Assessment of the protection offered by single dose of COVID-19 vaccines in individuals previously affected with COVID-19

Phase 4

Registration Number: CTRI/2021/10/037099

Lead Sponsor: Indian Council of Medical research ICMR

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Males and females >=18 years and willing to give informed consent

2.Group I and II: Subjects with positive history of RT-PCR proven COVID-19, 3 months or more, prior to their enrolment

3.Group III: Subjects with no history of COVID-19 infection in the past

4.Females should be non-pregnant and willing to adopt contraception for minimum three months (group 1 - 3 months after the 1st dose; group 2 & 3 - during the period between 1st & 2nd doses and 3 months after 2nd dose)

4.Subjects with co morbidities including Diabetes and Hypertension with stable medical condition

Exclusion Criteria

1.Subjects with significant co-morbid conditions with unacceptable clinical and / or laboratory profile in view of the investigator

2.Those who are on long term steroid therapy (>=3 months) and immunosuppressive treatment including anticancer treatment within past 6 months

3.Those who are in immunosuppressed or immunodeficient state

4.Subjects with active malignancy of any organ or system

5.Those who have received blood / blood products / immunoglobulins in the past 3 months

6.Subjects on regular anticoagulant therapy

7.History of bleeding disorders

8.H/O hypersensitivity to any of the vaccines and / or the constituents in the vaccine

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Humoral immune response <br/ ><br>2.Cell-mediated immune response <br/ ><br>Timepoint: Baseline,3 months, 6 months, 9 months and 12 months

Secondary Outcome Measures

Name	Time	Method
1.Incidence of solicited local and systemic adverse reactions within 7 days after each dose of vaccination <br/ ><br>2.Incidence of unsolicited local and systemic adverse reactions within 28 days after each dose of vaccination <br/ ><br>3.Incidence of serious adverse events (SAE) within 28 days after each dose of vaccination <br/ ><br>4.Occurrence of laboratory confirmed SARS Co-V-2 infection after vaccination throughout the study period (12 months) <br/ ><br>Timepoint: Throughout the study period