None listed
Conditions
Interventions
Intervention1: Sputnik-Light Vector Vaccine: Recombinant adenovirus serotype 26 particles containing the SARS-CoV-2 protein S gene, in the amount of (1.0±0.5) Ñ? 1011 particles per dose.
Control Inte
Sponsors
Dr Reddys Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: Subjects will be enrolled in the study if they meet all the following criteria. 1. Male and female aged >= 18 years 2. Subject who had recieved primary vaccination (both doses completed) with either a. COVAXIN (Group 1) OR b. COVISHIELD (Group 2) Where last dose of primary vaccination was taken 6-7 months prior to the screening visit 3. Subjects who are determined by medical/surgical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study 4. If the subject had COVID-19 after primary vaccination, that subject should have passed 3 months after being asymptomatic or RT-PCR negative 5. Negative COVID-19 Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) test result at the screening visit 6. Consent for using effective methods of contraception during the entire trial and 3 months after its completion 7. No evidence of pronounced vaccine-induced reactions or complications after receiving immunobiological products in medical history 8. No acute infectious and/or respiratory diseases within at least 14 days before the enrollment
Exclusion criteria
Exclusion criteria: Subjects will be entered into the study only if they meet none of the following criteria. 1. Prior receipt of any COVID-19 vaccine in less than 6 months of duration 2. Currently receiving or have received (in last 4 weeks) medication intended to prevent COVID-19 except for multi-vitamin supplements 3. Receipt of steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products within 30 days prior to enrollment 4. Pregnancy or breast-feeding 5. Tuberculosis, chronic systemic infections associated with immunocompromised subjects in medical history 6. History of severe allergic reaction to drug or vaccine (anaphylactic shock, or other life-threatening allergic reactions), acute exacerbation of allergic diseases on screening and randomization day 7. Chronic immune disease or systemic collagenosis in medical history 8. Subjects who received transplantation and on immunosuppressive therapy 9. Other immunosuppressive therapy (other than steroids) that completed less than three months prior to randomization into the study 10. Splenectomy in the past medical history 11. Subjects with oncological disease within 5 years prior to inclusion into the study 12. Neutropenia (absolute number of neutrophils less than 13. Significant loss of blood, Immunodeficiency in the medical history within 6 months before the enrolment 14. Active form of a disease caused by the human immunodeficiency virus, syphilis, hepatitis B, or C 15. Acute Kidney injury or dialysis 16. Anorexia or Malnutrition 17. Tattoos or scars at the injection site (deltoid muscle area), which in the medical opinion of the investigator does not allow assessing the local response to the study vaccine administration 18. Alcohol or Drug addiction in medical history 19. Participation in other interventional clinical trial within the previous 90 days prior to enrolment and over duration of the trial 20. Any other condition that the study physician considers as a barrier to the trial completion as per the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To show the non-inferiority between Sputnik Light Booster vs Covaxin and Covishield as booster in terms of: â?¢ Proportion of subjects achieving â?¥2-fold increase in neutralizing antibodies at Day 28 from baselineTimepoint: Day 28 from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Proportion of subjects achieving â?¥2-fold increase in SARS-CoV-2 glycoprotein specific antibodies at Day 28 from baseline â?¢ CD4/CD8 lymphoproliferation after RBD stimulation on day 28 â?¢ Interferon gamma induction after RBD stimulation on day 28Timepoint: Day 28 from baseline;To show the non-inferiority between Sputnik Light Booster vs Covaxin and Covishield as booster in terms of: â?¢ GMT and GMFR for SARS-CoV-2 glycoprotein specific antibody on days 28, 90 and 180 â?¢ GMT and GMFR for SARS-CoV-2 Virus neutralizing antibody on days 28, 90 and 180Timepoint: Day 28, 90 and 180 | — |
Countries
India
Contacts
Public ContactDr Jayashri Krishnan
JSS Medical Research Asia Pacific Pvt. Ltd.
Outcome results
None listed