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OpenTrials
Completed

NCT Number: NCT04961385

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

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

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Immunogenicity Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Vaccine Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Thananda Trakarnvanich

Bangkok, 10300, Thailand

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Biological

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

Primary outcomes

  1. Antispike RBD IgG level

    Time frame: Baseline

    Level inBAU/ml

  2. Antispike RBD IgG level

    Time frame: 3 monnths

    Level inBAU/ml

  3. Antispike RBD IgG level

    Time frame: 6 months

    Level inBAU/ml

  4. Neutralizing antibody

    Time frame: Baseline

    Percent inhibition

  5. Neutralizing antibody

    Time frame: 3 months

    Percent inhibition

  6. Neutralizing antibody

    Time frame: 6 months

    Percent inhibition

Secondary outcomes

  1. Adverse events

    Time frame: through study completion,an average of 1 year

    Any abnormal symptoms post vaccination

  2. Covid-19 infection

    Time frame: through study completion,an average of 1 year

    Incidence of COVID-19 infection

Sponsors and collaborators

Lead sponsor

Bangkok Metropolitan Administration Medical College and Vajira Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 14, 2021
Registry last updated
Jul 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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