Clinical trial NCT05952596: 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
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Diphtheria
Tetanus
Pertussis
Poliomyelitis
Hepatitis B
Haemophilus Influenzae Type b Infection
Lead sponsor: LG Chem
Sponsor class: INDUSTRY
First posted: 2023-07-19
Enrollment: 42
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: active-controlled model
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Number of subjects with immediate reactions
timeFrame: For 30 minutes after the vaccination
measure: Number of subjects with solicited adverse events
timeFrame: For 7 days after the vaccination [Day 1-8]
measure: Number of subjects with unsolicited adverse events
timeFrame: For 28 days (+7 days of window period) after the vaccination [Day 1-29]
measure: Number of subjects with serious adverse events
timeFrame: For 181 days (+7 days of window period) after the vaccination [Day 1-181]
Secondary outcomes:
measure: 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.
timeFrame: Day 29 (+7 days window period)
measure: Proportion of the subjects who meet one of the following regarding anti-PT, anti-FHA, and anti-PRN
timeFrame: Day 29 (+7 days window period)
measure: GMC or GMT values for each antigen prior to and 28 days post-vaccination with the study vaccine (Day 29)
timeFrame: Day 29 (+7 days window period)
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University College of Medicine
name: Nam Joong Kim
role: PRINCIPAL_INVESTIGATOR
References: