Other substances

LUNAR-COV19

COVID-19 candidate vaccine

Phase of research

Potential treatment - pre-clinical evidence

How it helps

Vaccine

Drug status

Experimental

Supporting references

Contradictory references

AI-suggested references

Clinical trials

General information

LUNAR-COV19 is a candidate vaccine being developed by Arcturus/Duke-NUS. It is an mRNA type of candidate vaccine. It is based on the RNA platform, which is also used for multiple non-COVID-19 candidates. Currently, this COVID-19 candidate vaccine is to be evaluated in Phase I/II clinical trial.

Synonyms

ARCT-021

Supporting references

Link	Tested on	Impact factor	Notes	Publication date
DRAFT landscape of COVID-19 candidate vaccines – 26 March 2020	in vitro			Mar/26/2020

AI-suggested references

Link	Publication date
A Single Dose of Self-Transcribing and Replicating RNA Based SARS-CoV-2 Vaccine Produces Protective Adaptive Immunity In Mice.	Apr/05/2021

Clinical trials

ID	Title	Status	Phase	Start date	Completion date
NCT04728347	Open Label Extension Study to Assess the Safety and Long-Term Immunogenicity of ARCT-021	Recruiting	Phase 2	Jan/04/2021	Jun/01/2022
Alternative id - ARCT-021-02 Interventions - Biological: ARCT-021 Study type - Interventional Study results - No Results Available Locations - SingHealth Investigational Medicine Unit (IMU), Singapore General Hospital, Singapore, Singapore Study designs - Allocation: Non-Randomized\|Intervention Model: Parallel Assignment\|Masking: None (Open Label)\|Primary Purpose: Treatment Enrollment - 106 Age - 21 Years to 80 Years (Adult, Older Adult) Outcome measures - Percentages of participants reporting solicited local adverse events\|Percentages of participants reporting solicited systemic adverse events\|Percentages of participants reporting adverse events\|Percentages of participants reporting serious adverse events\|Percentages of participants reporting medically attended adverse events\|Percentages of participants reporting new onset of chronic disease\|Percentages of participants with abnormal safety laboratory test values\|Percentages of participants with abnormal vital sign assessments\|SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs\|SARS-CoV-2 binding antibody levels, expressed as GMCs
NCT04480957	Ascending Dose Study of Investigational SARS-CoV-2 Vaccine ARCT-021 in Healthy Adult Subjects	Completed	Phase 1\|Phase 2	Aug/04/2020	Jan/29/2021
Alternative id - ARCT-021-01 Interventions - Biological: ARCT-021 Dose 1\|Biological: ARCT-021 Dose 2\|Biological: ARCT-021 Dose 3\|Biological: ARCT-021 Dose 4\|Biological: ARCT-021 Dose Regimen 1\|Biological: ARCT-021 Dose Regimen 2\|Other: Placebo Study type - Interventional Study results - No Results Available Locations - SingHealth Investigational Medicine Unit (IMU), Singapore General Hospital, Singapore, Singapore Study designs - Allocation: Randomized\|Intervention Model: Parallel Assignment\|Masking: Double (Participant, Investigator)\|Primary Purpose: Treatment Enrollment - 106 Age - 21 Years to 80 Years (Adult, Older Adult) Outcome measures - Incidence, severity and dose-relationship of AEs\|Geometric mean titre for SARS-CoV-2-specific serum neutralizing antibody\|Mean titre for SARS-CoV-2-specific serum neutralizing antibody levels\|Geometric mean fold rise in titre for SARS-CoV-2-spike protein specific neutralizing antibody levels
NCT04668339	A Trial Evaluating the Safety and Effects of an RNA Vaccine ARCT-021 in Healthy Adults	Active, not recruiting	Phase 2	Jan/07/2021	Apr/30/2022
Alternative id - ARCT-021-04 Interventions - Biological: ARCT-021 single dose priming\|Biological: ARCT-021 two lower dose priming\|Biological: ARCT-021 two higher dose priming\|Biological: Placebo (two doses), priming\|Biological: Randomized booster\|Biological: Placebo booster Study type - Interventional Study results - No Results Available Locations - Arcturus Investigational Site 103, Chandler, Arizona, United States\|Arcturus Investigational Site 107, Tucson, Arizona, United States\|Arcturus Investigational Site 112, San Diego, California, United States\|Arcturus Investigational Site 104, Melbourne, Florida, United States\|Arcturus