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Safety and Immunogenicity of a Chimeric Recombinant Covid19 Vaccine SpiN-Tec MCTI UFMG

NCT07134725 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 432

Last updated 2025-09-15

No results posted yet for this study

Summary

SpiN-Tec MCTI UFMG will be used as a vaccine booster against COVID-19 and will be evaluated using the active comparator, a vaccine approved by ANVISA (Brazilian Health Regulatory Agency). The study will consist of two parts: Part A) a Phase 1 dose-escalation clinical trial to assess safety and reactogenicity; followed by Part B) a Phase 2 clinical trial to assess the safety and immunogenicity of SpiN-Tec. The study will include healthy participants of both sexes, aged 18 to 85, who have already received the full COVID-19 vaccination schedule with CoronaVac® (Butantan) or Covishield® (AstraZeneca) and who have received one or two booster doses of Covishield® or Comirnaty® (Pfizer's RNA-based vaccine) at least 6 months ago. Participants may or may not have had natural SARS-CoV-2 infection.

Conditions

  • COVID - 19

Interventions

BIOLOGICAL

SpiN-Tec MCTI UFMG

Chimeric recombinant protein (SpiN) adjuvanted with CTVad1

OTHER

Active Comparator: Covishield® vaccine

active comparator using vaccine approved by ANVISA (Brazilian Health Regulatory Agency)

OTHER

Active Comparator: Comirnaty® vaccine

active comparator using vaccine approved by ANVISA (Brazilian Health Regulatory Agency)

Sponsors & Collaborators

  • Oswaldo Cruz Foundation

    collaborator OTHER

  • The Ministry of Science, Technology and Innovation, Brazil

    collaborator UNKNOWN

  • Prefeitura de Belo Horizonte (PBH)

    collaborator UNKNOWN

  • Federal University of Minas Gerais

    lead OTHER

Principal Investigators

  • Ricardo T Gazzinelli, DVM, PhD · Vaccine Technology Center (CT Vacinas)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-11-23
Primary Completion
2023-05-22
Completion
2025-05-07

Countries

  • Brazil

Study Locations

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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 NCT07134725 on ClinicalTrials.gov