A open label, dose escalation phase I clinicalstudy to evaluate the safety, tolerability andimmunogenicity of SARS-CoV-2Recombinant protein subunit vaccine in healthyvolunteers.

Phase 1

Completed

• Conditions: Healthy Volunteers

• Registration Number: CTRI/2021/11/038168
• Lead Sponsor: Reliance Life Sciences Pvt Ltd RLS

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-19
• Study Completion: 2022-09-27
• Last Update Posted: 2022-11-24

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• 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.
• Healthy status as determined by the investigator based on history, clinical laboratory results, vital sign measurements, and on medical physical examination at screening.
• Body temperature is between 95.6 to 99.0 ºF.
• Body mass index (BMI) at 18.5 to 30.0 kg/m2 (inclusive).
• 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.

Exclusion Criteria

• 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.
• 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.
• 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).
• Have taken antipyretics or analgesics within 24 hours before the first dose of vaccine.
• 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.
• 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.
• Have received blood or blood-related products, including immunoglobulin within 3 months; or plan to use it during the study.
• Lactating women or pregnant women (as determined by serum beta HCG).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
after administration in healthy volunteers.	From Day 0 to Day 56
To evaluate the safety and tolerability after RLS Protein Subunit Vaccine against SARS-CoV-2 Virus	From Day 0 to Day 56

Secondary Outcome Measures

Name	Time	Method
To evaluate the immunogenicity of RLS Protein Subunit Vaccine against SARS-CoV-2 Virus	after administration in healthy volunteers.

Trial Locations

Locations (19)

Shree Siddhivinayak Maternity & Nursing home; 🇮🇳 Nashik, MAHARASHTRA, India

Ashiewad Hospital & Research Centre,; 🇮🇳 Thane, MAHARASHTRA, India

Bharati Vidyapeeth (Deemed to be University) Medical College and Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Chopda Medicare & Research Center Pvt. Ltd: Magnum Heart Institute,; 🇮🇳 Nashik, MAHARASHTRA, India

Dr. D.Y Patil Medical college & Hospital; 🇮🇳 Thane, MAHARASHTRA, India

Global Hospital & Research Institute; 🇮🇳 Pune, MAHARASHTRA, India

Grant Government Medical College and Sir J.J. Group of Hospitals; 🇮🇳 Mumbai, MAHARASHTRA, India

Jeevan Rekha Hospital; 🇮🇳 Belgaum, KARNATAKA, India

King George Hospital Andhra Medical College; 🇮🇳 Visakhapatnam, ANDHRA PRADESH, India

Lifepoint Multispecialty Hospital; 🇮🇳 Pune, MAHARASHTRA, India

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Shree Siddhivinayak Maternity & Nursing home

🇮🇳Nashik, MAHARASHTRA, India

Dr Sandesh Patil

Principal investigator

9892503486

drsandeshpatil@gmail.com