Trial NCT04636697
Publication Gobeil P, medRxiv, 2021
Dates: 2020-11-25 to 2021-03-24
Funding: Private (Medicago Inc)
Conflict of interest: Yes
Methods | |
RCT | |
Location :
Multicenter / Canada, USA Follow-up duration (months): 1.4 | |
3.75 mcg CoVLP adjuvanted vaccine (n=632) Placebo (n=121) |
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Inclusion criteria |
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Exclusion criteria |
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Interventions | |
Intervention
2 IM doses of 3.75 mcg CoVLP, 21 days apart |
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Control
2 IM doses of placebo, 21 days apart | |
Participants | |
Randomized 753 participants | |
Characteristics of participants Type of participants: Healthy adults, adults with comorbidities and older adults N=753 357 males Children: 0 Pregnant women: 0 Mean age: Age range: 18-88 | |
Description of participants Healthy adults, adults with comorbidities, non-institutionalized older adults (seronegative and seropositive) in multiple centers in Canada and the USA | |
Primary outcome | |
In the register Immediate adverse event (AEs) [ Time Frame: 30 minutes ]; Solicited local and systemic adverse events (AEs) [ Time Frame: 7 days]; Unsolicited adverse events (AEs) [ Time Frame: 21 days ]; Number of subjects with normal and abnormal clinically significant urine values [ Time Frame: 3 days ]; Number of subjects with normal and abnormal clinically significant haematological values [ Time Frame: 3 days ]; Number of subjects with normal and abnormal clinically significant biochemical values [ Time Frame: 3 days ]; Percentage of subjects with normal and abnormal clinically significant urine values [ Time Frame: 3 days ]; Percentage of subjects with normal and abnormal clinically significant haematological values [ Time Frame: 3 days ]; Percentage of subjects with normal and abnormal clinically biochemical values [ Time Frame: 3 days ]; Serious adverse events (SAEs), adverse events (AEs) leading to withdrawal, adverse event of special interest (AESI) (including vaccine-enhanced disease) and deaths [ Time Frame: 21 days ]; Neutralizing antibody (Nab assay) response [ Time Frame: Day 21 ]; Neutralizing antibody (Nab assay) response [ Time Frame: Day 42 ]; Specific Th1 cell-mediated immunity (CMI) response [ Time Frame: Day 21 ]; Specific Th1 cell-mediated immunity (CMI) response [ Time Frame: Day 42 ] | |
In the report Primary safety outcomes were the occurrence(s) of i) immediate AEs within 30 minutes after each vaccination; ii) solicited local and systemic AEs up to 7 days after each vaccination; iii) unsolicited AEs, serious AEs (SAEs), AEs leading to withdrawal, AEs of special interest (AESIs), and deaths up to 21 days after each vaccination; iv) normal and abnormal urine, haematological, and biochemical values. Primary immunogenicity outcomes were i) neutralizing antibody (NAb) titers measured using a pseudovirion neutralization assays and ii) interferon (IFN)-γ and IL-4 ELISpot responses at 21 days after each dose of vaccine. | |
Documents available |
Protocol NR Statistical plan * Data-sharing stated:
Yes, At the end of the clinical trial, which is currently scheduled to be 1 year after the last participant is enrolled, unless granted an extension |
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 |
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General comment | In addition to the pre-print article, the prospective study registry was used in data extraction and risk of bias assessment. Neither protocol nor statistical analysis plan was available. There were no substantive differences between the pre-print article and the registry in population, procedures, interventions or outcomes. The pre-print reported on an interim analysis for phase 2 of an ongoing phase 2/3 study. The safety and immunogenicity data collected at later timepoints will be released once study follow-up has been completed. No outcomes were reported in a format that could be extracted for the review, pending contact with authors. |