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

2
 Supporting references
0
 Contradictory references
4
 AI-suggested references
14
 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
Draft landscape of COVID-19 candidate vaccines
healthy adults Jul/28/2020
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

AI-suggested references

Link Publication date
Evaluating the Neutralizing Ability of a CpG-Adjuvanted S-2P Subunit Vaccine Against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Variants of Concern.
Jun/11/2021
Safety and immunogenicity of a Recombinant Stabilized Prefusion SARS-CoV-2 Spike Protein Vaccine (MVC-COV1901) Adjuvanted with CpG 1018 and Aluminum Hydroxide in healthy adults: A Phase 1, dose-escalation study.
Jun/26/2021
Safety and immunogenicity of CpG 1018 and aluminium hydroxide-adjuvanted SARS-CoV-2 S-2P protein vaccine MVC-COV1901: interim results of a large-scale, double-blind, randomised, placebo-controlled phase 2 trial in Taiwan
Feb/23/2021
CpG-adjuvanted stable prefusion SARS-CoV-2 spike protein protected hamsters from SARS-CoV-2 challenge
Jan/16/2021

Clinical trials

ID Title Status Phase Start date Completion date
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
  • 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
  • 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
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
  • 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
  • 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)
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
  • 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
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
  • 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)
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
  • 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
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
  • 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)
NCT04695652 A Study to Evaluate MVC-COV1901 Vaccine Against COVID-19 in Adult Completed Phase 2 Dec/30/2020 Oct/29/2021
  • 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
  • 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
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
  • 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
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
  • 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
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
  • 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
  • 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
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
  • 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
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