Other substances

MVC-COV1901

A COVID-19 candidate protein subunit vaccine.

Phase of research

Potential treatment - pre-clinical evidence

How it helps

Vaccine

Drug status

Experimental

Supporting references

Contradictory references

Clinical trials

General information

MVC-COV1901 is a COVID-19 candidate protein subunit vaccine being developed by Medigen Vaccine Biologics Corporation/NIAID/Dynavax. It is based on a prefusion SARS-CoV-2 spike immunogen with CpG 1018 (a Th1-biasing synthetic toll-like receptor 9 agonist) and aluminum hydroxide serving as adjuvants (Kuo et al., 2020). Currently, this COVID-19 candidate vaccine is being evaluated in Phase I and Phase II clinical trials.

Synonyms

S-2P subunit vaccine

Supporting references

Link	Tested on	Impact factor	Notes	Publication date	DB entry date
Development of CpG-adjuvanted stable prefusion SARS-CoV-2 spike antigen as a subunit vaccine against COVID-19 Protein factor Animal model Mixed substance	HEK293-hACE2 cells; Vero E6 cells; female BALB/c and C57BL/6 mice; Wuhan-Hu-1 strain SARS-CoV-2 spike protein pseudovirus; live SARS-CoV-2 (hCoV-19/Taiwan/CGMH-CGU-01/2020, GenBank accession MT192759)		Used with CpG 1018 (a Th1-biasing synthetic toll-like receptor 9 agonist) and aluminum hydroxide as adjuvants, the candidate vaccine induced high titer of neutralizing antibodies against pseudotyped virus or live SARS-CoV-2 in sera of immunized mice. No serious adverse reactions were noted.	Nov/29/2020	Nov/29/2020
Draft landscape of COVID-19 candidate vaccines	healthy adults			Jul/28/2020	Aug/06/2020

