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Safety and Immunogenicity of a Self-Amplifying RNA Vaccine Against Crimean-Congo Hemorrhagic Fever

NCT06799013 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-07-28

No results posted yet for this study

Summary

The goal of this clinical trial is to assess the safety, tolerability and immunogenicity of three dosage levels, and a single or two-dose administration regimen, of the investigational HDT-321 product administered intra-muscularly. The main questions it aims to answer are:

* Is HDT-321 safe to use
* Does HDT-321 provide protection against Crimean-Congo hemorrhagic fever virus (CCHFV)

Researchers will record any adverse events and test blood samples to see if HDT-321 is safe and works to protect participants against Crimean-Congo hemorrhagic fever virus (CCHFV)

Participants will:

* Receive 1 or 2 doses of HDT-321
* Complete a memory aid and measurements for 7 days after receiving each dose of HDT-321
* Be followed throughout the study using phone calls and clinic visits to check for and record adverse events
* Provide blood samples at specific study visits

Conditions

  • Vaccine
  • Crimean-Congo Hemorrhagic Fever

Interventions

BIOLOGICAL

10 ug HDT 321

HDT-321 Investigational Vaccine (a Nanoparticle Carrier-Formulated self-amplifying RNA encoding the NP of CCHFV)

BIOLOGICAL

25ug HDT-321

HDT-321 Investigational Vaccine (a Nanoparticle Carrier-Formulated self-amplifying RNA encoding the NP of CCHFV)

BIOLOGICAL

50ug HDT-321

HDT-321 Investigational Vaccine (a Nanoparticle Carrier-Formulated self-amplifying RNA encoding the NP of CCHFV)

Sponsors & Collaborators

  • DFNet Research Inc.

    collaborator OTHER

  • Technical Resources International, Inc. (TRI)

    collaborator UNKNOWN

  • BioAgilytix Labs, LLC

    collaborator UNKNOWN

  • The University of Texas Medical Branch, Galveston

    collaborator OTHER

  • Clinical Trials of Texas, Inc.

    collaborator OTHER

  • Quest Laboratories

    collaborator UNKNOWN

  • HDT Bio

    lead INDUSTRY

Principal Investigators

  • Malcolm Duthie, PhD · HDT Bio

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-07-10
Primary Completion
2026-12-31
Completion
2027-07-31
FDA Drug
Yes

Countries

  • United States

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 NCT06799013 on ClinicalTrials.gov