A Study to Evaluate Safety and Immunogenicity of APV006 in Healthy Adults
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ClinicalTrials.gov Identifier: NCT05952596 |
Recruitment Status :
Not yet recruiting
First Posted : July 19, 2023
Last Update Posted : July 19, 2023
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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 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 |
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) |
- 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.
- 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.
- 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.
- 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.
- 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)
- 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
- 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
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Ages Eligible for Study: | 19 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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
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
Contact: Study Lead | +82-2-3777-1114 | lgclinical@lgchem.com |
Principal Investigator: | Nam Joong Kim | Seoul National University College of Medicine |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
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 |