Safety and Immune Response of a Rabies Vaccine With the Essen Schedule and a Two-Dose Booster (NCT07672626) | Clinical Trial Compass
CompletedPhase 3
Safety and Immune Response of a Rabies Vaccine With the Essen Schedule and a Two-Dose Booster
China1,200 participantsStarted 2022-07-19
Plain-language summary
Rabies is caused by rabies virus with a 100% mortality rate in humans. Most of cases occur in Africa and Asia, mainly in underserved populations. Rabies is a vaccine-preventable disease in both humans and animals. Over the years, the Vero cell rabies vaccine has been recognized by the World Health Organization (WHO) and the European Union, and is widely used globally. Currently, one of the post-exposure prophylaxis (PEP) regimens recommended by the World Health Organization (WHO) is the five-dose "Essen" regimen (1-1-1-1-1), involving one intramuscular dose administered on days 0, 3, 7, 14, and 28 respectively. This clinical trial was to assess the immunogenicity and safety of a freeze-dried human rabies vaccine (Vero Cell) in healthy population for the large-scale developing, and explore the booster vaccination.
Who can participate
Age range
10 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 immunosu…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Seroconversion rate of rabies virus-specific neutralizing antibodies (RFFIT) in pre-immunization seronegative subjects.
Timeframe: 14 days following the 5 doses full-course immunization
2
Geometric mean concentration (GMC) of rabies virus-specific neutralizing antibodies in pre-immunization seronegative subjects.
Timeframe: 14 days following the 5 doses full-course immunization
3
Seroconversion rate of rabies virus-specific neutralizing antibodies (RFFIT) in pre-immunization seronegative subjects.
Timeframe: 14 days following the first dose
4
Geometric mean concentration (GMC) of rabies virus-specific neutralizing antibodies in pre-immunization seronegative subjects.
Timeframe: 14 days following the first dose
Trial details
NCT IDNCT07672626
SponsorJiangsu Province Centers for Disease Control and Prevention