Rabies Vaccine Adverse ReactionPhase 3NCT04852068
A Clinical Trial of Freeze-dried Human Rabies Vaccine (Vero Cells)
A Phase 3 study testing Freeze-dried human rabies vaccine (Vero cells) Zhifeilongkoma - 5-dose program, Freeze-dried human rabies vaccine (Vero cells) Zhifeilongkoma - 4-dose program and Freeze-dried human rabies vaccine (Vero cells) Chengda - 5-dose program in people with Rabies Vaccine Adverse Reaction and Safety and Efficacy, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. at 1 site in China.
Trial summary
This clinical trial is carried out in two phases. The first phase adopts an open design, and the second phase adopts a randomized, blinded, and similar vaccine-controlled non-inferiority trial design. Read more about this study
- Who is it for?
- Ages 10 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Rabies Vaccine Adverse Reaction, Safety and Efficacy
- What is being tested?
- Freeze-dried human rabies vaccine (Vero cells) Zhifeilongkoma - 5-dose program, Freeze-dried human rabies vaccine (Vero cells) Zhifeilongkoma - 4-dose program and Freeze-dried human rabies vaccine (Vero cells) Chengda - 5-dose program
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,480 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2021to 30 Oct 2024
- 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
- Age 10-60 on the day of enrollment, able to provide legal identification
- Subjects and/or their guardians voluntarily agree to participate in the study and sign an adult informed consent form or a minor's informed consent form
- Subjects and/or their legal guardians have the ability to understand (non-illiterate) research procedures and participate in all planned follow-ups
- On the day of enrollment, the axillary body temperature of people aged 14 and under was <37.5℃, and the axillary body temperature of people over 14 years of age was <37.3℃
- Female subjects of childbearing age were not breast-feeding at the time of enrollment, were not pregnant (the urine pregnancy test was negative before vaccination (on the day)), had no pregnancy plan within 2 months after enrollment, and agreed to take effective measures within 2 months after enrolling in the study Contraceptive measures
Who cannot join
- Have a history of rabies vaccination or use of rabies virus passive immunization preparations
- A history of bites by mammals (such as dogs, cats, etc.) within 1 year before the first dose of vaccination (wound skin damage)
- Previous vaccination has a history of severe allergies to any vaccine component that requires medical intervention: such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis, severe urticaria, etc.
- Within 3 days before vaccination, acute febrile disease (body temperature under armpit>38.5℃) or in the acute onset of chronic disease, or taking antipyretic, analgesic, and anti-allergic drugs
- Have received blood/blood-related products or immunoglobulins within 3 months before the first dose of vaccination; or plan to use such products within 1 month after the last dose of vaccination
- Get any vaccine within 14 days before the first dose of vaccination
Show all 13Show fewer
- Any condition (such as splenectomy) caused asplenia or functional asplenia
- Has been diagnosed with congenital or acquired immunodeficiency (HIV), or received immunosuppressive therapy within 3 months
- Severe congenital malformations or autoimmune (hereditary) diseases, serious chronic diseases (including but not limited to: heart disease, kidney disease, diabetes with comorbidities, allergic constitution, Guillain-Barre syndrome, etc.), evaluated by the investigator that it may affect research evaluation
- People with a history or family history of convulsions, epilepsy, encephalopathy, and psychosis (including but not limited to: congenital brain hypoplasia, brain trauma, brain tumor, cerebral hemorrhage, cerebral obstruction, brain nerve tissue damage caused by infection, chemical drug poisoning, etc.)
- There are contraindications for intramuscular injection (diagnosed as any coagulation disorder or receiving anticoagulant treatment)
- Are participating in other research or unregistered products (drugs, vaccines or devices, etc.) clinical research, or plan to participate in other clinical research before the end of this clinical research
- The researcher believes that the subject has any conditions that may interfere with the evaluation of the research purpose
Trial locations and contacts
1 site in 1 country.
China1 site
Hunan Provincial Center for Disease Control and Prevention
Changsha, Hunan, 410005
About this study
Official title: A Randomized, Blinded, and Similar Vaccine-controlled Phase III Clinical Trial to Evaluate the Immunogenicity and Safety of the 5-dose Program and 4-dose (2-1-1) Program of Freeze-dried Human Rabies Vaccine (Vero Cells)
This clinical trial is carried out in two phases. The first phase adopts an open design, and the second phase adopts a randomized, blinded, and similar vaccine-controlled non-inferiority trial design.
