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Immunogenicity and Safety of A Lyophilized Purified Human Diploid Cell Rabies Vaccine .

Primary Purpose

Adverse Effect and Immunogenicity of Vaccine

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Human diploid cell rabies vaccine (Minhai Biothechnology Co., Ltd)

Human diploid cell rabies vaccine (Chengdu Kanghua Biological Products Co., Ltd.)

About this trial

This is an interventional prevention trial for Adverse Effect and Immunogenicity of Vaccine

Eligibility Criteria

10 Years - 60 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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
Subjects who can and will comply with the requirements of the protocol
Subjects with temperature ≤37.0°C on axillary setting

Exclusion Criteria:

- Subject who was administered human rabies vaccine.
Suspected or have a history of injury caused by warm-blooded mammals.
Women who are breastfeeding, pregnant, or planning to become pregnant during the trial.
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 serious chronic illness (such as Down's syndrome, diabetes, sickle cell anemia or neurological disorders, guillain-barre syndrome)
Known or suspected co-existing diseases included: respiratory disease, acute infection or active period of chronic disease, HIV infection, cardiovascular disease, severe hypertension, malignant tumor treatment, skin disease.
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 prevention or treatment.
Any prior administration of blood products in last 3 months.
Any prior administration of other research drugs in last 30 days
Any prior administration of attenuated live vaccine in last 14 days
Any prior administration of subunit or inactivated vaccines in last 7 days
Had fever 3 days before vaccination, Subjects with temperature ≥38.0°C on axillary setting
Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives

Sites / Locations

Jiangsu Provincial Center for Diseases Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Experimental 1

Experimental 2

Positive Control

Arm Description

Outcomes

Primary Outcome Measures

To evaluate immunogenicity after the first dose

Percentage of participants with rabies virus neutralizing antibody concentration ≥0.5 IU/ml.

Secondary Outcome Measures

Percentage of participants with rabies virus neutralizing antibody concentration ≥0.5 IU/ml after the last dose.

GMC of rabies virus neutralizing antibody

Proportion of subjects reporting of adverse reaction and unsolicited adverse events

Proportion of subjects with Serious Adverse Events occurring throughout the trial

Full Information

NCT ID

NCT03971370

First Posted

May 30, 2019

Last Updated

May 30, 2019

Sponsor

Jiangsu Province Centers for Disease Control and Prevention

1. Study Identification

Unique Protocol Identification Number

NCT03971370

Brief Title

Immunogenicity and Safety of A Lyophilized Purified Human Diploid Cell Rabies Vaccine .

Official Title

Immunogenicity and Safety of A Lyophilized Purified Human Diploid Cell Rabies Vaccine in Chinese Healthy People Aged 10-60 Years.: A Randomized, Blinded, Phase III Clinical Trial.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Completed

Study Start Date

September 10, 2017 (Actual)

Primary Completion Date

September 29, 2018 (Actual)

Study Completion Date

February 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jiangsu Province Centers for Disease Control and Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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. The WHO clearly states that human diploid cell rabies vaccine is the "gold standard" rabies vaccine, because of no carcinogenicity and any foreign animal impurity or neurotoxicity factor. China does not approve the import of foreign HDCV and has insufficiency domestic HDCV, so this clinic trial was to assess the immunogenicity and safety of HDCV in healthy population for the large-scale developing of a lyophilized and purified HDCV.

