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CTRI Number  CTRI/2021/04/032688 [Registered on: 08/04/2021] Trial Registered Prospectively
Last Modified On: 29/05/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Safety and immunogenicity study of mRNA based vaccine (HGCO19) against COVID-19 in healthy adult participants. 
Scientific Title of Study   Randomized, Phase I/II, Placebo-controlled, Dose-Ranging, study to evaluate the Safety, Tolerability and Immunogenicity of the candidate HGCO19 (COVID-19 vaccine) in healthy adult subjects. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
GBL/HGCO19/2020/01; Version 1.0 Dated 11 Nov 2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query
 
Name  Dr Amit Saraf 
Designation  Assistant General Manager 
Affiliation  Gennova Biopharmaceuticals Limited 
Address  Gennova Vaccine Formulation Centre and Research Laboratory, BTS-2 Building, Chrysalis Enclave, Block-2, Plot-2, International Biotech Park, Phase II, MIDC Hinjawadi,

Pune
MAHARASHTRA
411057
India 
Phone  02039166300  
Fax    
Email  amit.saraf@gennova.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Amit Saraf 
Designation  Assistant General Manager 
Affiliation  Gennova Biopharmaceuticals Limited 
Address  Gennova Vaccine Formulation Centre and Research Laboratory, BTS-2 Building, Chrysalis Enclave, Block-2, Plot-2, International Biotech Park, Phase II, MIDC Hinjawadi,

Pune
MAHARASHTRA
411057
India 
Phone  02039166300  
Fax    
Email  amit.saraf@gennova.co.in  
 
Source of Monetary or Material Support  
Gennova Biopharmaceuticals Limited, Block 1, Plot No. P-1 and P-2, ITBT Park, Phase-II, MIDC, Hinjawadi, Pune- 411057  
 
Primary Sponsor  
Name  Gennova Biopharmaceuticals Limited 
Address  Gennova Biopharmaceuticals Limited, Block 1, Plot No. P-1 and P-2, ITBT Park, Phase-II, MIDC, Hinjawadi, Pune- 411057, Maharashtra 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pradeep DCosta  KEM Hospital Research Center  KEM Hospital Research Center, Sardar Moodliar Road, Rasta Peth,
Pune
MAHARASHTRA 
09822632812

pradeepdcosta@yahoo.co.in 
Dr Vijaykumar B Barge  Rajashree Chhatrapati Shahu Maharaj Govt. Medical College  Dasara Chowk, Town Hall, Bhausingji road,
Kolhapur
MAHARASHTRA 
09011066766

drvijaybarge12@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Ethics Committee, Dr. D.Y. Patil Vidyapeeth, Pimpri, Pune   Approved 
Institutional Ethics Committee II, RCSMGMC and CPR Hospital, Kolhapur  Approved 
KEM Hospital Research Centre Ethics Committee, Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Active immunization for prevention of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  HGCO19 (COVID-19 vaccine)   Novel mRNA-based candidate vaccine candidate, using Spike (S)-protein of the virus as antigen. HGCO19 will be administered IM at day 1 and day 29. 
Comparator Agent  Placebo  Two doses of 0.5 ml of placebo (buffer), administered Intramuscularly at 4-weeks apart.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Applicable for both phases of study: 1. Male and female subjects aged between 18 to 70 years (Phase I) / 18 to 75 years (Phase II) (both inclusive) at randomization. 2. Healthy as judged by medical history, physical and other examination or investigations and in the clinical opinion of the Investigator. 3. Subject should be capable and willing to give voluntary written informed consent prior to inclusion in the study. 4. Able to comprehend and comply with study requirements and procedures and be able and willing to complete subject diary. 5. Negative / Non-reactive for antibodies against SARS-CoV-2. 6. Negative / Non-reactive RT-PCR screening of nasopharyngeal swabs/suitable sample for SARS CoV-2 within 72 hours prior vaccination. 7. Male subjects who are sexually active or married and female subjects who are sexually active or married and are of child bearing potential should be willing to follow effective birth control methods for duration of the study. Note: Birth control methods include vasectomised subject/partner; or any 2 of the following methods: intrauterine device; oral, transdermal, injected, or implanted contraceptive; condoms; occlusive cap (diaphragm or cervical vault caps); spermicidal foam/gel/cream, etc. OR Exception to the above are male subjects who are infertile (post vasectomy with documented azoospermia or bilateral orchidectomy) and female subjects who are of non-childbearing potential [who are surgically sterile (hysterectomy, bilateral tubal ligation or bilateral salpingo-oophorectomy) or postmenopausal subjects with amenorrhea for at least 2 years] 
 
