A open label, dose escalation phase I clinicalstudy to evaluate the safety, tolerability andimmunogenicity of SARS-CoV-2Recombinant protein subunit vaccine in healthyvolunteers.
- Registration Number
- CTRI/2021/11/038168
- Lead Sponsor
- Reliance Life Sciences Pvt Ltd RLS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 72
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.
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:
ï?? History of confirmed SARS-CoV 2 infection or symptomatic disease,
ï?? RTPCR test which is positive within 72 hours prior to enrollment.
ï?? 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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the safety and tolerability after RLS Protein Subunit Vaccine against SARS-CoV-2 Virus <br/ ><br>after administration in healthy volunteers.Timepoint: 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 <br/ ><br>after administration in healthy volunteers.Timepoint: From Day 0 to Day 56