A bridging study to evaluate immunogenicity and safety of single dose of Sputnik Light in Indian adults and elderly for prevention of SARS-CoV-2 Infectio
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2021/09/036830
- Lead Sponsor
- Dr Reddys Laboratories Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Subjects will be enrolled in the study if they meet all the following criteria.
1.Ability to provide written informed consent and Willingness to participate in the study
2.Participants of either gender of age of more than >=18 years to <99 years
3.Negative COVID-19 RT-PCR test result at the screening visit (within 96 hours prior to Visit 1 [Day 1]). and negative IgM SARS specific antibodies at the screening visit
4.No medical history of COVID-19 in last 90 days
5.Consent for using effective methods of contraception during the entire trial and 3 months after its completion
6.No history of any vaccine-induced reactions or complications after receiving immunobiological products
7.No history of acute infection and/or respiratory diseases within at least 14 days before the enrollment
Subjects will be entered into the study only if they meet none of the following criteria.
1.Any vaccination/immunization within 30 days before the enrolment
2.Any vaccination/immunization against COVID 19 before the enrolment
3.Any ongoing systemic steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products in the last 30 days before the enrolment
4.On Immunosuppressive therapy within 3 months of the enrolment
5.Neutropenia (absolute neutrophil count <1,000 mm3),severe anemia (hemoglobin <80 g/L), in screening test
6.Immunodeficiency or autoimmune disorders in the medical history within 6 months before the enrolment
7.Pregnancy or breast-feeding
8.Acute coronary syndrome or stroke in the last one year before the enrolment
9.Active Tuberculosis or any other ongoing chronic systemic
infections
10.Anorexia, or protein deficiency of any origin
11.Tattoos at the injection site (deltoid muscle area), which does not allow assessing the local response to the IMP administration
12.Alcohol or drug addiction in the medical history
13.Participation in any other interventional clinical trial within 90 days prior to the Screening
14.Any other medical condition that would limit the participation of the subject as per Investigatorâ??s discretion
15.HIV, hepatitis B or C infection
16.Medical history of malignancy
17.Splenectomy in the medical history
18.Subjects contraindicated for vaccination
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method GMT for SARS-CoV-2 glycoprotein specific antibody on days 42, 90 & 180.Timepoint: Days 42, 90 & 180.
- Secondary Outcome Measures
Name Time Method Adverse EventsTimepoint: Within 7 days of vaccination and from days 8 to 180;CD4/CD8 lymphoproliferation after RBD stimulationTimepoint: Day 10;COVID-19 outcomes (hospitalization, death, recovery without hospitalization) in study subjects till end of study Secondary outcomeTimepoint: Till EOS;GMT for SARS-CoV-2 glycoprotein specific antibodyTimepoint: Day 28;GMT for SARS-CoV-2 Virus neutralizing antibodyTimepoint: Days 28, 42, 90 and 180;Incidence of mild, moderate & severe COVID-19 in studyTimepoint: Till EOS;Incidence of symptomatic COVID-19 in study subjectsTimepoint: Till EOS;Interferon gamma induction after RBD stimulation on day 10Timepoint: Day 10;Seroconversion (4-fold rise from baseline) for SARS-CoV-2 glycoprotein specific antibodyTimepoint: Days 28, 42, 90 and 180;Seroconversion (4-fold rise from baseline) for SARS-CoV-2 virus neutralizing antibodyTimepoint: Days 28, 42, 90 and 180