A randomized control trial to study the antibody response and side effects after the booster dose of COVID-19 vaccine

Interventional study to determine efficacy, safety and immunogenicity of booster dose of ChAdOx1 nCoV-19 (COVISHIELD) Coronavirus Disease (COVID-19) vaccine in vaccine recipients.- A single centre, randomised control trial - COVIBOOST

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/01/039677

Enrollment

180

Registered

2022-01-25

Start date

Unknown

Completion date

Unknown

Last updated

2022-02-21

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

Conditions

None listed

Interventions

Intervention1: ChAdOx1 nCoV-19 vaccine 0.5 ml intramuscularly: Biological: ChAdOx1 nCoV-19 vaccine A dose of 0.5 ml ChAdOx1 nCoV-19 vaccine 6 months after receiving a double dose of 5x1010vp of ChAdOx

Eligibility

Inclusion criteria

Inclusion criteria: Healthy volunteers above 18 years who have received 2 doses of ChAdOx1 nCoV-19 vaccine Able and willing to comply with study requirements Willing to refrain from blood donation during the study period giving consent

Exclusion criteria

Exclusion criteria: Anaphylactic reaction following administration of vaccine previously Pregnant or lactating women Any adverse event that in the opinion of the Investigator may affect the safety of the participant or the interpretation of the study results Subject not giving consent Individuals who have received any other COVID1-9 vaccine

Design outcomes

Primary

Measure	Time frame
Assess efficacy and immunogenicity of the booster dose of ChAdOx1 nCoV-19 (COVISHIELD) against COVID-19 in vaccine recipients compared to the placebo groupTimepoint: 6 months	—

Secondary

Measure	Time frame
Assess the safety of the booster dose of ChAdOx1 nCoV (COVISHIELD: Occurrence of serious adverse events (SAEs)Timepoint: Upto 6 months	—

Countries

India

Contacts

Public ContactDr Pratibha Kale

Institute of Liver and Biliary Sciences

drpratibhapgi@gmail.com9013921202

Outcome results