Trial NCT04480957
Publication Low J, medRxiv, 2021
Funding: Private (Arcturus Therapeutics Inc.)
Conflict of interest: Yes
Methods | |
RCT | |
Location :
Single center / Singapore Follow-up duration (months): 2.8 | |
3.0 mcg ARCT-021 (n = 24) 5.0 mcg ARCT-021 (n = 24) Placebo (n = 16) |
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Inclusion criteria | Healthy males or females aged 21 to 80 at the time of informed consent; Body Mass Index 18-35 kg/m2, inclusive, at screening; Willing to refrain from strenuous exercise/activity (for example heavy lifting, weight training, intense aerobics classes etc.) and alcohol for at least 72 hours prior to study visits; Temperature is less than 99.3 degrees Fahrenheit (37.4 degrees Celsius) at screening AND at the pre-dose evaluation on Day 1; Willing and able to comply with protocol-defined procedures and complete all study visits; Males must be surgically sterile or willing to use adequate contraception; females must be post-menopausal, surgically sterile or willing to use adequate contraception |
Exclusion criteria | Pregnant or breast feeding; Clinically significant abnormalities in medical history; Out of range screening laboratory results; Known history of or positive test for human immunodeficiency virus (HIV), hepatitis C or chronic hepatitis B; Uncontrolled hypertension (BP > 160/100 mm Hg); Uncontrolled diabetes; Any history of autoimmune disease; Immunodeficiency of any cause; History of Chronic liver disease; Treatment with another investigational drug, biological agent, or device within one month of screening, or 5 half-lives of investigational drug, whichever is longer; Recent (within 1 year) history of, or current drug or alcohol abuse; Has any blood dyscrasias or significant disorder of coagulation; Has an acute illness, as determined by the investigator, with or without fever [temperature >38.0 degrees Celsius (100.4 degrees Fahrenheit)] within 72 hours prior to each vaccination; Malignancy within 5 years, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated.; Received or plans to receive another vaccine within 4 weeks before study vaccination or at any time during the study.; Receipt of any other SARS CoV-2 or other experimental coronavirus vaccine at any time prior to study or planned during the study; Have any other conditions, which, in the opinion of the Investigator or Sponsor would make the subject unsuitable for inclusion, or could interfere with the subject participating in or completing the Study |
Interventions | |
Intervention
2 IM doses 3.0 mcg ARCT-021 28 days apart 2 IM doses 5.0 mcg ARCT-021 28 days apart |
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Control
2 IM doses 0.9% saline placebo 28 days apart | |
Participants | |
Randomized 64 participants | |
Characteristics of participants Type of participants: Adults N=64 49 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: 22-68 | |
Description of participants Healthy HIV-negative adults at a single Center in Singapore. | |
Primary outcome | |
In the register Incidence, severity and dose-relationship of AEs [ Time Frame: 56 days ] | |
In the report Local and systemic solicited adverse events (AEs) reported immediately and up to 7 days post-inoculation and unsolicited events reported up to 56 days after inoculation | |
Variants description | |
Variants | |
Description * | |
Documents avalaible |
Protocol NR Statistical plan * Data-sharing stated:
Yes |
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
Some concerns |
General comment | In addition to the pre-print article, the prospective trial registry was used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. The study met the target sample size reported in the registry. One pre-stated outcome was not reported in the pre-print (i.e., SARS-CoV-2-specific serum neutralizing antibody seroconversion rate). The trial registry does not clearly report the doses administered to each vaccine arm in Phase 2 of the trial. |