The first stage: According to the order of two age groups of 18-60 years old and 10-17 years old, 40 cases were enrolled in each age group (20 persons for the 5-dose program and 20 for the 4-dose program). Subjects in the 5-dose group received 1 dose of test vaccine on 0, 3, 7, 14, and 28 days each. Subjects in the 4-dose group received 1 dose each on both arms on day 0, and 1 dose on day 7 and day 21 each. All subjects in the first stage were only observed for safety and were followed up to 6 months after the entire course of vaccination.
Read more
The second stage: the total number of enrolled 2400 cases, 10-60 years old, the 4-dose program group and the 5-dose program group of the test vaccine, the 4-dose program group and the 5-dose program group of the control vaccine according to the random ratio 1:1:1:1. Among the total number of participants, 1680 cases (420 cases per group) were simultaneously observed for immunogenicity and safety, and the remaining 720 subjects (180 cases per group) only underwent safety observation. 800 subjects (200 cases in each group) received 6-month immune persistence observation after full vaccination, and 400 subjects in the test vaccine group received 12 months immune persistence observation after full vaccination.
In the second stage, 1680 subjects were collected before the immunization, 7 days after the first dose, 14 days after the first dose, and 14 days after the full vaccination to test rabies virus antibodies to evaluate the immunogenicity of the test vaccine. 800 subjects were in the whole process Immune persistent blood sampling was performed 6 months after vaccination, and subjects in the test vaccine group were further subjected to immune persistent blood sampling 12 months after the full course of vaccination to evaluate immune durability. Collect all AEs within 30 minutes after each dose, AEs from 0-7 days, all non-collective AEs from the first dose to 30 days after the full course of vaccination, and all serious AEs from the first dose to 6 months after the full course of vaccination Adverse events.
- Being tested
- Freeze-dried human rabies vaccine (Vero cells) Zhifeilongkoma - 5-dose program, Freeze-dried human rabies vaccine (Vero cells) Zhifeilongkoma - 4-dose program, Freeze-dried human rabies vaccine (Vero cells) Chengda - 5-dose program, Freeze-dried human rabies vaccine (Vero cells) Chengda - 4-dose program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freeze-dried human rabies vaccine (Vero cells) Zhifeilongkoma - 5-dose programBiological
Inoculate 1 dose of Investigational vaccine each on 0, 3, 7, 14, 28 days, by intramuscular injection of deltoid muscle of upper arm
Freeze-dried human rabies vaccine (Vero cells) Zhifeilongkoma - 4-dose programBiological
Inoculate 1 dose of Investigational vaccine each on both arms on day 0, and 1 dose each on day 7 and 21, by intramuscular injection of deltoid muscle of upper arm
Freeze-dried human rabies vaccine (Vero cells) Chengda - 5-dose programBiological
Inoculate 1 dose of control vaccine each on 0, 3, 7, 14, 28 days, by intramuscular injection of deltoid muscle of upper arm
Freeze-dried human rabies vaccine (Vero cells) Chengda - 4-dose programBiological
Inoculate 1 dose of control vaccine each on both arms on day 0, and 1 dose each on day 7 and 21, by intramuscular injection of deltoid muscle of upper arm
| Study group | Role | What they receive |
|---|---|---|
| Investigational Vaccine - 5-dose program | Experimental | Freeze-dried human rabies vaccine (Vero cells), 0.5ml after reconstitution, with a titer of not less than 2.5IU, Anhui Zhifeilongkoma Biopharmaceutical Co., Ltd. Receives: Biological: Freeze-dried human rabies vaccine (Vero cells) Zhifeilongkoma - 5-dose program |
| Investigational Vaccine - 4-dose program | Experimental | Freeze-dried human rabies vaccine (Vero cells), 0.5ml after reconstitution, with a titer of not less than 2.5IU, Anhui Zhifeilongkoma Biopharmaceutical Co., Ltd. Receives: Biological: Freeze-dried human rabies vaccine (Vero cells) Zhifeilongkoma - 4-dose program |
| Control vaccine - 5-dose program | Active comparator | Freeze-dried human rabies vaccine (Vero cells), 0.5ml after reconstitution, titer not less than 2.5IU, Liaoning Chengda Biological Co., Ltd. Receives: Biological: Freeze-dried human rabies vaccine (Vero cells) Chengda - 5-dose program |
