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

Completed

• Conditions: Covid19; Vaccine; Immunogenicity
• Interventions: Biological: Immunogenicity after first dose of participants who received first dose of ChAdox-1 n COV-19 vaccine

• Registration Number: NCT04961385
• Lead Sponsor: Bangkok Metropolitan Administration Medical College and Vajira Hospital

Brief Summary

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

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

Study Timeline

• Study Start: 2021-04-01
• Primary Completion: 2021-05-31
• Study Completion: 2021-05-31
• Study First Submitted: 2021-06-25
• Status Verified: 2021-07
• Study First Submitted QC: 2021-07-13
• Last Update Submitted: 2021-07-13
• Study First Posted: 2021-07-14
• Last Update Posted: 2021-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ChAd0x1 nCoV-19 vaccinees	Immunogenicity after first dose of participants who received first dose of ChAdox-1 n COV-19 vaccine	Participants who received first dose of ChAdox-1 n COV-19 were recruited. Participants were eligible if they were more than 18 years old

Primary Outcome Measures

Name	Time	Method
Antispike RBD IgG level	6 months	Level inBAU/ml
Neutralizing antibody	6 months	Percent inhibition

Secondary Outcome Measures

Name	Time	Method
Adverse events	through study completion,an average of 1 year	Any abnormal symptoms post vaccination
Covid-19 infection	through study completion,an average of 1 year	Incidence of COVID-19 infection

Trial Locations

Locations (1)

Thananda Trakarnvanich; 🇹🇭 Bangkok, Thailand