meta|Evidence - COVID-19
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CanSino (Convidecia) (n=147) vs. CoronaVac (SinoVac) (n=152)
randomized controlled trial risk of bias NA
Ad-5 based vaccine (D2 or D3)
inactivated Coronavac vaccine (D2 or D3)
COVID-19 prophylaxis (excluding children)
single-blind
1 center, China
CanSino (Convidecia) (n=382) vs. placebo (n=126)
randomized controlled trial risk of bias NA
CanSino
1×10¹¹ or 5×10¹⁰ viral particles per mL - 1 injection
placebo
COVID-19 prophylaxis (excluding children)
double-blind
single centre in Wuhan, China
The secondary safety outcomes included the occurrence of adverse events from days 0 to 28 after vaccination, and serious adverse events reported up to 6 months
CanSino (Convidecia) (n=320) vs. placebo (n=110)
randomized controlled trial risk of bias NA
low-dose vaccine, middle-dose, 2 doses
placebo
COVID-19 prophylaxis (excluding children)
double blind
1 center, China
Comirnaty (tozinameran - Pfizer/BIONTECH) (n=-9) vs. control (n=-9)
- risk of bias NA
mRNA BNT162b2
COVID-19 prophylaxis (excluding children)
Comirnaty (tozinameran - Pfizer/BIONTECH) (n=21720) vs. placebo (n=21728)
randomized controlled trial some concerns about risk of bias
BNT162b2
two doses, 21 days apart, of BNT162b2 vaccine candidate (30 μg per dose)
placebo
COVID-19 prophylaxis (excluding children)
Adults 16 years of age or older who were healthy or had stable chronic medical conditions, including but not limited to human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus infection. Key exclusion criteria included a medical history of Covid-19, treatment with immunosuppressive therapy, or diagnosis with an immunocompromising condition
double-blind
152 sites worldwide
phase1/2/3 study (seamless)
Comirnaty - first boost (n=5081) vs. Comirnaty (tozinameran - Pfizer/BIONTECH) (n=5044)
randomized controlled trial low risk of bias
BNT162b2 vaccine
third dose
placebo
participants had previously received 2 doses of Comirnaty
COVID-19 prophylaxis (excluding children)
single-blind
123 sites in the United States, South Africa, and Brazil
During the interim analysis, the data monitoring committee recommended that participants be made aware of their trial-group assignments to allow those in the placebo group to receive a third vaccine dose. Data from participants who were made aware of trial-group assignments before the first interim analysis because of the regulatory decision were censored at the time of the unblinding of the trial group.
CoronaVac (SinoVac) (n=6195) vs. placebo (n=6201)
randomized controlled trial risk of bias NA
CoronaVac
two doses of vaccine (3 μg in 0.5 mL) at day 0 and 14
placebo
COVID-19 prophylaxis (excluding children)
double-blind
16 centres, Brazil
very preliminary results from press release
CoronaVac (SinoVac) (n=752) vs. placebo (n=570)
randomized controlled trial risk of bias NA
COVID-19 prophylaxis (excluding children)
very preliminary results of a interim analysis
Covishield (Oxford/AZ formulation) (n=1200) vs. placebo (n=300)
randomized controlled trial risk of bias NA
SII-ChAdOx1 nCoV-19
Two doses of vaccine at a dosing interval of 4 ( 2) weeks
placebo
COVID-19 prophylaxis (excluding children)
double-blind
14 hospitals across India
first booster dose (n=-9) vs. complete primary vaccine series (n=-9)
randomized controlled trial risk of bias NA
30-µg booster dose of the Pfizer-BioNTech COVID-19 Vaccine
The median time between second dose and administration of the booster dose or placebo was approximately 11 months.
Placebo
COVID-19 prophylaxis (excluding children)
Double-blind.
