ZF2001

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ZF2001
Vaccine description
TargetSARS-CoV-2
Vaccine typeProtein subunit
Clinical data
Trade namesRBD-Dimer
Routes of
administration		Intramuscular
ATC code
  • None
Identifiers
DrugBank
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COVID-19 pandemic
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ZF2001, trade-named RBD-Dimer, is an adjuvanted protein subunit COVID-19 vaccine developed by Anhui Zhifei Longcom in collaboration with the Institute of Microbiology at the Chinese Academy of Sciences.[1][2] As of December 2020, the vaccine candidate was in Phase III trials with 29,000 participants in China, Ecuador, Malaysia, Pakistan, and Uzbekistan.[3][4]

ZF2001 employs technology similar to other protein-based vaccines in Phase III trials from Novavax, Vector Institute, and Medicago.[5] It is administered in 3 doses over a period of 2 months.[6]

ZF2001 was first approved for use in Uzbekistan and later China.[7][8] Production capacity is expected to be one billion doses a year.[6] Phase II results published in The Lancet on the three dose administration showed seroconversion rates of neutralizing antibodies of between 92% to 97%.[9]

Description[edit]

As described in Cell, the CoV spike receptor-binding domain (RBD) is an attractive vaccine target for coronaviruses but is constrained by limited immunogenicity, however a dimeric form of MERS-CoV RBD offers greater protection. The RBD-dimer significantly increases neutralizing antibodies compared to a conventional monomeric form and protected mice against MERS-CoV infection. CoV RBD-dimer have been produced at high yields in pilot scale production.[10]

Rather than injecting a whole virus, subunit vaccines contains virus particles specially selected to stimulate an immune response. Because the fragments are incapable of causing disease, subunit vaccines are considered very safe.[11] Subunit vaccines in widespread use include the Hepatitis B vaccine and Pertussis vaccine. However, as only a few viral components are included in the vaccine which does not display the full complexity of the virus, their efficacy may be limited.[12] Subunit vaccines are delivered alongside adjuvants and booster doses may be required.[11]

According to industry experts, production for this kind of vaccine is stable and reliable, and easier to achieve large-scale industrial production at home and overseas. However it was noted it can be very inconvenient for people to come back for a second and third dose.[6]

Development[edit]

Phase I and II trials and results[edit]

In June, Longcom began a double-blind, randomized, placebo parallel controlled Phase I trial with 50 participants aged 18–59 in Chongqing divided into low-dose, high-dose, and placebo groups.[13]

In July, Longcom began a randomized, double-blind, placebo-controlled Phase II trial with 900 participants aged 18–59 in Changsha, Hunan divided into low-dose, high-dose, and placebo groups.[14] In August, an additional Phase II trial was launched with 50 participants aged 60 and above.[15][1]

In Phase II results published in The Lancet, on the two-dose schedule, seroconversion rates of neutralizing antibodies after the second dose were 76% (114 of 150 participants) in a 25 μg group and 72% (108 of 150) in a 50 μg group. On the three-dose schedule, seroconversion rate of neutralizing antibodies after the third dose were 97% (143 of 148 participants) in the 25 μg group and 93% (138 of 148) in the 50 μg group. 7 to 14 days after the administration of the third dose, the GMTs of neutralizing antibodies reached levels that were significantly higher than observed in human convalescent serum of recovering COVID-19 patients, especially in the 25 μg group.[9]

Phase III trials[edit]

In December, Longcom began enrollment of a Phase III randomized, double-blind, placebo-controlled clinical trial for 29,000 participants, including 750 participants between 18-59 and 250 participants 60 and older in China and 21,000 participants between 18-59 and 7,000 participants 60 and older outside China.[16][17]

In December, Malaysia's MyEG announced it would conduct Phase III trials. If the trials were successful, MyEG would be the sole distributor of ZF2001 in Malaysia for 3 years.[4]

In December, Uzbekistan began a year-long Phase III trial of ZF2001 with 5,000 volunteers between 18 and 59.[18][19]

