Establishment of a Reference Material in Quality Control for Use in Infectivity and Identity Assays of Recombinant COVID-19 Vaccine, in Accordance with International Standards Organization Guidance
Abstract
:1. Introduction
2. Materials and Methods
2.1. Batch of RCV to Be Tested as RM for Infectivity and Identity Assays
2.2. Chimpanzee Adenovirus AZD1222 Virus Titration
2.3. Identity of the Chimpanzee Adenovirus AZD1222 Virus by Real-Time PCR
2.4. Determination of Homogeneity
2.5. Determination of Stability
2.6. Certified Value Metrological Traceability
3. Results
3.1. Homogeneity Assessment
3.2. Stability Assessment
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Vial | Infectivity Assay (log10 IFU 1/mL) | Identity Assay (Ct 2) | ||||
---|---|---|---|---|---|---|
Flank | Spike | |||||
Replicate 1 | Replicate 2 | Replicate 1 | Replicate 2 | Replicate 1 | Replicate 2 | |
1 | 9.31 | 9.31 | 22.99 | 21.52 | 20.70 | 20.42 |
2 | 9.27 | 9.26 | 23.40 | 20.87 | 21.93 | 20.11 |
3 | 9.24 | 9.22 | 22.60 | 21.25 | 21.65 | 20.78 |
4 | 9.24 | 9.29 | 21.66 | 23.07 | 20.95 | 21.36 |
5 | 9.22 | 9.25 | 22.87 | 22.16 | 23.76 | 20.51 |
6 | 9.30 | 9.20 | 24.70 | 22.39 | 25.19 | 20.55 |
7 | 9.30 | 9.25 | 23.70 | 22.19 | 22.76 | 19.65 |
8 | 9.28 | 9.31 | 22.31 | 21.35 | 20.39 | 20.63 |
9 | 9.21 | 9.22 | 22.20 | 22.19 | 20.97 | 20.20 |
10 | 9.24 | 9.25 | 24.91 | 20.97 | 19.66 | 19.94 |
11 | 9.30 | 9.33 | 19.62 | 22.11 | 20.10 | 20.99 |
12 | 9.25 | 9.26 | 19.67 | 21.38 | 19.71 | 20.51 |
13 | 9.26 | 9.18 | 19.49 | 21.36 | 20.02 | 18.71 |
14 | 9.19 | 9.20 | 19.73 | 20.51 | 19.53 | 19.65 |
15 | 9.26 | 9.29 | 20.60 | 21.64 | 20.44 | 20.04 |
16 | 9.26 | 9.23 | 20.04 | 22.01 | 20.38 | 21.11 |
17 | 9.20 | 9.24 | 19.89 | 21.66 | 19.80 | 20.58 |
18 | 9.19 | 9.21 | 21.17 | 22.07 | 21.07 | 20.14 |
19 | 9.25 | 9.26 | 20.92 | 23.86 | 20.59 | 19.49 |
20 | 9.21 | 9.27 | 21.89 | 21.88 | 21.13 | 19.02 |
Time (Days) | Temperature (°C) | ||||||||
---|---|---|---|---|---|---|---|---|---|
−70 ± 10 | 5 ± 3 | 22.5 ± 2.5 | |||||||
Infectivity 1 | Flank 2 | Spike 2 | Infectivity | Flank | Spike | Infectivity | Flank | Spike | |
0 | 9.23 | 21.26 | 20.57 | 9.25 | 20.92 | 19.83 | 9.25 | 21.37 | 20.45 |
1 | NR 3 | NR | NR | 9.24 | 21.69 | 20.68 | 9.16 | 21.56 | 20.60 |
2 | NR | NR | NR | 9.22 | 20.56 | 20.10 | 9.06 | 20.44 | 20.25 |
3 | NR | NR | NR | 9.19 | 20.68 | 20.28 | 9.12 | 20.10 | 19.72 |
7 | 9.23 | 20.56 | 19.43 | 9.25 | 20.53 | 19.62 | 8.98 | 20.48 | 19.98 |
8 | NR | NR | NR | 9.28 | 20.75 | 20.07 | 9.00 | 20.48 | 19.42 |
9 | NR | NR | NR | 9.25 | 20.67 | 19.90 | 8.96 | 20.43 | 19.56 |
