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To understand the effect of additional dose of Covid vaccine in autoimmune double dose vaccinated patients who had covid infection and those who did not have covid infection

Effect of Additional Dose of AZD1222 in Autoimmune Rheumatic Disease patients (AIRD) with Hybrid immunity : A PILOT STUDY - Hybrid study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/05/042572
Enrollment
200
Registered
2022-05-17
Start date
Unknown
Completion date
Unknown
Last updated
2023-02-06

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

Conditions

Health Condition 1: U071- COVID 19 virus identified Health Condition 2: M058- Other rheumatoid arthritis with rheumatoid factor Health Condition 3: M459- Ankylosing spondylitis of unspecified sites in spine Health Condition 4: M329- Systemic lupus erythematosus, unspecified Health Condition 5: M068- Other specified rheumatoid arthritis

Interventions

Intervention1: Covishield Vaccine: Autoimmune patients naïve with covid infection who has taken both dose covid vaccine (Hybrid immunity) Booster dose (covishield vaccine) as IM(Intra muscular) Do

Sponsors

Centre for Arthritis and Rheumatism Excellence CARE
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient above 18 yrs of age 2. Patients with diagnosed case of Autoimmune Rheumatic Disease 3. Patients who had completed Both dose of AZD 1222 vaccine and had a documentedCovid 19 infection (irrespective of the order ofImmune hit) 4. Patients who had completed both dose of AZD1222 vaccine with no history of Covid infection (Controlgroup) 5. Patients who are willing to provide informed consent and to comprehend with the study

Exclusion criteria

Exclusion criteria: 1. Patients with unstable disease activity and past history of flare following vaccinations. 2. Patients with non-repopulated peripheral B cell 3. Patients with history of allergic reaction to vaccine or its components 4. Patients who received live vaccine within 2 months prior the study

Design outcomes

Primary

MeasureTime frame
Effect of booster dose will be assessed based on 1. Anti SARS CoV 2S Antibody levels after 1 month of booster dose 2. Neutralization antibody levels against Omicron and Delta variant Timepoint: 1 month of booster dose—

Secondary

MeasureTime frame
1. Proportion of patients who experience solicited local and systemic adverse events post booster dose of vaccine (7 day follow up period following vaccination) Timepoint: 7 days post vaccine—

Countries

India

Contacts

Public ContactDr Padmanabha Shenoy

Dr Shenoys Care Private Limited

drdpshenoy@gmail.com9446567000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026