Table 2 Clinical tolerated doses of RNA-based medicines.

From: Next generation self-replicating RNA vectors for vaccines and immunotherapies

Name

Company

Bases

Formulation

ROA

Target

Highest dose reported with favorable safety profile

Ref

mRNA-1893

Moderna

Modified

Internal LNP

Intramuscular

Zika

30 µg (interim reporting, 100 and 250 µg doses pending)

[85]

VAL-506440; VAL-339851

Moderna

Modified

Internal LNP

Intramuscular, Intradermal

Influenza

100 µg (IM),

50 µg (ID)

[86, 87]

mRNA-1273

Moderna

Modified

Internal LNP

Intramuscular

SARS-CoV-2

100 µg

[7, 87, 88]

BNT162b2

Pfizer/BioNTech

Modified

Acuitas LNP

Intramuscular

SARS-CoV-2

30 µg

[89, 90]

CVnCoV

CureVac

Unmodified

Acuitas LNP

Intramuscular

SARS-CoV-2

12 µg

[91]

ARCT-21

Arcturus

Unmodified

Internal LNP

Intramuscular

SARS-CoV-2

7.5 µg

[14]

LNP-nCoVsaRNA

ICL/VaxEquity

Unmodified

Internal LNP

Intramuscular

SARS-CoV-2

10 µg

[15]

CORAL (BOOST)

Gritstone

Unmodified

Genevant LNP

Intramuscular

SARS-CoV-2

10 µg (interim reporting, 30 µg dose pending)

[92]

MRT5500

Translate Bio

Unmodified

Internal LNP

Intramuscular

SARS-CoV-2

45 µg (no DLTs reported)

[93, 94]

CV7202

CureVac

Unmodified

Acuitas LNP

Intramuscular

Rabies

2 µg

[95]

SLATE/GRANITE

Gritstone

Unmodified

Genevant LNP

Intramuscular

Neoantigens

300 µg

[96]

BI1361849 (CV9202)

CureVac

Unmodified

Protamine

Intramuscular

Prostate Cancer

1920 µg

[97]

MRT5005

Translate Bio

Unmodified

Internal LNP

Nebulization

Cystic Fibrosis

SAD: 24 mg MAD: 16 mg

[37]