HDT-321 Vaccine for Crimean-Congo Hemorrhagic Fever

Overseen By James Keary

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: HDT Bio

Must not be taking: Immunosuppressants, Immunemodifying drugs

Disqualifiers: Significant respiratory, cardiovascular, neurological, malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

Duration: 8 weeks

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Do I need to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on immunosuppressants or immune-modifying drugs, you may need to stop them if taken for more than 14 days in the past 6 months. It's best to discuss your specific medications with the trial team.

How does the HDT-321 vaccine for Crimean-Congo Hemorrhagic Fever differ from other treatments?

The HDT-321 vaccine is unique because it is a novel vaccine candidate for Crimean-Congo Hemorrhagic Fever, a condition for which no approved vaccines currently exist. It uses a modified poxvirus vector to express virus proteins, aiming to provide protection against the disease, which is a new approach compared to other experimental vaccines. ^{1 2 3 4 5}

What data supports the effectiveness of the HDT-321 treatment for Crimean-Congo Hemorrhagic Fever?

Research on similar treatments shows promising results, such as a vaccine using a poxvirus vector that protected 100% of mice from the disease. Additionally, a single-dose vaccine using virus replicon particles also completely protected mice from different strains of the virus, suggesting potential effectiveness for HDT-321. ^{2 3 4 5 6}

Who Is on the Research Team?

Malcolm Duthie, PhD

Principal Investigator

HDT Bio

Are You a Good Fit for This Trial?

This trial is for individuals who are healthy and willing to receive a new vaccine against Crimean-Congo Hemorrhagic Fever. Participants will get one or two doses of the HDT-321 vaccine and must be available for follow-ups via phone calls, clinic visits, and provide blood samples as required.

Inclusion Criteria

Body mass index (BMI) 17 to 35 inclusive at screening

I agree not to get any vaccines 28 days before or after study shots.

Provide written informed consent before initiation of any study procedures

Exclusion Criteria

History of hypersensitivity or severe reactions to previous vaccinations

I haven't taken long-term immune system drugs in the last 6 months.

Any medical disease or condition that, in the opinion of the participating site PI or appropriate sub-investigator, precludes study participation. Including significant respiratory disease (COPD), asthma that is not well controlled, significant cardiovascular disease, history of myocarditis or pericarditis, myocardial infarction, coronary artery bypass surgery or stent placement, or uncontrolled cardiac arrhythmia, neurological or neurodevelopmental conditions, ongoing malignancy or recent diagnosis of malignancy in the last five years excluding basal cell and squamous cell carcinoma of the skin, blood dyscrasias or significant disorder of coagulation, chronic liver disease, autoimmune disease, including localized or history of psoriasis or hypothyroidism without a defined non-autoimmune cause and immunodeficiency of any cause

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive 1 or 2 doses of HDT-321, with follow-up for adverse events and blood sample collection

8 weeks

10 visits (in-person) for Groups 1, 2, and 4; 9 visits (in-person) for Group 3

Follow-up

Participants are monitored for safety and effectiveness after treatment, including collection of adverse events and immunogenicity data

56 weeks

Combination of in-person visits and phone calls

What Are the Treatments Tested in This Trial?

Interventions

• HDT-321

Trial Overview The study tests the safety and immune response to three different doses (25ug, 10ug, 50ug) of HDT-321 vaccine against Crimean-Congo Hemorrhagic Fever. It aims to determine if it's safe and can protect against the virus with either a single or double dose regimen.

How Is the Trial Designed?

Group I: Group 4 Experimental Treatment 1 Intervention

Group 4 will include 12 participants who will receive a 50 ug two dose schedule of HDT-321 at day 1 and day 29.

Group II: Group 3 Experimental Treatment 1 Intervention

Group 3 will include 12 participants who will receive a 50 ug one dose schedule of HDT-321 at day 1.

Group III: Group 2 Experimental Treatment 1 Intervention

Group 2 will include 12 participants who will receive a 25 ug, two dose schedule of HDT-321 at day 1 and day 29.

Group IV: Group 1 Experimental Treatment 1 Intervention

Group 1 will include 12 participants who will receive a 10 ug two dose schedule of HDT-321 at day 1 and day 29.

Who Is Running the Clinical Trial?

HDT Bio

Lead Sponsor

Trials

2

Recruited

100+

BioAgilytix Labs, LLC

Collaborator

Trials

1

Recruited

50+

DFNet Research Inc.

Collaborator

Trials

2

Recruited

680+

Quest Laboratories

Collaborator

Trials

1

Recruited

50+

The University of Texas Medical Branch, Galveston

Collaborator

Trials

263

Recruited

55,400+

Technical Resources International, Inc. (TRI)

Collaborator

Trials

3

Recruited

2,300+

Clinical Trials of Texas, Inc.

Collaborator

Trials

3

Recruited

190+

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Development of Multi-epitope Based Subunit Vaccine Against Crimean-Congo Hemorrhagic Fever Virus Using Reverse Vaccinology Approach. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A novel vaccine against Crimean-Congo Haemorrhagic Fever protects 100% of animals against lethal challenge in a mouse model. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Vaccine efficacy trials for Crimean-Congo haemorrhagic fever: Insights from modelling different epidemiological settings. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Healthy individuals' immune response to the Bulgarian Crimean-Congo hemorrhagic fever virus vaccine. [2018]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Heterologous protection against Crimean-Congo hemorrhagic fever in mice after a single dose of replicon particle vaccine. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Immunization of knock-out α/β interferon receptor mice against high lethal dose of Crimean-Congo hemorrhagic fever virus with a cell culture based vaccine. [2019]