Detailed Description

Rabies is caused by rabies virus with a 100% mortality rate in humans. An estimated 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. WHO and its partners have endorsed a target of Zero Human Rabies Deaths from dog-transmitted rabies by 2030 (Zero by 30). Fortunately, rabies is a vaccine-preventable disease in both humansand animals. At present, chicken embryo cell vaccine, Vero cell vaccine, hamster kidney cell vaccine, and human diploid cell (HDC) rabies vaccine (HDCV) have been approved. The WHO clearly states that HDCV is the "gold standard" rabies vaccine. Because HDCs are normal karyotype cells without carcinogenicity, the HDCV does not contain any foreign animal impurity or neurotoxicity factor. Furthermore, there are fewer injections required and mild adverse reactions and it is safe and efficacious; thus, it is recommended by the WHO as the "nearly ideal human vaccine." Although HDCV was primarily used in developed countries prior to 2015, China does not approve the import of foreign HDCV. Meanwhile, domestic diploid rabies vaccine for human use is insufficiency and in this regard, Minhai Biothechnology Co., Ltd in China has overcome technical difficulties for the large-scale developing of a lyophilized and purified HDCV. This clinic trial was to assess the immunogenicity and safety of HDCV in healthy population vaccinated according to the Essen and Zagreb post-exposure immunization schedule, exploring the appropriate immunization procedures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adverse Effect and Immunogenicity of Vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

1800 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental 1

Arm Type

Experimental

Arm Title

Experimental 2

Arm Type

Experimental

Arm Title

Positive Control

Arm Type

Active Comparator

Intervention Type

Biological

Intervention Name(s)

Human diploid cell rabies vaccine (Minhai Biothechnology Co., Ltd)

Intervention Description

Essen post-exposure immunization schedule at day 0,3,7,14,28.

Intervention Type

Biological

Intervention Name(s)

Human diploid cell rabies vaccine (Minhai Biothechnology Co., Ltd)

Intervention Description

Zagreb post-exposure immunization schedule at day 0,7,21.

Intervention Type

Biological

Intervention Name(s)

Human diploid cell rabies vaccine (Chengdu Kanghua Biological Products Co., Ltd.)

Intervention Description

Essen post-exposure immunization schedule at day 0,3,7,14,28.

Primary Outcome Measure Information:

Title

To evaluate immunogenicity after the first dose

Description

Percentage of participants with rabies virus neutralizing antibody concentration ≥0.5 IU/ml.

Time Frame

14 days following the first dose

Secondary Outcome Measure Information:

Title

Percentage of participants with rabies virus neutralizing antibody concentration ≥0.5 IU/ml after the last dose.

Description

Percentage of participants with rabies virus neutralizing antibody concentration ≥0.5 IU/ml after the last dose.

Time Frame

14 days following the last dost

Title

GMC of rabies virus neutralizing antibody

Time Frame

day 7 and 14 post the first dose and day 14 post the last dose

Title

Proportion of subjects reporting of adverse reaction and unsolicited adverse events

Time Frame

from day 0 to day 28 post the last dose

Title

Proportion of subjects with Serious Adverse Events occurring throughout the trial

Time Frame

Day 0 up to month 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 Subjects who can and will comply with the requirements of the protocol Subjects with temperature ≤37.0°C on axillary setting Exclusion Criteria: - Subject who was administered human rabies vaccine. Suspected or have a history of injury caused by warm-blooded mammals. Women who are breastfeeding, pregnant, or planning to become pregnant during the trial. 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 serious chronic illness (such as Down's syndrome, diabetes, sickle cell anemia or neurological disorders, guillain-barre syndrome) Known or suspected co-existing diseases included: respiratory disease, acute infection or active period of chronic disease, HIV infection, cardiovascular disease, severe hypertension, malignant tumor treatment, skin disease. 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 prevention or treatment. Any prior administration of blood products in last 3 months. Any prior administration of other research drugs in last 30 days Any prior administration of attenuated live vaccine in last 14 days Any prior administration of subunit or inactivated vaccines in last 7 days Had fever 3 days before vaccination, Subjects with temperature ≥38.0°C on axillary setting Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yuemei Hu, Master

Organizational Affiliation

Jiangsu Provincial Center for Diseases Control and Prevention

Official's Role

Principal Investigator

Facility Information:

Facility Name

Jiangsu Provincial Center for Diseases Control and Prevention

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210009

Country

China

12. IPD Sharing Statement

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Immunogenicity and Safety of A Lyophilized Purified Human Diploid Cell Rabies Vaccine .

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