Investigational Site 105, Orlando, Florida, United States\|Arcturus Investigational Site 106, Pinellas Park, Florida, United States\|Arcturus Investigational Site 109, The Villages, Florida, United States\|Arcturus Investigational Site 101, Peoria, Illinois, United States\|Arcturus Investigational Site 110, Rockville, Maryland, United States\|Arcturus Investigational Site 102, Anderson, South Carolina, United States\|Arcturus Investigational Site 111, Austin, Texas, United States\|Arcturus Investigational Site 108, Dallas, Texas, United States\|Arcturus Investigational Site 204, Singapore, Singapore\|Arcturus Investigational Site 201, Singapore, Singapore\|Arcturus Investigational Site 203, Singapore, Singapore Study designs - Allocation: Randomized\|Intervention Model: Parallel Assignment\|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)\|Primary Purpose: Prevention Enrollment - 600 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Percentages of participants reporting solicited local adverse events\|Percentages of participants reporting solicited systemic adverse events\|Percentages of participants reporting adverse events\|Percentages of participants reporting serious adverse events\|Percentages of participants reporting medically attended adverse events\|Percentages of participants reporting new onset of chronic disease\|Percentages of participants with abnormal chemistry and hematology values\|SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs\|Changes in SARS-CoV-2 serum neutralizing titers from before vaccination to each subsequent time point, expressed as GMFRs\|Percentages of participants achieving greater than or equal to 2-fold and 4-fold rises from before vaccination in SARS-CoV-2 serum neutralizing antibody levels\|SARS-CoV-2 anti-S1, anti-RBD, and anti-N binding antibody levels, expressed as GMCs\|Changes in SARS-CoV-2 anti-S1, anti-RBD, and anti-N binding antibody levels from before vaccination to each subsequent time point, expressed as GMFRs\|Percentages of participants achieving greater than or equal to 2-fold and 4-fold rises from before vaccination in SARS-CoV-2 SARS-CoV-2 anti-S1, anti-RBD, and anti-N binding antibody levels
NCT05037097	A Trial Evaluating the Safety and Immunogenicity of 3 COVID-19 SARS-CoV-2 RNA Vaccines in Healthy Adults	Recruiting	Phase 1\|Phase 2	Aug/30/2021	Mar/01/2023
Alternative id - ARCT-165-01 Interventions - Biological: ARCT-165\|Biological: ARCT-154\|Biological: ARCT-021 Study type - Interventional Study results - No Results Available Locations - Arcturus Investigational Site 202, Wichita, Kansas, United States\|Arcturus Investigational Site 201, Kansas City, Missouri, United States\|Arcturus Investigational Site 101, Singapore, Singapore Study designs - Allocation: Randomized\|Intervention Model: Parallel Assignment\|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)\|Primary Purpose: Treatment Enrollment - 72 Age - 21 Years to 80 Years (Adult, Older Adult) Outcome measures - Percentage of participants reporting solicited local or systemic adverse events\|Percentage of participants reporting unsolicited adverse events\|Percentage of participants reporting medically attended adverse events\|Percentage of participants reporting adverse events leading to discontinuation from study vaccine/study withdrawal\|Percentage of participants reporting serious adverse events\|SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs\|Changes in SARS-CoV-2 serum neutralizing levels from before vaccination to each subsequent time point, expressed as GMFRs\|Percentages of participants achieving greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 serum neutralizing antibody levels\|GMT ratio (ARCT-021/ARCT-165, ARCT-165/ARCT-154, and ARCT-021/ARCT-154)\|SARS-CoV-2 full-length spike, RBD, and N binding antibody levels, expressed as GMCs\|Changes in SARS-CoV-2 full-length spike, RBD, and N binding antibody levels from before vaccination to each subsequent time point, expressed as GMFRs\|Percentages of participants achieving greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 full-length spike, RBD, and N binding antibody levels

Export (.csv)