ExclusionCriteria 
Details  Exclusion Criteria for Phase I:
1. Subject with a medical history of COVID-19 infection or who has received vaccine to prevent COVID-19 infection.
2. Subjects with a BMI > 30 kg/m2
3. Protocol defined laboratory assessments outside the range/limit defined in Appendix 2. Any other laboratory value if ≥ Grade 2 as per DAIDs criteria.
Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected version 2.1, July 2017, of the US National Institutes of Health
4. Any illness or any other current or pre-existing health condition (e.g. any major pulmonary, cardiovascular, renal, neurological, metabolic, gastro-intestinal, hepato-biliary, haematological functional abnormality, mental or physical disability, blood dyscrasia, major congenital defects, etc.) which in the opinion of the Investigator may affect the safety of the subject or the study endpoints.
5. Individuals currently working in occupations with high risk of exposure to SARS-CoV-2 (e.g. healthcare worker in direct care of COVID-19 patients, front line workers in COVID 19 hotspots / outbreak areas).
6. History of allergic/hypersensitivity reactions or anaphylaxis to any vaccine or components of study vaccine.
7. Subject has any acute illness (moderate or severe) at the time of vaccination and/or fever (oral temperature ≥38°C or ≥100.4 °F) within 48 hours prior to vaccination.
8. History of cancer, organ transplant, any other clinically significant immunosuppressive condition or autoimmune disease.
9. Subject has uncontrolled chronic disease including asthma, diabetes (HbA1c of >9%), hypertension (Systolic Blood pressure of >160 mm of Hg and/ or Diastolic Blood Pressure of >100 mm of Hg), thyroid disorder as assessed by the Investigator.
10. Subjects who are pregnant or breast feeding or willingness/intention to become pregnant during the study.
11. Prior major surgery or any radiation therapy within 4 weeks of Screening visit.
12. Positive serologic test for HIV 1 and 2, HBsAg or HCV.
13. Current (within 14 days prior to Screening visit) or anticipated concomitant immune modifying or immunosuppressive therapy (excluding inhaled, topical skin or eye drop-containing corticosteroids, low-dose methotrexate, or corticosteroids at a dose less than 20 mg/day).
14. Planned or actual receipt of any vaccine other than the study intervention within 30 days before and after each study vaccination.
15. Eczema or other significant skin lesion or infection at the site of vaccination.
16. Administration of blood, blood products and/or plasma derivatives or any immunoglobulin preparation 90 days prior to screening visit.
17. Bleeding diathesis or condition associated with prolonged bleeding.
18. Participating in another clinical trial within 30 days prior to Screening visit or planning to participate in another clinical trial during the study duration or planning to migrate.
19. Any other condition which in the opinion of the Investigator may affect subject’s safety or participation.

