Adverse Effect and Immunogenicity of VaccinePhase 3NCT03971370
Immunogenicity and Safety of A Lyophilized Purified Human Diploid Cell Rabies Vaccine .
A Phase 3 study testing Human diploid cell rabies vaccine (Minhai Biothechnology Co., Ltd) and Human diploid cell rabies vaccine (Chengdu Kanghua Biological Products Co., Ltd.) in people with Adverse Effect and Immunogenicity of Vaccine, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Adverse Effect and Immunogenicity of Vaccine
- What is being tested?
- Human diploid cell rabies vaccine (Minhai Biothechnology Co., Ltd) and Human diploid cell rabies vaccine (Chengdu Kanghua Biological Products Co., Ltd.)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2017to 22 Feb 2019
- Phase
- Phase 3
- 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 10 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- - 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
Who cannot join
- - 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, 210009
About this study
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.
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.
Read the 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.
- Being tested
- Human diploid cell rabies vaccine (Minhai Biothechnology Co., Ltd), Human diploid cell rabies vaccine (Chengdu Kanghua Biological Products Co., Ltd.)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human diploid cell rabies vaccine (Minhai Biothechnology Co., Ltd)Biological
Essen post-exposure immunization schedule at day 0,3,7,14,28.
Human diploid cell rabies vaccine (Minhai Biothechnology Co., Ltd)Biological
Zagreb post-exposure immunization schedule at day 0,7,21.
Human diploid cell rabies vaccine (Chengdu Kanghua Biological Products Co., Ltd.)Biological
Essen post-exposure immunization schedule at day 0,3,7,14,28.
| Study group | Role | What they receive |
|---|---|---|
| Experimental 1 | Experimental | Not described Receives: Biological: Human diploid cell rabies vaccine (Minhai Biothechnology Co., Ltd) |
| Experimental 2 | Experimental | Not described Receives: Biological: Human diploid cell rabies vaccine (Minhai Biothechnology Co., Ltd) |
| Positive Control | Active comparator | Not described Receives: Biological: Human diploid cell rabies vaccine (Chengdu Kanghua Biological Products Co., Ltd.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate immunogenicity after the first dose
Percentage of participants with rabies virus neutralizing antibody concentration ≥0.5 IU/ml.
Measured: 14 days following the first dose
Secondary outcomes (4)
Percentage of participants with rabies virus neutralizing antibody concentration ≥0.5 IU/ml after the last dose.
Percentage of participants with rabies virus neutralizing antibody concentration ≥0.5 IU/ml after the last dose.
Measured: 14 days following the last dost
GMC of rabies virus neutralizing antibody
Measured: day 7 and 14 post the first dose and day 14 post the last dose
Proportion of subjects reporting of adverse reaction and unsolicited adverse events
Measured: from day 0 to day 28 post the last dose
Proportion of subjects with Serious Adverse Events occurring throughout the trial
Measured: Day 0 up to month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start10 Sep 2017
- Primary completion29 Sep 2018
- Study completion22 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 Adverse Effect and Immunogenicity of VaccineStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Province Centers for Disease Control and Prevention
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Yuemei Hu, Master, Principal investigator, Jiangsu Provincial Center for Diseases Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03971370
- Sponsor's protocol ID
- JSVCT041
- Status last verified
- May 2019
- First submitted
- 30 May 2019
- Last updated
- 3 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li G, Cao S, Xu B, Hu J, Zhang L, Shi L, Zhao D, Li Y, Liu Y, Liang Q, Wu X. Safety, immunogenicity and immune persistence of a lyophilized purified human diploid cells rabies vaccine following rabies PEP regimen Essen and Zagreb: A randomized, blinded controlled phase 3 trial in healthy participants aged 10-60 years old. Vaccine. 2025 Apr 19;53:127082. doi: 10.1016/j.vaccine.2025.127082. Epub 2025 Apr 5.
PubMed 40188565
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03971370
- Acronym / sponsor ID
- JSVCT041
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,800 participants (actual)
- Lead sponsor
- Jiangsu Province Centers for Disease Control and PreventionResearch network
- Study start
- 10 Sep 2017 (actual)
- Primary completion
- 29 Sep 2018 (actual)
- Study completion
- 22 Feb 2019 (actual)
- First posted
- 3 Jun 2019 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental 1 | Experimental | Biological: Human diploid cell rabies vaccine (Minhai Biothechnology Co., Ltd) |
| Experimental 2 | Experimental | Biological: Human diploid cell rabies vaccine (Minhai Biothechnology Co., Ltd) |
| Positive Control | Active comparator | Biological: Human diploid cell rabies vaccine (Chengdu Kanghua Biological Products Co., Ltd.) |
Who may qualify
- Ages
- 10 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- - 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
Key exclusion criteria (19 listed)
- - 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.
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 |
|---|---|---|
| Human diploid cell rabies vaccine (Minhai Biothechnology Co., Ltd)Essen post-exposure immunization schedule at day 0,3,7,14,28. | Biological | Experimental 1 |
| Human diploid cell rabies vaccine (Minhai Biothechnology Co., Ltd)Zagreb post-exposure immunization schedule at day 0,7,21. | Biological | Experimental 2 |
| Human diploid cell rabies vaccine (Chengdu Kanghua Biological Products Co., Ltd.)Essen post-exposure immunization schedule at day 0,3,7,14,28. | Biological | Positive Control |
Primary outcome
To evaluate immunogenicity after the first dose
Time frame: 14 days following the first dose
Percentage of participants with rabies virus neutralizing antibody concentration ≥0.5 IU/ml.
4 secondary outcomes
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
GMC of rabies virus neutralizing antibody
Time frame: day 7 and 14 post the first dose and day 14 post the last dose
Proportion of subjects reporting of adverse reaction and unsolicited adverse events
Time frame: from day 0 to day 28 post the last dose
Proportion of subjects with Serious Adverse Events occurring throughout the trial
Time frame: Day 0 up to month 12
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 3 Jun 2019.
- Derived from this study: PubMed 40188565Li G, Cao S, Xu B, Hu J, Zhang L, Shi L, Zhao D, Li Y, Liu Y, Liang Q, Wu X. Safety, immunogenicity and immune persistence of a lyophilized purified human diploid cells rabies vaccine following rabies PEP regimen Essen and Zagreb: A randomized, blinded controlled phase 3 trial in healthy participants aged 10-60 years old. Vaccine. 2025 Apr 19;53:127082. doi: 10.1016/j.vaccine.2025.127082. Epub 2025 Apr 5.
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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.
Yuemei Hu, Master principal investigator
Jiangsu Provincial Center for Diseases Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Human diploid cell rabies vaccine (Minhai Biothechnology Co., Ltd) and Human diploid cell rabies vaccine (Chengdu Kanghua Biological Products Co., Ltd.) in people with Adverse Effect and Immunogenicity of Vaccine, 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 19 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 3 Jun 2019. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To evaluate immunogenicity after the first dose (time frame: 14 days following the first dose). 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 NCT03971370, 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 3 Jun 2019.