CTRI/2021/11/038168 [Registered on: 22/11/2021] Trial Registered Prospectively
Last Modified On:
24/11/2022
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Vaccine
Study Design
Non-randomized, Active Controlled Trial
Public Title of Study
A open label, dose escalation phase I clinical
study to evaluate the safety, tolerability and
immunogenicity of SARS-CoV-2
Recombinant protein subunit vaccine in healthy
volunteers.
Scientific Title of Study
A prospective, open label, dose escalation phase I clinical study to evaluate the safety, tolerability and immunogenicity of Reliance Life Sciences’ SARS-CoV-2 Recombinant protein subunit vaccine in healthy volunteers
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Ajaykumar Yadav
Designation
Head - Clinical Research (overall Trial Coordinator)
Affiliation
Reliance Life Sciences Pvt. Ltd. (RLS)
Address
Reliance Life Sciences Pvt. Ltd. (RLS) Dhirubhai Ambani Life Sciences Centre (DALC) Plot R 282 TTC Area of MIDC Thane Belapur Road Rabale, Navi Mumbai Reliance Life Sciences Pvt. Ltd. (RLS) Dhirubhai Ambani Life Sciences Centre (DALC) Plot R 282 TTC Area of MIDC Thane Belapur Road Rabale, Navi Mumbai 400 701 Thane MAHARASHTRA 400701 India
Reliance Life Sciences Pvt. Ltd. (RLS) Dhirubhai Ambani Life Sciences Centre (DALC) Plot R 282 TTC Area of MIDC Thane Belapur Road Rabale, Navi Mumbai Reliance Life Sciences Pvt. Ltd. (RLS) Dhirubhai Ambani Life Sciences Centre (DALC) Plot R 282 TTC Area of MIDC Thane Belapur Road Rabale, Navi Mumbai 400 701 Thane MAHARASHTRA 400701 India
Phone
9321701597
Fax
Email
Gajanan.Namjoshi@relbio.com
Details of Contact Person Public Query
Name
Mr Sachin Singh
Designation
Head of Clinical operation RLS
Affiliation
Reliance Life Sciences Pvt. Ltd. (RLS)
Address
Reliance Life Sciences Pvt. Ltd. (RLS) Dhirubhai Ambani Life Sciences Centre (DALC) Plot R 282 TTC Area of MIDC Thane Belapur Road Rabale, Navi Mumbai Reliance Life Sciences Pvt. Ltd. (RLS) Dhirubhai Ambani Life Sciences Centre (DALC) Plot R 282 TTC Area of MIDC Thane Belapur Road Rabale, Navi Mumbai 400 701 Thane MAHARASHTRA 400701 India
Phone
9004246165
Fax
Email
Sachin2.Singh@relbio.com
Source of Monetary or Material Support
Reliance Life Sciences Pvt. Ltd. (RLS),
Dhirubhai Ambani Life
Sciences Centre (DALC), Plot R 282 TTC Area of MIDC, Thane Belapur Road Rabale, Navi Mumbai 400 701, Maharashtra, India
Primary Sponsor
Name
Reliance Life Sciences Pvt Ltd RLS
Address
Dhirubhai Ambani Life Sciences Centre (DALC), Plot R 282 TTC Area of MIDC, Thane Belapur Road Rabale, Navi Mumbai 400 701, Maharashtra, India
2nd floor, Department of Medicine,Unity Campus, Opp. KTHM College, gangapur Road Nashik MAHARASHTRA
9892503486
drsandeshpatil@gmail.com
Dr Shrikant Vishnu Deshpande
Ashiewad Hospital & Research Centre,
Near Jijamata Udyan, Maratha Section Ulhasnagar, 420004 Thane MAHARASHTRA
9822017445
writetoshrikant@rediffmail.com
Dr Prachi Makashir
Bharati Vidyapeeth (Deemed to be University) Medical College and Hospital
Pune-Satara road, Pune MAHARASHTRA
9011073840
drprachee@gmail.com
Dr Swapnil Sakhala
Chopda Medicare & Research Center Pvt. Ltd: Magnum Heart Institute,
3/5, Patil Lane No.1, Laxmi Nagar, Near K.B.H. Vidyalaya, Canada Corner,
Nashik - 422005, Maharashtra India
Nashik MAHARASHTRA
9922719347
swapnilsakhala@yahoo.com
Dr Deepak Kumar Langade
Dr. D.Y Patil Medical college & Hospital
Department of Pharmacology, D.Y.Patil University, 5th Floor, D.Y.Patil Medical College, Plot no. 2, Sector 5, Nerul, Navi Mumbai - 400706, Maharashtra, India Thane MAHARASHTRA
9930550009
deepak.langade@dypatil.edu
DrKaustubh Shendkar
Global Hospital & Research Institute
Ground floor, OPD no 9-, 577/2, off Sinhgad road, Near dattawadi pune, Maharastra 411030 Pune MAHARASHTRA
9763060606
kaustubhshendkar@gmail.com
Dr Akash Khobragade
Grant Government Medical College and Sir J.J. Group of Hospitals
Department of Pharmacology,Grant Government Medical College and Sir J.J. Group of Hospitals, JJ Marg, Nagpada, Mumbai – 400008, Maharashtra, India Mumbai MAHARASHTRA
9702658822
drakashk.research@gmail.com
Dr Amit Bhate
Jeevan Rekha Hospital
Dr. B R Ambedkar road Belgaum KARNATAKA
9667177125
dramitsureshbhate@gmail.com
Dr Yandrapati Gnana Sundra Raju
King George Hospital Andhra Medical College
Department of General Medicine, Rupendra Prasad Ward,Maharanjpeta, Vishakhapatnam-530002 Visakhapatnam ANDHRA PRADESH
RLS Protein Subunit Vaccine against SARS-CoV-2 Virus
This Phase I dose determining study will evaluate following three doses for which volume of vaccine administration will be the same i.e. 0.5 ml: -First dose level (Antigenic Content: 2.5 μg of Receptor Binding Domain + 2.5 μg of Nucleocapsid), -Second dose level (Antigenic Content: 5 μg of Receptor Binding Domain + 5 μg of Nucleocapsid) and -Third dose level (Antigenic Content: 10 μg of Receptor Binding Domain + 10 μg of Nucleocapsid).
