A study to assess the safety and immunogenicity of Anti-COVID-19 AKS-452 vaccine for SARS-Сov-2infection in Indian healthy subjects.

Phase 2

• Registration Number: CTRI/2021/10/037269
• Lead Sponsor: Akston Biosciences Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Written informed consent of a subject to participate in the trial.

2. Males and females aged �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

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 <1,000 mm3), agranulocytosis, significant

blood loss, severe anaemia (haemoglobin <80 g/L), immunodeficiency including

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the safety, tolerability and humoral immunogenicity profile of AKS- <br/ ><br>452 following two injections in a combinatorial bridging and phase II/III clinical <br/ ><br>study at day 56.Timepoint: To evaluate the safety, tolerability and humoral immunogenicity profile of AKS- <br/ ><br>452 following two injections in a combinatorial bridging and phase II/III clinical <br/ ><br>study at day 56.

Secondary Outcome Measures

Name	Time	Method
To evaluate the safety, tolerability and humoral immunogenicity profile of AKS- <br/ ><br>452 following two injections in a combinatorial bridging and phase II/III clinical <br/ ><br>study at day 28, 90 and 180. <br/ ><br> <br/ ><br>To evaluate the inhibitory/neutralization potency of the SP/RBD-specific IgG <br/ ><br>titers induced by adjuvanted AKS-452 and to estimate peak titers and duration of <br/ ><br>the response. <br/ ><br>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. <br/ ><br>Serum titer inhibition of recombinant ACE2-SP/RBD binding and/or <br/ ><br>neutralization of live SARS-CoV-2 virus infection of live cells (Plaque <br/ ><br>Reduction Neutralization Test, PRNT) at days 1, 28, 56, 90, and 180.