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. 2022 Jan 28;40(4):587-593.
doi: 10.1016/j.vaccine.2021.12.023. Epub 2021 Dec 22.

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

Anan Manomaipiboon  1 , Uraporn Phumisantiphong  1 , Jakravoot Maneerit  1 , Yupin Chalearmchai  1 , Warissara Jirawathin  1 , Achiraya Prajongsai  1 , Patchara Phankavong  1 , Thananda Trakarnvanich  2
Affiliations

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

Anan Manomaipiboon et al. Vaccine. .

Abstract

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/m2. 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.

Keywords: Anti-spike RBD; ChAd0x1 nCoV-19; Covid-19; Immunogenicity; Neutralising antibody.

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Conflict of interest statement

Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Fig. 1
Fig. 1
Seroconversion rate after first dose of ChAdOx1 vaccine.
Fig. 2
Fig. 2
Anti-spike protein IgG antibody titres (BAU/ml) after the first dose of vaccination were higher among females than males (N = 25 among males and 35 among females). Box plots indicated the median and interquartile range (IQR) of anti-spike protein IgG antibody titres.
Fig. 3
Fig. 3
Neutralizing antibody titres measured among males and females. Datapoints are median (IQR).
Fig. 4
Fig. 4
Correlation between neutralising activity and anti-spike protein IgG antibody titres. Spearman’s correlation test was performed to statistically analyse matched pairs.
See this image and copyright information in PMC

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