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Immunity Duration of Rabies Vaccine and Booster Dose Effects at 10 Years Post-primary Vaccination

Primary Purpose

Rabies

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Chengdu Kanghua (one booster shot)

Chengdu Kanghua (two booster shots)

About this trial

This is an interventional prevention trial for Rabies

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Participants who participated in the Phase III clinical study of the vaccine and completed the full immunization
Subjects or legal guardians can and will comply with the requirements of the protocol
Subjects are able to understand and sign the informed consent
Subjects with temperature <=37.0°C on axillary setting

Exclusion Criteria:

Female in pregnancy
Subjects who have been vaccinated other rabies vaccines after participating in the phase III clinical study of the vaccine (excluding those who participated in the 8-year booster immunization)
Subject who has serious adverse reaction history after vaccination such as allergies, hives, difficulty in breathing, angioedema or abdominal pain or allergic to any ingredient of the this rabies vaccine, including excipient
Any acute disease, serious chronic disease, fever，and chronic disease at acute stage
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 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 uncontrolled epilepsy or other progressive neurological disease
Asplenia, functional asplenia, without a spleen or removal of the spleen caused by any situation
Any prior administration of immunodepressant, cytotoxic treatment or inhaled corticosteroids in last 6 months, excluding those corticosteroid spray therapy for allergic rhinitis, topical corticosteroid treatment for acute non-concurrent dermatitis)
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
Any medical, psychological, social or other condition judged by investigator, that may interfere subject's compliance with the protocol or signature on informed consent
Untolerable adverse reactions occurred after booster dose injection within 10 years later;
Any condition that in the opinion of the investigators may be not suitable for continued participation after booster dose injection within 10 years later

Sites / Locations

Lianshui Xinyi Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Chengdu Kanghua (one booster shot)

Chengdu Kanghua (two booster shots)

Arm Description

one dose, A rabies vaccine (human diploid cell) for human use, Freeze-dried produced by Chengdu Kanghua Biological Products Co.,Ltd.

two doses at 0 and 3 days, on A rabies vaccine (human diploid cell) for human use, Freeze-dried produced by Chengdu Kanghua Biological Products Co.,Ltd.

Outcomes

Primary Outcome Measures

Proportion of serum rabies virus neutralizing antibodies to protective levels 10 years after primary vaccination

calculate the proportion of serum rabies virus neutralizing antibodies to protective levels 10 years after primary vaccination

Geometric mean concentration (GMC) of serum rabies virus neutralizing antibody 10 years after primary vaccination

calculate the geometric mean concentration (GMC) of serum rabies virus neutralizing antibody 10 years after primary vaccination

Proportion of serum rabies virus neutralizing antibodies to protective levels

calculate the proportion of serum rabies virus neutralizing antibodies to protective levels 6 hours, 1 day, 3 days, 7 days or 14 days after booster dose injection within 10 years later

Positive seroconversion rate of serum rabies virus neutralizing antibody

calculate the positive seroconversion rate of serum rabies virus neutralizing antibody 6 hours, 1 day, 3 days, 7 days or 14 days after booster dose injection within 10 years later

Geometric mean concentration (GMC) of serum rabies virus neutralizing antibody

calculate the geometric mean concentration (GMC) of serum rabies virus neutralizing antibody 6 hours, 1 day, 3 days, 7 days or 14 days after booster dose injection within 10 years later

Mean geometric increases (GMIs) of serum rabies virus neutralizing antibody

calculate the mean geometric increases (GMIs) of serum rabies virus neutralizing antibody 6 hours, 1 day, 3 days, 7 days or 14 days after booster dose injection within 10 years later

Secondary Outcome Measures

Full Information

NCT ID

NCT03774628

First Posted

December 11, 2018

Last Updated

November 28, 2020

Sponsor

Jiangsu Province Centers for Disease Control and Prevention

1. Study Identification

Unique Protocol Identification Number

NCT03774628

Brief Title

Immunity Duration of Rabies Vaccine and Booster Dose Effects at 10 Years Post-primary Vaccination

Official Title

Long-term Immunity of Rabies Vaccine(Human Diploid Cell)for Human Use,Freeze-dried and Booster Dose Effects at 10 Years Post-primary Vaccination

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

August 1, 2018 (Actual)

Primary Completion Date

February 19, 2019 (Actual)

Study Completion Date

February 19, 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

5. Study Description

Brief Summary

A rabies vaccine (human diploid cell) for human use, Freeze-dried produced by Chengdu Kanghua Biological Products Co.,Ltd is used to prevent human rabies. The vaccine was completed in the Phase III clinical trial from August 2008 to February 2009 in Lianshui County, Jiangsu Province (Approval of Drug Clinical Trial No. 2008L03156). A total of 1200 subjects aged 10-60 years were randomly assigned trial group (Kanghua vaccine group, 600 participants) and control groups (Pasteur vaccine group, 600 participants). The result showed that this vaccine could provide good immunogenicity and mild adverse reactions. On April 28, 2012, the drug registration approval was obtained (Approval No. 2012S00222). To disclose the effects of booster immunization of human diploid cell rabies vaccine (HDCV) after eight years of primary vaccination. Sixty subjects who had participated the phase Ⅲ clinical trial of freeze-dried HDCV were selected and given booster immunization after eight years of primary vaccination. The result showed that the freeze-dried HDCV has good immune effects with one-dose of booster immunization after eight years of primary vaccination． In order to find a ten years of immunization persistence and booster dose immune effect, the investigators decided to perform this immunization persistence and booster immunity trial among these subjects who had received five doses of rabies vaccine vaccines (around ten years after the fundamental immunity). The investigators do the recruitment among these subjects who had participated in the previous phase Ⅲ trail and the subjects were divided into two layers, such as trial group (Kanghua vaccine group) and the control group (Paste vaccine group). Each layer of the subjects randomly received one booster dose (Day 0) and two booster doses (Day 0, 3) the freeze-dried HDCV in a ratio of 1:1.

