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Evaluation of Safety and Immunogenicity of a Novel Vaccine for Prevention of Covid-19 in Adults Previously Immunized

NCT05016934 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2021-08-27

No results posted yet for this study

Summary

Randomized controlled trial to evaluate safety, immunogenicity and efficacy of three different doses (10, 25 and 50 mcg) of a novel vaccine compared with placebo in adult volunteers previously immunized against Covid-19 with other vaccines \[Corona Vac (Sinovac), ChAdOx1 (AZ 1222, Astra Zeneca) or Ad26.Co2.S (Janssen)\].

Conditions

  • Covid19

Interventions

BIOLOGICAL

A vaccine composed of a recombinant S1 antigen

Two applications of three different doses of a vaccine composed of a recombinant S1 antigen, a subunit of SARS-CoV-2 virus S protein

Sponsors & Collaborators

  • Farmacore Biotecnologia Ltda

    collaborator UNKNOWN

  • Hospital do Coracao

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2022-03-04
Completion
2022-04-20

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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 NCT05016934 on ClinicalTrials.gov