ZF2001

ZF2001, trade-named RBD-Dimer, is an adjuvanted protein subunit COVID-19 vaccine candidate 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, Indonesia, Malaysia, Pakistan, and Uzbekistan.[3][4] If the trials are successful, the company plans to make 300 million doses of the vaccine each year.[5]

ZF2001
Vaccine description
Target diseaseCOVID-19
TypeSubunit vaccine
Clinical data
Trade namesRBD-Dimer
Routes of
administration		Intramuscular
ATC code
  • None
Part of a series on the
COVID-19 pandemic
Timeline
2019

2020

2021
Locations
  • By continent
  • By conveyance
International response
Medical response
Impact
  • Socio-economic
  • By industry
 COVID-19 Portal

ZF2001 employs technology similar to other protein-based vaccines in Phase III trials from Novavax, Vector Institute, and Medicago.[6]

Description

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.[7]

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.[8] 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.[9] Subunit vaccines are delivered alongside adjuvants and booster doses may be required.[8]

Development

Phase I and II trials

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.[10] Later 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.[11][1]

In August, an additional Phase II trial was launched with 50 participants aged 60 and above.[12][1]

Phase III trials

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.[13][14]

In December, Malaysia's MyEG announced it would conduct Phase III trials under the supervision of the Ministry of Health. 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.[15][16]

In December, Ecuador's Minister of Health, Juan Carlos Zevallos announced Phase III trials would involve between 5,000 and 8,000 volunteers.[17]

Discussions to begin Phase III trials are also underway in Indonesia and Pakistan.[14][5]

Manufacturing

The company's vaccine manufacturing facility was put into use in September, with an annual production capacity of 300 million doses.[14][5]

References
  1. "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. 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. "Covid vaccine tracker: How do the leading jabs compare?". www.ft.com. 23 December 2020. Retrieved 27 December 2020.
  6. Zimmer C, Corum J, Wee SL (10 June 2020). "Coronavirus Vaccine Tracker". The New York Times. ISSN 0362-4331. Retrieved 27 December 2020.
  7. 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.
  8. "What are protein subunit vaccines and how could they be used against COVID-19?". www.gavi.org. Retrieved 27 December 2020.
  9. 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.
  10. Clinical trial number NCT04445194 for "Phase I Clinical Study of Recombinant Novel Coronavirus Vaccine" at ClinicalTrials.gov
  11. 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
  12. 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
  13. 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
  14. "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.
  15. Reuters Staff (11 November 2020). "Uzbekistan to carry out late-stage trial of Chinese COVID-19 vaccine candidate". Reuters. Retrieved 27 December 2020.
  16. "Uzbekistan poised to start trials on Chinese COVID-19 vaccine | Eurasianet". eurasianet.org. Retrieved 27 December 2020.
  17. "Ecuador participará en ensayos de una vacuna china contra el covid-19". CNN (in Spanish). 29 December 2020. Retrieved 23 January 2021.
This article is issued from Wikipedia. The text is licensed under Creative Commons - Attribution - Sharealike. Additional terms may apply for the media files.