Immunogenicity of the ChAdox1 n CoV-19 Vaccine With 12-dose Vial

Study Overview
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Brief Summary
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ChAd0x1 nCoV-19 (AZD 1222) is the main vaccine that is planned to roll-out in Thailand and involve vaccinating people especially in high-risk categories. This vaccine is contained in the multiple-dose vial for vaccinating 10 recipients for 0.5 mL each. However, the additional volume of vaccine was overfilled to 6.5 mL per vial which the vaccination can be administered to more than 10 doses. The University Hospital Network (UHOSNET) and Faculty of Medicine Vajira Hospital, Navamindradhiraj University have jointly stipulated the preparation and vaccination of ChAdox1 - n CoV-19 vaccine with 12 doses per vial injection with traditional 21 or 24 G needle. Taken together, The investigators planned to investigate the immune response of participants after first dose of ChAd0x1 nCoV-19 vaccination with such technique

Detailed Description
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The investigators measured anti-SARS-CoV-2 antispike RBD IgG and neutralizing antibody by surrogate virus neutralizing test (sVNT) in adults between age 18-72 year after first dose of ChAd0x1 nCoV-19 vaccine.The primary outcome was the antibody levels.The secondary outcome were adverse events,factors affecting antibody levels and incidence of COVID-19 infection at the time of study

Official Title
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Immunogenicity of the ChAdox1 n CoV-19 Vaccine Against SARS-CoV-2 With 12-dose Vials: an Interim Analysis

Conditions
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Covid19, Vaccine, Immunogenicity

Intervention / Treatment
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* Biological: Immunogenicity after first dose of participants who received first dose of ChAdox-1 n COV-19 vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants were eligible if they were more than 18 years old. Exclusion Criteria: Allergic to components of vaccine Risk of COVID-19 infection in the previous 14 days before enrollment i.e close contact with index cases or history of fever with upper respiratory tract infection.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ChAd0x1 nCoV-19 vaccinees<br>Participants who received first dose of ChAdox-1 n COV-19 were recruited. Participants were eligible if they were more than 18 years old | Biological: Immunogenicity after first dose of participants who received first dose of ChAdox-1 n COV-19 vaccine<br>* Blood samples were taken from the vaccinated participants for antibody testing against SARS-CoV-2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antispike RBD IgG level | Level inBAU/ml | Baseline | 
| Antispike RBD IgG level | Level inBAU/ml | 3 monnths | 
| Antispike RBD IgG level | Level inBAU/ml | 6 months | 
| Neutralizing antibody | Percent inhibition | Baseline | 
| Neutralizing antibody | Percent inhibition | 3 months | 
| Neutralizing antibody | Percent inhibition | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Any abnormal symptoms post vaccination | through study completion,an average of 1 year | 
| Covid-19 infection | Incidence of COVID-19 infection | through study completion,an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Immunogenicity, Neutralising antibody, Antispike RBD, ChAd0x1 nCoV-19