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

Part of paid clinical trials in San Antonio, Texas.

Sponsor
HDT Bio
Study ID
NCT06799013
Phase
PHASE1
Status
Recruiting
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Conditions

  • Crimean-Congo Hemorrhagic Fever
  • Vaccine

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Accepted

Interventions

  • 10 ug HDT 321 — BIOLOGICAL
    HDT-321 Investigational Vaccine (a Nanoparticle Carrier-Formulated self-amplifying RNA encoding the NP of CCHFV)
  • 25ug HDT-321 — BIOLOGICAL
    HDT-321 Investigational Vaccine (a Nanoparticle Carrier-Formulated self-amplifying RNA encoding the NP of CCHFV)
  • 50ug HDT-321 — BIOLOGICAL
    HDT-321 Investigational Vaccine (a Nanoparticle Carrier-Formulated self-amplifying RNA encoding the NP of CCHFV)

Study Details

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

Key Dates

Start date
Jul 10, 2025
Status verified
Jul 2025
Primary completion
Dec 31, 2026
Completion
Jul 31, 2027

Study Design

Enrollment
48 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Group 1
    Group 1 will include 12 participants who will receive a 10 ug two dose schedule of HDT-321 at day 1 and day 29.
  • Experimental: Group 2
    Group 2 will include 12 participants who will receive a 25 ug, two dose schedule of HDT-321 at day 1 and day 29.
  • Experimental: Group 3
    Group 3 will include 12 participants who will receive a 50 ug one dose schedule of HDT-321 at day 1.
  • Experimental: Group 4
    Group 4 will include 12 participants who will receive a 50 ug two dose schedule of HDT-321 at day 1 and day 29.

Primary Outcome Measure

Solicited local and systemic adverse events (AEs) [ Time Frame: Day 1-7 post administration ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Flourish Research San Antonio (Clinical Trials of Texas)San AntonioTexas78229
Jessie Williams
[email protected]
210-949-0122
Barbara Corral, DNP
[email protected]
210-949-0122
Douglas Denham, MD (PRINCIPAL_INVESTIGATOR)
Barbara Corral, DNP (SUB_INVESTIGATOR)

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By research site
Flourish Research San Antonio (Clinical Trials of Texas)· San Antonio, TX

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