Other substances

Recombinant new coronavirus vaccine

COVID-19 candidate vaccine

Phase of research

Potential treatment - pre-clinical evidence

How it helps

Vaccine

Drug status

Experimental

1
 Supporting references
0
 Contradictory references
0
 AI-suggested references
9
 Clinical trials

General information

The candidate vaccine being developed by Anhui Zhifei Longcom Biopharmaceutical is an adjuvanted recombinant protein (RBD-dimer) type of candidate vaccine. It is based on the protein subunit platform. Currently, this COVID-19 candidate vaccine is in Phase I and II of clinical evaluation. 

 

Supporting references

Link Tested on Impact factor Notes Publication date
Draft landscape of COVID-19 candidate vaccines
healthy adults Jul/28/2020

Clinical trials

ID Title Status Phase Start date Completion date
NCT05089045 Immunogenicity and Safety Evaluation of Recombinant Novel Coronavirus Vaccine (CHO Cells) in Enhancing Immunity Completed Not Applicable Aug/31/2021 Sep/30/2021
  • Alternative id - LKM-2021-NCV04
  • Interventions - Biological: Recombinant new coronavirus vaccine (CHO cell) group
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Hunan Provincial Center for Disease Control and Prevention, Changsha, Hunan, China
  • Study designs - Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
  • Enrollment - 360
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - The number of adverse events after intramuscular injection|Immunogenic end point
NCT05091411 Clinical Trials of the Consistency and Non-inferiority Bridging Between Batches of Recombinant New Coronavirus Vaccine (CHO Cells) Recruiting Phase 3 Sep/09/2021 Dec/01/2022
  • Alternative id - LKM-2021-NCV02
  • Interventions - Biological: Recombinant new coronavirus vaccine (CHO cell) group
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Hunan Provincial Center for Disease Control and Prevention, Changsha, Hunan, China
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Prevention
  • Enrollment - 1680
  • Age - 18 Years to 59 Years   (Adult)
  • Outcome measures - Immunogenicity endpoint
NCT05109598 Clinical Trial of Immunogenicity Bridging of a Recombinant New Coronavirus（COVID-19） Vaccine (CHO Cell) Recruiting Phase 2 Nov/04/2021 Mar/01/2023
  • Alternative id - LKM-2021-NCV03
  • Interventions - Biological: Recombinant new coronavirus vaccine (CHO cell)
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Hunan Provincial Center for Disease Control and Prevention, Changsha, Hunan, China
  • Study designs - Allocation: Non-Randomized|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
  • Enrollment - 400
  • Age - 3 Years to 17 Years   (Child)
  • Outcome measures - Immunogenic end point|The number of adverse events after intramuscular injection|The number of serious adverse events after intramuscular injection|Immunopersistence results
NCT05107375 Clinical Study of Recombinant Novel Coronavirus（COVID-19） Vaccine (CHO Cell) Combined With Influenza Vaccine Recruiting Phase 3 Sep/03/2021 Mar/04/2022
  • Alternative id - IIT-LKM-2021-NCV01
  • Interventions - Biological: Tetravalent influenza virus lysis vaccine|Biological: Recombinant new coronavirus vaccine (CHO cell) group
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Hunan Provincial Center for Disease Control and Prevention, Changsha, Hunan, China
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
  • Enrollment - 300
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Primary endpoint:|Secondary endpoint:
NCT04550351 Recombinant New Coronavirus Vaccine (CHO Cells) to Prevent SARS-CoV-2 Phase I Clinical Trial (≥60 Years Old) Active, not recruiting Phase 1 Aug/19/2020 Dec/31/2021
  • Alternative id - LKM-2020-NCV03
  • Interventions - Biological: Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cell) low-dose group|Biological: Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cells) high-dose group|Biological: Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cells) placebo group
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Hunan Provincial Center for Disease Control and Prevention, Xiangtan, Changsha, China
  • Study designs - Allocation: Randomized|Intervention Model: Sequential Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Prevention
  • Enrollment - 50
  • Age - 60 Years and older   (Adult, Older Adult)
