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

Evaluation of Immunogenicity, Efficacy and Safety of single dose of COVID-19 vaccines (Covishield, Covaxin and Sputnik V) in previously SARS-CoV2 infected individuals - A Randomized controlled clinical trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/10/037099

Enrollment

450

Registered

2021-10-05

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Covishield, Covaxin and Sputnik V 0.5 ml IM in deltoid region (single dose for 150 subjects and 2 doses for 150 subjects) in previously COVID-19 infected: Covishield, Covaxin and Sputni

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
1.Humoral immune response 2.Cell-mediated immune response Timepoint: Baseline,3 months, 6 months, 9 months and 12 months	—

Secondary

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

Measure

Time frame

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

—

Countries

India

Contacts

Public ContactDr Abinaya Elango

Chettinad Hospital and Research Institute, Chettinad Academy of Research and Education

dr.abi.smc@gmail.com9003011630

Outcome results