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NCT06799013 · ClinicalTrials.gov registry record · Phase 1
Safety and Immunogenicity of a Self-Amplifying RNA Vaccine Against Crimean-Congo Hemorrhagic Fever
A Phase 1 study of Vaccine and Crimean-Congo Hemorrhagic Fever, sponsored by HDT Bio.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT06799013: Recruiting Phase 1 study of Vaccine and Crimean-Congo Hemorrhagic Fever, sponsored by HDT Bio.
NCT06799013 is a Phase 1 study of Vaccine and Crimean-Congo Hemorrhagic Fever that is actively recruiting participants, run by HDT Bio. The registered enrollment target is 48 participants, below the 13,297-participant average among 6 other Vaccine trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06799013, a Phase 1 study of Vaccine and Crimean-Congo Hemorrhagic Fever, is actively recruiting participants, sponsored by HDT Bio.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
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
Primary Outcome
Frequency and grade of solicited local and systemic AEs during the 7-day follow-up period after each study injection (i.e. the day of administration and 6 subsequent days).
Conditions Studied
Interventions
- BIOLOGICAL 10 ug HDT 321
- BIOLOGICAL 25ug HDT-321
- BIOLOGICAL 50ug HDT-321
Study Locations (1)
Texas
- Flourish Research San Antonio (Clinical Trials of Texas) - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2025-07-10 |
| Est. Completion | 2027-07 |
| Phase | Phase 1 |
What NCT06799013 shows while recruiting
NCT06799013 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 13,297-participant average among 6 other Vaccine trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with Vaccine appearing as the primary indexed condition, and to 3 interventions - of which 10 ug HDT 321 is the first listed.
NCT06799013 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT06799013 about?
NCT06799013 is a clinical study titled "Safety and Immunogenicity of a Self-Amplifying RNA Vaccine Against Crimean-Congo Hemorrhagic Fever". 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 ...
What is the current status of trial NCT06799013?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2025-07-10. Estimated completion is 2027-07.
What conditions does trial NCT06799013 study?
This clinical trial studies the following conditions: Vaccine, Crimean-Congo Hemorrhagic Fever.
What interventions are being tested in trial NCT06799013?
The interventions under investigation include: 10 ug HDT 321 (BIOLOGICAL), 25ug HDT-321 (BIOLOGICAL), 50ug HDT-321 (BIOLOGICAL).
Who is sponsoring clinical trial NCT06799013?
This trial is sponsored by HDT Bio, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06799013 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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