Data extracted from press realease: https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-phase-3-trial-data-showing
heterologous prime-boost (n=450) vs. control (n=226)
randomized controlled trial risk of bias NA
BNT162b2 (0·3 mL) via a single intramuscular injection
BNT162b2 (Comirnaty) administered as second dose in participants primed with ChAdOx1-S (Vaxzevria) 50-84 days before
continue observation
only one dose of ChAdOx1-S (Vaxzevria)
COVID-19 prophylaxis (excluding children)
open-label
five university hospitals in Spain
Janssen AD26 vaccine (JNJ-78436735) (n=100) vs. Comirnaty (tozinameran - Pfizer/BIONTECH) (n=101)
randomized controlled trial risk of bias NA
Ad26COVS1 vaccine
homologous (mRNA) vaccine
mRNA (BNT162b2 or mRNA-1273) or vector (Ad26COVS1) as a third dose of a SARS-CoV-2 vaccine after 2 doses of an mRNA vaccine
COVID-19 prophylaxis (excluding children)
single-blinded
1 center, Austria
Janssen AD26 vaccine (JNJ-78436735) (n=-9) vs. placebo (n=-9)
randomized controlled trial risk of bias NA
placebo
five arms: low dose followed by low dose, low dose followed by placebo, high dose followed by high dose, high dose followed by placebo, and placebo followed by placebo cohorts 1 and 3 were grouped together regardless of the dose received
COVID-19 prophylaxis (excluding children)
double-blind
12 centers in Belgium and the United States
Janssen AD26 vaccine (JNJ-78436735) (n=21895) vs. placebo (n=21888)
randomized controlled trial some concerns about risk of bias
Janssen Ad26.COV2.S vaccine single dose (5x1010 vp) intramuscular
placebo
COVID-19 prophylaxis (excluding children)
double blind
Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa, and the United States
Nuvaxovid (NVX-CoV2373) Novavax (n=-9) vs. placebo (n=-9)
randomized controlled trial risk of bias NA
NVX-CoV2373
placebo
COVID-19 prophylaxis (excluding children)
double-blind
very preliminary unpublished results from a press release
Nuvaxovid (NVX-CoV2373) Novavax (n=108) vs. placebo (n=23)
randomized controlled trial risk of bias NA
NVX-CoV2373
5-μg and 25-μg doses, with or without Matrix-M1 adjuvant
placebo
COVID-19 prophylaxis (excluding children)
double blind
9 sites in Australia and 8 sites in the United States
Phase 2
Nuvaxovid (NVX-CoV2373) Novavax (n=-9) vs. placebo (n=-9)
randomized controlled trial low risk of bias
NVX-CoV2373
placebo
COVID-19 prophylaxis (excluding children)
observer-blinded
119 locations in the United States and Mexico
Efficacy endpoints were accrued from January 25 through April 30, 2021, a time when the Alpha (B.1.1.7) variant became the predominant strain in the U.S
Nuvaxovid (NVX-CoV2373) Novavax (n=2199) vs. placebo (n=2188)
randomized controlled trial some concerns about risk of bias
NVX-CoV2373 2 doses
two doses, administered 21 days apart, of NVX-CoV2373 nanoparticle vaccine(5 μg recombinant spike protein with 50 μg Matrix-M1 adjuvant)
placebo
COVID-19 prophylaxis (excluding children)
B.1.351 (501Y.V2) variant was largely predominant during trial efficacy endpoint accrual
double-blind
South Africa
phase 2a/b
Sinopharm Beijing (BBIBP-CorV) (n=-9) vs. placebo (n=-9)
randomized controlled trial risk of bias NA
placebo
COVID-19 prophylaxis (excluding children)
double-blind
China
phase 1/2
Sinopharm Wuhan (n=13765) vs. placebo (n=13765)
randomized controlled trial risk of bias NA
placebo
COVID-19 prophylaxis (excluding children)
prespecified interim analysis
Spikevax (Moderna mRNA-1273 COVID-19 vaccine) (n=15181) vs. placebo (n=15170)
randomized controlled trial some concerns about risk of bias
mRNA-1273 vaccine
100 μg of mRNA-1273 two-dose schedule given one month apart
placebo
saline placebo two-dose schedule given one month apart
COVID-19 prophylaxis (excluding children)
double blind
100 centres, USA
Randomization was stratified based on age and the presence or absence of risk factors for severe illness for COVID-19
Spikevax (Moderna mRNA-1273 COVID-19 vaccine) (n=189) vs. placebo (n=186)
randomized controlled trial risk of bias NA
mRNA-1273 100µg
placebo
COVID-19 prophylaxis (excluding children)
double-blind
phase 2a
Sputnik V (Gam-COVID-Vac) (n=16501) vs. placebo (n=5476)
