Objective: To evaluate the quality of recombinant adenovirus type-5-vectored COVID-19 vaccine seed (XBB.1.5 virus strain). Methods: Conducted viral vector identity and target gene identity by PCR and agarose gel electrophoresis to determine whether it was an adenovirus type vector and whether the insertion fragment was correct; conducted infectious viral titer (IFU) test to evaluate the infectivity of the virus; conducted sterility test, mycoplasma test, extraneous virus agents test, and adeno-associated virus (AAV) test on the virus seed to detect whether there was exogenous contamination. Results: The results showed that the vector and inserted fragment of the virus seed were correct, and the virus seed was with high infectivity and no bacteria, fungi, mycoplasma, extraneous virus agents and adeno-associated virus (AAV). Conclusion: The quality of recombinant adenovirus type-5-vectored COVID-19 vaccine seed (XBB.1.5 virus strain) met the specification of products approved. The viral vector identity and target gene identity, infectious viral titer test and methods about vaccine safety had guiding significance for vaccine production.
WU Xiao-hong, YANG Li-hong, ZHENG Xiu-yu, ZHAO Dan-hua, HUANG Yan-qiu , FU Rui, LIU Xin-yu, LI Yu-hua, YE Qiang
. Quality evaluation of recombinant adenovirus type-5-vectored COVID-19 variant vaccine (XBB.1.5 virus strain)[J]. Chinese Journal of Pharmaceutical Analysis, 2023
, 43(12)
: 2165
-2170
.
DOI: 10.16155/j.0254-1793.2023.12.23
[1] SAKURAI F, TACHIBANA M, MIZUGUCHI H. Adenovirus vector-based vaccine for infectious diseases[J]. Drug Metab Pharmacokinet, 2022, 42: 100432
[2] ROMANENKO M, OSIPOV I, NETESOV SV, et al. Adenovirus type 6: Subtle structural distinctions from adenovirus type 5 result in essential differences in properties and perspectives for gene therapy[J]. Pharmaceutics, 2021, 13(10):1641
[3] LOGUNOV DY, DOLZHIKOVA IV, ZUBKOVA OV, et al. Safety and immunogenicity of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine in two formulations: two open, non-randomised phase 1/2 studies from Russia[J]. Lancet, 2020, 396(10255):887
[4] RAMASAMY MN, MINASSIAN AM, EWER KJ, et al. 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[J]. Lancet, 2021, 396(10267):1979
[5] JACOB-DOLAN C, BAROUCH D H. COVID-19 vaccines: Adenoviral vectors[J]. Annu Rev Med, 2022, 73: 41
[6] ZHU F C, LI Y H, GUAN X H, et al. Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomised, first-in-human trial[J]. Lancet, 2020, 395(10240):1845
[7] ZHU FC, GUAN XH, LI YH, et al. Immunogenicity and safety of a recombinant adenovirus type-5-vectored COVID-19 vaccine in healthy adults aged 18 years or older: a randomised, double-blind, placebo-controlled, phase 2 trial[J]. Lancet, 2020, 396(10249):479
[8] HALPERIN S A, YE L, MACKINNON-CAMERON D, et al. Final efficacy analysis, interim safety analysis, and immunogenicity of a single dose of recombinant novel coronavirus vaccine (adenovirus type 5 vector) in adults 18 years and older: an international, multicentre, randomised, double-blinded, placebo-controlled phase 3 trial[J]. Lancet, 2022, 399(10321):237
[9] WU S, HUANG J, ZHANG Z, et al. Safety, tolerability, and immunogenicity of an aerosolised adenovirus type-5 vector-based COVID-19 vaccine (Ad5-nCoV) in adults: preliminary report of an open-label and randomised phase 1 clinical trial[J]. Lancet Infect Dis, 2021, 21(12):1654
[10] ZHU F, JIN P, ZHU T, et al. Safety and immunogenicity of a recombinant adenovirus type-5-vectored coronavirus disease 2019 (COVID-19) vaccine with a homologous prime-boost regimen in healthy participants aged ≥6 years: A randomized, double-blind, placebo-controlled, phase 2b trial[J]. Clin Infect Dis, 2022, 75(1):e783
[11] SADOFF J, LE GARS M, SHUKAREV G, et al. Interim results of a phase 1-2a trial of Ad26.COV2.S COVID-19 Vaccine[J]. N Engl J Med, 2021, 384(19):1824
[12] ABBASI J. What to know about EG.5, the latest SARS-CoV-2 “variant of interest”[J]. JAMA, 2023, 330(10):900
[13] 夏训明. 美国FDA建议新冠疫苗生产商生产含有新冠病毒XBB.1.5成分的单价新冠疫苗[J]. 广东药科大学学报, 2023, 39(4):134
Xia X M. FDA recommends vaccine manufacturers make single-strain COVID-19 boosters that target Omicron variant XBB.1.5[J]. J Guangdong Pharm Univ, 2023, 39(4):134
[14] WASHINGTON NL, GANGAVARAPU K, ZELLER M, et al. Emergence and rapid transmission of SARS-CoV-2 B.1.1.7 in the United States[J]. Cell, 2021, 184(10):2587
[15] LIU C, ZHOU D, NUTALAI R, et al. The antibody response to SARS-CoV-2 Beta underscores the antigenic distance to other variants[J]. Cell Host Microbe, 2022, 30(1):53
[16] MAGGI F, NOVAZZI F, GENONI A, et al. Imported SARS-CoV-2 variant P.1 in traveler returning from Brazil to Italy[J]. Emerg Infect Dis, 2021, 27(4):1249
[17] REN SY, WANG WB, GAO RD, et al. Omicron variant (B.1.1.529) of SARS-CoV-2: mutation, infectivity, transmission, and vaccine resistance[J]. World J Clin Cases, 2022, 10(1):1
[18] DAYA S, BERNS KI. Gene therapy using adeno-associated virus vectors[J]. Clin Microbiol Rev, 2008, 21(4):583