Clinical trials

ID	Title	Status	Phase	Start date	Completion date
NCT05198596	A Study to Evaluate Immunogenicity and Safety of MVC-COV1901 Compared With AZD1222 in Adults Aged 18 Years and Above	Not yet recruiting	Phase 3	Mar/01/2022	Dec/01/2022
Alternative id - CT-COV-32 Interventions - Biological: MVC-COV1901, Biological: AZD1222 Study type - Interventional Study results - No Results Available Study locations - Uthumpornphisai Hospital, Sisaket, Thailand Study designs - Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Triple (Participant, Care Provider, Investigator), Primary Purpose: Prevention Enrollment - 250 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Immunogenicity of neutralizing antibody (GMT), Incidence of Adverse Event within 28 days post the second study intervention, Immunogenicity of neutralizing antibody(SCR), Immunogenicity of neutralizing antibody(GMT ratio), Incidence of Adverse Event throughout study conduct
NCT05216601	A Study to Evaluate the Safety, Tolerability, and Immunogenicity of MVC-COV1901 or MVC-COV1901(Beta) Against COVID-19	Not yet recruiting	Phase 2	Mar/01/2022	Dec/01/2022
Alternative id - CT-COV-25 Interventions - Biological: MVC-COV1901(Beta), Biological: MVC-COV1901 Study type - Interventional Study results - No Results Available Study locations - Tri-Service General Hospital, Taipei, Taiwan Study designs - Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Triple (Participant, Care Provider, Investigator), Primary Purpose: Prevention Enrollment - 160 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Incidence of Adverse Events from Day 1 to 29, Primary Immunogenicity-1, Primary Immunogenicity-2, Primary Immunogenicity-3, Primary Immunogenicity-4, Incidence of Adverse Events from Day 1 to 181, Secondary Immunogenicity (Humoral)-1, Secondary Immunogenicity (Humoral)-2, Secondary Immunogenicity (Humoral)-3, Secondary Immunogenicity (Cellular)-4, Secondary Immunogenicity (Cellular)-5
NCT05197153	A Study to Evaluate the Safety and Immunogenicity of Booster With AZD1222, mRNA-1273, or MVC-COV1901 Against COVID-19	Not yet recruiting	Phase 2	Jan/01/2022	Dec/01/2022
Alternative id - CT-COV-24 Interventions - Biological: Half dose of MVC-COV1901, Biological: Full dose of MVC-COV1901, Biological: AZD1222, Biological: Half dose of mRNA-1273 Study type - Interventional Study results - No Results Available Study locations - Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, Taiwan; National Taiwan University Hospital, Taipei, Taiwan; Taipei Municipal Wan Fang Hospital, Taipei, Taiwan; Taipei Veteran General Hospital, Taipei, Taiwan Study designs - Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Triple (Participant, Care Provider, Investigator), Primary Purpose: Prevention Enrollment - 960 Age - 18 Years to 80 Years (Adult, Older Adult) Outcome measures - Incidence of Adverse Events from Day 1 to 28, Primary Immunogenicity-1, Primary Immunogenicity-2, Primary Immunogenicity-3, Primary Immunogenicity-4, Incidence of Adverse Events from Day 1 to 181, Secondary Immunogenicity (Humoral)-1, Secondary Immunogenicity (Humoral)-2, Secondary Immunogenicity (Humoral)-3, Secondary Immunogenicity (Cellular)
NCT05132855	The Immune Response of Heterologous Boost Third Dose of mRNA and Protein COVID-19 Vaccine	Active, not recruiting	Phase 1\|Phase 2	Nov/30/2021	Apr/01/2023
Alternative id - 202101767A3 Interventions - Biological: BNT162b2, Biological: mRNA-1273, Biological: MVC-COV1901 Study type - Interventional Study results - No Results Available Study locations - Chang Gung Memorial Hospital, Taoyuan city, Taiwan Study designs - Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single (Participant), Primary Purpose: Prevention Enrollment - 340 Age - 20 Years and older (Adult, Older Adult) Outcome measures - The immune response after heterologous boost third dose of COVID-19 vaccines after homologous prime-boost AZD1222 vaccination, The safety of heterologous boost third dose of COVID-19 vaccines
NCT05011526	A Study to Evaluate Immunogenicity and Safety of MVC-COV1901 Compared With AZD1222 Against COVID-19 in Adults	Active, not recruiting	Phase 3	Oct/08/2021	Jun/01/2022
Alternative id - CT-COV-31 Interventions - Biological: MVC-COV1901, Biological: AZD1222 Study type - Interventional Study results - No Results Available Study locations - Hospital Fundación Tesai, Ciudad del Este, Paraguay; Hospital de Clinicas - Facultad de Ciencias Médicas, Universidad Nacional de Asunción, San Lorenzo, Paraguay Study designs - Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double (Participant, Investigator), Primary Purpose: Prevention Enrollment - 1020 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Immunogenicity of neutralizing antibody (GMT ratio), Incidence of Adverse Event within 28 days post the second study intervention, Immunogenicity of neutralizing antibody (GMT), Immunogenicity of neutralizing antibody(SCR), Immunogenicity of neutralizing antibody(GMT ratio), Incidence of Adverse Event throughout study conduct
