Immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2 with 12-dose vials: An interim analysis

BACKGROUND: ChAdOx1 nCoV-19 (AZD 1222) is the main vaccine planned for general administration in Thailand. This vaccine is stored in multiple-dose vials meant to be administered to 10 recipients with a volume of 0.5 mL for each dose. However, the vaccine vials were overfilled, which allows the administration of more than 10 doses per vial. We have stipulated the preparation and use of ChAdOx1 nCoV-19 vaccine using traditional 21 or 25G needles and planned to investigate the immune responses of participants who were administered the ChAdOx1 nCoV-19 vaccine using this technique. METHODS: We measured anti-SARS-CoV-2 anti-spike RBD IgG and neutralising antibody using a surrogate virus neutralising test (sVNT) among adults aged 18–72 years on average of 8.57 weeks (IQR 6.85–8.93) after the first dose of ChAdOx1 nCoV-19 vaccine. The primary outcome was the antibody level. The secondary outcomes included adverse events, factors affecting antibody levels, and incidence of COVID-19 infection. FINDINGS: In all, 60 participants comprised 25 males and 35 females. The mean age was 53.70 ± 17.48 years. BMI was 23.45 ± 3.69 kg/m(2). Tests for the neutralising antibody were positive in 60% of the participants (71.4% among males and 44% among females). The median anti-SARS-CoV-2 QuantiVac (anti-spike IgG) level among male and female samples was 111.83 BAU/mL (IQR 73.48–196.74 BAU/mL) and 159.65 BAU/mL (IQR 100.39–371.81), respectively. The positive QuantiVac value of male and female samples was 88.00% and 98.44%, respectively (p-value = 0.382) .A good correlation was observed between neutralising Ab and anti-spike RBD IgG. CONCLUSION: Patients receiving 12-dose per vial injections of ChAdOx1 nCoV-19 exhibited high levels of immunity without severe side effects. This technique can be adopted to maximise the number of doses per vial while preserving vaccine effectiveness.