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Solidarity/Tokomeza Ebola Trial

NCT05909358 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 2121

Last updated 2023-06-18

No results posted yet for this study

Summary

The TokomezaPlus Ebola trial is a phase I/II double blind randomised clinical trial designed to assess the safety and immunogenicity of candidate SUDV vaccines in Uganda during the inter outbreak period. Uganda is prone to Ebola virus disease outbreaks especially those caused by the Ebola Sudan (SUDV) species. TokomezaPlus Ebola Vaccine trial protocol has two main components: a) Safety b) Immunogenicity and is designed to create a living protocol that will be used to study the safety and immunogenicity of SUDV-candidate vaccines in the East African EVD-prone countries.

Conditions

  • Sudan Ebola Virus Vaccines

Interventions

BIOLOGICAL

CAd3

CAd3 candidate vaccine which is one of the investigational products

BIOLOGICAL

ChAdox1

ChAdox1 candidate vaccine which is one of the investigational products

BIOLOGICAL

rVSV-SUDV

rVSV-SUDV candidate vaccine which is one of the investigational products

OTHER

Control

Placebo

Sponsors & Collaborators

  • Makerere University Lung Institute

    collaborator UNKNOWN

  • MRC/UVRI and LSHTM Uganda Research Unit

    collaborator OTHER

  • Makerere University Walter Reed Program

    collaborator UNKNOWN

  • Epicentre

    collaborator OTHER

  • Uganda Virus Research Institute-International Aids Vaccine Initiative

    collaborator UNKNOWN

  • Ministry of Health, Uganda

    collaborator OTHER_GOV

  • Makerere University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-31
Primary Completion
2027-09-30
Completion
2027-09-30
FDA Drug
Yes

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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 NCT05909358 on ClinicalTrials.gov