NCT05097053	A Heterologous 3rd COVID-19 Vaccine of MVC-COV1901 to Evaluate Immunogenicity and Safety in Adults With ChAdOx1-nCov-19	Recruiting	Phase 4	Oct/07/2021	Jul/01/2022
Alternative id - TYGH110044 Interventions - Biological: MVC-COV1901(3 Months), Biological: MVC-COV1901(6 Months) Study type - Interventional Study results - No Results Available Study locations - Taoyuan General Hospital, Taoyuan, Taiwan Study designs - Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: None (Open Label), Primary Purpose: Prevention Enrollment - 200 Age - 20 Years to 64 Years (Adult) Outcome measures - Primary Immunogenicity, Primary Safety, Secondary Immunogenicity, Secondary Safety
NCT05079633	A Heterologous Prime-boost Study to Evaluate Immunogenicity and Safety of mRNA-1273 With MVC-COV1901 in Adults	Active, not recruiting	Phase 4	Sep/30/2021	Jun/01/2022
Alternative id - 202108058MINB Interventions - Biological: Homologous boost schedule, Biological: Heterologous boost schedule Study type - Interventional Study results - No Results Available Study locations - National Taiwan University Hospital, Taipei, Taiwan Study designs - Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double (Participant, Investigator), Primary Purpose: Prevention Enrollment - 220 Age - 20 Years to 69 Years (Adult, Older Adult) Outcome measures - Primary Immunogenicity-GMT, Primary Immunogenicity-SCR, Primary Immunogenicity-GMR, Primary Safety, Secondary Immunogenicity-GMT, Secondary Immunogenicity-SCR, Secondary Immunogenicity-GMR, Secondary Safety
NCT05054621	Immunogenicity of COVID-19 Vaccine on Heterologous Schedule	Recruiting	Phase 2	Sep/15/2021	Aug/31/2022
Alternative id - Heterologous_AZ_Medigen Interventions - Biological: Heterologous prime-boost schedule with AZD1222 and MVC-COV1901, Biological: Homologous prime-boost schedule with two doses of AZD1222 Study type - Interventional Study results - No Results Available Study locations - ChangGungMH, Taoyuan, Taiwan Study designs - Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single (Participant), Primary Purpose: Prevention Enrollment - 110 Age - 20 Years to 70 Years (Adult, Older Adult) Outcome measures - Immunogenicity: Neutralizing antibody against SARS-CoV-2, Immunogenicity：Anti-SARS-CoV-2 Spike antibody, Adverse events, Immunogenicity: Anti-SARS-CoV-2 Nucleocapsid antibody, Immunogenicity: T cell immunity
NCT05038618	A Study o Evaluate the Safety, Tolerability, and Immunogenicity of MVC-COV1901, CT-COV-21 Sub-study	Active, not recruiting	Phase 2	Aug/02/2021	Apr/01/2022
Alternative id - CT-COV-21s Interventions - Biological: MVC-COV1901(S protein with adjuvant) Study type - Interventional Study results - No Results Available Study locations - Chang-Guang Memorial Hospital Lin-Kou, Taoyuan, Taiwan Study designs - Allocation: N/A, Intervention Model: Single Group Assignment, Masking: None (Open Label), Primary Purpose: Prevention Enrollment - 399 Age - 20 Years to 64 Years (Adult) Outcome measures - Incidence of Adverse Event within 28 days post the second study intervention (Safety of MVC-COV1901), Immunogenicity of MVC-COV1901, Incidence of Adverse Event throughout study conduct (Safety of MVC-COV1901)
NCT04951388	A Study to Evaluate MVC-COV1901 Vaccine Against COVID-19 in Adolescents	Active, not recruiting	Phase 2	Jul/22/2021	Apr/01/2022
Alternative id - CT-COV-22 Interventions - Biological: MVC-COV1901(S protein with adjuvant), Biological: MVC-COV1901(Saline) Study type - Interventional Study results - No Results Available Study locations - Mackay Memorial Hospital Hsinchu, Hsinchu, Taiwan; Chang-Guang Memorial Hospital Lin-Kou, Taipei, Taiwan; MacKay Memorial Hospital, Taipei, Taiwan; National Taiwan University Hospital-HsinChu, Taipei, Taiwan; National Taiwan University Hosptial, Taipei, Taiwan Study designs - Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Triple (Participant, Care Provider, Investigator), Primary Purpose: Prevention Enrollment - 399 Age - 12 Years to 18 Years (Child, Adult) Outcome measures - Incidence of Adverse Events(AEs) [Safety and Tolerability], Immunogenicity of MVC-COV1901-1, Immunogenicity of MVC-COV1901-2, Immunogenicity of MVC-COV1901-3