14 | NR | 19.73 | 18.70 | 9.28 | 19.87 | 19.38 | 8.97 | 19.99 | 19.19 |
21 | 9.20 | 21.38 | 20.32 | 9.21 | 21.36 | 20.54 | NR | NR | NR |
28 | 9.32 | 20.78 | 19.77 | 9.27 | 20.67 | 19.91 | NR | NR | NR |
45 | 9.11 | 20.04 | 18.87 | 9.03 | 20.13 | 19.32 | NR | NR | NR |
62 | 9.28 | 20.64 | 19.49 | 9.20 | 20.69 | 19.99 | NR | NR | NR |
153 | 9.35 | 21.81 | 20.66 | 9.18 | 21.06 | 20.13 | NR | NR | NR |
243 | 9.28 | 17.99 | 17.87 | 9.09 | 18.39 | 18.00 | NR | NR | NR |
313 | 9.23 | 20.95 | 19.08 | 8.96 | 21.04 | 20.25 | NR | NR | NR |
380 | 9.31 | 21.50 | 20.45 | NR | NR | NR | NR | NR | NR |
Storage Temperature | Type of Study | Period (Days) | log10 IFU 1/mL | 95% Confidence Interval | Result | ||
---|---|---|---|---|---|---|---|
Slope Per Day | Standard Error Per Day | Lower | Higher | ||||
−70 ± 10 °C | Long-term | 380 | −0.00016 | 0.00040 | −0.0010 | 0.00069 | Sufficiently stable |
5 ± 3 °C | Long-term | 313 | −0.00081 | 0.00013 | −0.0011 | −0.00053 | Insufficiently stable |
97 | −0.00094 | 0.00049 | −0.0020 | 0.00011 | Sufficiently stable | ||
22.5 ± 2.5 °C | Short-term | 14 | −0.018 | 0.005 | −0.030 | −0.007 | Insufficiently stable |
3 | −0.048 | 0.026 | −0.16 | 0.064 | Sufficiently stable |
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Ajorio, A.C.F.B.; Chagas, M.G.; Rhodes, V.P.; Rodrigues, A.P.; Gonçalves, N.P.; Godinho, R.M.d.C.; Forsythe, S.J.; da Costa, L.V.; Brandão, M.L.L. Establishment of a Reference Material in Quality Control for Use in Infectivity and Identity Assays of Recombinant COVID-19 Vaccine, in Accordance with International Standards Organization Guidance. Vaccines 2024, 12, 967. https://doi.org/10.3390/vaccines12090967
Ajorio ACFB, Chagas MG, Rhodes VP, Rodrigues AP, Gonçalves NP, Godinho RMdC, Forsythe SJ, da Costa LV, Brandão MLL. Establishment of a Reference Material in Quality Control for Use in Infectivity and Identity Assays of Recombinant COVID-19 Vaccine, in Accordance with International Standards Organization Guidance. Vaccines. 2024; 12(9):967. https://doi.org/10.3390/vaccines12090967
Chicago/Turabian StyleAjorio, Ana Carolina Ferreira Ballestê, Michel Gomes Chagas, Vinicius Pessanha Rhodes, Anderson Peclat Rodrigues, Natália Pedra Gonçalves, Rodrigo Maciel da Costa Godinho, Stephen James Forsythe, Luciana Veloso da Costa, and Marcelo Luiz Lima Brandão. 2024. "Establishment of a Reference Material in Quality Control for Use in Infectivity and Identity Assays of Recombinant COVID-19 Vaccine, in Accordance with International Standards Organization Guidance" Vaccines 12, no. 9: 967. https://doi.org/10.3390/vaccines12090967