Other substances

ZF2001

An experimental COVID-19 protein subunit vaccine.

Phase of research

Potential treatment - clinical evidence

How it helps

Vaccine

Drug status

Experimental

Supporting references

Contradictory references

AI-suggested references

Clinical trials

General information

ZF2001 is an experimental COVID-19 protein subunit vaccine, which carries a dimeric RBD of SARS-CoV-2 Spike protein serving as the immunogen. It showed a good safety and immunogenicity profile in phase I and phase II clinical trials. A three-dose regimen was suggested for phase III clinical trials (Yang et al., 2021).

Supporting references

Link	Tested on	Impact factor	Notes	Publication date
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 Spike protein Protein factor Phase II clinical trial Phase I clinical trial Randomized controlled double-blind trial Mixed substance	Healthy adults (18–59 years of age)	24.45	The vaccine was generally well-tolerated. The vaccine formulations elicited humoral and cellular (balanced Th1/Th2) responses. A three-dose regimen provided a better immune response compared to a two-dose regimen. The higher dosing scheme did not have superior outcomes to the lower one; therefore, the regimen of 3 doses of 25 μg was selected for a phase III trial. Sample size (completed immunogenicity analyses): Phase I (three doses): 20 (25 μg dose group) + 20 (50 μg dose group) + 10 placebo. Phase II: two doses: 150 (25 μg dose group) + 150 (50 μg dose group) + 150 placebo; three doses: 148 (25 μg dose group) + 148 (50 μg dose group) + 146 placebo. Dosage: Two to three doses, 25 μg or 50 μg each, 30 days apart. Primary outcomes: Safety (phase I) and immunogenicity (phase II).	Mar/24/2021

AI-suggested references

Link	Publication date
Covid-19: Lessons from hospital preparedness for radiation accidents.	Dec/30/2022
Efficacy and Safety of the RBD-Dimer-Based Covid-19 Vaccine ZF2001 in Adults.	May/04/2022
Omicron variant showed lower neutralizing sensitivity than other SARS-CoV-2 variants to immune sera elicited by vaccines after boost	Dec/23/2021
Reduced neutralization of SARS-CoV-2 B.1.617 variant by convalescent and vaccinated sera	Dec/03/2021
A tandem-repeat dimeric RBD protein-based covid-19 vaccine zf2001 protects mice and nonhuman primates	Mar/22/2022
Protective prototype-Beta and Delta-Omicron chimeric RBD-dimer vaccines against SARS-CoV-2.	Jun/23/2022
Sequentially immune-induced antibodies could cross-neutralize SARS-CoV-2 variants	Nov/12/2020
Effective protection of ZF2001 against the SARS-CoV-2 Delta variant in lethal K18-hACE2 mice	Apr/21/2022
Humoral immune response to circulating SARS-CoV-2 variants elicited by inactivated and RBD-subunit vaccines.	May/21/2021

