Trial NCT04450004
Publication Ward B, Nat Med, 2021
Dates: 2020-07-13 to 2020-08-09
Funding: Private (Medicago)
Conflict of interest: Yes
Methods | |
RCT | |
Location :
Multicenter / Canada Follow-up duration (months): 1.4 | |
•3.75 mcg CoVLP (n = 20) •3.75 mcg CoVLP + CpG 1018 (n = 20) •3.75 mcg CoVLP + AS03 (n = 20) • 7.5 mcg CoVLP (n = 20) •7.5 mcg CoVLP + CpG 1018 (n = 20) •7.5 mcg CoVLP + AS03 (n = 20) •15 mcg CoVLP (n = 20) • 15 mcg CoVLP + CpG 1018 (n = 20) •15 mcg CoVLP + AS03 (n = 20) |
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Inclusion criteria |
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Exclusion criteria |
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Interventions | |
Intervention
2 IM doses of 3.75mcg CoVLP with CPG1018 adjuvant, 21 days apart 2 IM doses of 3.75mcg CoVLP with AS03 adjuvant, 21 days apart 2 IM doses of 7.5mcg CoVLP with CPG1018 adjuvant, 21 days apart 2 IM doses of 7.5mcg CoVLP with AS03 adjuvant, 21 days apart 2 IM doses of 15mcg CoVLP with CPG1018 adjuvant, 21 days apart 2 IM doses of 15mcg CoVLP with AS03 adjuvant, 21 days apart |
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Control
2 IM doses of 3.75mcg unadjuvanted CoVLP 21 days apart2 IM doses of 7.5mcg unadjuvanted CoVLP, two IM doses 21 days apart2 IM doses of 15mcg unadjuvanted CoVLP, 21 days apart | |
Participants | |
Randomized 180 participants | |
Characteristics of participants Type of participants: Healthy volunteers N=180 78 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: 35 Age range: 18-53 | |
Description of participants Healthy SARS-CoV-2 infection-free adults aged 18-55 years at 2 centers in Canada | |
Primary outcome | |
In the register 1. Immediate adverse event (AEs) [ Time Frame: 30 minutes ] Percentage, intensity, and relationship to vaccination of immediate adverse events (AEs); 2. Solicited local and systemic adverse events (AEs) [ Time Frame: 7 days ] Percentage, intensity, and relationship to vaccination of solicited local and systemic adverse events (AEs) following each vaccination; 3. Unsolicited adverse events (AEs) [ Time Frame: 21 days ] Percentage, intensity, and relationship of unsolicited adverse events (AEs) following each vaccine administration; 4. 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 ] Occurrences of serious adverse events (SAEs), adverse events (AEs) leading to withdrawal, adverse event of special interest (AESIs) (including vaccine-enhanced disease (VED)), and deaths following each vaccine administration; 5. Safety labs [ Time Frame: 3 days ] Number and percentage of subjects with normal and abnormal clinically significant urine, haematological and biochemical values prior to and 3 days following each vaccination.; 6. Neutralizing antibody (Nab assay) response [ Time Frame: 21 days ] Nab response induced by the vaccine against the SARS-CoV-2 virus; 7. Specific Th1 cell-mediated immunity (CMI) response [ Time Frame: 21 days ] Cell-mediated immunity (CMI) response induced by the vaccine against the SARS-CoV-2 virus after each vaccination, as measured by Interferon-gamma (IFN-?) enzyme-linked immunospot (ELISpot); 8. Specific Th2 cell-mediated immunity (CMI) response [ Time Frame: 21 days ] Cell-mediated immunity (CMI) response induced by the vaccine against the SARS-CoV-2 virus after each vaccination, as measured by Interleukin-4 (IL-4) ELISpot | |
In the report Primary safety outcomes were the occurrence(s) of: (1) immediate AEs within 30 min after each vaccination; (2) solicited local and systemic AEs up to 7 d after each vaccination; (3) unsolicited AEs, SAEs, AEs leading to withdrawal, AESIs and deaths up to 21 d after each vaccination; (4) participants with normal and abnormal urine and hematological and biochemical values. Primary immunogenicity outcomes were: (1) NAb titers measured using a wild-type MNA and a PNA; and (2) IFN-γ and IL-4 ELISpot responses at 21 d after each dose of vaccine | |
Documents available |
Protocol NR Statistical plan * Data-sharing stated:
Yes, upon completion of the safety follow-up period |
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 published/pre-print, the online trial registry, protocol and supplementary materials were used for extraction and assessment of bias. There were no major differences between the pre-print article and the trial registry in study population, procedures, interventions or outcomes. This was an interim analysis of a phase 1 trial. Recruitment is completed and planned sample size has been reached, however, the study is still ongoing for longer term follow-up. There were no major differences in population, procedures or interventions between the published/pre-print article and registry.
This study was updated on October 21st, 2021 with data from the published report. |