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New treatment option for Rabies
Official title A Clinical Trial of Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried
ClinicalTrials.gov ID: NCT07021703
What this study is testing
What is Freeze-dried Human Rabies Vaccine（Human Diploid Cell）, Essen?
Freeze-dried Human Rabies Vaccine（Human Diploid Cell）, Essen is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for rabies.
Also referred to as AIM2301.
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 Phase 1 clinical trial of the freeze-dried human rabies vaccine (human diploid cells) will be conducted on participants aged 10 to 60. This study will design a single-arm, randomized, open-access trial with different immunization schedules (5-dose schedule and 2-1-1 schedule) to evaluate the safety and tolerability of the vaccine in participants aged 10 to 60
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 to 60. Healthy volunteers may be eligible.
You may be able to join if
- (1) The participants' ages range from 10 to 60 years old (≥10 years old and \<61 years old).
- (2) Participants aged 10 to 17 and their guardians can provide valid identification documents, and participants aged 18 to 60 can provide their own...
- (3) Participants aged 10 to 17 and their guardians, as well as participants aged 18 to 60, can sign the informed consent form voluntarily to...
- (4) Possess basic reading and writing skills, and be capable of reading, understanding and filling in diary cards and contact cards; (5) Female...
You likely can't join if
- For the standards marked with \ , if the participants have the circumstances stipulated in the standard, the visit can be rescheduled when they no...
- After inquiry, it is found that there is a history of rabies vaccination or the use of passive immunization preparations for rabies virus.
- There was a history of injury from rabies virus-susceptible animals (such as cats and dogs) before the first dose of vaccination;
- The axillary body temperature of the participants on the day of enrollment was ≥37.3℃\ ;
- Those whose various examination results during the screening period are abnormal and are determined by clinicians to be of clinical significance;
- Women who have a positive urine pregnancy test before vaccination (on the day of vaccination), or who, after assessment, cannot rule out the...
See the full eligibility criteria
- (1) The participants' ages range from 10 to 60 years old (≥10 years old and \<61 years old).
- (2) Participants aged 10 to 17 and their guardians can provide valid identification documents, and participants aged 18 to 60 can provide their own valid identification documents.
- (3) Participants aged 10 to 17 and their guardians, as well as participants aged 18 to 60, can sign the informed consent form voluntarily to participate in the trial, fully understand the trial procedures, the risks of...
- (4) Possess basic reading and writing skills, and be capable of reading, understanding and filling in diary cards and contact cards; (5) Female participants with fertility must also meet the following conditions: 1)...
- For the standards marked with \ , if the participants have the circumstances stipulated in the standard, the visit can be rescheduled when they no longer have these circumstances
- After inquiry, it is found that there is a history of rabies vaccination or the use of passive immunization preparations for rabies virus.
- There was a history of injury from rabies virus-susceptible animals (such as cats and dogs) before the first dose of vaccination;
- The axillary body temperature of the participants on the day of enrollment was ≥37.3℃\ ;
- Those whose various examination results during the screening period are abnormal and are determined by clinicians to be of clinical significance;
- Women who have a positive urine pregnancy test before vaccination (on the day of vaccination), or who, after assessment, cannot rule out the possibility of pregnancy or are breastfeeding;
- Hypertension that cannot be controlled by medication, such as systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg for participants aged 18 years and above before enrollment;
- Allergy to any component of the vaccine used in the test, such as human albumin, sucrose, or maltose;
- Those with a history of severe allergies in the past, such as anaphylactic shock, allergic laryngeal edema, allergic purpura, local allergic necrosis reaction (Arthus reaction), severe urticaria, allergic bronchitis...
- Has been diagnosed with congenital or acquired immune system diseases Such as Human Immunodeficiency Virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid...
- Known or suspected of having serious diseases, including severe respiratory diseases, liver and kidney diseases, cardiovascular and cerebrovascular diseases, malignant tumors, and other chronic diseases that are poorly...
- Abnormal coagulation function (such as deficiency of coagulation factors, coagulation disorders, abnormal platelets) or coagulation disorders diagnosed by a doctor;
- Anplenia or functional anplenia, as well as anplenia or splenectomy caused by any circumstances;
- Previous or current clearly diagnosed neurological or mental disorders (including but not limited to dementia, schizophrenia, bipolar disorder, etc.) or confirmed epilepsy, convulsions, as well as other neurological or...
- It is planned to receive such treatment within 30 days after the first dose of vaccination and the full course of vaccination, such as long-term systemic glucocorticoid therapy (used continuously for 2 weeks or more, at...
- Have received or plan to receive immunoenhancers or inhibitors, immunoglobulins or blood-related products throughout the trial period within 3 months prior to enrollment;
- Have received attenuated live vaccines within 14 days before enrollment, and subunit vaccines or inactivated vaccines within 7 days \ ;
- Within 3 days before enrollment, have suffered from acute diseases or be in the acute attack stage of chronic diseases \ ;
- Antipyretic, analgesic and antihistamine drugs were used within 3 days before enrollment.
- Currently participating in or planning to participate in other clinical trials during this clinical trial;
- According to the researcher's judgment, due to various medical, psychological, social conditions or other circumstances contrary to the trial protocol, or the participants' inability to comply with the requirements of...
The study team makes the final eligibility decision.
Where it's taking place
- Zhengzhou, Henan, China
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, 10 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhengzhou, Henan, China. 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.