Safety and Immunogenicity of CVI-VZV-001 for Prevention of Herpes Zoster in Healthy Adults Age 50 Years and Above
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age50-64
SponsorCHA Vaccine Institute Co., Ltd.
About this trial
The purpose of this study is to evaluate the safety and immunogenicity of the investigational medicinal product, CVI-VZV-001.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy adults over 50 years old and under 65 years old
Those who voluntarily decided to participate and gave written consent after hearing and understanding the detailed explanation of this clinical trial
Women with childbearing potential and those who agree to use the contraceptive method* permitted up to 3 months after the final vaccination for clinical trials (* Combination use such as hormonal contraception, intrathyroidal device (IUD (Intrauterine device) or IUS (Intrauterine system), vasectomy, tubal stomy, double block method (cervical cap, use with contraceptive diaphragm)
Women of childbearing potential with negative result at pregnancy test before vaccination for clinical trials.
Disqualifiers
Those with a past history of shingles before screening
Persons with hypersensitivity to clinical investigational products or the ingredients of clinical investigational products
Those with thrombocytopenia or other coagulation disorders who should not receive intramuscular injections, or those receiving anticoagulant therapy*
Those with a history of immune dysfunction, including immunodeficiency disease
Trial design
Design model
Sequential
Treatments tested in this trial
CVI-VZV-001
Biological/VaccineInvestigational Product
Shingrix
Biological/VaccineInvestigational Product
Treatment groups
32 Participants
are divided into 4 treatment groupsGroup A: Group 1Experimental treatment 1 intervention
Group B: Group 2Experimental treatment 1 intervention
Group C: Group 3Experimental treatment 1 intervention
Group D: Active ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Immediate adverse events
Occurrence of immediate adverse events
Time frame
within 30 minutes at each vaccination timepoint2
Solicited local and systemic signs and symptoms
Occurrence, severity, and duration of solicited local injection site reactions for 7 days (Day 0-Day 6) following each vaccination. (i.e., pain, redness, swelling) Occurrence, severity, and duration of solicited systemic reactions for 7 days (Day 0-Day 6) following each vaccination. (i.e., myalgia, fatigue, headache, chills, fever)
Time frame
Day 0 - Day 6 for each vaccination timepoint3
Unsolicited signs and symptoms
Occurrence, severity, and relationship to vaccination of unsolicited adverse events until 28 days following the last vaccination
Time frame
Until Week 4 post the 2nd vaccination4
SAEs
Occurrence of serious adverse events (SAEs)
Time frame
Until Week 48 post the 2nd vaccinationSecondary outcomes
1
Humoral immune response before the first and second vaccinations of investigational drugs and at 4, 24, and 48 weeks after the second vaccination.
Anti-VZV antibody titer, Anti-VZV glycoprotein ELISA
Time frame
Pre vaccinations(Day0, week 8) of 1st and 2nd vaccination, and at 4, 24, and 48 weeks post the 2nd vaccination2
Cell-mediated immunity (CMI) immune response before the first and second vaccinations of investigational drugs and at 4, 24, and 48 weeks after the second vaccination.
IFN-gamma ELISpot, Polyfunctional T cell(ICS)
Time frame
Pre vaccinations(Day0, week 8) of 1st and 2nd vaccination, and at 4, 24, and 48 weeks post the 2nd vaccinationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov