None listed
Conditions
Interventions
Intervention1: Anti-COVID-19 AKS-452 vaccine: Test product (Anti-COVID-19 AKS-452 Vaccine as two doses: 0.5 mL,(comprising Test product (150�µL AKS-452)
Each subject will be administered two doses o
Sponsors
Akston Biosciences Corporation
Veeda Clinical Research Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Written informed consent of a subject to participate in the trial. 2. Males and females aged ââ?°Â¥18 years. 3. Negative human immunodeficiency virus (HIV 1 & 2) and hepatitis B and C test results. 12. Sexually active women, unless surgically sterile (at least 6 months prior to Study drug administration) or postmenopausal for at least 12 consecutive months, must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives [any hormonal method in conjunction with a secondary method], intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile [at least 6 months prior to Study drug administration] sexual partner) for at least 1 month prior to study drug administration, during study and up to 6 month after the last dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician. 10. No evident vaccine-induced reactions or complications after receiving immune biological products in the medical history. 11. No acute infectious and/or respiratory diseases within at least 14 days before the enrolment. 5. Negative COVID-19 Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) test result at the screening visit (72 hours prior to Visit 2 [Day 1]). 6. No history of COVID-19 infection. 7. No history of receiving any COVID-19 vaccine (even a single dose) prior to enrollment. 8. No history of contact with patients with COVID-19 infections within at least 14 days before the enrolment (according to history provided by subjects). 9. Negative serum pregnancy test at the screening visit and negative urine pregnancy test at randomization visit for child-bearing age women. 4. Negative immunoglobulin M (IgM) and immunoglobulin G (IgG) SARS-CoV-2 antibodies through enzyme immunoassay test result. 13. In case of male subjects: either partner or subject must use an effective method of avoiding pregnancy for at least 1 month prior to study drug administration, during study and up to 3 month after the last dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician. It is investigatorââ?¬•s responsibility to ensure that above points regarding an effective method of avoiding pregnancy are discussed with subject/legally acceptable representative in detail and subject agreed for this and it is documented in source document. The investigator should ensure that the subject is using an effective method of avoiding pregnancy as per protocol. LAR is an individual or juridical or other body authorised under applicable law to represent the interests of an individual, including providing consent on behalf of a prospective subject to the subject participation in the clinical trial. Women must not participate in egg donation programs for assisted reproductive technologies for 3 months after the administration of the last dose of the vaccine studied. Men must not donate sperm for assisted reproductive technologies for 3 months after the administration of the last dose of the vaccine
Exclusion criteria
Exclusion criteria: 1. Any vaccination/immunization within 30 days before the enrolment. 2. Steroids (except hormonal contraceptives) and/or immune globulins or other blood products therapy not finished 30 days before the enrolment. 3. Immuno suppressor therapy finished within 3 months before the enrolment. 4. Pregnancy or breast-feeding. 5. Acute coronary syndrome or stroke suffered less than one year before the enrolment. 6. Tuberculosis, chronic systemic infections. 7. Drug allergy anaphylactic shock, Quincke s edema, polymorphic exudative eczema, atopy, serum disease, hypersensitivity or allergic reaction to immune biological products, known allergic reactions to study product components, acute exacerbation of allergic diseases on the enrolment day. 8. Subjects who are on drugs that could have potential drug interactions with the vaccine:drugs for multiple sclerosis (dimethyl fumarate, fingolimod, ozanimod, etc.), ïâ??· monoclonal antibodies, corticosteroids, corticotropin,antineoplastic drugs, cytostatic agents (platinum-based drugs, bleomycin, taxanes, methotrexate, melphalan, capecitabine, carmustine, vincristine, vinblastine, cyclophosphamide, cyclosporine, docetaxel, doxorubicin, daunorubicin, fluorouracil, etc.) and target drugs (dasatinib, lenalidomide, nilotinib, pemetrexed, everolimus, sirolimus, asparaginase, bortezomib, etc.) immune globulins, interleukins, X-ray contrast agents. 9. Medical history of malignancy. 10. Donated blood or plasma (450+ mL) within 2 months before the enrolment. 11. Splenectomy in the medical history. 12. Neutropenia (absolute neutrophil count blood loss, severe anaemia (haemoglobin autoimmune disorders in the medical history within 6 months before the enrolment. 13. Active form of a disease caused by the HIV and hepatitis B or C. 14. Anorexia, protein deficiency of any origin. 15. Tattoos at the injection site, which does not allow assessing the local response to the IMP/placebo administration. 16. Alcohol or drug addiction in the medical history. 17. Participation in any other interventional clinical trial within 1 month prior to the screening. 18. Any other medical condition that would limit the participation of the subject as per Investigatorââ?¬•s discretion. 19. Study centre staff or other employees directly involved in the trial and their families. 20. Subjects contraindicated for vaccination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety, tolerability and humoral immunogenicity profile of AKS- 452 following two injections in a combinatorial bridging and phase II/III clinical study at day 56.Timepoint: To evaluate the safety, tolerability and humoral immunogenicity profile of AKS- 452 following two injections in a combinatorial bridging and phase II/III clinical study at day 56. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety, tolerability and humoral immunogenicity profile of AKS- 452 following two injections in a combinatorial bridging and phase II/III clinical study at day 28, 90 and 180. To evaluate the inhibitory/neutralization potency of the SP/RBD-specific IgG titers induced by adjuvanted AKS-452 and to estimate peak titers and duration of the response. ïâ??· To evaluate the Th1/Th2 immune response profile.Timepoint: Anti-SARS-CoV-2 SP RBD IgG titers at days 1, 28, 56, 90, and 180. Serum titer inhibition of recombinant ACE2-SP/RBD binding and/or neutralization of live SARS-CoV-2 virus infection of live cells (Plaque Reduction Neutralization Test, PRNT) at days 1, 28, 56, 90, and 180. | — |
Countries
India
Contacts
Public ContactDr Ravi Alamchandani
Veeda Clinical Research Pvt, Ltd.
Outcome results
None listed