Trial to evaluate singlebooster dose of ZyCoV-D of M/s ZydusLifesciences Limited in adult subjects alreadyvaccinated with 2 doses of Covaxin or Covishield
- Registration Number
- CTRI/2022/06/043365
- Lead Sponsor
- Zydus Lifesciences Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 576
1. Subjects (healthy / high risk) of either gender =18 years of age
2. Subjects who have received 2 doses on Covaxin or Covishield with last dose 6 (+1)
months prior to screening date
3. Informed consent from subjects
4. Subjects literate enough to fill the diary card
5. Females of childbearing potential, must agree to use one of the approved contraception methods (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization), from screening until completion of the followup visit and males who agree to use contraception
1. Febrile illness (temperature = 38°C or 100.4°F) or any acute illness or infection within
4 weeks of enrolment
2. History or laboratory evidence of confirmed SARS-CoV-2 infection after primary
vaccination or RTPCR positive for COVID-19 at the time of screening
3. Subjects who have received one or two doses of any approved or experimental
COVID-19 vaccine other than Covaxin or Covishield in past.
4. History of contact with a confirmed active SARS-CoV-2 positive patient within 14 days
5. History of SARS/ MERS infection
6. Past history of hypersensitivity reaction or any serious adverse event after any
vaccination
7. Subjects with known history of thrombocytopenia or any coagulation disorder, or
subjects on anticoagulation therapy
8. Subjects with confirmed or suspected immunosuppressive or immunodeficiency
disorder; or subjects on any immunosuppressive or immunostimulant therapy
9. Clinically significant (uncontrolled) systemic disorder such as cardiovascular,
respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, haematological,
psychiatric or immunological disorder
10. Subjects administered blood, blood containing products or immunoglobulins within the
last 3 months or planned administration during the study
11. Any other vaccine administration within the last 30 days or planned to be administered
during 8 weeks after enrolment (upto day 56 of study)
12. Participation in another clinical trial in the past 3 months
13. Pregnant and lactating women
14. History of drug / alcohol abuse
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To establish non-inferiority of single 3mg booster dose of ZyCoV-D as compared to <br/ ><br>Homologous booster (Covaxin) in terms of seroconversion rate (IgG by ELISA and <br/ ><br>NAB) in subjects who have received Covaxin as primary vaccination <br/ ><br>2. To establish non-inferiority of single 3mg booster dose of ZyCoV-D as compared to <br/ ><br>Homologous booster (Covishield) in terms of seroconversion rate (IgG by ELISA and <br/ ><br>NAB) in subjects who have received Covishield as primary vaccinationTimepoint: Day 0, Day 28 and Day 168
- Secondary Outcome Measures
Name Time Method 1. Adverse events (solicited, unsolicited and SAEs) reported during the study ZyCoV-D <br/ ><br>and homologous booster (Covaxin / Covishield)Timepoint: Throughout the Study;1. To establish non-inferiority of single 3mg booster dose of ZyCoV-D as compared to <br/ ><br>homologous booster (Covaxin / Covishield) in terms of GMTs of IgG by ELISA and <br/ ><br>NAB <br/ ><br>2. To compare the long term persistence of IgG antibodies against S1 antigen (by ELISA) <br/ ><br>at and Neutralizing antibodies 24 weeks after booster dose (Seroconversion rate and <br/ ><br>GMTs) with ZyCoV-D and homologous booster (Covaxin / Covishield) <br/ ><br>3. To compare cellular response after booster dose with ZyCoV-D and homologous <br/ ><br>booster (Covaxin / Covishield) <br/ ><br>Timepoint: Day 0, Day 28 and Day 168