None listed
Conditions
Brief summary
This project is evaluating the safety, tolerability (if any side effects occur), and immunogenicity (the ability of a molecule or substance to provoke an immune response) of two vaccinations with the study drug TVAX-006, a vaccine which is being developed with the aim to help prevent shingles. To evaluate the study drug, it will be tested in different groups who will receive different comparators. Grand Theravac Life Sciences (Nanjing) Co., Ltd is developing the study vaccine, a recombinant zoster vaccine, as a potential new way to prevent shingles for adults aged between 30-70 years. These long-term complications are the primary reason why vaccination is needed. Vaccination protects individuals from herpes zoster and postherpetic neuralgia and reduces associated medical and psychosocial outcomes and costs for the patient. The current treatments available once someone has herpes zoster and postherpetic neuralgia have limited success, so it is much better to prevent it from occurring at all. This makes vaccination a particularly important strategy for Australians to prevent this debilitating disease, especially in the elderly.
Interventions
Arm 1 Low dose adjuvant + antigen group: 0.5 mL/vial, administered 0.5 mL intramuscular injection per vaccination on Day 1 and Day 61. Containing 50 µg of Varicella-zoster Virus Glycoprotein E (VZV-gE) antigen, along with half-dose adjuvant system TVA01: 25 µg of Quillaja saponaria Molina, fraction 21 (QS-21), 250 µg of cytosine-phosphate-guanine Oligodeoxynucleotides (CpG ODN).
Arm 2 high dose adjuvant + antigen group: 0.5 mL/vial, administered 0.5 mL intramuscular injection per vaccination on
Arm 1 Low dose adjuvant + antigen group: 0.5 mL/vial, administered 0.5 mL intramuscular injection per vaccination on Day 1 and Day 61. Containing 50 µg of Varicella-zoster Virus Glycoprotein E (VZV-gE) antigen, along with half-dose adjuvant system TVA01: 25 µg of Quillaja saponaria Molina, fraction 21 (QS-21), 250 µg of cytosine-phosphate-guanine Oligodeoxynucleotides (CpG ODN). Arm 2 high dose adjuvant + antigen group: 0.5 mL/vial, administered 0.5 mL intramuscular injection per vaccination on Day 1 and Day 61. Containing 50 µg of Varicella-zoster Virus Glycoprotein E (VZV-gE) antigen, along with half-dose adjuvant system TVA01: 50 µg of Quillaja saponaria Molina, fraction 21 (QS-21,500) µg of cytosine-phosphate-guanine Oligodeoxynucleotides (CpG ODN). Arm 3 Low dose adjuvant group: 0.5 mL/vial, administered 0.5 mL intramuscular injection per vaccination on Day 1 and Day 61. Containing half-dose adjuvant system TVA01: 25 µg of Quillaja saponaria Molina, fraction 21 (QS-21), 250 µg of cytosine-phosphate-guanine Oligodeoxynucleotides (CpG ODN). Arm 4 high dose adjuvant group: 0.5 mL/vial, administered 0.5 mL intramuscular injection per vaccination on Day 1 and Day 61. Containing adjuvant system TVA01: 50 µg of Quillaja saponaria Molina, fraction 21 (QS-21), 500 µg of cytosine-phosphate-guanine Oligodeoxynucleotides (CpG ODN). A registered nurse will administer the injections to participants. The nurse will record the time of injection in trial notes and if it's completed or interrupted. Other staff can assess clinic notes for any indications of medication non-adherence.
Sponsors
Bestudy Australia Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
30 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1) Healthy men or women aged 30 to 70 years. 2) Able to fully understand and voluntarily sign the informed consent form ICF. 3) Able to comply with the requirements for the clinical research protocol to complete the trial. 4) Females of childbearing potential must agree not to become pregnant from signing the ICF and through 6 months after the last vaccination. Men and women of childbearing potential must agree to use contraception from signing the ICF and through 6 months after the last vaccination OR be defined as not of childbearing potential 5). Female subjects of childbearing potential, must have a negative pregnancy test at screening, and negative urine pregnancy test at D1, and are not lactating and agree not to breastfeed up to 6 months post full vaccination. 6). Male participants must be vasectomized or agree to wear a condom during intercourse with a women of child bearing potential (WOCBP). Male participants must inform their female partners who are WOCBP of the contraceptive requirements of the protocol and are expected to adhere to using contraception with their partner.