randomized controlled trial high risk of bias
Gam-COVID-Vac
(0·5 mL/dose) intramuscularly in a prime-boost regimen: a 21-day interval between the first dose (rAd26) and the second dose (rAd5), both vectors carrying the gene for the full-length SARS-CoV-2 glycoprotein S
placebo
2 doses IM (day 0 and day 21 /-2)
COVID-19 prophylaxis (excluding children)
double blind
25 hospitals and polyclinics in Moscow, Russia
interim analysis without adjustment of type 1 error rate
interim results
Vaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19) (n=-9) vs. Comirnaty (tozinameran - Pfizer/BIONTECH) (n=-9)
randomized controlled trial risk of bias NA
eight groups receiving ChAd/ChAd, ChAd/BNT, BNT/BNT or BNT/ChAd, administered at 28- or 84-day intervals
8 arms
COVID-19 prophylaxis (excluding children)
single-blind
UK
non-inferiority tria
Vaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19) (n=5807) vs. control (n=5829)
randomized controlled trial some concerns about risk of bias
ChAdOx1 nCoV-19 vaccine
ChAdOx1nCoV-19 group received two doses containing 5 × 10¹⁰ viral particles (standard dose; SD/SD cohort); a subset in the UK trial received a half dose as their first dose (low dose) and a standard dose as their second dose (LD/SD cohort)
meningococcal group A, C, W, and Y conjugate vaccine or saline
interval between dose 1 and dose 2 ranged from 4 to 26 weeks
COVID-19 prophylaxis (excluding children)
exclusion criteria: h history of anaphylaxis or angioedema; participants with severe and/or uncontrolled cardiovascular, gastrointestinal, liver, renal, endocrine/metabolic disease, and neurological illnesses; as well as those with immunosuppression
double blind
UK, Brazil, and South Africa.
pooled analysis of 4 studies done across the UK, Brazil, and South Africa : ISRCTN89951424(COV003), NCT04400838 (COV002), NCT04324606 (COV001), and NCT04444674 (COV005).
Vaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19) (n=12282) vs. control (n=11962)
randomized controlled trial risk of bias NA
ChAdOx1 nCoV-19 vaccin
as a single-dose or two-dose regimen (28 days apart) at either the low dose ( 2·2 × 10¹⁰ virus particles) or the standard dose (3·5–6·5 × 10¹⁰ virus particles)
quadrivalent MenACWY protein-polysaccharide conjugate vaccine.
ten different groups
COVID-19 prophylaxis (excluding children)
We recruited participants in an age-escalation manner. We recruited adults aged 18 –55 years, then adults aged 56–69 years, and then adults aged 70 years and older
single-blind
20 centres in the UK
Safety was assessed in all participants who received at least one dose
Vaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19) (n=21583) vs. placebo (n=10796)
randomized controlled trial risk of bias NA
AZD1222
two doses of 5 x1010 viral particles four weeks apart
placebo
COVID-19 prophylaxis (excluding children)
double-blind
88 sites in the United States, Chile and Peru
Unsolicited adverse events were recorded for all participants for 28 days after each dose
Vaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19) (n=174) vs. placebo (n=-9)
randomized controlled trial risk of bias NA
AZD1222 (ChAdOx1 nCoV-19) Days 1 and 29
placebo
COVID-19 prophylaxis (excluding children)
double-blind
5 centers, Japan
Unsolicited AEs were recorded for 28 days following each dose (Days 1–29 and Days 29–57
phase 1-2
Vaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19) (n=-9) vs. placebo (n=10796)
randomized controlled trial risk of bias NA
AZD1222
two doses of 5 x1010 viral particles four weeks apart
placebo
COVID-19 prophylaxis (excluding children)
double-blind
88 sites in the United States, Chile and Peru
Unsolicited adverse events were recorded for all participants for 28 days after each dose
Vaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19) (n=-9) vs. vaccines (n=-9)
randomized controlled trial risk of bias NA
D2 vaxzevria
all other D2 vaccines
6 arms : D1 Vaxzevria D2 Vaxzevria or Spikevax or NovavaxD1 Comirnaty D2 Comirnaty or Spikevax or Novavax
COVID-19 prophylaxis (excluding children)
single-blind
UK multicentre
non-inferiority trial
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