Safety and immune response kinetics of GRAd-COV2 vaccine: phase 1 clinical trial results.


Journal

NPJ vaccines
ISSN: 2059-0105
Titre abrégé: NPJ Vaccines
Pays: England
ID NLM: 101699863

Informations de publication

Date de publication:
24 Sep 2022
Historique:
received: 18 02 2022
accepted: 30 08 2022
entrez: 24 9 2022
pubmed: 25 9 2022
medline: 25 9 2022
Statut: epublish

Résumé

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.

Identifiants

pubmed: 36153335
doi: 10.1038/s41541-022-00531-8
pii: 10.1038/s41541-022-00531-8
pmc: PMC9509317
doi:

Types de publication

Journal Article

Langues

eng

Pagination

111

Subventions

Organisme : Ministry of Health, Italy | Agenzia Italiana del Farmaco, Ministero della Salute (Italian Medicines Agency)
ID : Ricerca corrente line1
Organisme : Ministry of Health, Italy | Agenzia Italiana del Farmaco, Ministero della Salute (Italian Medicines Agency)
ID : Ricerca corrente line1
Organisme : Ministry of Health, Italy | Agenzia Italiana del Farmaco, Ministero della Salute (Italian Medicines Agency)
ID : Ricerca corrente line1
Organisme : Ministry of Health, Italy | Agenzia Italiana del Farmaco, Ministero della Salute (Italian Medicines Agency)
ID : Ricerca corrente line1
Organisme : Ministry of Health, Italy | Agenzia Italiana del Farmaco, Ministero della Salute (Italian Medicines Agency)
ID : Ricerca corrente line1
Organisme : Ministry of Health, Italy | Agenzia Italiana del Farmaco, Ministero della Salute (Italian Medicines Agency)
ID : Ricerca corrente line1
Organisme : Ministry of Health, Italy | Agenzia Italiana del Farmaco, Ministero della Salute (Italian Medicines Agency)
ID : Ricerca corrente line1
Organisme : Ministry of Health, Italy | Agenzia Italiana del Farmaco, Ministero della Salute (Italian Medicines Agency)
ID : Ricerca corrente line1
Organisme : Ministry of Health, Italy | Agenzia Italiana del Farmaco, Ministero della Salute (Italian Medicines Agency)
ID : Ricerca corrente line1
Organisme : Ministry of Health, Italy | Agenzia Italiana del Farmaco, Ministero della Salute (Italian Medicines Agency)
ID : Ricerca corrente line1
Organisme : Ministry of Health, Italy | Agenzia Italiana del Farmaco, Ministero della Salute (Italian Medicines Agency)
ID : Ricerca corrente line1
Organisme : Ministry of Health, Italy | Agenzia Italiana del Farmaco, Ministero della Salute (Italian Medicines Agency)
ID : Ricerca corrente line1
Organisme : Ministry of Health, Italy | Agenzia Italiana del Farmaco, Ministero della Salute (Italian Medicines Agency)
ID : Ricerca corrente line1
Organisme : Ministry of Health, Italy | Agenzia Italiana del Farmaco, Ministero della Salute (Italian Medicines Agency)
ID : Ricerca corrente line1
Organisme : Ministry of Health, Italy | Agenzia Italiana del Farmaco, Ministero della Salute (Italian Medicines Agency)
ID : Ricerca corrente line1
Organisme : Ministry of Health, Italy | Agenzia Italiana del Farmaco, Ministero della Salute (Italian Medicines Agency)
ID : Ricerca corrente line1
Organisme : Ministry of Health, Italy | Agenzia Italiana del Farmaco, Ministero della Salute (Italian Medicines Agency)
ID : Ricerca corrente line1
Organisme : Ministry of Health, Italy | Agenzia Italiana del Farmaco, Ministero della Salute (Italian Medicines Agency)
ID : Ricerca corrente line1
Organisme : Ministry of Health, Italy | Agenzia Italiana del Farmaco, Ministero della Salute (Italian Medicines Agency)
ID : Ricerca corrente line1
Organisme : Ministry of Health, Italy | Agenzia Italiana del Farmaco, Ministero della Salute (Italian Medicines Agency)
ID : Ricerca corrente line1
Organisme : Ministry of Health, Italy | Agenzia Italiana del Farmaco, Ministero della Salute (Italian Medicines Agency)
ID : Ricerca corrente line1
Organisme : Ministry of Health, Italy | Agenzia Italiana del Farmaco, Ministero della Salute (Italian Medicines Agency)
ID : Ricerca corrente line1
Organisme : Ministry of Health, Italy | Agenzia Italiana del Farmaco, Ministero della Salute (Italian Medicines Agency)
ID : Ricerca corrente line1
Organisme : Ministry of Health, Italy | Agenzia Italiana del Farmaco, Ministero della Salute (Italian Medicines Agency)
ID : Ricerca corrente line1
Organisme : Ministry of Health, Italy | Agenzia Italiana del Farmaco, Ministero della Salute (Italian Medicines Agency)
ID : Ricerca corrente line1

