Safety and immune response kinetics of GRAd-COV2 vaccine: phase 1 clinical trial results.
Chiara AgratiConcetta CastillettiSimone BattellaEleonora CiminiGiulia MatusaliAndrea SommellaAlessandra SacchiFrancesca ColavitaAlessandra M ContinoVeronica BordoniSilvia MeschiGiulia GramignaFederica BarraGermana GrassiLicia BordiDaniele LapaStefania NotariRita CasettiAurora BettiniMassimo FrancalanciaFederica CiufoliAlessandra VergoriSerena VitaMichela GentileAngelo RaggioliMaria M PlazziAntonella BacchieriEmanuele NicastriAndrea AntinoriStefano MilleriSimone LaniniStefano CollocaEnrico GirardiRoberto CameriniGiuseppe IppolitoFrancesco VaiaAntonella FolgoriStefania CaponePublished in: NPJ vaccines (2022)
Despite the successful deployment of efficacious vaccines and therapeutics, the development of novel vaccines for SARS-CoV-2 remains a major goal to increase vaccine doses availability and accessibility for lower income setting. We report here on the kinetics of Spike-specific humoral and T-cell response in young and old volunteers over 6 months follow-up after a single intramuscular administration of GRAd-COV2, a gorilla adenoviral vector-based vaccine candidate currently in phase-2 of clinical development. At all three tested vaccine dosages, Spike binding and neutralizing antibodies were induced and substantially maintained up to 3 months, to then contract at 6 months. Potent T-cell responses were readily induced and sustained throughout the study period, with only minor decline. No major differences in immune response to GRAd-COV2 vaccination were observed in the two age cohorts. In light of its favorable safety and immunogenicity, GRAd-COV2 is a valuable candidate for further clinical development and potential addition to the COVID-19 vaccine toolbox to help fighting SARS-CoV-2 pandemic.
Keyphrases
- sars cov
- respiratory syndrome coronavirus
- immune response
- clinical trial
- coronavirus disease
- high glucose
- diabetic rats
- mental health
- endothelial cells
- oxidative stress
- drug induced
- toll like receptor
- physical activity
- randomized controlled trial
- study protocol
- phase ii
- inflammatory response
- open label
- zika virus
- dengue virus
- human health
- double blind
- placebo controlled