A Phase 3 interventional study of the tested vaccine and the control vaccine in Vaccine, sponsored by Jiangsu Province Centers for Disease Control and Prevention. Completed at 1 site in China. Open to participants aged 10 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-29.
Sponsored by Jiangsu Province Centers for Disease Control and Prevention · Phase 3, Interventional, and Prevention
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.
Rabies is caused by rabies virus with a case fatality rate approaching 100% in humans. Studies reported that about 59000 human deaths and over 3.7 million disability-adjusted life years lost every year. Most of cases occur in Africa and Asia, mainly in underserved populations, with approximately 40% of cases in children aged \<15 years. Fortunately, rabies is a vaccine-preventable disease in both humans and animals. Post-exposure prophylaxis (PEP), is the critical intervention for preventing the onset of the disease.
Conventional Vero cell rabies vaccines have been used globally for decades, demonstrating excellent safety and immunogenicity. However, their production typically requires the use of animal-derived components, such as fetal bovine serum or human serum albumin, in the cell culture medium. This practice raises potential concerns regarding the risk of contamination with adventitious agents, batch-to-batch variability, and the potential for allergic reactions. To address these limitations, a new generation of purified Vero rabies vaccine produced in serum-free medium has been developed. This vaccine uses the same Pitman-Moore virus strain as the traditional vaccines but is manufactured without any human or animal serum-derived components, significantly reducing the risk of extraneous protein contamination and representing a substantial advancement in vaccine technology and safety. The shift to a serum-free production process, while a clear advantage for safety, raises critical questions regarding the vaccine's immunogenicity and the duration of protection it confers.
This study aims to systematically evaluate the available evidence of the serum-free Vero cell rabies vaccine. First, we will critically assess its immunogenicity in PEP settings. Second, we will assess the long-term persistence of protective antibody titers following primary vaccination. Finally, we will discuss the rationale for and evidence on booster vaccination strategies.
Jiangsu Province Centers for Disease Control and Prevention is the lead sponsor of 77 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria for the first dose:
Exclusion Criteria for other doses:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
receive the lyophilized human rabies vaccine (Vero Cells) produced by Shanghai Rongsheng Biotech Co., Ltd.
Biological: the tested vaccine
receive the lyophilized human rabies vaccine (Vero Cells) produced by Liaoning Chengda Biotechnology Co., Ltd.
Biological: the control vaccine
Subjects from the tested group with freeze-dried human rabies vaccine (Vero Cell) (Shanghai Rongsheng Biotech Co., Ltd.) vaccinated according to booster schedule on day 0,3 at month 3 following the full-course immunization.
Biological: the tested vaccine
Subjects from the experimental 1 with freeze-dried human rabies vaccine (Vero Cell) (Shanghai Rongsheng Biotech Co., Ltd.) vaccinated according to booster schedule on day 0,3 at month 12 following the full-course immunization.
Biological: the tested vaccine
The tested vaccine is a lyophilized human rabies vaccine (Vero Cells) produced by Shanghai Rongsheng Biotech Co., Ltd.
The control vaccine is a lyophilized human rabies vaccine (Vero Cells) produced by Liaoning Chengda Biotechnology Co., Ltd.
Seroconversion rate of rabies virus-specific neutralizing antibodies (RFFIT) in pre-immunization seronegative subjects.
Percentage of participants with rabies virus neutralizing antibody concentration ≥0.5 IU/ml, the experimental group is non-inferior to the control group, non-inferiority margin for seroconversion rate:-5%.
Time frame: 14 days following the 5 doses full-course immunization
Geometric mean concentration (GMC) of rabies virus-specific neutralizing antibodies in pre-immunization seronegative subjects.
GMC, concentration of participants with rabies virus neutralizing antibody concentration, the experimental group is non-inferior to the control group, non-inferiority margin for GMC ratio:0.67.
Time frame: 14 days following the 5 doses full-course immunization
Seroconversion rate of rabies virus-specific neutralizing antibodies (RFFIT) in pre-immunization seronegative subjects.
Seroconversion rate, percentage of participants with rabies virus neutralizing antibody concentration ≥0.5 IU/ml, the experimental group is non-inferior to the control group, non-inferiority margin for seroconversion rate:-5%.
Time frame: 14 days following the first dose
Geometric mean concentration (GMC) of rabies virus-specific neutralizing antibodies in pre-immunization seronegative subjects.
GMC, concentration of participants with rabies virus neutralizing antibody concentration, the experimental group is non-inferior to the control group, non-inferiority margin for GMC ratio:0.67.
Time frame: 14 days following the first dose
Percentage of participants with rabies virus neutralizing antibody concentration ≥0.5 IU/ml or increase by 4 folds after vaccination
Time frame: 7、14 days post the first dose and 14 days post the 5 doses full-course immunization
Geometric mean concentration (GMC) of rabies virus-specific neutralizing antibodies
Time frame: 7、14 days post the first dose and 14 days post the 5 doses full-course immunization
Percentage of participants with rabies virus neutralizing antibody concentration ≥0.5 IU/ml after vaccination.
Time frame: Month 3、6、12 following the 5 doses full-course immunization
GMC of rabies virus neutralizing antibody
Time frame: Month 3、6、12 following the 5 doses full-course immunization
Proportion of subjects reporting adverse events
Time frame: Day 30 post-each dose
Proportion of subjects with Serious Adverse Events occurring throughout the trial
Time frame: Day 0 up to month 12 following the full-course immunization
Percentage of participants with rabies virus neutralizing antibody concentration ≥0.5 IU/ml or increase by 4 folds after booster vaccination
Time frame: 14 days post booster vaccination
GMC of rabies virus neutralizing antibody after booster vaccination
Time frame: 14 days post booster vaccination
Proportion of subjects reporting adverse events after booster vaccination
Time frame: 30 days post booster vaccination
Ran from Jul 2022 to primary completion in Aug 2024, 25 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Jiangsu Province Centers for Disease Control and Prevention