A Study of SN2001 Dose, Safety & Immunogenicity in Healthy Adults
ConditionChronic Hepatitis B Infection
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-55
SponsorChimivac INC
About this trial
This is a randomized, double-blind, placebo-controlled, multiple-ascending-dose study of SN2001 in healthy adult subjects. The study is designed to evaluate the safety, tolerability and immunogenicity of SN2001.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18 to 55 years, inclusive.
Body mass index (BMI) ≥18.0 kg/m2 and ≤ 32.0 kg/m2.
Participants are in good general health as determined by the investigator, based on a medical evaluation including medical history, vital signs, physical examination, 12-lead electrocardiogram, clinical laboratory tests.
Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as hysterectomy, bilateral ovariectomy or post-menopause. A postmenopausal state should be confirmed by at least 12 months since last menstrual period and FSH > 40 IU.
Disqualifiers
History of Hepatitis B virus (HBV) infection as evidenced by detection of HBV Surface and Core antigens.
Clinical laboratory evidence of active infection with human immunodeficiency virus (HIV) infection, or hepatitis C virus (HCV) infection, or hepatitis A virus (HAV), or hepatitis D virus (HDV), or syphilis and/or any other chronic viral infection.
Known exposure (e.g., sexual contact or blood exposure) to HBV within the past 6 weeks.
Have not previously been vaccinated in the community for Hepatitis B (Engerix-B or similar), or
Trial design
Design model
Sequential
Treatments tested in this trial
SN2001
Biological/Vaccine100 µg, for subcutaneous (SC) injection
SN2001
Biological/Vaccine200 µg, for subcutaneous (SC) injection
SN2001
Biological/Vaccine300 µg, for subcutaneous (SC) injection
Treatment groups
36 Participants
are divided into 3 treatment groupsGroup A: Cohort AExperimental treatment 1 intervention
Group B: Cohort BExperimental treatment 1 intervention
Group C: Cohort CExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of adverse events (AEs)
Number of subjects with AEs assessed by the 2007 FDA Guidance to Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Solicited local injection site reactions and solicited systemic symptoms on the day of each study injection and for 7 days. Non-serious unsolicited AEs will be collected until 21 days after 1st, 2nd, and 3rd study injection, and until 28 days after last study injection. All serious adverse events (SAEs), medically attended adverse events (MAAEs) and adverse events of special interest (AESIs) must be collected from the time of the first study injection through 48 weeks after the final study injection.
Time frame
from the time of the first study injection through 48 Weeks after the final study injection2
Number of subjects with clinically significant abnormalities in vital signs graded by 2007 FDA Guidance.
Vital sign measurements include blood pressure, pulse rate, respiratory rate and temperature. The number (n) and percentages (%) of "normal", "abnormal not clinically significant (NCS)", and "abnormal clinically significant (CS)" from baseline through the worst post-baseline visit will be summarized.
Time frame
from the time of the first study injection through 48 Weeks after the final study injection3
Number of subjects with clinically significant abnormalities in physical examination graded by 2007 FDA Guidance.
A full physical examination will include general appearance, head, neck, chest/respiratory, heart/cardiovascular, gastrointestinal/liver, extremities, skin, and neurological assessments. The number (n) and percentages (%) of "normal", "abnormal not clinically significant (NCS)", and "abnormal clinically significant (CS)" from baseline through the worst post-baseline visit will be summarized.
Time frame
from the time of the first study injection through 48 Weeks after the final study injection4
Number of subjects with clinically significant abnormalities in 12-lead electrocardiogram (ECG) graded by 2007 FDA Guidance.
12-lead ECGs will include heart rate, PR intervals, QRS intervals, QT intervals, and QTcF intervals. The number (n) and percentages (%) of "normal", "abnormal not clinically significant (NCS)", and "abnormal clinically significant (CS)" from baseline through the worst post-baseline visit will be summarized.
Time frame
from the time of the first study injection through 48 Weeks after the final study injectionSecondary outcomes
1
Serum SN2001 antibody titers.
Serum SN2001 antibody titers will be measured by enzyme linked immunosorbent assay (ELISA). Geometric mean titers (GMTs), and 95% confidence intervals (95% CI) will be calculated per cohort.
Time frame
from before the first study injection through 24 Weeks after the final study injection2
Seroconversion (SN2001).
Serum SN2001 antibody titers will be measured by ELISA. Seroconversion is defined as the appearance of antibodies \[i.e., concentrations/titer greater than or equal to the lower limit of quantification (LLOQ)\] in the serum of subjects seronegative before investigational product administration.
Time frame
from before the first study injection through 24 Weeks after the final study injection3
Serum HBV Core protein antibody titers.
Serum HBV Core protein antibody titers will be measured by ELISA. Geometric mean titers (GMTs), and 95% confidence intervals (95% CI) will be calculated per cohort.
Time frame
from before the first study injection through 24 Weeks after the final study injection4
Seroconversion (HBV Core protein).
Serum HBV Core protein antibody titers will be measured by ELISA. Seroconversion is defined as the appearance of antibodies (i.e., concentrations/titer greater than or equal to the LLOQ) in the serum of subjects seronegative before investigational product administration.
Time frame
from before the first study injection through 24 Weeks after the final study injectionSponsors and contacts
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Source ClinicalTrials.gov