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CTRI Number  CTRI/2021/10/037269 [Registered on: 12/10/2021] Trial Registered Prospectively
Last Modified On: 08/03/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A study to assess the safety and immunogenicity of Anti-COVID-19 AKS-452 vaccine for SARS-Сov-2 infection in Indian healthy subjects.  
Scientific Title of Study   A randomized, double-blinded, placebo-controlled, parallel-group, multi-centre, adaptive, seamless bridging study followed by a phase II/III study to assess the safety and immunogenicity of Anti-COVID-19 AKS-452 vaccine for SARS-Сov-2 infection in Indian healthy subjects. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Protocol 21-VIN-0277 version 01 dated 05 Aug 2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sumit Arora 
Designation  Vice President Clinical Operations 
Affiliation  Veeda Clinical Research Pvt, Ltd. 
Address  Veeda Clinical Research Ltd Shivalik Plaza, Near I.I.M. Ambawadi, Ahmedabad 380 015 India

Ahmadabad
GUJARAT
380015
India 
Phone  7930013000  
Fax  7930013010  
Email  Sumit.arora@veedacr.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ravi Alamchandani 
Designation  Dy. General Manager  
Affiliation  Veeda Clinical Research Pvt, Ltd. 
Address  Veeda Clinical Research Ltd Shivalik Plaza, Near I.I.M. Ambawadi, Ahmedabad 380 015 India

Ahmadabad
GUJARAT
380015
India 
Phone  7930013000  
Fax  7930013010  
Email  Ravi.A1950@veedacr.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ravi Alamchandani 
Designation  Dy. General Manager  
Affiliation  Veeda Clinical Research Pvt, Ltd. 
Address  Veeda Clinical Research Ltd Shivalik Plaza, Near I.I.M. Ambawadi, Ahmedabad 380 015 India


GUJARAT
380015
India 
Phone  7930013000  
Fax  7930013010  
Email  Ravi.A1950@veedacr.com  
 
Source of Monetary or Material Support  
Akston Biosciences Corporation, 100 Cummings Center, Suite 454C, Beverly, MA 01915, USA 
 
Primary Sponsor  
Name  Akston Biosciences Corporation 
Address  100 Cummings Center, Suite 454C, Beverly, MA 01915, USA 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Veeda Clinical Research Ltd  Shivalik Plaza, Near I.I.M., Ambawadi, Ahmedabad 380 015 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 12  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr S Suresh Kumar  Panimalar medical collage hospital and research Institute  Varadharjapuram, Poonamallee, Chennai 600123
Chennai
TAMIL NADU 
9994197191

Sureshgplus@gmail.com 
Dr Himanshiu Shashikant Pophale  ACE Hospital and Research  32, 2A, Gulawani Maharaj Road, Pandurang Colony, Erandwane, Pune, Maharashtra 411004
Pune
MAHARASHTRA 
7738363741

himanshupophale@yahoo.in 
Dr Kuntal Shah  Artham Hospital Multispeciality Hospital  Opp. Polytechnic college, near panjrapole cross road, Ambawadi, Ahmedabad- 380006
Ahmadabad
GUJARAT 
8980075065

kgshah.2008@gmail.com 
Dr Deshpande Shrikant Vinshnu  Ashirwad Hospital & Research Centre  Near Jijamata Udyan, Maratha Section, Ulhasnagar- 421004 Thane
Thane
MAHARASHTRA 
9822017445

writetosrikant@rediff.com 
Dr Krishna Giri  Dhadiwal Hospital in with Shreeji Health Care  Dhadiwal Hospital in with Shreeji Health Care, Trambakeshwar Rd, Opp. New, CBS, Matoshree Nagar, Nashik, Maharashtra 422002
Pune
MAHARASHTRA 
9825324056

drkmgiri@gmail.com 
Dr Smit Shah  DHS Multispeciality Hospital  Vastrapur lake, Himalaya mall link road, sunrise park, Vastrapur, Ahmedabad- 380054
Ahmadabad
GUJARAT 
7405310006

contactsmit@gmail.com 
Dr Gaurav Chhaya  Khyati Multispeciality Hospital  Opp Rajpath Club Road, S G Highway, Bodakdev, Ahmedabad – 380015
Ahmadabad
GUJARAT 
9825324056

