Safety and Immune Response of a Rabies Vaccine With the Essen Schedule and a Two-Dose Booster

NCT07672626 | Completed Phase 3

• 1 other identifier: JSVCT146
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vaccine

Keywords

human rabies vaccine (Vero Cell), immunogenicity, safety, Essen regimen

Outcome Measures

Primary Outcomes (4)

• 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%.

  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.

  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%.

  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.

  14 days following the first dose

Secondary Outcomes (6)

• Percentage of participants with rabies virus neutralizing antibody concentration ≥0.5 IU/ml or increase by 4 folds after vaccination

  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

  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.

  Month 3、6、12 following the 5 doses full-course immunization

• GMC of rabies virus neutralizing antibody

  Month 3、6、12 following the 5 doses full-course immunization

• Proportion of subjects reporting adverse events

  Day 30 post-each dose

Other Outcomes (3)

• Percentage of participants with rabies virus neutralizing antibody concentration ≥0.5 IU/ml or increase by 4 folds after booster vaccination

  14 days post booster vaccination

• GMC of rabies virus neutralizing antibody after booster vaccination

  14 days post booster vaccination

• Proportion of subjects reporting adverse events after booster vaccination

  30 days post booster vaccination

Study Arms (4)

the tested group

EXPERIMENTAL

receive the lyophilized human rabies vaccine (Vero Cells) produced by Shanghai Rongsheng Biotech Co., Ltd.

Biological: the tested vaccine

the control group

ACTIVE COMPARATOR

receive the lyophilized human rabies vaccine (Vero Cells) produced by Liaoning Chengda Biotechnology Co., Ltd.

Biological: the control vaccine

Sub tested A

EXPERIMENTAL

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

Sub tested B

EXPERIMENTAL

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

Interventions

the tested vaccine BIOLOGICAL

The tested vaccine is a lyophilized human rabies vaccine (Vero Cells) produced by Shanghai Rongsheng Biotech Co., Ltd.

Sub tested A; Sub tested B; the tested group

the control vaccine BIOLOGICAL

The control vaccine is a lyophilized human rabies vaccine (Vero Cells) produced by Liaoning Chengda Biotechnology Co., Ltd.

the control group

Eligibility Criteria

• Age: 10 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangsu Province Centers for Disease Control and Prevention: lead

Study Sites (1)

Pizhou county Center for Disease Control and Prevention

Pizhou, Jiangsu, China

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Masking Description
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Model Description

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: June 29, 2026
• Study Start: July 19, 2022
• Primary Completion: August 26, 2024
• Study Completion: December 16, 2024
• Last Updated: June 29, 2026

Record last verified: 2026-06

Locations

CN (1)