A Study to Evaluate INT101 in Healthy Adults for the Prevention of Norovirus Gastroenteritis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19-48
SponsorInThera Inc. Korea
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy adults aged 19 to 48 years (inclusive) as of the screening visit
Body Mass Index (BMI) of 18.0 to 30.0 kg/m² (inclusive) at screening
Women and men of reproductive potential willing to use a highly effective contraceptive method (hormonal contraceptives, intrauterine device/system, or sterilization) from 30 days prior to the first investigational product administration through 2 months after the last administration
For female participants, a negative pregnancy test result at screening
Disqualifiers
Autoimmune disease (e.g., rheumatoid arthritis, hypothyroidism) at screening
Uncontrolled hypertension (BP not controlled below 140/90 mmHg, or 130/80 mmHg if diabetic, despite maximal doses of 3 or more antihypertensive agents) or diabetes (HbA1c >7.0%)
Neurological disease (e.g., epilepsy, seizure, Guillain-Barre syndrome)
Asthma
Trial design
Design model
Sequential
Treatments tested in this trial
INT101 Low Dose
Biological/VaccineNorovirus 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.
INT101 High Dose
Biological/VaccineNorovirus 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.
INT101 Placebo (0.25 mL)
Biological/VaccineMatching 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.
INT101 Placebo (0.5 mL)
Biological/VaccineMatching 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.
Treatment groups
30 Participants
are divided into 4 treatment groupsGroup A: Test Group 1 (Low Dose)Experimental treatment 1 intervention
Group B: Test Group 2 (High Dose)Experimental treatment 1 intervention
Group C: Control Group 1Placebo comparator 1 intervention
Group D: Control Group 2Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence 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)2
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 administration3
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 administration4
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 9Secondary outcomes
1
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 baseline2
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 baseline3
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 baselineSponsors and contacts
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Source ClinicalTrials.gov