccine)
    Intervention Type
    Biological
    Intervention Name(s)
    DTaP-HepB-IPV-Hib vaccine
    Intervention Description
    Hexavalent vaccine (DTaP-HepB-IPV-Hib vaccine: Diphtheria-Tetanus-Acellular Pertussis-Hepatitis B-poliomyelitis(inactived)-Haemophilus influenzae type b vaccine)
    Primary Outcome Measure Information:
    Title
    Number of subjects with immediate reactions
    Description
    Immediate reactions after vaccination with the study vaccine mean all the signs and symptoms occurring within 30 minutes after the vaccination.
    Time Frame
    For 30 minutes after the vaccination
    Title
    Number of subjects with solicited adverse events
    Description
    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.
    Time Frame
    For 7 days after the vaccination [Day 1-8]
    Title
    Number of subjects with unsolicited adverse events
    Description
    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.
    Time Frame
    For 28 days (+7 days of window period) after the vaccination [Day 1-29]
    Title
    Number of subjects with serious adverse events
    Description
    serious adverse events that occur after the ICF is obtained until 6 months after vaccination.
    Time Frame
    For 181 days (+7 days of window period) after the vaccination [Day 1-181]
    Secondary Outcome Measure Information:
    Title
    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.
    Description
    Immunogenicity of each components (antibodies against Diphtheria, Tetanus, Acellular Pertussis, Polio, Hepatitis B, and Haemophilus influenzae type b)
    Time Frame
    Day 29 (+7 days window period)
    Title
    Proportion of the subjects who meet one of the following regarding anti-PT, anti-FHA, and anti-PRN
    Description
    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
    Time Frame
    Day 29 (+7 days window period)
    Title
    GMC or GMT values for each antigen prior to and 28 days post-vaccination with the study vaccine (Day 29)
    Description
    Immunogenicity of each components (antibodies against Diphtheria, Tetanus, Acelluar Pertussis, Polio, Hepatitis B, and Haemophilus influenzae type b
    Time Frame
    Day 29 (+7 days window period)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Study Lead
    Phone
    +82-2-3777-1114
    Email
    lgclinical@lgchem.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nam Joong Kim
    Organizational Affiliation
    Seoul National University College of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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