Clinical trials

ID	Title	Status	Phase	Start date	Completion date
NCT04833101	Study on Heterologous Prime-boost of Recombinant COVID-19 Vaccine (Ad5 Vector) and RBD-based Protein Subunit Vaccine	Active, not recruiting	Phase 4	Apr/07/2021	Dec/15/2021
Alternative id - JSVCT115 Interventions - Biological: recombinant Ad5 vectored COVID-19 vaccine\|Biological: RBD-based protein subunit vaccine (ZF2001) against COVID-19\|Biological: trivalent split influenza vaccine Study type - Interventional Study results - No Results Available Locations - Jiangsu Provincial Center for Diseases Control and Prevention, Nanjing, Jiangsu, China Study designs - Allocation: Randomized\|Intervention Model: Parallel Assignment\|Masking: Triple (Participant, Investigator, Outcomes Assessor)\|Primary Purpose: Prevention Enrollment - 120 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Incidence of solicited adverse events within 7 days after vaccination.\|GMT of neutralizing antibodies against live SARS-CoV-2 virus at Day 14 after the booster vaccination.\|Incidence of adverse reactions within 28 days after vaccination.\|Incidence of adverse events within 28 days after vaccination.\|Incidence of unsolicited AE within 28 days after vaccination.\|Incidence of serious adverse events(SAE) from the first dose to the 6 months after completing the last dose of vaccination.\|GMT of binding antibodies against SARS-CoV-2 S and RBD protein measured by ELISA at day 14, day 28 after the second vaccination, and day 14, month 6 after the third vaccination.\|Proportion of the participants with at least a four-fold increase of the binding antibodies against SARS-CoV-2 S and RBD protein at day 14, day 28 after the second vaccination, and day 14, month 6 after the third vaccination.\|Fold increase of binding antibodies against SARS-CoV-2 S and RBD protein at day 14, day 28 after the second vaccination, and day 14, month 6 after the third vaccination.\|GMT of neutralizing antibodies against live SARS-CoV-2 virus at day 28 after the second vaccination, and day 14, month 6 after the third vaccination\|Proportion of the participants with at least a four-fold increase of neutralizing antibodies against live SARS-CoV-2 virus at day 14, day 28 after the second vaccination, and day 14, month 6 after the third vaccination.\|Fold increase of neutralizing antibodies against live SARS-CoV-2 virus at day 14, day 28 after the second vaccination and day 14, month 6 after the third vaccination.
NCT05198063	ZF2001 Booster Immunization Clinical Trials of 6 Months After the Completion of Basic Immunization	Active, not recruiting	Phase 1\|Phase 2	Jan/10/2022	Jul/01/2022
Alternative id - LKM-2021-NCV-JQ01 Interventions - Biological: Recombinant novel coronavirus vaccine (CHO cells) Study type - Interventional Study results - No Results Available Locations - Hunan Provincial Center for Disease Control and Prevention Preventive Medicine Clinic, Changsha, Hunan, China Study designs - Allocation: N/A\|Intervention Model: Single Group Assignment\|Masking: None (Open Label)\|Primary Purpose: Prevention Enrollment - 300 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Immunogenicity endpoint\|Safety endpoint
NCT05198102	ZF2001 Booster Immunization Clinical Trials of 12 Months After the Completion of Basic Immunization	Active, not recruiting	Phase 1\|Phase 2	Dec/29/2021	Jul/01/2022
Alternative id - LKM-2021-NCV-JQ02 Interventions - Biological: Recombinant novel coronavirus vaccine (CHO cells) 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 - 300 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Immunogenicity endpoint\|Safety endpoint
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
NCT05205096	Immunogenicity and Safety of Booster Immunization of ZF2001 After Inoculation With Two Doses of CoronaVac	Active, not recruiting	Phase 1\|Phase 2	Oct/21/2021	Jun/01/2022
Alternative id - IIT-LKM-2021-NCV03-02 Interventions - Biological: Recombinant novel coronavirus vaccine (CHO cells) Study type - Interventional Study results - No Results Available Locations - Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou, Zhejiang, China Study designs - Allocation: N/A\|Intervention Model: Single Group Assignment\|Masking: None (Open Label)\|Primary Purpose: Prevention Enrollment - 480 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Immunogenicity endpoint\|Safety endpoint
NCT05205083	Immunogenicity and Safety of Booster Immunization of ZF2001 After Inoculation With Two Doses of BBIBP-CorV	Recruiting	Phase 1\|Phase 2	Nov/10/2021	Jul/01/2022
Alternative id - IIT-LKM-2021-NCV03-01 Interventions - Biological: Recombinant novel coronavirus vaccine (CHO cells) Study type - Interventional Study results - No Results Available Locations - Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou, Zhejiang, China Study designs - Allocation: N/A\|Intervention Model: Single Group Assignment\|Masking: None (Open Label)\|Primary Purpose: Prevention Enrollment - 480 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Immunogenicity endpoint\|Safety endpoint

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