NCT05048849	A Study to Evaluate the Safety, Tolerability, and Immunogenicity of COVID-19 Vaccine, CT-COV-21 Extension Study	Active, not recruiting	Phase 2	Jul/19/2021	May/01/2022
Alternative id - CT-COV-21e Interventions - Biological: MVC-COV1901(S protein with adjuvant) Study type - Interventional Study results - No Results Available Study locations - Changhua Christian Hospital, Changhua, Taiwan; Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, Taiwan; China Medical University Hospital, Taichung, Taiwan; National Cheng Kung University Hospital, Tainan, Taiwan; National Taiwan University Hospital, Taipei, Taiwan; Taipei Medical University Hospital, Taipei, Taiwan; Taipei Municipal Wan Fang Hospital, Taipei, Taiwan; Taipei Veteran General Hospital, Taipei, Taiwan; Tri-Service General Hospital, Taipei, Taiwan; Chang-Guang Memorial Hospital Lin-Kou, Taoyuan, Taiwan; Tao-Yuan General Hospital, Taoyuan, Taiwan Study designs - Allocation: N/A, Intervention Model: Single Group Assignment, Masking: None (Open Label), Primary Purpose: Prevention Enrollment - 274 Age - 20 Years and older (Adult, Older Adult) Outcome measures - Number of Adverse Event (Safety of MVC-COV1901), Percentage of Adverse Event (Safety of MVC-COV1901), Immunogenicity of MVC-COV1901(Neutralizing Antibody), Number of Adverse Event over the study period (Secondary Safety of MVC-COV1901), Percentage of Adverse Event over the study period (Secondary Safety of MVC-COV1901), Immunogenicity of MVC-COV1901(Antigen-specific Immunoglobulin)
NCT04822025	A Study to Evaluate MVC-COV1901 Vaccine Against COVID-19 in Elderly Adults	Active, not recruiting	Phase 2	May/20/2021	Feb/01/2022
Alternative id - CT-COV-23 Interventions - Biological: MVC-COV1901 (High-Dose), Biological: MVC-COV1901(Mid-Dose) Study type - Interventional Study results - No Results Available Study locations - Hualien Tzu Chi Hospital, Hualien City, Taiwan; Shuang H Hospital, New Taipei City, Taiwan; National Taiwan University Hospital, Taipei, Taiwan; Chang Gung Medical Hospital Linkou, Taoyuan, Taiwan Study designs - Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double (Participant, Investigator), Primary Purpose: Prevention Enrollment - 420 Age - 65 Years and older (Older Adult) Outcome measures - Incidence of Adverse Events(AEs) [Safety and Tolerability], Immunogenicity of MVC-COV1901
NCT04695652	A Study to Evaluate MVC-COV1901 Vaccine Against COVID-19 in Adult	Completed	Phase 2	Dec/30/2020	Oct/29/2021
Acronym - COVID-19 Alternative id - CT-COV-21 Interventions - Biological: MVC-COV1901(S protein with adjuvant), Biological: MVC-COV1901(Saline) Study type - Interventional Study results - No Results Available Study locations - Changhua Christian Hospital, Changhua, Taiwan; Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, Taiwan; China Medical University Hospital, Taichung, Taiwan; National Cheng Kung University Hospital, Tainan, Taiwan; National Taiwan University Hospital, Taipei, Taiwan; Taipei Medical University Hospital, Taipei, Taiwan; Taipei Municipal Wan Fang Hospital, Taipei, Taiwan; Taipei Veteran General Hospital, Taipei, Taiwan; Tri-Service General Hospital, Taipei, Taiwan; Chang-Guang Memorial Hospital Lin-Kou, Taoyuan, Taiwan; Tao-Yuan General Hospital, Taoyuan, Taiwan; National Institute of Hygiene and Epidemiology, Hanoi, Vietnam Study designs - Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double (Participant, Investigator), Primary Purpose: Prevention Enrollment - 3854 Age - 20 Years and older (Adult, Older Adult) Outcome measures - Incidence of Adverse Event within 28 days post the second study intervention (Safety of MVC-COV1901), Immunogenicity of MVC-COV1901, Incidence of Adverse Event throughout study conduct (Safety of MVC-COV1901), lot to lot consistency
NCT04487210	A Study to Evaluate the Safety and Immunogenicity of MVC-COV1901 Against COVID-19	Completed	Phase 1	Oct/07/2020	Dec/06/2021
Alternative id - CT-COV-11 Interventions - Biological: MVC-COV1901 Study type - Interventional Study results - No Results Available Study locations - National Taiwan University Hospital, Taipei, Taiwan Study designs - Allocation: Non-Randomized, Intervention Model: Sequential Assignment, Masking: None (Open Label), Primary Purpose: Prevention Enrollment - 45 Age - 20 Years to 50 Years (Adult) Outcome measures - Safety of MVC-COV1901, Immunogenicity (neutralizing antibody titers and antigen specific binding antibody titers), Immunogenicity (antigen specific cellular immune responses)

MVC-COV1901

General information

Synonyms

Supporting references

Clinical trials

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References

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