Evidence map›Paper›PMID 37315558›Full record

Trial reportCell reports. Medicine2023

GRAd-COV2 vaccine provides potent and durable humoral and cellular immunity to SARS-CoV-2 in randomized placebo-controlled phase 2 trial.

Stefania Capone, Francesco M Fusco, Stefano Milleri, Silvio Borrè, Sergio Carbonara, Sergio Lo Caputo, Sebastiano Leone, Giovanni Gori, Paolo Maggi, Antonio Cascio and 29 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialClinical Trial, Phase II
In one paragraph

Trial report in Cell reports. Medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04791423 (A Phase II/III, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of GRAd-COV2 Vaccine in Adults Aged 18 Years and Older), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
2.5field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04791423 phase2 / phase3completednot on this map

A Phase II/III, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of GRAd-COV2 Vaccine in Adults Aged 18 Years and Older

TypeinterventionalSponsorReiThera SrlRan2021 to 2022Enrolled10,300ConditionsCovid19ArmsGRAd-COV2, Placebo
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 13 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Developing the next-generation of adenoviral vector vaccines.Human vaccines & immunotherapeutics · 2025
    Review
  5. Review
  6. Review
  7. Article
  8. Article
  9. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

39 authors at 20 institutions in 1 country.

Stefania CaponeReiThera srl - Castel Romano, Rome, Italy. Electronic address: stefania.capone@reithera.com.
Francesco M Fusco"D. Cotugno" Hospital, Azienda Specialistica dei Colli, Naples, Italy.
Stefano MilleriCentro Ricerche Cliniche di Verona - CRC, Verona, Italy.
Silvio BorrèASL Vercelli Malattie Infettive, Vercelli, Italy.
Sergio CarbonaraU.O.C. Malattie Infettive - P.O.V. Emanuele II, Bisceglie (BT), Italy.
Sergio Lo CaputoMalattie infettive, Dipartimento di Scienze Mediche e Chirurgiche - A.O.U. Policlinico Foggia, Foggia, Italy.
Sebastiano LeoneDivision of Infectious Diseases, San Giuseppe Moscati Hospital, Avellino, Italy.
Giovanni GoriCentro di Farmacologia Clinica per la Sperimentazione dei Farmaci - Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.
Paolo MaggiUniversità degli Studi della Campania Luigi Vanvitelli, Caserta, Italy.
Antonio CascioDepartment of Health Promotion Sciences, Maternal and Infant Care, Internal Medicine and Medical Specialties, University of Palermo, Palermo, Italy.
Miriam LichtnerDepartment NESMOS Sapienza University of Rome, Infectious Disease Unit, SM Goretti Hospital, Latina, Italy.
Roberto CaudaFondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Sarah Dal ZoppoUO Malattie Infettive, ASST Cremona, Cremona, Italy.
Maria V CossuI Divisione Malattie Infettive - ASST FBF SACCO, Milan, Italy.
Andrea GoriDepartment of Pathophysiology and Transplantation, University of Milan, Milan, Italy; Infectious Diseases Unit, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Silvia RodaU.O.C. Malattie Infettive - Fondazione IRCCS Policlinico San Matteo di Pavia, Viale Camillo Golgi, Italy.
Paola ConfalonieriStruttura Complessa Pneumologia - Azienda Sanitaria Universitaria Giuliano-Isontina, Trieste, Italy.
Stefano BonoraUnit of Infectious Diseases, Department of Medical Sciences, University of Torino, Turin, Italy.
Gabriele MissaleDepartment of Medicine and Surgery, University of Parma, Parma, Italy; Unit of Infectious Diseases and Hepatology - Azienda Ospedaliero-Universitaria di Parma, Parma, Italy.
Mauro CodeluppiUOC di Malattie Infettive - Ospedale Guglielmo da Saliceto - AUSL Piacenza, Piacenza, Italy.
Ivano MezzaromaUOC Malattie Infettive, AOU Policlinico Umberto 1, Department of Translational and Precision Medicine, Sapienza University of Rome, Rome, Italy.