In December, Ecuador's Minister of Health, Juan Carlos Zevallos announced Phase III trials would involve between 5,000 and 8,000 volunteers.[20]

In February, Pakistan's Drug Regulatory Authority (DRAP) approved Phase III trials with approximately 10,000 participants to be conducted at UHS Lahore, National Defense Hospital, and Agha Khan Hospital.[21]

Discussions to begin Phase III trials are also underway in Indonesia.[17][22]

COVID-19 Variants[edit]

In February, lab studies of twelve serum samples taken from recipients of BBIBP-CorV and ZF2001 retained neutralizing activity against 501.V2 variant although with weaker activity than against the original virus.[23] For ZF-2001, geometric mean titers declined by 1.6-fold, from 106.1 to 66.6, which was less than antisera from mRNA vaccine recipients with a 6-folds decrease.[24] Preliminary clinical data from Novavax and Johnson & Johnson also showed they were less effective in preventing COVID-19 in South Africa, where the new variant is widespread.[23]

Manufacturing[edit]

The company's vaccine manufacturing facility was put into use in September.[17] In February 2021, Pu Jiang, General Manager of Zhifei Longcom, said the company had an annual production capacity of 1 billion doses.[6]

Marketing and deployment[edit]

  Full authorization
  Emergency authorization
See also: List of COVID-19 vaccine authorizations § RBD-Dimer

On March 1, Uzbekistan granted approval for ZF2001 (under tradename ZF-UZ-VAC 2001) after having taken part in the Phase III trials.[8] In March, Uzbekistan received 1 million doses and plans to start mass vaccinations on April 5.[25]

On March 15, China approve of ZF2001 for limited use after being approved for use by Uzbekistan earlier in the month.[7]

References[edit]