  • Outcome measures - The number of adverse events after intramuscular injection|Immunogenic end point
NCT04961359 Recombinant New Coronavirus Vaccine (CHO Cells) to Prevent SARS-CoV-2（COVID-19） Phase I Clinical Trial (3~17 Years Old) Recruiting Phase 1 Jul/03/2021 Dec/01/2022
  • Alternative id - LKM-2021-NCV01
  • Interventions - Biological: Recombinant new coronavirus vaccine (CHO cell) group|Biological: Recombinant new coronavirus vaccine (CHO cells) placebo group
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Hunan Provincial Center for Disease Control and Prevention, Changsha, Hunan, China
  • Study designs - Allocation: Randomized|Intervention Model: Sequential Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Prevention
  • Enrollment - 75
  • Age - 3 Years to 17 Years   (Child)
  • Outcome measures - The number of adverse events after intramuscular injection|Immunogenic end point
NCT04466085 Clinical Study of Recombinant Novel Coronavirus Vaccine Active, not recruiting Phase 2 Jul/12/2020 Dec/15/2021
  • Alternative id - NCV-Ⅱ-healthy
  • Interventions - Biological: Recombinant new coronavirus vaccine (CHO cell) low-dose group|Biological: Recombinant new coronavirus vaccine (CHO cells) high-dose group|Biological: Recombinant new coronavirus vaccine (CHO cells) placebo group
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Hunan Provincial Center for Disease Control and Prevention, Hunan, Changsha, China
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Prevention
  • Enrollment - 900
  • Age - 18 Years to 59 Years   (Adult)
  • Outcome measures - Neutralizing antibody positive conversion rate|Neutralizing antibody GMT, positive rate|Neutralizing antibody GMT, positive conversion rate/positive rate|Neutralizing antibody GMT|Neutralizing antibody GMI, positive rate|IL-2, IL-4, IL-5, IL-6 and IFN-γ levels|Adverse events|Serious adverse event
NCT04445194 Phase I Clinical Study of Recombinant Novel Coronavirus Vaccine Active, not recruiting Phase 1 Jun/22/2020 Sep/20/2021
  • Alternative id - NCV-Ⅰ-healthy
  • Interventions - Biological: Recombinant new coronavirus vaccine (CHO cell) low-dose group|Biological: Recombinant new coronavirus vaccine (CHO cells) high-dose group|Biological: Recombinant new coronavirus vaccine (CHO cells) placebo group
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - The Second Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing, China
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Prevention
  • Enrollment - 50
  • Age - 18 Years to 59 Years   (Adult)
  • Outcome measures - The number of adverse events after intramuscular injection|Immunogenic end point
NCT04646590 A Phase III Clinical Trial to Determine the Safety and Efficacy of ZF2001 for Prevention of COVID-19 Active, not recruiting Phase 3 Dec/16/2020 Dec/01/2022
  • Alternative id - LKM-2020-NCV-GJ01
  • Interventions - Biological: Recombinant new coronavirus vaccine (CHO cell) group|Biological: Recombinant new coronavirus vaccine (CHO cells) placebo group
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Hunan Provincial Center for Disease Control and Prevention, Changsha, Hunan, China|Biodimed Guayaquil Clinical Research Center, Guayaquil, Guayas, Ecuador|Biodimed Alemania Clinical Research Center, Quito, Pichincha, Ecuador|Biodimed Eloy Alfaro Clinical Research Center, Quito, Pichincha, Ecuador|Fkui-Rscm, Jakarta, Daerah Khusus Ibukota Jakarta, Indonesia|FK Unpad/RSHS, Bandung, Jawa Barat, Indonesia|Aziz Fatimah Hospital, Faisalabad, Punjab, Pakistan|Avicenna Hospital, Lahore, Punjab, Pakistan|Central Park Teaching Hospital, Lahore, Punjab, Pakistan|National Hospital & Medical Center, Lahore, Punjab, Pakistan|University of Health Sciences, Lahore, Punjab, Pakistan|Al-Shifa Trust Eye Hospital, Rawalpindi, Punjab, Pakistan|Indus Hospital and Health Network, Karachi, Sindh, Pakistan|Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad, Pakistan|Family Hospital No.15, Tashkent, Uzbekistan|GUVD Poliklinika, Tashkent, Uzbekistan|IIV Markaziy Poliklinika, Tashkent, Uzbekistan|Toshkent viloyat IIV Poliklinika, Tashkent, Uzbekistan
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Prevention
  • Enrollment - 28904
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - The endpoint of efficacy study|The endpoint of safety study|Endpoint of immunogenicity and immune persistence study
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