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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04961385
• Other study ID #: 111/64
• Status: Completed
• Start date: April 1, 2021
• Est. completion date: May 31, 2021

Study information

• Verified date: July 2021
• Source: Bangkok Metropolitan Administration Medical College and Vajira Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Covid19
• Immunogenicity
• Vaccine

Intervention

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

Locations

Country	Name	City	State
Thailand	Thananda Trakarnvanich	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Bangkok Metropolitan Administration Medical College and Vajira Hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (8)

Folegatti PM, Ewer KJ, Aley PK, Angus B, Becker S, Belij-Rammerstorfer S, Bellamy D, Bibi S, Bittaye M, Clutterbuck EA, Dold C, Faust SN, Finn A, Flaxman AL, Hallis B, Heath P, Jenkin D, Lazarus R, Makinson R, Minassian AM, Pollock KM, Ramasamy M, Robinso — View Citation

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. — View Citation

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. — View Citation

Mehran R, Dangas GD, Weisbord SD. Contrast-Associated Acute Kidney Injury. N Engl J Med. 2019 May 30;380(22):2146-2155. doi: 10.1056/NEJMra1805256. Review. — View Citation

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 — View Citation

Strauss K, van Zundert A, Frid A, Costigliola V. Pandemic influenza preparedness: the critical role of the syringe. Vaccine. 2006 May 29;24(22):4874-82. Epub 2006 Mar 20. — View Citation

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. — View Citation

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, Fen — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antispike RBD IgG level	Level inBAU/ml	Baseline
Primary	Antispike RBD IgG level	Level inBAU/ml	3 monnths
Primary	Antispike RBD IgG level	Level inBAU/ml	6 months
Primary	Neutralizing antibody	Percent inhibition	Baseline
Primary	Neutralizing antibody	Percent inhibition	3 months
Primary	Neutralizing antibody	Percent inhibition	6 months
Secondary	Adverse events	Any abnormal symptoms post vaccination	through study completion,an average of 1 year
Secondary	Covid-19 infection	Incidence of COVID-19 infection	through study completion,an average of 1 year