RabiesNCT03774628
Immunity Duration of Rabies Vaccine and Booster Dose Effects at 10 Years Post-primary Vaccination
A study testing Chengdu Kanghua (one booster shot) and Chengdu Kanghua (two booster shots) in people with Rabies, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Rabies
- What is being tested?
- Chengdu Kanghua (one booster shot) and Chengdu Kanghua (two booster shots)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 342 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2018to 19 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Lianshui Xinyi Center for Disease Control and Prevention
Huai'an, Jiangsu, 223400
About this study
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
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.
- Conditions
- Rabies
- Being tested
- Chengdu Kanghua (one booster shot), Chengdu Kanghua (two booster shots)
- Medical subject headings
- Rabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chengdu Kanghua (one booster shot)Biological
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
Chengdu Kanghua (two booster shots)Biological
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
| Study group | Role | What they receive |
|---|---|---|
| Chengdu Kanghua (one booster shot) | Experimental | one dose, A rabies vaccine (human diploid cell) for human use, Freeze-dried produced by Chengdu Kanghua Biological Products Co.,Ltd. Receives: Biological: Chengdu Kanghua (one booster shot) |
| Chengdu Kanghua (two booster shots) | Experimental | 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. Receives: Biological: Chengdu Kanghua (two booster shots) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 hours, 1 day, 3 days, 7 days or 14 days after booster dose injection within 10 years later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2018
- Study start1 Aug 2018
- Primary completion19 Feb 2019
- Study completion19 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RabiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 342 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Province Centers for Disease Control and Prevention
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03774628
- Sponsor's protocol ID
- JSVCT061
- Status last verified
- Nov 2020
- First submitted
- 11 Dec 2018
- Last updated
- 1 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33945439
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03774628
- Acronym / sponsor ID
- JSVCT061
- Conditions
- Rabies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- Jiangsu Province Centers for Disease Control and PreventionResearch network
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 19 Feb 2019 (actual)
- Study completion
- 19 Feb 2019 (actual)
- First posted
- 13 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chengdu Kanghua (one booster shot) | Experimental | Biological: Chengdu Kanghua (one booster shot)one dose, A rabies vaccine (human diploid cell) for human use, Freeze-dried produced by Chengdu Kanghua Biological Products Co.,Ltd. |
| Chengdu Kanghua (two booster shots) | Experimental | Biological: Chengdu Kanghua (two booster shots)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. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chengdu Kanghua (one booster shot)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 | Biological | Chengdu Kanghua (one booster shot) |
| Chengdu Kanghua (two booster shots)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 | Biological | Chengdu Kanghua (two booster shots) |
Primary outcome
Proportion of serum rabies virus neutralizing antibodies to protective levels 10 years after primary vaccination
Time frame: 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
Time frame: 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
Time frame: 6 hours, 1 day, 3 days, 7 days or 14 days after booster dose injection within 10 years later
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
Time frame: 6 hours, 1 day, 3 days, 7 days or 14 days after booster dose injection within 10 years later
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
Time frame: 6 hours, 1 day, 3 days, 7 days or 14 days after booster dose injection within 10 years later
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
Time frame: 6 hours, 1 day, 3 days, 7 days or 14 days after booster dose injection within 10 years later
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2020.
- Derived from this study: PubMed 33945439Hu 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.
Related trials for Rabies
RecruitingPhase 4
Age-Associated Differences in Germinal Center Responses to Influenza and Rabies Vaccination in Humans
Healthy Adult Participants, Age 65 and Older
Active, not recruitingPhase 3
A Clinical Trial of Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried in a Population Aged 10 to 60 Years
Rabies
Active, not recruitingObservational study
Real-World Effectiveness of Zamerovimab and Mazorelvimab and Vaccine for Rabies Grade III Exposure in Nanyang
Rabies Post-exposure Prophylaxis, Rabies
RecruitingObservational study
Real World Evidence Study of SYN023 in Children Exposed to Rabies
Rabies Post-exposure Prophylaxis
Enrolling by invitationPhase 3
A Phase III Clinical Trial on Immunogenicity and Safety of Lyophilized Rabies Vaccine for Human Use (Human Diploid Cell)
Rabies Prevention
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chengdu Kanghua (one booster shot) and Chengdu Kanghua (two booster shots) in people with Rabies, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of serum rabies virus neutralizing antibodies to protective levels 10 years after primary vaccination (time frame: 10 years after primary vaccination). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03774628, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2020.