| Control vaccine - 4-dose program | Active comparator | Freeze-dried human rabies vaccine (Vero cells), 0.5ml after reconstitution, titer not less than 2.5IU, Liaoning Chengda Biological Co., Ltd. Receives: Biological: Freeze-dried human rabies vaccine (Vero cells) Chengda - 4-dose program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody positive conversion rate - Immunogenicity endpoint
Antibody positive conversion rate of the test group and the control group of the pre-immune antibody-negative population
Measured: 14 days after the first dose of vaccination
Geometric mean concentration - Immunogenicity endpoint
Geometric mean concentration of the test group and the control group of the pre-immune antibody-negative population
Measured: 14 days after the first dose of vaccination
Incidence of Adverse Events [Safety and Tolerability]
Incidence of Adverse Events
Measured: within 30 minutes after each dose of vaccination; the first dose of vaccination to 30 days after the full course of vaccination
Incidence of Serious Adverse Events [Safety and Tolerability]
Incidence of Serious Adverse Events
Measured: The first dose of vaccination to 6 months after the full course of vaccination
Secondary outcomes (2)
Antibody positive conversion rate - Immunogenicity endpoint
Antibody positive conversion rate
Measured: 7 days after the first dose of vaccination; 14 days, 6 months, 12 months after the full vaccination
Geometric mean concentration - Immunogenicity endpoint
Geometric mean concentration
Measured: 7 days after the first dose of vaccination; 14 days, 6 months, 12 months after the full vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start10 Apr 2021
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rabies Vaccine Adverse ReactionStudies 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
- Model description
- Similar vaccine control
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04852068
- Sponsor's protocol ID
- LKM-2020-Rab01
- Status last verified
- Nov 2023
- First submitted
- 12 Apr 2021
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blinded, and Similar Vaccine-controlled Phase III Clinical Trial to Evaluate the Immunogenicity and Safety of the 5-dose Program and 4-dose (2-1-1) Program of Freeze-dried Human Rabies Vaccine (Vero Cells)
- ClinicalTrials.gov ID
- NCT04852068
- Acronym / sponsor ID
- LKM-2020-Rab01
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,480 participants (estimated)
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Apr 2021 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 21 Apr 2021 (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.
This clinical trial is carried out in two phases. The first phase adopts an open design, and the second phase adopts a randomized, blinded, and similar vaccine-controlled non-inferiority trial design.
The first stage: According to the order of two age groups of 18-60 years old and 10-17 years old, 40 cases were enrolled in each age group (20 persons for the 5-dose program and 20 for the 4-dose program). Subjects in the 5-dose group received 1 dose of test vaccine on 0, 3, 7, 14, and 28 days each. Subjects in the 4-dose group received 1 dose each on both arms on day 0, and 1 dose on day 7 and day 21 each. All subjects in the first stage were only observed for safety and were followed up to 6 months after the entire course of vaccination.
The second stage: the total number of enrolled 2400 cases, 10-60 years old, the 4-dose program group and the 5-dose program group of the test vaccine, the 4-dose program group and the 5-dose program group of the control vaccine according to the random ratio 1:1:1:1. Among the total number of participants, 1680 cases (420 cases per group) were simultaneously observed for immunogenicity and safety, and the remaining 720 subjects (180 cases per group) only underwent safety observation. 800 subjects (200 cases in each group) received 6-month immune persistence observation after full vaccination, and 400 subjects in the test vaccine group received 12 months immune persistence observation after full vaccination.
