A Phase 3 Clinical Trial for a Rabies Vaccine (Vero Cell) for Human Use in Healthy Chinese Subjects

A Single-centre, Randomized, Double-blind, Parallel Control, Phase 3 Study to Evaluate the Safety and Immunogenicity of a Rabies Vaccine (Vero Cell) for Human Use in Healthy Chinese Subjects Aged 10-60 Years

The purpose of this single-centre, randomized, double-blind, parallel control, phase 3 study is to evaluate the safety and immunogenicity of a rabies vaccine (Vero Cell) for human use in healthy Chinese subjects aged 10-60 years, according to the Essen methods (1-1-1-1-1) vaccination.

Study Overview

• Status: Completed
• Conditions: Rabies
• Intervention / Treatment: Biological: Changchun Werersai; Biological: Jilin Maifeng

Detailed Description

There will be two immunization arms. 1200 healthy subjects will be randomly assigned (1:1) to receive an experimental vaccine or a parallel comparator vaccine. All of them will be received five doses of rabies vaccine at day 0,3,7,14,28 according to the traditional Essen methods (1-1-1-1-1) vaccination.

• Study Type: Interventional
• Enrollment (Actual): 1200
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Xuzhou, Jiangsu, China, 221400
      • Xinyi Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Aged from 10 to 60 years old
• Subjects or legal guardians can and will comply with the requirements of the protocol
• Subjects or legal guardians are able to understand and sign the informed consent
• Healthy subjects judged from medical history after investigator's inquiry
• Subjects with temperature <=37.0°C on axillary setting

Exclusion Criteria:

• Female in lactation or pregnancy, or plan to be pregnant during the study period
• Subject who has allergic history to any vaccine or other medicines
• Subject who has injury history by dogs or other mammals and has been vaccinated with rabies vaccine
• Subject who has serious adverse reaction history after vaccination such as allergies, hives, difficulty in breathing, angioedema or abdominal pain
• Subject with congenital malformation, developmental disorder or serious chronic disease
• Subject with autoimmune diseases or immunodeficiency
• Subject with asthma, unstable over the past two years requiring emergency treatment, hospitalization, intubation, oral or intravenous corticosteroids
• Subject with diabetes (Type I or II) excluding gestational diabetes
• Subject with thyroidectomy history, or require treatment in the past 12 months due to thyroid disease
• Subject with severe angioedema in the past 3 years or require treatment in the past 2 years
• Subject with hypertension and with a blood pressure exceeding 145/95 mmHg at enrollment time
• Subject with coagulation abnormalities diagnosed by doctors (such as clotting factor deficiency, coagulation disorders, platelet disorder) or obvious bruises or blood clotting disorder
• Subject with cancer, or has been treated in active cancer period or not clearly cured, or may recur during the study period
• Subject with epilepsy, excluding those alcohol epilepsy within three years before quitting drinking or those do not need treatment in the past 3 years
• Asplenia, functional asplenia, without a spleen or removal of the spleen caused by any situation
• Guillain-Barre syndrome
• Any prior administration of immunodepressant or corticosteroids in last 6 months
• Any prior administration of blood products in last 3 months
• Any prior administration of other research medicine/vaccine in last 30 days
• Any prior administration of any attenuated live vaccine in last 30 days
• Any prior administration of subunit or inactivated vaccines in last 14 days, such as pneumococcal vaccine
• Ongoing anti-tuberculosis prevention or treatment
• Subject who cannot comply with the trial requirements, or with mental illness/ dual-stage affective psychosis in the past or at present; or has not been controlled and needs to take psychiatric drugs the past 2 years; or with suicidal tendencies in the past 5 years
• Any medical, psychological, social or other condition judged by investigator, that may interfere subject's compliance with the protocol or signature on informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Changchun Werersai; A rabies vaccine (Vero Cell) for human use produced by Changchun Werersai Biotech Pharmaceutical Co., Ltd.	Biological: Changchun Werersai; A rabies vaccine (Vero Cell) for human use produced by Changchun Werersai Biotech Pharmaceutical Co., Ltd. 1.0 ml experimental vaccine on day 0,3,7,14,28
Active Comparator: Jilin Maifeng; A rabies vaccine (Vero Cell) for human use produced by Jilin Maifeng Biotech Pharmaceutical Co., Ltd.	Biological: Jilin Maifeng; A rabies vaccine (Vero Cell) for human use produced by Jilin Maifeng Biotech Pharmaceutical Co., Ltd. 1.0 ml comparator vaccine on day 0,3,7,14,28

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Positive seroconversion rate of serum rabies virus neutralizing antibody 42 days after full vaccination	42 days after full vaccination

Secondary Outcome Measures

Outcome Measure	Time Frame
Geometric mean concentration (GMC) of serum rabies virus neutralizing antibody 42 days after full vaccination	42 days after full vaccination
Positive seroconversion rate of serum rabies virus neutralizing antibody 14 days after full vaccination	14 days after full vaccination
Geometric mean concentration (GMC) of serum rabies virus neutralizing antibody 14 days after full vaccination	14 days after full vaccination
Incidence of local and systemic adverse reactions during safety observation period after each vaccination	0-7 days after each vaccination and 8-28 days after the fifth vaccination

Collaborators and Investigators

• Sponsor: Jiangsu Province Centers for Disease Control and Prevention
• Investigators: Principal Investigator: Yuemei Hu, Jiangsu Provincial Center for Diseases Control and Prevention

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: July 3, 2015
• First Submitted That Met QC Criteria: July 3, 2015
• First Posted (Estimate): July 8, 2015

Study Record Updates

• Last Update Posted (Estimate): July 9, 2015
• Last Update Submitted That Met QC Criteria: July 8, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Mononegavirales Infections; Rhabdoviridae Infections; Rabies
• Other Study ID Numbers: 20120002