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

July 13, 2021 updated by: Thananda Trakarnvanich, Bangkok Metropolitan Administration Medical College and Vajira Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10300
        • Thananda Trakarnvanich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants who received first dose of ChAdox-1 n COV-19 were recruited.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bangkok Metropolitan Administration Medical College and Vajira Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2021

Primary Completion (ACTUAL)

May 31, 2021

Study Completion (ACTUAL)

May 31, 2021

Study Registration Dates

First Submitted

June 25, 2021

First Submitted That Met QC Criteria

July 13, 2021

First Posted (ACTUAL)

July 14, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 14, 2021

Last Update Submitted That Met QC Criteria

July 13, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 111/64

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Mandeley website

IPD Sharing Time Frame

As soon as the manuscript is accepted for publication

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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