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

NCT ID: NCT04961385

Last Updated: 2021-07-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2021-05-31

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

Conditions

Covid19; Vaccine; Immunogenicity

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

ChAd0x1 nCoV-19 vaccinees

Participants who received first dose of ChAdox-1 n COV-19 were recruited. Participants were eligible if they were more than 18 years old

Immunogenicity after first dose of participants who received first dose of ChAdox-1 n COV-19 vaccine

Intervention Type: BIOLOGICAL

Blood samples were taken from the vaccinated participants for antibody testing against SARS-CoV-2

Interventions

Immunogenicity after first dose of participants who received first dose of ChAdox-1 n COV-19 vaccine

Blood samples were taken from the vaccinated participants for antibody testing against SARS-CoV-2

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bangkok Metropolitan Administration Medical College and Vajira Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Thananda Trakarnvanich

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Thananda Trakarnvanich

Bangkok, , Thailand

Countries

Thailand

References

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Other Identifiers

111/64

Identifier Type: -

Identifier Source: org_study_id