Informations de copyright

© 2022. The Author(s).

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Auteurs

Chiara Agrati (C)

Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani IRCCS, Rome, Italy.

Concetta Castilletti (C)

Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani IRCCS, Rome, Italy.

Simone Battella (S)

ReiThera Srl, Rome, Italy.

Eleonora Cimini (E)

Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani IRCCS, Rome, Italy.

Giulia Matusali (G)

Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani IRCCS, Rome, Italy.

Andrea Sommella (A)

ReiThera Srl, Rome, Italy.

Alessandra Sacchi (A)

Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani IRCCS, Rome, Italy.

Francesca Colavita (F)

Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani IRCCS, Rome, Italy.

Alessandra M Contino (AM)

ReiThera Srl, Rome, Italy.

Veronica Bordoni (V)

Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani IRCCS, Rome, Italy.

Silvia Meschi (S)

Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani IRCCS, Rome, Italy.

Giulia Gramigna (G)

Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani IRCCS, Rome, Italy.

Germana Grassi (G)

Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani IRCCS, Rome, Italy.

Licia Bordi (L)

Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani IRCCS, Rome, Italy.

Daniele Lapa (D)

Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani IRCCS, Rome, Italy.

Stefania Notari (S)

Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani IRCCS, Rome, Italy.

Rita Casetti (R)

Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani IRCCS, Rome, Italy.

Aurora Bettini (A)

Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani IRCCS, Rome, Italy.

Massimo Francalancia (M)

Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani IRCCS, Rome, Italy.

Federica Ciufoli (F)

ReiThera Srl, Rome, Italy.

Alessandra Vergori (A)

Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani IRCCS, Rome, Italy.

Serena Vita (S)

Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani IRCCS, Rome, Italy.

Michela Gentile (M)

ReiThera Srl, Rome, Italy.

Maria M Plazzi (MM)

Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani IRCCS, Rome, Italy.

Antonella Bacchieri (A)

Clinical Research and Development Consultants srls, Sesto Fiorentino, Florence, Italy.

Emanuele Nicastri (E)

Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani IRCCS, Rome, Italy.

Andrea Antinori (A)

Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani IRCCS, Rome, Italy.

Stefano Milleri (S)

Centro Ricerche Cliniche di Verona srl, Verona, Italy.

Simone Lanini (S)

Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani IRCCS, Rome, Italy.

Stefano Colloca (S)

ReiThera Srl, Rome, Italy.

Enrico Girardi (E)

Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani IRCCS, Rome, Italy.

Roberto Camerini (R)

ReiThera Srl, Rome, Italy.

Giuseppe Ippolito (G)

Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani IRCCS, Rome, Italy.

Francesco Vaia (F)

Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani IRCCS, Rome, Italy.

Antonella Folgori (A)

ReiThera Srl, Rome, Italy.

Stefania Capone (S)

ReiThera Srl, Rome, Italy. stefania.capone@reithera.com.

Classifications MeSH