Exclusion criteria
Exclusion criteria for first dose 1) A history of herpes zoster. 2) Subject has received any varicella zoster vaccine or herpes zoster vaccine or planning to take those vaccines during the study. 3) Any clinically significant allergic history, including to any vaccine or vaccine-related component, such as urticaria, difficulty breathing, or angioneurotic edema, or any clinically significant allergic reactions. 4) Received any immunosuppressive therapy (e.g. long-term application of systemic glucocorticoids greater than or equal to 14 days, with dose greater than or equal to 2 mg/kg/day or greater than or equal to 20 mg/day of prednisone or equivalent dose of prednisone dose) within 3 months before dosing (excluding administration of inhaled, intra-articular, and topical steroids); receipt of whole blood or blood products within 3 months before vaccination or plan to use them during the study period. 5) Previous vaccination with any vaccine within 30 days before each vaccination or planning to take any vaccine 30 days after each vaccination. 6) History of convulsions, epilepsy, encephalopathy (e.g. congenital cerebral hypoplasia, brain trauma, brain tumor, cerebral hemorrhage, cerebral infarction, brain infection, cerebral nerve tissue damage caused by chemical drug poisoning, etc.); clinically significant history of psychiatric disease or family history of bipolar disorder, schizophrenia. 7) History of malignancy [excluding basal cell carcinomas (BCC) and squamous cell carcinomas (SCC)] within 5 years prior to randomization 8) Asplenia or functional asplenia, or splenectomy caused by any circumstances. 9) Presence of primary or secondary immunodeficiencies or have been diagnosed with congenital or acquired immunodeficiency, infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease (IBD), or other autoimmune disease. 10) Has severe cardiovascular diseases (pulmonary heart disease, pulmonary edema), severe liver or renal diseases, chronic obstructive pulmonary; uncontrolled diabetes [hemoglobin A1c (HbA1c) >9.0%]. 11) History of thrombocytopenia or other coagulation disorders which may be contraindications for an intramuscular injection. 12) Abnormal blood pressure in sitting position at any time points during screening and before the first vaccination (systolic pressure greater than or equal to 145 mmHg and/or diastolic pressure greater than or equal to 95 mmHg). 13) History of fever within 3 days before the first dose (tympanic temperature greater than 37.5 degree celsius) or have suffered acute diseases requiring systemic application of antibiotics or antiviral therapy or in the acute phase of chronic infection within 7 days before vaccination. 14) Any laboratory values out-of-range at the investigator’s discretion, or with clinical significance as judged by the investigator. 16) Positive serology test results for hepatitis C virus antibody (HCV Ab), human immunodeficiency virus (HIV) antibody, syphilis treponema pallidum (S-TP) antibody, Hepatitis B core antibody (HBcAb) or hepatitis B virus surface antigen (HBsAg) test at screening. 17) Those who have a history of alcoholism or excessive drinking (14 units/week for female and 21 units/week for male. 1 unit = 285 mL beer, or 25 mL liquor, or 100 mL wine) within 6 months prior to dosing or have a positive result in alcohol breath test. 18) Subject does not have one suitable injection site (deltoid muscle of either arm) due to any conditions that are judged by the investigator to be unsuitable for intramuscular injection, such as tattoo/scars, ulceration, etc.. 19) Received any investigational drugs or vaccines within 30 days before vaccination. 20) Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to the first dosing. 21) Received anticoagulants including aspirin within 15 days or the first vaccination planning to take such drugs from the first vaccination to 6 weeks after the full vaccination. 22) Any reason which, in the opinion of the investigator, would interfere with the study objectives or the safety of participants, including but not limited to subject is judged to be unlikely to complete the protocol for any reason. Exclusion criteria for second dose 1) Participants who meet the exclusion criteria for the first dose after receiving the first dose, as determined by the investigator, will not be eligible to continue participating in the study. 2) Participants who experience a serious adverse reaction (SAR) after receiving the first dose, as determined by the investigator, will not be eligible to continue participating in the study. 3) Participants who experience a severe allergic reaction after receiving the first dose, as determined by the investigator, will not be eligible to continue participating in the study. 4) Any other factors judged by investigator that are not suitable for the participants to continue the study.
Outcome results
None listed