DiphtheriaPhase 1NCT05952596
A Study to Evaluate Safety and Immunogenicity of APV006 in Healthy Adults
A Phase 1 study testing DTaP-HepB-IPV-Hib vaccine in people with Diphtheria and Tetanus, run by LG Chem.
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. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Diphtheria, Tetanus, Pertussis
- What is being tested?
- DTaP-HepB-IPV-Hib vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 17 Jul 2023to 31 Mar 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
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
- Being tested
- DTaP-HepB-IPV-Hib vaccine
- Medical subject headings
- Diphtheria, Tetanus, Whooping Cough, Poliomyelitis, Hepatitis B, Haemophilus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DTaP-HepB-IPV-Hib vaccineBiological
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 vaccineBiological
Hexavalent vaccine (DTaP-HepB-IPV-Hib vaccine: Diphtheria-Tetanus-Acellular Pertussis-Hepatitis B-poliomyelitis(inactived)-Haemophilus influenzae type b vaccine)
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | DTaP-HepB-IPV-Hib vaccine Receives: Biological: DTaP-HepB-IPV-Hib vaccine |
| Control group | Active comparator | DTaP-HepB-IPV-Hib vaccine Receives: Biological: DTaP-HepB-IPV-Hib vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Immunogenicity of each components (antibodies against Diphtheria, Tetanus, Acellular Pertussis, Polio, Hepatitis B, and Haemophilus influenzae type b)
Measured: Day 29 (+7 days window period)
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
Measured: 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)
Immunogenicity of each components (antibodies against Diphtheria, Tetanus, Acelluar Pertussis, Polio, Hepatitis B, and Haemophilus influenzae type b
Measured: Day 29 (+7 days window period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start17 Jul 2023 (estimated)
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiphtheriaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- active-controlled model
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LG Chem
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nam Joong Kim, Principal investigator, Seoul National University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05952596
- Sponsor's protocol ID
- LG-VGCL001
- Status last verified
- Jul 2023
- First submitted
- 11 Jul 2023
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05952596
- Acronym / sponsor ID
- LG-VGCL001
- Conditions
- Diphtheria, Tetanus, Pertussis, Poliomyelitis, Hepatitis B, Haemophilus Influenzae Type b Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- 17 Jul 2023 (estimated)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 19 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- active-controlled model
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Biological: DTaP-HepB-IPV-Hib vaccineDTaP-HepB-IPV-Hib vaccine |
| Control group | Active comparator | Biological: DTaP-HepB-IPV-Hib vaccineDTaP-HepB-IPV-Hib vaccine |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DTaP-HepB-IPV-Hib vaccineHexavalent vaccine (DTaP-HepB-IPV-Hib vaccine: Diphtheria-Tetanus-Acelluar Pertussis-Hepatitis B-Sabin Inactivated Poliovirus-Haemophilus influenzae type b vaccine) | Biological | Test group |
| DTaP-HepB-IPV-Hib vaccineHexavalent vaccine (DTaP-HepB-IPV-Hib vaccine: Diphtheria-Tetanus-Acellular Pertussis-Hepatitis B-poliomyelitis(inactived)-Haemophilus influenzae type b vaccine) | Biological | Control group |
Primary outcome
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.
3 secondary outcomes
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)
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Diphtheria
RecruitingPhase 2
A Phase II Clinical Trial of Absorbed Acellular Pertussis (Two-Component) Diphtheria-Tetanus Combined Vaccine (For Adults and Adolescents)
Pertussis (Whooping Cough), Diphtheria
RecruitingPhase 1/2
A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
Diphtheria, Pertussis
RecruitingPhase 4
Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy
RSV, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination
Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization
Active, not recruitingPhase 3
A Study on the Immune Response and Safety of a Combined Vaccine Against Diphtheria, Tetanus and Acellular Pertussis (dTpa) in Japanese Healthy Pregnant Women
Diphtheria-Tetanus-acellular Pertussis Vaccines
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nam Joong Kim principal investigator
Seoul National University College of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DTaP-HepB-IPV-Hib vaccine in people with Diphtheria and Tetanus, run by LG Chem.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Study Lead (+82-2-3777-1114, lgclinical@lgchem.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with immediate reactions (time frame: For 30 minutes after the vaccination). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2023.