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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04961385
Recruitment Status : Completed
First Posted : July 14, 2021
Last Update Posted : July 14, 2021
Sponsor:
Information provided by (Responsible Party):
Thananda Trakarnvanich, Bangkok Metropolitan Administration Medical College and Vajira Hospital

Study Description
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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
Covid19 Vaccine Immunogenicity Biological: Immunogenicity after first dose of participants who received first dose of ChAdox-1 n COV-19 vaccine

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
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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Immunogenicity of the ChAdox1 n CoV-19 Vaccine Against SARS-CoV-2 With 12-dose Vials: an Interim Analysis
Actual Study Start Date : April 1, 2021
Actual Primary Completion Date : May 31, 2021
Actual Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants who received first dose of ChAdox-1 n COV-19 were recruited.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04961385


Locations
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Thailand
Thananda Trakarnvanich
Bangkok, Thailand, 10300
Sponsors and Collaborators
Bangkok Metropolitan Administration Medical College and Vajira Hospital
More Information
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Publications of Results:
Voysey M, Clemens SAC, Madhi SA, Weckx LY, Folegatti PM, Aley PK, Angus B, Baillie VL, Barnabas SL, Bhorat QE, Bibi S, Briner C, Cicconi P, Collins AM, Colin-Jones R, Cutland CL, Darton TC, Dheda K, Duncan CJA, Emary KRW, Ewer KJ, Fairlie L, Faust SN, Feng S, Ferreira DM, Finn A, Goodman AL, Green CM, Green CA, Heath PT, Hill C, Hill H, Hirsch I, Hodgson SHC, Izu A, Jackson S, Jenkin D, Joe CCD, Kerridge S, Koen A, Kwatra G, Lazarus R, Lawrie AM, Lelliott A, Libri V, Lillie PJ, Mallory R, Mendes AVA, Milan EP, Minassian AM, McGregor A, Morrison H, Mujadidi YF, Nana A, O'Reilly PJ, Padayachee SD, Pittella A, Plested E, Pollock KM, Ramasamy MN, Rhead S, Schwarzbold AV, Singh N, Smith A, Song R, Snape MD, Sprinz E, Sutherland RK, Tarrant R, Thomson EC, Torok ME, Toshner M, Turner DPJ, Vekemans J, Villafana TL, Watson MEE, Williams CJ, Douglas AD, Hill AVS, Lambe T, Gilbert SC, Pollard AJ; Oxford COVID Vaccine Trial Group. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet. 2021 Jan 9;397(10269):99-111. doi: 10.1016/S0140-6736(20)32661-1. Epub 2020 Dec 8. Erratum In: Lancet. 2021 Jan 9;397(10269):98.
Ramasamy MN, Minassian AM, Ewer KJ, Flaxman AL, Folegatti PM, Owens DR, Voysey M, Aley PK, Angus B, Babbage G, Belij-Rammerstorfer S, Berry L, Bibi S, Bittaye M, Cathie K, Chappell H, Charlton S, Cicconi P, Clutterbuck EA, Colin-Jones R, Dold C, Emary KRW, Fedosyuk S, Fuskova M, Gbesemete D, Green C, Hallis B, Hou MM, Jenkin D, Joe CCD, Kelly EJ, Kerridge S, Lawrie AM, Lelliott A, Lwin MN, Makinson R, Marchevsky NG, Mujadidi Y, Munro APS, Pacurar M, Plested E, Rand J, Rawlinson T, Rhead S, Robinson H, Ritchie AJ, Ross-Russell AL, Saich S, Singh N, Smith CC, Snape MD, Song R, Tarrant R, Themistocleous Y, Thomas KM, Villafana TL, Warren SC, Watson MEE, Douglas AD, Hill AVS, Lambe T, Gilbert SC, Faust SN, Pollard AJ; Oxford COVID Vaccine Trial Group. Safety and immunogenicity of ChAdOx1 nCoV-19 vaccine administered in a prime-boost regimen in young and old adults (COV002): a single-blind, randomised, controlled, phase 2/3 trial. Lancet. 2021 Dec 19;396(10267):1979-1993. doi: 10.1016/S0140-6736(20)32466-1. Epub 2020 Nov 19. Erratum In: Lancet. 2021 Dec 19;396(10267):1978. Lancet. 2021 Apr 10;397(10282):1350.

Other Publications:

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Responsible Party: Thananda Trakarnvanich, Associate Professor, Bangkok Metropolitan Administration Medical College and Vajira Hospital
ClinicalTrials.gov Identifier: NCT04961385    
Other Study ID Numbers: 111/64
First Posted: July 14, 2021    Key Record Dates
Last Update Posted: July 14, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Mandeley website
Supporting Materials: Study Protocol
Time Frame: As soon as the manuscript is accepted for publication

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Thananda Trakarnvanich, Bangkok Metropolitan Administration Medical College and Vajira Hospital:
COVID-19
Immunogenicity
Neutralising antibody
Antispike RBD
ChAd0x1 nCoV-19
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases