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Phase I Study to Assess the Safety and Immunology of a COVID-19 Vaccine With GRAd-COV2 Vaccine

NCT04528641 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2022-02-08

Study results available
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Summary

RT-CoV-2 is a Phase I, open-label, dose escalation multicenter clinical trial to assess safety and immunogenicity of the candidate Coronavirus disease (COVID-19) vaccine GRAd-COV2 in Italian healthy volunteers aged 18-55 years and 65-85 years inclusive. GRAd-COV2 is based on a novel replication defective Gorilla Adenovirus and encodes for SARS-COV-2 Spike protein.

Conditions

Interventions

BIOLOGICAL

GRAd-COV2

Single intramuscular administration.

Sponsors & Collaborators

  • Istituto Nazionale per le Malattie Infettive "Lazzaro Spallanzani" IRCCS

    collaborator NETWORK

  • ReiThera Srl

    lead INDUSTRY

Principal Investigators

  • Simone Lanini · Istituto Nazionale per le Malattie Infettive "Lazzaro Spallanzani" IRCCS

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-10
Primary Completion
2021-05-19
Completion
2021-05-19

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04528641 on ClinicalTrials.gov