None listed
Conditions
Interventions
Intervention1: TETRALITE vaccine (1/5th dose (3 microgram) of VaxiFlu-4â?¢ + 0.5 mg LVA): Novel, inactivated, adjuvanted, seasonal influenza vaccine combining a low (1/5th) dose of VaxiFlu-4â?¢ and 0.
Sponsors
BRIC - Translational Health Science and Technology Institute (THSTI)
Gennova Biopharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Written and signed informed consent obtained before any study-related activities. 2.Aged 18 to 50 years (inclusive), at the time of signing the Informed Consent Form (ICF) 3.Participants who are considered to be in good general health as determined by a medical evaluation including medical history, Physical Examination (PE), and laboratory tests within 21 days prior to enrolment. 4.Participants with a Body Mass Index (BMI) within the range of 18.5 to 35 kg/m2 inclusive at screening. 5.No serologic markers of past or ongoing Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), and Human Immunodeficiency Virus (HIV) infection. 6.Women who are not pregnant or breastfeeding, and one of the following conditions applies: • Women of non-childbearing potential (WONCBP): Non-childbearing potential is defined as surgically sterilized (e.g. hysterectomy, bilateral oophorectomy, or tubal ligation/salpingectomy) or postmenopausal (defined as having no menstrual bleeding for at least 12 months) without an alternative medical cause prior to study. (OR) • Women of Childbearing Potential (WOCBP) and using a highly effective contraceptive method (with a failure rate of less than 1 % per year),from at least one month prior to study vaccination and for 3 months post vaccination. The investigator should evaluate the potential for contraceptive method failure (e.g. noncompliance, recently initiated) in relation to study vaccination. Highly effective contraception is defined as stabilized on oral birth control for at least one month before study participation, intrauterine device/system, implant, injection, transdermal patch, vasectomized partner, or sexual abstinence (excluding periodic abstinence). The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant. The participant should commit her abstinence for at least one month prior to study vaccination and for 3 monthsâ?? post vaccination. If the participant will not maintain abstinence and changes her status, the participant must first commit to another highly effective method of contraception, which should be discussed with the investigator prior to terminating sexual abstinence as a contraceptive method. 7.WOCBP must have a negative serum pregnancy test at screening and a negative urine pregnancy test before vaccination on day of randomization (Day 1). The investigator is responsible for reviewing medical history and menstrual history to decrease the risk of inclusion of a woman with early undetected pregnancy. 8.Participants who are willing and able to comply with the study procedures and are in the view of the investigator capable of completing the study.
Exclusion criteria
Exclusion criteria: 1.History of lab-confirmed influenza infection, excluding COVID-19, 12 months prior to the day of study vaccination. 2.Past history or current immune-mediated and/or autoimmune diseases as indicated by the investigator. 3.History of serious reactions to vaccines as determined by the investigator. 4.Clinical conditions which are a contraindication for IM administration, as judged by the investigator. 5.History of confirmed hypersensitivity, allergy, and/or anaphylaxis to eggs, squalene-based adjuvants, or other components of the study vaccine (neomycin, formaldehyde or octoxinol-9). 6.Uncontrolled medical illness (unstable for the past 3 months) as indicated by the investigator. 7.Past or current history of any neurological disorder,e.g. Guillain-Barré syndrome and seizure disorder other than: 1) febrile seizures, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) seizures that have not required treatment within the last 3 years. 8.History of asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen. 9.Malignancy that is active, or treated for which there is not reasonable assurance of sustained cure, or that is likely to recur during the period of the study. 10.Asthma that is unstable or requires emergent care,hospitalization or intubation during the past two years or that is expected to require the use of oral or intravenous corticosteroids. 11.History of hereditary angioedema, acquired angioedema and/or idiopathic forms of angioedema. 12.History of idiopathic urticaria within the past year. 13.History of heavy smoking, drug/alcohol abuse/addiction or psychiatric condition which in the investigatorâ??s opinion. 