1. Male and female healthy volunteers in age group 18-45 years (both inclusive),
2. The subjects voluntarily agreed to participate in the study, and signed an informed consent form, willing to comply with protocol requirements.
3. Healthy status as determined by the investigator based on history, clinical laboratory results, vital sign measurements, and on medical physical examination at screening.
4. Body temperature is between 95.6 to 99.0 ºF.
5. Body mass index (BMI) at 18.5 to 30.0 kg/m2 (inclusive).
6. Male and Female subjects of childbearing potential must be using adequate birth control measures, as discussed with the study doctor and should agree to continue such precautions for 6 months after receiving the last injection of study medication.
Menopausal females must have experienced their last period more than 12 months prior to study entry to be classified as not of childbearing potential.
Note-Female patients of child bearing potential must agree to use adequate contraception during the study and continue at least six months after the last dose of study drug. For this study, acceptable and effective methods of contraception for females include:
-Intrauterine device placed at least 3 months prior to the start of the study and remaining in place during the study period,
-Two barrier methods used together (cervical cap, diaphragm, contraceptive sponge, or vaginal spermicide plus a male or female condom) or
-Absolute sexual abstinence (no sexual intercourse or genital contact with a male partner).
For males, adequate birth control methods suggested and defined as double barrier contraception, i.e., condom + diaphragm, condom or diaphragm + spermicidal gel or foam.
ExclusionCriteria
Details
The following criteria should be checked at the time of study entry. If any of these apply at the time of study entry, the subject must not be included in the study:
1. History of any of the following:
• Any investigational vaccine or a COVID vaccine that has got emergency use
authorization or
• Any product (investigational or off-label) for prevention of COVID-19 disease
• Inoculated with any subunit vaccine and inactivated vaccine within 14 days
before the first dose of study vaccination,
• Inoculated live attenuated vaccine within 30 days.
• Received influenza vaccination within 14 days prior to first study vaccination
2. Have an acute or chronic illness, as determined by the site Principal Investigator (PI) or
sub-investigator, within 72 hours prior to study vaccination.
3. Seropositive for HIV 1 and 2, HBsAg and HCV
4. Have a history of severe allergies to any component of the research vaccine i.e. RLS
Protein Subunit Vaccine against SARS-CoV-2 Virus, including aluminum preparations,
such as: anaphylactic shock, allergic laryngeal edema, allergic purpura,
thrombocytopenic purpura, local allergic necrosis (Arthus reaction); or any previous
History of serious side effects of vaccines or drugs, such as allergies, urticaria, skin
eczema, dyspnea, angioedema, etc . History of allergic disease or reactions likely to be
exacerbated by any component of the vaccines in study.
5. Those with a history of SARS COVID-19 or current COVID-19 infection meeting any of
the following:
 History of confirmed SARS-CoV 2 infection or symptomatic disease,
 RTPCR test which is positive within 72 hours prior to enrollment.
 Positive for SARS-CoV-2 IgG antibodies ≥ 5 (Index value).
6. Have taken antipyretics or analgesics within 24 hours before the first dose of vaccine.
7. Suspected or known current alcohol abuse as defined by an alcohol intake of greater
than 42 units every week for at least one year;
8. Chronic administration (defined as more than 14 days in total) of immunosuppressant
(e.g. corticosteroids, cytotoxic drugs or antimetabolites, etc.) or other immune-modifying
drugs (e.g. interferons) during the period starting six months prior to the first vaccine
dose including use of any blood products. For corticosteroids, this will mean prednisone
> 0.5 mg/kg/day, or its equivalent (Methylprednisolone 0.4 mg/kg/day, Betamethasone0.08 mg/kg/day, Dexamethasone 0.08 mg/kg/day). Inhaled and topical steroids are allowed; Subjects under immune suppression post-transplant.
9. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
medical history and physical examination (no laboratory testing required);
10. Any medical condition that in the judgment of the investigator would make study
participation unsafe and/or can interfere with assessment or vaccine response.
11. Have received blood or blood-related products, including immunoglobulin within 3
months; or plan to use it during the study.
12. Lactating women or pregnant women (as determined by serum beta HCG).
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To evaluate the safety and tolerability after RLS Protein Subunit Vaccine against SARS-CoV-2 Virus
after administration in healthy volunteers.
From Day 0 to Day 56
Secondary Outcome
Outcome
TimePoints
To evaluate the immunogenicity of RLS Protein Subunit Vaccine against SARS-CoV-2 Virus
after administration in healthy volunteers.
From Day 0 to Day 56
Target Sample Size
Total Sample Size="72" Sample Size from India="72" Final Enrollment numbers achieved (Total)= "72" Final Enrollment numbers achieved (India)="72"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This is a prospective, open label, dose escalation phase I clinical study to evaluate the safety, tolerability and immunogenicity of Reliance Life Sciences’ SARS-CoV-2 Recombinant protein subunit vaccine in healthy volunteers. In phase I of the study, 72 healthy volunteers will be enrolled to receive RLS subunit vaccine in ascending dose levels. There would be step wise evaluation of higer doses. Thus first 24 subjects will receive low dose, subsequent 24 subjects will receive medium dose and final 24 subjects will receive high dose.