6. Conditions and Keywords

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

Rabies

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

342 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Chengdu Kanghua (one booster shot)

Arm Type

Experimental

Arm Description

one dose, A rabies vaccine (human diploid cell) for human use, Freeze-dried produced by Chengdu Kanghua Biological Products Co.,Ltd.

Arm Title

Chengdu Kanghua (two booster shots)

Arm Type

Experimental

Arm Description

two doses at 0 and 3 days, on A rabies vaccine (human diploid cell) for human use, Freeze-dried produced by Chengdu Kanghua Biological Products Co.,Ltd.

Intervention Type

Biological

Intervention Name(s)

Chengdu Kanghua (one booster shot)

Intervention Description

A rabies vaccine (human diploid cell) for human use, Freeze-dried produced by Chengdu Kanghua Biological Products Co.,Ltd. 1.0 ml experimental vaccine on day 0

Intervention Type

Biological

Intervention Name(s)

Chengdu Kanghua (two booster shots)

Intervention Description

A rabies vaccine (human diploid cell) for human use, Freeze-dried produced by Chengdu Kanghua Biological Products Co.,Ltd. 1.0 ml experimental vaccine on day 0 and 3

Primary Outcome Measure Information:

Title

Proportion of serum rabies virus neutralizing antibodies to protective levels 10 years after primary vaccination

Description

calculate the proportion of serum rabies virus neutralizing antibodies to protective levels 10 years after primary vaccination

Time Frame

10 years after primary vaccination

Title

Geometric mean concentration (GMC) of serum rabies virus neutralizing antibody 10 years after primary vaccination

Description

calculate the geometric mean concentration (GMC) of serum rabies virus neutralizing antibody 10 years after primary vaccination

Time Frame

10 years after primary vaccination

Title

Proportion of serum rabies virus neutralizing antibodies to protective levels

Description

calculate the proportion of serum rabies virus neutralizing antibodies to protective levels 6 hours, 1 day, 3 days, 7 days or 14 days after booster dose injection within 10 years later

Time Frame

6 hours, 1 day, 3 days, 7 days or 14 days after booster dose injection within 10 years later

Title

Positive seroconversion rate of serum rabies virus neutralizing antibody

Description

calculate the positive seroconversion rate of serum rabies virus neutralizing antibody 6 hours, 1 day, 3 days, 7 days or 14 days after booster dose injection within 10 years later

Time Frame

6 hours, 1 day, 3 days, 7 days or 14 days after booster dose injection within 10 years later

Title

Geometric mean concentration (GMC) of serum rabies virus neutralizing antibody

Description

calculate the geometric mean concentration (GMC) of serum rabies virus neutralizing antibody 6 hours, 1 day, 3 days, 7 days or 14 days after booster dose injection within 10 years later

Time Frame

6 hours, 1 day, 3 days, 7 days or 14 days after booster dose injection within 10 years later

Title

Mean geometric increases (GMIs) of serum rabies virus neutralizing antibody

Description

calculate the mean geometric increases (GMIs) of serum rabies virus neutralizing antibody 6 hours, 1 day, 3 days, 7 days or 14 days after booster dose injection within 10 years later

Time Frame

6 hours, 1 day, 3 days, 7 days or 14 days after booster dose injection within 10 years later

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Participants who participated in the Phase III clinical study of the vaccine and completed the full immunization Subjects or legal guardians can and will comply with the requirements of the protocol Subjects are able to understand and sign the informed consent Subjects with temperature <=37.0°C on axillary setting Exclusion Criteria: Female in pregnancy Subjects who have been vaccinated other rabies vaccines after participating in the phase III clinical study of the vaccine (excluding those who participated in the 8-year booster immunization) Subject who has serious adverse reaction history after vaccination such as allergies, hives, difficulty in breathing, angioedema or abdominal pain or allergic to any ingredient of the this rabies vaccine, including excipient Any acute disease, serious chronic disease, fever，and chronic disease at acute stage 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 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 uncontrolled epilepsy or other progressive neurological disease Asplenia, functional asplenia, without a spleen or removal of the spleen caused by any situation Any prior administration of immunodepressant, cytotoxic treatment or inhaled corticosteroids in last 6 months, excluding those corticosteroid spray therapy for allergic rhinitis, topical corticosteroid treatment for acute non-concurrent dermatitis) 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 Any medical, psychological, social or other condition judged by investigator, that may interfere subject's compliance with the protocol or signature on informed consent Untolerable adverse reactions occurred after booster dose injection within 10 years later; Any condition that in the opinion of the investigators may be not suitable for continued participation after booster dose injection within 10 years later

Facility Information:

Facility Name

Lianshui Xinyi Center for Disease Control and Prevention

City

Huai'an

State/Province

Jiangsu

ZIP/Postal Code

223400

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

33945439

Citation

Hu J, Wang S, Zhou R, Liu H, Gan X, Wei M, Zhu F, Meng F, Hou W. Long-term immunity and the effect of one or two booster doses with a lyophilized human rabies vaccine (human diploid cells) at 10 years post primary vaccination in China. Hum Vaccin Immunother. 2021 Sep 2;17(9):3162-3168. doi: 10.1080/21645515.2021.1906601. Epub 2021 May 4.

Results Reference

derived

Learn more about this trial

Immunity Duration of Rabies Vaccine and Booster Dose Effects at 10 Years Post-primary Vaccination

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