  1. ^ a b "Anhui Zhifei Longcom: RBD-Dimer – COVID19 Vaccine Tracker". covid19.trackvaccines.org. Retrieved 27 December 2020.
  2. ^ "COVID-19 Vaccine: RBD-Dimer by Anhui Zhifei Longcom Biopharma, Institute of Microbiology Chinese Academy of Sciences". covidvax.org. Retrieved 27 December 2020.
  3. ^ "Fifth Chinese Covid-19 vaccine candidate ready to enter phase 3 trials". South China Morning Post. 20 November 2020. Retrieved 27 December 2020.
  4. ^ a b Ying TP (7 December 2020). "MYEG to conduct phase 3 clinical trial for China's Covid-19 vaccine in Msia | New Straits Times". NST Online. Retrieved 27 December 2020.
  5. ^ Zimmer C, Corum J, Wee SL (10 June 2020). "Coronavirus Vaccine Tracker". The New York Times. ISSN 0362-4331. Retrieved 27 December 2020.
  6. ^ a b c d "China's production bottleneck 'could be eased with latest Covid-19 vaccine'". South China Morning Post. 17 March 2021. Retrieved 18 March 2021.
  7. ^ a b Liu, Roxanne (15 March 2021). "China IMCAS's COVID-19 vaccine obtained emergency use approval in China". Reuters. Retrieved 15 March 2021.
  8. ^ a b Mamatkulov, Mukhammadsharif (1 March 2021). "Uzbekistan approves Chinese-developed COVID-19 vaccine". Reuters. Retrieved 2 March 2021.
  9. ^ a b Yang, Shilong; Li, Yan; Dai, Lianpan; Wang, Jianfeng; He, Peng; Li, Changgui; Fang, Xin; Wang, Chenfei; Zhao, Xiang; Huang, Enqi; Wu, Changwei (24 March 2021). "Safety and immunogenicity of a recombinant tandem-repeat dimeric RBD-based protein subunit vaccine (ZF2001) against COVID-19 in adults: two randomised, double-blind, placebo-controlled, phase 1 and 2 trials". The Lancet Infectious Diseases. 0 (0). doi:10.1016/S1473-3099(21)00127-4. ISSN 1473-3099. PMC 7990482.
  10. ^ Dai L, Zheng T, Xu K, Han Y, Xu L, Huang E, et al. (August 2020). "A Universal Design of Betacoronavirus Vaccines against COVID-19, MERS, and SARS". Cell. 182 (3): 722–733.e11. doi:10.1016/j.cell.2020.06.035. PMC 7321023. PMID 32645327.
  11. ^ a b "What are protein subunit vaccines and how could they be used against COVID-19?". www.gavi.org. Retrieved 27 December 2020.
  12. ^ Dong Y, Dai T, Wei Y, Zhang L, Zheng M, Zhou F (October 2020). "A systematic review of SARS-CoV-2 vaccine candidates". Signal Transduction and Targeted Therapy. 5 (1): 237. doi:10.1038/s41392-020-00352-y. PMC 7551521. PMID 33051445.
  13. ^ Clinical trial number NCT04445194 for "Phase I Clinical Study of Recombinant Novel Coronavirus Vaccine" at ClinicalTrials.gov
  14. ^ Clinical trial number NCT04466085 for "A Randomized, Blinded, Placebo-controlled Trial to Evaluate the Immunogenicity and Safety of a Recombinant New Coronavirus Vaccine (CHO Cell) With Different Doses and Different Immunization Procedures in Healthy People Aged 18 to 59 Years" at ClinicalTrials.gov
  15. ^ Clinical trial number NCT04550351 for "A Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial to Evaluate the Safety and Tolerability of Recombinant New Coronavirus Vaccines (CHO Cells) in Healthy People Aged 60 Years and Above" at ClinicalTrials.gov
  16. ^ Clinical trial number NCT04646590 for "A Phase III Randomized, Double-blind, Placebo-controlled Clinical Trial in 18 Years of Age and Above to Determine the Safety and Efficacy of ZF2001, a Recombinant Novel Coronavirus Vaccine (CHO Cell) for Prevention of COVID-19" at ClinicalTrials.gov
  17. ^ a b c "Another Chinese Covid-19 vaccine enters late-stage human trials with a plan to produce 300 million doses annually". Business Insider. Retrieved 27 December 2020.
  18. ^ Reuters Staff (11 November 2020). "Uzbekistan to carry out late-stage trial of Chinese COVID-19 vaccine candidate". Reuters. Retrieved 27 December 2020.
  19. ^ "Uzbekistan poised to start trials on Chinese COVID-19 vaccine | Eurasianet". eurasianet.org. Retrieved 27 December 2020.
  20. ^ "Ecuador participará en ensayos de una vacuna china contra el covid-19". CNN (in Spanish). 29 December 2020. Retrieved 23 January 2021.
  21. ^ "China's third vaccine enters Pakistan". The Nation. 15 February 2021. Retrieved 28 February 2021.
  22. ^ "Covid vaccine tracker: How do the leading jabs compare?". www.ft.com. 23 December 2020. Retrieved 27 December 2020.
  23. ^ a b Liu, Roxanne (3 February 2021). "Sinopharm's COVID-19 vaccine remained active against S.Africa variant, effect reduced - lab study". Reuters. Retrieved 29 March 2021.
  24. ^ Huang, Baoying; Dai, Lianpan; Wang, Hui; Hu, Zhongyu; Yang, Xiaoming; Tan, Wenjie; Gao, George F. (2 February 2021). "Neutralization of SARS-CoV-2 VOC 501Y.V2 by human antisera elicited by both inactivated BBIBP-CorV and recombinant dimeric RBD ZF2001 vaccines". bioRxiv: 2021.02.01.429069. doi:10.1101/2021.02.01.429069.
  25. ^ uz, Kun. "Uzbekistan receives 1 million doses of ZF-UZ-VAC 2001 vaccine". Kun.uz. Retrieved 28 March 2021.

External links[edit]

Retrieved from "https://en.wikipedia.org/w/index.php?title=ZF2001&oldid=1020616416"