Immunogenicity of the ChAdox1 n CoV-19 Vaccine With 12-dose Vial
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 |
Biological: 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
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Outcome Measures
Primary Outcome Measures
- Antispike RBD IgG level [Baseline]
Level inBAU/ml
- Antispike RBD IgG level [3 monnths]
Level inBAU/ml
- Antispike RBD IgG level [6 months]
Level inBAU/ml
- Neutralizing antibody [Baseline]
Percent inhibition
- Neutralizing antibody [3 months]
Percent inhibition
- Neutralizing antibody [6 months]
Percent inhibition
Secondary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
- Participants were eligible if they were more than 18 years old.
Exclusion Criteria:
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Allergic to components of vaccine
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Thananda Trakarnvanich | Bangkok | Thailand | 10300 |
Sponsors and Collaborators
- Bangkok Metropolitan Administration Medical College and Vajira Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Kesten JM, Ayres R, Neale J, Clark J, Vickerman P, Hickman M, Redwood S. Acceptability of low dead space syringes and implications for their introduction: A qualitative study in the West of England. Int J Drug Policy. 2017 Jan;39:99-108. doi: 10.1016/j.drugpo.2016.09.005. Epub 2016 Oct 24.
- Le Daré B, Bacle A, Lhermitte R, Lesourd F, Lurton Y. Maximizing number of doses drawn from multi-dose COVID-19 vaccines by minimizing dead-volume. J Travel Med. 2021 Jun 1;28(4). pii: taab049. doi: 10.1093/jtm/taab049.
- Tan CW, Chia WN, Qin X, Liu P, Chen MI, Tiu C, Hu Z, Chen VC, Young BE, Sia WR, Tan YJ, Foo R, Yi Y, Lye DC, Anderson DE, Wang LF. A SARS-CoV-2 surrogate virus neutralization test based on antibody-mediated blockage of ACE2-spike protein-protein interaction. Nat Biotechnol. 2020 Sep;38(9):1073-1078. doi: 10.1038/s41587-020-0631-z. Epub 2020 Jul 23.
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