This study is being conducted to evaluate the safety and immunogenicity of INT101, an investigational vaccine intended to prevent norovirus gastroenteritis, in healthy adults. INT101 contains multivalent norovirus antigens (GII.3, GII.4, and GII.17) and is administered as an intramuscular injection. Participants will receive either INT101 or a placebo, given three times at 4-week intervals. This is a single-center, single-blind, randomized, dose-escalation, placebo-controlled, multiple-dose, Phase 1 clinical trial. Approximately 30 healthy adult participants will be enrolled and randomly assigned to receive either a low dose or high dose of INT101, or a matching placebo, in a 2:1 ratio within each dose group. The primary objective is to evaluate the safety of multiple intramuscular doses of INT101 compared to placebo. The secondary objective is to evaluate the immunogenicity (antibody response) of INT101 compared to placebo. Participants will be followed for approximately 6 months after their last dose to monitor safety and immune response.
This is a single-center, single-blind, randomized, dose-escalation, placebo-controlled, multiple-dose, Phase 1 clinical trial designed to evaluate the safety and immunogenicity of INT101 intramuscular injection in healthy adults. INT101 is a vaccine candidate containing multivalent norovirus antigens (genotypes GII.3, GII.4, and GII.17), formulated at 20 μg per antigen (60 μg total) per 0.5 mL vial. The matching placebo is identical in formulation and appearance, excluding the active norovirus antigens. Approximately 30 participants will be enrolled into two dose groups: a low-dose group (30 μg/0.25 mL) and a high-dose group (60 μg/0.5 mL). Each dose group consists of a sentinel cohort followed by a main cohort. Within each cohort, participants are randomized in a 2:1 ratio to receive either INT101 or placebo. Enrollment proceeds in a staggered, dose-escalation manner: Sentinel A (low dose) is dosed first, followed by a Day 7 DSMB safety review before proceeding to Cohort A. DSMB (Data and Safety Monitoring Board) evaluations are conducted at Day 7 after the first and third (last) doses within Cohort A before advancing to the high-dose groups (Sentinel B and Cohort B). Each participant receives 3 intramuscular injections (into the deltoid muscle) at 4-week intervals (Visit 2/Baseline, Visit 4, Visit 6). The study includes a screening period (up to 4 weeks), a treatment period (8 weeks, 3 doses), and a follow-up period of approximately 6 months after the last dose, for a total of 9 study visits. Safety endpoints include immediate adverse events, solicited local and systemic adverse events, unsolicited adverse events, serious adverse events, and clinically significant changes in laboratory tests, physical examinations, and vital signs. Immunogenicity endpoints include seroconversion rate, geometric mean titer (GMT), and geometric mean ratio (GMR) of norovirus antibodies, assessed at Days 7, 28, 35, 56, 63, 84, and 224 relative to baseline.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
30
Norovirus multivalent antigen vaccine (GII.3, GII.4, GII.17), total 30 μg per 0.25 mL, administered via intramuscular injection into the deltoid muscle, 3 doses at 4-week intervals.
Norovirus multivalent antigen vaccine (GII.3, GII.4, GII.17), total 60 μg per 0.5 mL, administered via intramuscular injection into the deltoid muscle, 3 doses at 4-week intervals.
Matching placebo identical in formulation and appearance to INT101, excluding the active norovirus antigens; 0.25 mL, administered via intramuscular injection into the deltoid muscle, 3 doses at 4-week intervals.
Matching placebo identical in formulation and appearance to INT101, excluding the active norovirus antigens; 0.5 mL, administered via intramuscular injection into the deltoid muscle, 3 doses at 4-week intervals.
Severance Hospital, Yonsei University Health System
Seoul, South Korea
RECRUITINGIncidence of Immediate Adverse Events (AEs)
Number and proportion of participants experiencing immediate adverse events occurring within 30 minutes after each administration of the investigational product.
Time frame: Within 30 minutes after each investigational product administration (up to 3 doses)
Incidence of Solicited Local Adverse Events
Number and proportion of participants experiencing solicited local adverse events (e.g., injection site pain, erythema, swelling) following each investigational product administration.
Time frame: Within 7 days after each investigational product administration
Incidence of Solicited Systemic Adverse Events
Number and proportion of participants experiencing solicited systemic adverse events (e.g., fever, fatigue, headache, myalgia) following each investigational product administration.
Time frame: Within 7 days after each investigational product administration
Incidence of Unsolicited Adverse Events
Number and proportion of participants experiencing unsolicited adverse events not specifically listed on the diary card, following each investigational product administration.
Time frame: Within 28 days after each investigational product administration, or occurring between Visit 8 and Visit 9
Incidence of Serious Adverse Events (SAEs)
Number and proportion of participants experiencing serious adverse events, regardless of causal relationship to the investigational product, from the first dose through the end of follow-up.
Time frame: From first investigational product administration up to Day 224 (approximately 32 weeks)
Incidence of Clinically Significant Abnormalities in Laboratory Tests, Physical Examinations, and Vital Signs
Number and proportion of participants with a shift from normal or not clinically significant abnormal at baseline to clinically significant abnormal at any post-baseline visit in laboratory test results, physical examination findings, or vital sign measurements.
Time frame: From baseline (Day 0, first investigational product administration) through Day 224 (end of study, approximately 32 weeks)
Seroconversion Rate of Norovirus Antibodies
Proportion of participants achieving seroconversion, defined as a ≥4-fold increase from baseline in norovirus IgG, IgA, or HBGA blocking antibody titer, at each post-baseline time point.
Time frame: Day 7, 28, 35, 56, 63, 84, and 224 after the first investigational product administration, compared to baseline
Geometric Mean Titer (GMT) of Norovirus Antibodies
Geometric mean titer of norovirus antibodies (IgG, IgA, and HBGA blocking antibody) at each post-baseline time point compared to baseline.
Time frame: Day 7, 28, 35, 56, 63, 84, and 224 after the first investigational product administration, compared to baseline
Geometric Mean Ratio (GMR) of Norovirus Antibodies
Geometric mean ratio (fold-rise from baseline) of norovirus antibody titers at each post-baseline time point compared to baseline.
Time frame: Day 7, 28, 35, 56, 63, 84, and 224 after the first investigational product administration, compared to baseline
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