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

NCT05952596 | Unknown Phase 1 DMC

• 1 other identifier: LG-VGCL001
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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

• 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]

• 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]

• 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 Outcomes (3)

• 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)

• Proportion of the subjects who meet one of the following regarding anti-PT, anti-FHA, and anti-PRN

  Day 29 (+7 days window period)

• 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)

Study Arms (2)

Test group

EXPERIMENTAL

DTaP-HepB-IPV-Hib vaccine

Biological: DTaP-HepB-IPV-Hib vaccine

Control group

ACTIVE COMPARATOR

DTaP-HepB-IPV-Hib vaccine

Biological: DTaP-HepB-IPV-Hib vaccine

Interventions

DTaP-HepB-IPV-Hib vaccine BIOLOGICAL

Hexavalent vaccine (DTaP-HepB-IPV-Hib vaccine: Diphtheria-Tetanus-Acelluar Pertussis-Hepatitis B-Sabin Inactivated Poliovirus-Haemophilus influenzae type b vaccine)

Test group

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LG Chem: lead

MeSH Terms

Conditions

Diphtheria; Tetanus; Whooping Cough; Poliomyelitis; Hepatitis B; Haemophilus Infections

Condition Hierarchy (Ancestors)

Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Clostridium Infections; Bordetella Infections; Gram-Negative Bacterial Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Myelitis; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases; Blood-Borne Infections; Communicable Diseases; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Pasteurellaceae Infections

Study Officials

• Nam Joong Kim

  Seoul National University College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Lead

CONTACT

+82-2-3777-1114; lgclinical@lgchem.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: active-controlled model

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: July 19, 2023
• Study Start: July 17, 2023
• Primary Completion: October 31, 2023
• Study Completion: March 31, 2024
• Last Updated: July 19, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share