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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 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.

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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

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

FieldValue
Enrollment Target 48 participants
Start Date 2025-07-10
Est. Completion 2027-07
Phase Phase 1

Sponsor

HDT Bio

2 total trials

What the Registry Record Tells You About NCT06799013

The ClinicalTrials.gov registry entry for NCT06799013 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 13,297-participant average among 6 other Vaccine trials with a reported enrollment target (100% lower). The listed sponsor is HDT Bio, which has 2 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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