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Tests treatment safety and results for Vaccine
Official title Safety and Immunogenicity of a Self-Amplifying RNA Vaccine Against Crimean-Congo Hemorrhagic Fever
ClinicalTrials.gov ID: NCT06799013
What this study is testing
What is 10 ug HDT 321?
10 ug HDT 321 is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for vaccine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64. Healthy volunteers may be eligible.
You may be able to join if
- Males and non-pregnant females 18 to 64 years of age at the time of signing the ICF.
- Body mass index (BMI) 17 to 35 inclusive at screening.
- Considered by the PI or designee to be in good general health as determined by medical history, physical examination, vital sign measurements\ , and...
- Screening laboratory values within the laboratory reference ranges or considered non-clinically significant (NCS) if within Grade 1 severity on the...
- Negative human immunodeficiency virus (HIV) 1/2 antibody, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody.
You likely can't join if
- Any medical disease or condition that, in the opinion of the participating site PI or appropriate sub-investigator, precludes study participation...
- Abnormal screening electrocardiogram (ECG)
- History of hypersensitivity or severe reactions to previous vaccinations
- History of hypersensitivity or severe reactions to products known to contain polyethylene glycol (PEG).
- Allergy to antibiotics structurally similar to kanamycin (including but not limited to neomycin, streptomycin, tobramycin, and gentamycin).
- Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immunemodifying drugs within 6 months prior to the...
See the full eligibility criteria
- Males and non-pregnant females 18 to 64 years of age at the time of signing the ICF.
- Body mass index (BMI) 17 to 35 inclusive at screening.
- Considered by the PI or designee to be in good general health as determined by medical history, physical examination, vital sign measurements\ , and clinical laboratory assessments conducted no more than 30 days prior...
- Screening laboratory values within the laboratory reference ranges or considered non-clinically significant (NCS) if within Grade 1 severity on the toxicity grading scale.
- Negative human immunodeficiency virus (HIV) 1/2 antibody, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody.
- Women of childbearing potential must agree to use or have practiced true abstinence or use at least one acceptable primary form of contraception3 for at least 30 days prior to the first injection and for 60 days after...
- Able to understand and comply with planned study procedures and willing to be available for all study required procedures, visits, and telephone calls for the duration of the study.
- Provide written informed consent before initiation of any study procedures.
- Willing to abstain from donating whole blood or blood derivatives 30 days prior to screening and for the duration of the study.
- Willing to refrain from receiving any licensed vaccine within 28 days prior to and after scheduled study injections.
- Any medical disease or condition that, in the opinion of the participating site PI or appropriate sub-investigator, precludes study participation. Including Acute, subacute, intermittent, or chronic medical diseases or...
- Abnormal screening electrocardiogram (ECG)
- History of hypersensitivity or severe reactions to previous vaccinations
- History of hypersensitivity or severe reactions to products known to contain polyethylene glycol (PEG).
- Allergy to antibiotics structurally similar to kanamycin (including but not limited to neomycin, streptomycin, tobramycin, and gentamycin).
- Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immunemodifying drugs within 6 months prior to the first study injection (for corticosteroids: prednisone ≥20 mg/day or...
- Received immunoglobulins or any blood products within 60 days prior to enrollment/Day 1.
- Donated blood products within 30 days prior to enrollment/Day 1.
- Received an investigational or non-registered medicinal product within 30 days prior to screening.
- Currently enrolled, or plan to participate, in another clinical trial with an investigational agent to be received during the study period.
- Received or plans to receive any non-study vaccine within 28 days before and after each study injection.
- Febrile illness\ , as determined by the participating site PI or appropriate sub-investigator, with or without fever (oral temperature ≥38.0°C/100.4°F), within 24 hours prior to each study injection.
- Current heavy smoking/vaping (defined as 1 pack or more of cigarettes a day or vaping equivalent\ ). \ 1-2 mL of 20 mg/mL of nicotine salt
- Known or suspected alcohol or illicit drug abuse within the past 12 months prior to Study Day 1.
- Breastfeeding or plans to breastfeed from the time of the first vaccination through 60 days after the last study injection.
- Participants unlikely to cooperate with the requirements of the study protocol.
The study team makes the final eligibility decision.
Where it's taking place
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 64 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Antonio, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.