New Freeze-Dried rabies vaccine aims to save lives in High-Risk regions
NCT ID NCT07672626
First seen Jun 29, 2026 · Last updated Jun 30, 2026 · Updated 1 time
Summary
This phase 3 trial tests a freeze-dried rabies vaccine in healthy Chinese volunteers aged 10 to 60. The study compares the new vaccine's ability to trigger protective antibodies and its safety against an existing rabies vaccine. Rabies is nearly always fatal once symptoms appear, so effective vaccines are critical for prevention.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- freeze-dried human rabies vaccine (Vero cell)
- What this could lead to
- If successful, this could provide a safe and effective rabies vaccine option for large-scale use, potentially saving lives in regions where rabies is a threat.
- What could go wrong
- This is a phase 3 trial, but results may not generalize beyond the Chinese population studied. The vaccine may not prove non-inferior to the control, or rare side effects could emerge.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
1,200 people
The number who actually took part.
- Started
-
Jul 2022
- Finished
-
Dec 2024
- Lead sponsor
-
A research network
The lead sponsor is a research network or cooperative group.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
10 to 60 years
- Sex
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Healthy subjects aged 10-60 years as established by medical history and clinical examination * The subjects are able to understand and sign the informed consent * Female subjects aged 18-60 years must have a negative urine pregnancy test result and commit to using contraception for 2 months following the first vaccine dose in this study. * Subjects who can and will comply with the requirements of the protocol * Subjects with temperature ≤37.0°C on axillary setting Exclusion Criteria: Exclusion Criteria for the first dose: * Subject who was administered human rabies vaccine or rabies immunoglobulin. * Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine, especially allergic to neomycin. * Has been diagnosed or suspected of having an immune deficiency, autoimmune disease, or immune system disorder. * History of thyroidectomy, or thyroid disease requiring treatmentin the past 12 months * Bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with injections or blood draws * History of epilepsy, convulsions or convulsions, or a family history of psychosis. * Absence of spleen, functional absence of spleen, and any circumstances leading to absence of spleen or splenectomy. * Have a malignant tumor in active phase, or a tumor that have been treated but not clearly cured, or may relapse during the study period. * In the past 6 months, there have been immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding corticosteroid spray therapy for allergic rhinitis, and surface corticosteroid therapy for acute non-complicated dermatitis). * Taking anti-TB or HIV treatment. * Any prior administration of immunoglobulin or blood products in last 3 months. * Coagulopathy (such as coagulation factor deficiency, coagulative disorders, platelet abnormalities) or obvious bruising or coagulation impairment * Any prior administration of other research drugs in last 30 days * Any prior administration of attenuated live vaccine in last 4 weeks * Any prior administration of subunit or inactivated vaccines in last 2 weeks * Have acute diseases, severe chronic diseases, acute exacerbation of chronic diseases, or those with fever * Suspected or have a history of injury caused by warm-blooded mammals in last 3 months. * Women who are breastfeeding, pregnant, or planning to become pregnant in 2 months past the first dose. * Use of antipyretic, analgesic, or antiallergic drugs within 3 days * Having used other investigational or unregistered products (drugs or vaccines) within 6 months prior to the vaccination of the study vaccine, or having plans to participate in other clinical studies after enrollment in this clinical study (except for emergency-use novel coronavirus vaccines, but the vaccination details must be recorded in the concomitant medication section) * Planning to move out of the local area or be away from the local area for a long time before the end of the study; * Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives Exclusion Criteria for other doses: * Any incidences in the first dose exclusion criteria occur after inclusion * Grade 3 or higher systemic adverse reactions related to this study, or intolerable injection site adverse reactions, that occurred between the previous vaccination and the current vaccination. * Any serious adverse events caused by vaccination. * Other reactions that in the opinion of the investigator ( include: severely serious symptom of pain, swelling, Limitation of motion, continuous high fever, headache and other Systemic or local reactions )
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Pizhou county Center for Disease Control and Prevention
Pizhou, Jiangsu, China
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Other studies related to the condition(s) this trial covers.
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