14.A rash, dermatological condition, or tattoos that would, in the opinion of the investigator, interfere with injection local reaction rating. 15.Receipt of a seasonal or pandemic influenza vaccination 6 months before administration of the study vaccine or planning to receive the influenza vaccination during the study period. 16.Receipt of an investigational pandemic influenza vaccine 6 months before administration of study vaccine or planning to receive such a product during the study period. 17.Receipt of a live attenuated vaccine, or subunit or inactivated vaccines 28 days prior to administration of the study vaccine, other than seasonal or pandemic influenza vaccination, excluding COVID-19 vaccine. 18.Receipt of a COVID-19 vaccine 7 days before administration of study vaccine. 19.Planning to receive any vaccine (other than influenza) during the first 28 days following the administration of the study vaccine. 20.Currently participating in another clinical study, or planning to participate in another study during the study period, or administration of any investigational drug or medical device in the 4 weeks prior to study vaccination. 21.Prior receipt of blood, blood-derived products, or immunoglobulins in the 6 months prior to administration of study vaccine, or planning to receipt such product during the study period. 22.Use of drugs that can affect immune response such as systemic corticosteroids (excluding topical preparations and inhaled preparations) or immunosuppressive drugs in the 30 days before study vaccination and/or in the first 28 days following study vaccination, with the exception that a short course
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of a single administration of TETRALITE(3 microgram VaxiFlu-4â?¢+0.5mg or 1mg adjuvant)versus15 microgram VaxiFlu 4â?¢ without adjuvant in healthy participants(18-50years).Timepoint: 1.Occurrence of solicited local and systemic adverse events (AEs) for 7 days after vaccination. 2.Occurrence of unsolicited AEs for 28 days after vaccination. 3.Occurrence of serious adverse events (SAEs), potential immune-mediated disorders (pIMDs), and adverse events of special interest (AESIs) for 180 days after vaccination. 4.Occurrence of clinically abnormal haematology and serum biochemistry laboratory values at 7 days, 28 days, and 180 days after vaccination versus baseline (Day1, pre-vaccination). | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate humoral immune responses from a single administration of TETRALITE (3 microgram VaxiFlu-4â?¢ + 1mg adjuvant) versus VaxiFlu-4â?¢ without adjuvant (3 microgram and 15 microgram) in healthy participants (18-50 years).Timepoint: Immunogenicity of TETRALITE will be determined by: 1. HI antibody titre in serum samples against the 4 vaccine influenza strains at 7 days, 28 days, and 180 days after vaccination versus baseline (Day 1, pre-vaccination) 2. MN antibody titre in serum samples against the 4 vaccine influenza strains at 7 days, 28 days, and 180 days after vaccination versus baseline (Day 1, pre-vaccination). ;To evaluate the T cell immune responses from a single administration of TETRALITE (3 microgram VaxiFlu-4â?¢ + 0.5 mg or 1mg adjuvant) versus 15 microgram VaxiFlu-4â?¢ without adjuvant in healthy participants (18-50 years).Timepoint: 1. T cell-mediated immune response in PBMCs at 7 days, 28 days, and 180 days after vaccination versus baseline (Day 1, pre-vaccination) confirmed by the presence of influenza-specific CD4 plus and CD8 plus T cells producing at least CD40L, IL-2, Interferon gamma and/or TNF alpha, measured by flow cytometry (intracellular cytokine staining). 2. Additional assays may include but are not limited to genetic analysis and omics approaches such as transcriptomics, proteomics, and metabolomics. ;To further evaluate the humoral response from a single administration of TETRALITE (3 microgram VaxiFlu-4â?¢ + 0.5 mg or 1mg adjuvant) versus 15 microgram VaxiFlu-4â?¢ without adjuvant in healthy participants (18-50 years).Timepoint: Additional assays may include but are not limited to cross-reactive antibodies.;To identify participants who have been infected with influenza virus during the study.Timepoint: The measurement of anti-nucleoprotein (NP) Immunoglobulin G (IgG) concentration in serum samples at baseline (Day 1, pre-vaccination), 28 days, and 180 days after vaccination. | — |
Countries
India
Contacts
Public ContactDr Nitya Wadhwa
BRIC-Translational Health Science and Technology Institute (THSTI)
Outcome results
None listed