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Clinical Trial to Evaluate the Safety and Immunogenicity of the Vivaxin Vaccine for Malaria Caused by Plasmodium Vivax."

NCT07172724 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-09-15

No results posted yet for this study

Summary

Phase 1 clinical trial to evaluate the safety, reactogenicity, and immunogenicity of a malaria vaccine named Vivaxin against the protozoan Plamodium vivax in participants with no prior malaria infection

Conditions

  • Malaria Vivax

Interventions

BIOLOGICAL

Vivaxin vaccine manufactured by CT Vacinas/Cristália Laboratory

lyophilized antigen for reconstitution with the adjuvant CTVad (a squalene-based nanoemulsion), at the time of use.

OTHER

Placebo

adjuvant CTVad (a squalene-based nanoemulsion)

Sponsors & Collaborators

  • University of Sao Paulo

    collaborator OTHER

  • Financiadora de Estudos e Projetos

    collaborator OTHER

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

    collaborator OTHER_GOV

  • INCTV National Institute of Vaccine Science and Technology

    collaborator UNKNOWN

  • The Ministry of Science, Technology and Innovation, Brazil

    collaborator UNKNOWN

  • CT Vacinas - Centro de Tecnologia em Vacinas/Universidade Federal de Minas Gerais

    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
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2026-03-31
Completion
2027-06-30

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 NCT07172724 on ClinicalTrials.gov