gaurav.chhaya2010@yahoo.com 
Dr Prakash Sadashiv Shende  Lokmanya Medical Research Center  Railway Station, Lokmanya Hospital 314/B Telco road near Chinchwad, Pune, Maharashtra 411033
Pune
MAHARASHTRA 
9822246881

drprakashshende1979@gmail.com 
Dr Ambrish   Medstar specialist Hospital   Medstar specialist Hospital # 641/17/1/3 kodigehalli Main road sahakar Nagar Bangalore 560092 Karnataka
Bangalore
KARNATAKA 
9845895911

medstarclinicalresearch@gamil.com 
Dr Suresh Kumar  Panimalar medical collage hospital and research Institute  Varadharjapuram, Poonamallee, Chennai -600123
Chennai
TAMIL NADU 
9994197191

Sureshgplus@gmail.com 
Dr Vinay Bhomia  Sanjivani Supar Speciality Hospital Pvt Ltd   Near, 1, Uday Park Society, Sunrise Park Road, Vastrapur, Ahmedabad, Gujarat 380015
Ahmadabad
GUJARAT 
9825007385

drvinaybhomir@gmail.com 
Dr Pravin Dinkar Supe  Supe Heart and Diabetes and Research Center   Gharapure Ghat Rd, near Rungta High School, Ashok Stambh, Raviwar Karanja, Panchavati, Nashik, Maharashtra 422002
Nashik
MAHARASHTRA 
9405366165
02532232483
Pravinsupe@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 12  
Name of Committee  Approval Status 
Aartham Ethics Committe  Approved 
AMAI Trust ACE Hospital   Approved 
Ashirwad Ethics committee   Approved 
Asian Education & Research Foundation   Approved 
Institutional Human Ethics Committee  Approved 
Lokmanya Medical Research Center Ethics committee   Approved 
Medstar specilist Hospital Ethics committee  Approved 
Panimalar medical college and research institute Ethics committee  Approved 
Sangini Hospital Ethics Committee  Approved 
Sanjivani Hospital Ethics Committee   Approved 
Shree Institutional Ethics Commitee  Approved 
Supe Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  SARS-Сov-2 infection 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Anti-COVID-19 AKS-452 vaccine  Test product (Anti-COVID-19 AKS-452 Vaccine as two doses: 0.5 mL,(comprising Test product (150µL AKS-452) Each subject will be administered two doses of the IMP, subcutaneously, during Visit 2 (Day 1) and Visit 3 (Day 28±2). 
Comparator Agent  Mixture of normal saline (30% by volume) and Montanide ISA 720 adjuvant (70% by volume) (500 µL of adjuvanted placebo volume)  Medical grade injectable normal saline sourced, sterile filtered, and filled into sterile vials similar to AKS-452-IMP. Manufacturer of injectable normal saline – Sodium chloride 0.9% solution for infusion Product Each subject will be administered two doses of the IMP, subcutaneously, during Visit 2 (Day 1) and Visit 3 (Day 28±2). 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  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 investigator’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 studied. 
 
ExclusionCriteria 
Details  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.),
 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 Investigator’s discretion.
19. Study centre staff or other employees directly involved in the trial and their
families.
20. Subjects contraindicated for vaccination. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
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. 
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 Outcome  
Outcome  TimePoints 
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.
 To evaluate the Th1/Th2 immune response profile. 
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. 
 
Target Sample Size   Total Sample Size="1600"
Sample Size from India="1600" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   25/10/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response - None of the above

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 03-10-2021 and end date provided 08-12-2021?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Anti-COVID-19 AKS-452 Vaccine for severe acute respiratory syndrome coronavirus 2 (SARS-СoV-2) infection has been developed by Sponsor and is undergoing clinical dose finding studies in other countries. In order to evaluate the  safety, immunogenicity and efficacy of this vaccine in Indian healthy subjects a bridging study followed by a phase II/III study has been planned by the Sponsor. As per the Guidelines for the Clinical Evaluation of Vaccines by the European Medical Agency (2018 EMA) in the event that a "gold standard" does not exist as a comparator, it is considered reasonable that the control group receive a placebo in the comparative clinical study. The United States (US) Food and Drug Administration (FDA) June 2020 Guidance for Industry on Development and Licensure of Vaccines to Prevent COVID-19 Section C (Trial Design) explicitly state that the trials of vaccines aimed to prevent coronavirus infection induced by SARS-CoV-2 virus should be randomized, double blinded and placebo controlled.
 
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