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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05952596
Recruitment Status : Not yet recruiting
First Posted : July 19, 2023
Last Update Posted : July 19, 2023
Sponsor:
Information provided by (Responsible Party):
LG Chem

Study Description
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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 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: active-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
Estimated Study Start Date : July 17, 2023
Estimated Primary Completion Date : October 31, 2023
Estimated Study Completion Date : March 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Number of subjects with immediate reactions [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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
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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05952596


Contacts
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Contact: Study Lead +82-2-3777-1114 lgclinical@lgchem.com

Sponsors and Collaborators
LG Chem
Investigators
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Principal Investigator: Nam Joong Kim Seoul National University College of Medicine
More Information
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Responsible Party: LG Chem
ClinicalTrials.gov Identifier: NCT05952596    
Other Study ID Numbers: LG-VGCL001
First Posted: July 19, 2023    Key Record Dates
Last Update Posted: July 19, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis B
Diphtheria
Poliomyelitis
Haemophilus Infections
Hepatitis
Liver Diseases
Digestive System Diseases
Blood-Borne Infections
Communicable Diseases
Infections
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Gram-Negative Bacterial Infections
 Bacterial Infections
Bacterial Infections and Mycoses
Gram-Positive Bacterial Infections
Corynebacterium Infections
Actinomycetales Infections
Myelitis
Central Nervous System Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuroinflammatory Diseases
Neuromuscular Diseases