Vaccines for covid-19 patients
As part of the COVID-NMA initiative, we are identifying all randomized controlled trials (RCTs) of COVID-19 vaccine.
Below, you can access
- A table with the general characteristics and risk of bias assessment for all RCTs identified.
- A synthesis with forest plots and summary of findings table/evidence profile including phase 2-3 trials. For the vaccine (dose and schedule) evaluated in phase 2-3 trials, results available for the same vaccine (dose and schedule) in phase 1-2 trial will also be included in the synthesis.
Of note: For risk of bias assessment, we are considering the “effect of assignment to intervention” which might not be the analysis planned and reported by investigators. Consequently, when investigators planned to assess and report the “per-protocol” effect, the risk of bias for domain 2 may be evaluated as “some concerns”. We will contact investigators to obtain the results of the intent-to-treat analysis.
We present the risk of Bias for phase 1-2 studies assessed for safety outcomes only.
Treatment comparisons
We report below the forest plots for the main treatment comparisons.
Please choose a Treatment Comparison:
- Ad26.COV2.S (5×10^10 vp) D0 vs Placebo (Janssen Biotech, Inc.)
- ChAdOx1 vs MenACWY (University of Oxford/AstraZeneca )
- Gam-COVID-Vac rAd26-S/rAd5-S vs Placebo (Gamaleya Research Institute of Epidemiology and Microbiology)
- BNT162b2 vs Placebo (BioNTech/Fosun Pharma/Pfizer )
- mRNA-1273 vs Placebo (ModernaTX)
Press releases
We acknowledged the publication of press release on the findings of the Novavax vaccine: COVID-19 Vaccine Demonstrates 89.3% Efficacy in UK Phase 3 Trial ">Novavax vaccine We will summarize and assess the study results once the full study reports have been published.Last update: 16/04/2021
| Trial | Type | Comparisons | Design | Participants | Sample size | Overall risk of bias Highest assessment |
Full description | |
|---|---|---|---|---|---|---|---|---|
| Intervention 1 | Intervention 2 | |||||||
|
NCT04368988 Novavax Keech C, N Engl J Med, 2020 Full text Commentary |
Non replicating viral vector |
25mcg NVX-D0/21 5mcg NVX/M1-D0/21 25mcg NVX/M1-D0/21 25mcg NVX/M1+Placebo-D0/2 |
Placebo |
RCTPhase 1 | Healthy adult volunteers, SARS-CoV-2 infection-free and no history of SARS-CoV-2 infection in two centres in Australia. | N=134 |
Some concerns Details |
|
|
NCT04530396 Gamaleya Research Institute of Epidemiology and Microbiology Logunov D, Lancet, 2021 RESIST Full text Commentary ; Commentary ; Commentary |
Non replicating viral vector |
Gam-COVID-Vac rAd26-S/rAd |
Placebo |
RCTPhase 3 | SARS-CoV-2- and HIV infection-free adult volunteers at 25 centers in Russia | N=21977 |
Some concerns Details |
|
|
NCT04444674 University of Oxford/AstraZeneca Madhi S, N Engl J Med, 2021 COV005 Updated Full text Commentary |
Non replicating viral vector |
ChAdOx1 5X10^10vp D0/D28 |
Placebo |
RCTPhase 1-2 | Healthy adult volunteers that were HIV-negative and SARS-CoV-2 infection-free in 7 centres in South Africa | N=2026 | N/A | |
|
NCT04436276 Janssen Pharmaceutical Companies Sadoff J, N Engl J Med, 2021 Full text Commentary |
Non replicating viral vector |
Ad26.COV2.S 5x10^10vp Ad26.COV2.S 1x10^11vp |
Placebo |
RCTPhase 1-2 | Healthy SARS-CoV-2 nucleic acid negative adults 18-55 years old and elderly >65 years old in multiple centres in Belgium and the US | N=810 |
Some concerns Details |
|
|
ISRCTN89951424 University of Oxford/AstraZeneca Voysey M, Lancet, 2020 COV003 Updated Full text Commentary |
Non replicating viral vector |
ChAdOx1 SD/SD |
MenACWY/saline |
RCTPhase 3 | Healthy SARS-CoV-2 serology/DNA negative adults in six centres in Brazil | N=10002 |
Some concerns Details |
|
|
NCT04400838 University of Oxford/AstraZeneca Voysey M, Lancet, 2020 COV002 Updated Full text Commentary |
Non replicating viral vector |
ChAdOx1 LD/SD ChAdOx1 SD/SD |
MenACWY |
RCTPhase 2/3 | Healthy adults in 18 centres in the UK | N=10673 |
Some concerns Details |
|
|
NCT04324606 / EudraC University of Oxford/AstraZeneca Voysey M, Lancet, 2021 COV001/COV002/COV003/COV005 Full text Commentary ; Commentary ; Commentary |
Non replicating viral vector |
ChAdOx1 |
MenACWY/saline |
RCTphase 1/2/3 | Adults seronegative at baseline from four studies in multiple centres in Brazil, South Africa, and the UK | N=24422 |
Some concerns Details |
|
|
NCT04341389 CanSino Biological Inc./Beijing Institute of Biotechnology Zhu F, Lancet, 2020 Full text Commentary Commentary |
Non replicating viral vector |
Ad5-vectored 1×10¹¹ vp Ad5-vectored 1×10¹¹ vp Ad5-vectored 5×10¹⁰ vp |
Ad5-vectored 5×10¹⁰ vp Placebo Placebo |
RCTPhase 2 | Healthy adult volunteers with HIV-negative and SARS-CoV-2 infection-free in a single centre in China. | N=508 |
Some concerns Details |
|
The link in the column "Overall risk of bias" provides access to a complete description of the assessment of each risk of bias domain with supports for judgement produced using the Revised Cochrane risk-of-bias tool for randomized trials RoB 2.
The risk of bias by domain as well as overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review. The link in the column "Full description" provides access to the general characteristics of the study.
We acknowledge that we may have been unable to extract some information from pre-prints, as they represent preliminary forms of scientific communication.