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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04961385
Enrollment
60
Registered
2021-07-14
Start date
2021-04-01
Completion date
2021-05-31
Last updated
2021-07-14

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

Conditions

Covid19, Immunogenicity, Vaccine

Keywords

COVID-19, Immunogenicity, Neutralising antibody, Antispike RBD, ChAd0x1 nCoV-19

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

Interventions

BIOLOGICALImmunogenicity 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

Sponsors

Bangkok Metropolitan Administration Medical College and Vajira Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Antispike RBD IgG levelBaselineLevel inBAU/ml
Neutralizing antibodyBaselinePercent inhibition

Secondary

MeasureTime frameDescription
Adverse eventsthrough study completion,an average of 1 yearAny abnormal symptoms post vaccination
Covid-19 infectionthrough study completion,an average of 1 yearIncidence of COVID-19 infection

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026