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

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:

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
NCT04412538
Institute of Medical Biology (IMB), Chinese Academy of Medical Sciences (CAMS).
Che Y, Clin Infect Dis, 2020

Full text
Commentary
Inactivated virus

KMS-1 100 EU D0/14

KMS-1 150 EU D0/14

KMS-1 100 EU D0/28

KMS-1 150 EU D0/28

Adjuvant

RCT
Phase 2
Healthy SARS-CoV-2 serology/DNA negative adults in two centres in China N=750
Some concerns
Details

Full description

NCT04471519 ; CTRI/2
Bharat Biotech
Ella R, Lancet Infect Dis, 2021

Full text
Commentary
Inactivated virus

3mcg BBV152 + Algel-IMDG

6mcg BBV152 + Algel-IMDG

6mcg BBV152 + Algel

Adjuvant

RCT
Phase 1
Healthy SARS-CoV-2 serology/PCR negative adults in 11 centres in India N=375
Low
Details

Full description

NCT04471519 ; CTRI/2
Bharat Biotech
Ella R, Lancet Infect Dis, 2021
Updated

Full text
Commentary
; Commentary
Inactivated virus

6mcg BBV152 + Algel-IMDG

3mcg BBV152 + Algel-IMDG

RCT
Phase 2
Healthy adults (<65 yo) and children (≥12 yo)volunteers, SARS-CoV-2 infection-free in 9 centres in India N=380
Some concerns
Details

Full description

NCT04412538
The Institute of Medical Biology (IMB), Chinese Academy of Medical Sciences (CAM
Pu J, MedRxiv, 2020

Full text
Commentary
; Commentary
Inactivated virus

KMS-1 100 EU D0/14

KMS-1 100 EU D0/28

Placebo

RCT
Phase 1
Healthy adults aged 18 to 59 years, SARS-CoV-2 nucleic acid or antibodies negative in a single centre in China N=192
Some concerns
Details

Full description

NCT04383574
Sinovac Biotech
Wu Z, Lancet Infect Dis, 2021

Full text
Commentary
; Commentary
Inactivated virus

CoronaVac 1.5mcg D0/28

CoronaVac 3mcg D0/28

CoronaVac 6mcg D0/28

Adjuvant

RCT
Phase 2
Healthy adults aged 60 years and older with no history of SARS-CoV-2 infection in a single centre in China N=422
Low
Details

Full description

ChiCTR2000032459
Beijing Institute of Biological Products/Sinopharm
Xia S, Lancet Infect Dis, 2020

Full text
Commentary
Inactivated virus

BBIBP-CorV 8mcg once

BBIBP-CorV 4mcg D0/14

BBIBP-CorV 4mcg D0/21

BBIBP-CorV 4mcg D0/28

Adjuvant

RCT
Phase 2
Healthy SARS-CoV-2 serology negative adults 18-59 years old and ≥60 years old in a single centre in China N=448
Some concerns
Details

Full description

ChiCTR2000031809
Wuhan Institute of Biological Products Co Ltd./Sinopharm
Xia S, JAMA, 2020

Full text
Commentary
Inactivated virus

Inactivated 2.5mcg-D0/28/

Inactivated 5mcg-D0/28/56

Inactivated 10mcg-D0/28/5

Inactivated 5mcg-D0/14

Inactivated 5mcg-D0/21

Adjuvant

RCT
Phase 1
Healthy adults, aged 18 to 59 years, without history ofSARS-CoV(via on-site inquiry) or SARS-CoV-2 infection (via serologicaland nucleic acid test N=320
Low
Details

Full description

NCT04352608
Sinovac
Zhang Y, Lancet Infect Dis, 2020

Full text
Commentary
; Commentary
Inactivated virus

CoronaVac 3 μg D0/14

CoronaVac 6 μg D0/14

CoronaVac 3 μg D0/28

CoronaVac 6 μg D0/28

Adjuvant

RCT
Phase 2
Healthy SARS-CoV-2 serology/DNA negative adults in a single centre in China N=600
Some concerns
Details

Full description

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.