Exclusion Criteria for Phase II:
1. Subject with a medical history of COVID-19 infection or who has received vaccine to prevent COVID-19 infection.
2. Any clinically significant laboratory values or illness or any other current or pre-existing health condition (e.g. any major pulmonary, cardiovascular, renal, neurological, metabolic, gastro-intestinal, hepato-biliary, haematological functional abnormality, mental or physical disability, blood dyscrasia, major congenital defects, etc.) which in the opinion of the Investigator may affect the safety of the subject or the study endpoints.
3. History of allergic/hypersensitivity reactions or anaphylaxis to any vaccine or components of study vaccine.
4. Subject has any acute illness (moderate or severe) at the time of vaccination and/or fever (oral temperature ≥38°C or ≥100.4 °F) within 48 hours prior to vaccination.
5. History of cancer, organ transplant, any other clinically significant immunosuppressive condition or autoimmune disease.
6. Subject has uncontrolled chronic disease including asthma, diabetes (HbA1c of >9%), hypertension (Systolic Blood pressure of >160 mm of Hg and/ or Diastolic Blood Pressure of >100 mm of Hg), thyroid disorder as assessed by the Investigator.
7. Subjects who are pregnant or breast feeding or willingness/intention to become pregnant during the study.
8. Prior major surgery or any radiation therapy within 4 weeks of Screening visit.
9. Positive serologic test for HIV 1 and 2, HBsAg or HCV.
10. Current (within 14 days prior to Screening visit) or anticipated concomitant immune modifying or immunosuppressive therapy (excluding inhaled, topical skin or eye drop-containing corticosteroids, low-dose methotrexate, or corticosteroids at a dose less than 20 mg/day).
11. Planned or actual receipt of any vaccine other than the study intervention within 30 days before and after each study vaccination.
12. Eczema or other significant skin lesion or infection at the site of vaccination
13. Administration of blood, blood products and/or plasma derivatives or any immunoglobulin preparation 90 days prior to screening visit.
14. Bleeding diathesis or condition associated with prolonged bleeding.
15. Participating in another clinical trial within 30 days prior to Screening visit or planning to participate in another clinical trial during the study duration or planning to migrate.
16. Any other condition which in the opinion of the Investigator may affect subject’s safety or participation.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Occurrence and severity of local reactogenicity AEs for 7 days following each dose of vaccination.
2. Occurrence, severity and relationship of systemic reactogenicity AEs for 7 days following each dose of vaccination.
3. Occurrence, severity and relationship of unsolicited AEs up to 28 days following each dose of vaccination.
4. Occurrence of SAE at any time during study participation.
5. Changes in safety assessments including laboratory parameters and vital signs from baseline. 
Occurrence of solicited AEs within 7 days post each dose of vaccine. Occurrence of Unsolicited AEs upto 28 days post each dose of vaccine (day 29 and day 57). SAEs thorough out the duration of the study.  
 
Secondary Outcome  
Outcome  TimePoints 
1. Geometric mean titer (GMT) as measured by IgG-ELISA to SARS-CoV-2 Spike protein and against the RBD of Spike protein at Day 57 (28 days post Dose 2).
2. Geometric mean fold rise (GMFR) in SARS CoV-2 Spike protein-specific binding antibody (IgG) levels and in RBD of Spike protein IgG levels from baseline at Day 57.
 
At day 57. 
Exploratory Outcomes:
1. GMT of SARS-CoV-2 specific serum neutralizing antibody levels as measured by pseudovirus/ surrogate virus neutralization assay at Day 29 (before Dose 2), Day 57, Day 119 and Day 209.
2. GMT of SARS-CoV-2 specific serum neutralizing antibody levels as measured by live virus SARS-CoV-2 neutralization assay [Plaque Reduction Neutralization Test (PRNT)] at Day 29, Day 57, Day 119 and Day 209.
 
At day 29, day 57, day 119 and day 209.  
Exploratory Outcomes:
3. Relationship (correlation analysis) between SARS-CoV-2 neutralizing antibody and S-protein and RBD of S-protein IgG titers at Days 29, 57, 119, and 209.
4. GMT as measured by IgG-ELISA to SARS-CoV-2 S-protein and against the RBD of S-protein at Days 29, 119 and 209.
5. GMT as measured by IgM-ELISA to SARS-CoV-2 S-protein at Days 29, 57, 119, and 209.
6. SARS-CoV-2 Spike protein specific T-cell responses as measured by flow cytometry at Days 29, 57, 119, and 209.
 
At day 29, day 57, day 119 and day 209. 
Exploratory Outcome:
7. Number of subjects with laboratory confirmed COVID-19 infection during study participation. 
Throughout the study duration. 
 
Target Sample Size   Total Sample Size="620"
Sample Size from India="620" 
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 1/ Phase 2 
Date of First Enrollment (India)   19/04/2021 
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 Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Not Available 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sanjay.singh@gennova.co.in].

  6. For how long will this data be available start date provided 01-09-2021 and end date provided 30-09-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

This is a dose ranging, placebo-controlled, Phase I/II study in healthy adult subjects. The study will evaluate escalating dose strengths of HGCO19 administered intramuscularly as a two-dose regimen 28 days apart. Phase-1 study is a randomized, open-label, placebo-controlled, multi-centre study to assess the safety and immunogenicity of HGCO19 vaccine. Phase-1 study will enrol 120 healthy participants in the age group of 18-70 years. Phase II study is a randomized, observer-blind, placebo-controlled, multi-centre study to assess safety and immunogenicity of HGCO19 in comparison to placebo. In the Phase-2 study, approximately 500 healthy subjects in the age group of 18 to 75 years will be enrolled.

 
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