Serena CapiciPhase 1 Research Unit, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy.
Emanuele PontaliDepartment of Infectious Diseases - E.O. Ospedali Galliera, Genova, Italy.
Marco LibanoreDepartment Infectious Diseases, Arcispedale Sant'Anna - Azienda Ospedaliero-Universitaria di Ferrara, Ferrara, Italy.
Augusta DianiOspedale di Circolo e Fondazione Macchi, Varese, Italy.
Simone LaniniINMI Spallanzani, Rome, Italy.
Simone BattellaReiThera srl - Castel Romano, Rome, Italy.
Alessandra M ContinoReiThera srl - Castel Romano, Rome, Italy.
Eva Piano MortariB Cell Unit, Immunology Research Area, Bambino Gesù Children's Hospital, IRCCS, Viale di San Paolo, 00146 Rome, Italy.
Francesco GenovaReiThera srl - Castel Romano, Rome, Italy.
Gessica ParenteReiThera srl - Castel Romano, Rome, Italy.
Rosella DragonettiReiThera srl - Castel Romano, Rome, Italy.
Stefano CollocaReiThera srl - Castel Romano, Rome, Italy.
Luigi VisaniExom-Group, Milan, Italy.
Claudio IannaconeSPARC Consulting, Milan, Italy.
Rita CarsettiB Cell Unit, Immunology Research Area, Bambino Gesù Children's Hospital, IRCCS, Viale di San Paolo, 00146 Rome, Italy.
Antonella FolgoriReiThera srl - Castel Romano, Rome, Italy.
Roberto CameriniReiThera srl - Castel Romano, Rome, Italy.
COVITAR study group
Azienda Sanitaria Universitaria Integrata di Trieste · ITBambino Gesù Children's Hospital · ITGuglielmo da Saliceto Hospital · ITPoliclinico San Matteo Fondazione · ITUniversity of Milan · ITAzienda Ospedaliera San Gerardo · ITFIT Consulting (Italy) · ITIstituti Ospitalieri di Cremona · ITOspedale Santa Maria Goretti · ITUniversity of Campania "Luigi Vanvitelli" · ITAgostino Gemelli University Polyclinic · ITArcispedale Sant'Anna · ITASST Fatebenefratelli Sacco · ITAzienda Ospedaliera S.Giuseppe Moscati · ITAzienda Ospedaliera Universitaria Pisana · ITAzienda Sanitaria Locale Roma 3 · ITEnte Ospedaliero Ospedali Galliera · ITIstituto Nazionale per le Malattie Infettive Lazzaro Spallanzani · ITOspedale D. Cotugno · ITOspedale di Circolo e Fondazione Macchi · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The ongoing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic and heterologous immunization approaches implemented worldwide for booster doses call for diversified vaccine portfolios. GRAd-COV2 is a gorilla adenovirus-based COVID-19 vaccine candidate encoding prefusion-stabilized spike. The safety and immunogenicity of GRAd-COV2 is evaluated in a dose- and regimen-finding phase 2 trial (COVITAR study, ClinicalTrials.gov: NCT04791423) whereby 917 eligible participants are randomized to receive a single intramuscular GRAd-COV2 administration followed by placebo, or two vaccine injections, or two doses of placebo, spaced over 3 weeks. Here, we report that GRAd-COV2 is well tolerated and induces robust immune responses after a single immunization; a second administration increases binding and neutralizing antibody titers. Potent, variant of concern (VOC) cross-reactive spike-specific T cell response peaks after the first dose and is characterized by high frequencies of CD8s. T cells maintain immediate effector functions and high proliferative potential over time. Thus, GRAd vector is a valuable platform for genetic vaccine development, especially when robust CD8 response is needed.

Indexed as

COVID-19VaccinesCOVID-19 VaccinesHumansImmunity, CellularSARS-CoV-2COVID-19 VaccinesVaccinesCD4CD8COVID-19immunological memoryneutralizing antibodiesphase 2 clinical trialsafetySars-CoV-2 vaccinesimian adenoviral vectorT cell response

Identifiers

PMID37315558
PMCPMC10243192
OpenAlexW4378717008

What OpenQuestion holds

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LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.