In the second stage, 1680 subjects were collected before the immunization, 7 days after the first dose, 14 days after the first dose, and 14 days after the full vaccination to test rabies virus antibodies to evaluate the immunogenicity of the test vaccine. 800 subjects were in the whole process Immune persistent blood sampling was performed 6 months after vaccination, and subjects in the test vaccine group were further subjected to immune persistent blood sampling 12 months after the full course of vaccination to evaluate immune durability. Collect all AEs within 30 minutes after each dose, AEs from 0-7 days, all non-collective AEs from the first dose to 30 days after the full course of vaccination, and all serious AEs from the first dose to 6 months after the full course of vaccination Adverse events.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Similar vaccine control
| Arm | Type | Receives |
|---|---|---|
| Investigational Vaccine - 5-dose program | Experimental | Biological: Freeze-dried human rabies vaccine (Vero cells) Zhifeilongkoma - 5-dose programFreeze-dried human rabies vaccine (Vero cells), 0.5ml after reconstitution, with a titer of not less than 2.5IU, Anhui Zhifeilongkoma Biopharmaceutical Co., Ltd. |
| Investigational Vaccine - 4-dose program | Experimental | Biological: Freeze-dried human rabies vaccine (Vero cells) Zhifeilongkoma - 4-dose programFreeze-dried human rabies vaccine (Vero cells), 0.5ml after reconstitution, with a titer of not less than 2.5IU, Anhui Zhifeilongkoma Biopharmaceutical Co., Ltd. |
| Control vaccine - 5-dose program | Active comparator | Biological: Freeze-dried human rabies vaccine (Vero cells) Chengda - 5-dose programFreeze-dried human rabies vaccine (Vero cells), 0.5ml after reconstitution, titer not less than 2.5IU, Liaoning Chengda Biological Co., Ltd. |
| Control vaccine - 4-dose program | Active comparator | Biological: Freeze-dried human rabies vaccine (Vero cells) Chengda - 4-dose programFreeze-dried human rabies vaccine (Vero cells), 0.5ml after reconstitution, titer not less than 2.5IU, Liaoning Chengda Biological Co., Ltd. |
Who may qualify
- Ages
- 10 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age 10-60 on the day of enrollment, able to provide legal identification
- Subjects and/or their guardians voluntarily agree to participate in the study and sign an adult informed consent form or a minor's informed consent form
- Subjects and/or their legal guardians have the ability to understand (non-illiterate) research procedures and participate in all planned follow-ups
- On the day of enrollment, the axillary body temperature of people aged 14 and under was <37.5℃, and the axillary body temperature of people over 14 years of age was <37.3℃
- Female subjects of childbearing age were not breast-feeding at the time of enrollment, were not pregnant (the urine pregnancy test was negative before vaccination (on the day)), had no pregnancy plan within 2 months after enrollment, and agreed to take effective measures within 2 months after enrolling in the study Contraceptive measures
Key exclusion criteria (13 listed)
- Have a history of rabies vaccination or use of rabies virus passive immunization preparations
- A history of bites by mammals (such as dogs, cats, etc.) within 1 year before the first dose of vaccination (wound skin damage)
- Previous vaccination has a history of severe allergies to any vaccine component that requires medical intervention: such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis, severe urticaria, etc.
- Within 3 days before vaccination, acute febrile disease (body temperature under armpit>38.5℃) or in the acute onset of chronic disease, or taking antipyretic, analgesic, and anti-allergic drugs
- Have received blood/blood-related products or immunoglobulins within 3 months before the first dose of vaccination; or plan to use such products within 1 month after the last dose of vaccination
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 |
|---|---|---|
| Freeze-dried human rabies vaccine (Vero cells) Zhifeilongkoma - 5-dose programInoculate 1 dose of Investigational vaccine each on 0, 3, 7, 14, 28 days, by intramuscular injection of deltoid muscle of upper arm | Biological | Investigational Vaccine - 5-dose program |
| Freeze-dried human rabies vaccine (Vero cells) Zhifeilongkoma - 4-dose programInoculate 1 dose of Investigational vaccine each on both arms on day 0, and 1 dose each on day 7 and 21, by intramuscular injection of deltoid muscle of upper arm | Biological | Investigational Vaccine - 4-dose program |
| Freeze-dried human rabies vaccine (Vero cells) Chengda - 5-dose programInoculate 1 dose of control vaccine each on 0, 3, 7, 14, 28 days, by intramuscular injection of deltoid muscle of upper arm | Biological | Control vaccine - 5-dose program |
| Freeze-dried human rabies vaccine (Vero cells) Chengda - 4-dose programInoculate 1 dose of control vaccine each on both arms on day 0, and 1 dose each on day 7 and 21, by intramuscular injection of deltoid muscle of upper arm | Biological | Control vaccine - 4-dose program |
Primary outcome
Antibody positive conversion rate - Immunogenicity endpoint
Time frame: 14 days after the first dose of vaccination
Antibody positive conversion rate of the test group and the control group of the pre-immune antibody-negative population
Geometric mean concentration - Immunogenicity endpoint
Time frame: 14 days after the first dose of vaccination
Geometric mean concentration of the test group and the control group of the pre-immune antibody-negative population
Incidence of Adverse Events [Safety and Tolerability]
Time frame: within 30 minutes after each dose of vaccination; the first dose of vaccination to 30 days after the full course of vaccination
Incidence of Adverse Events
Incidence of Serious Adverse Events [Safety and Tolerability]
Time frame: The first dose of vaccination to 6 months after the full course of vaccination
Incidence of Serious Adverse Events
2 secondary outcomes
Antibody positive conversion rate - Immunogenicity endpoint
Time frame: 7 days after the first dose of vaccination; 14 days, 6 months, 12 months after the full vaccination
Geometric mean concentration - Immunogenicity endpoint
Time frame: 7 days after the first dose of vaccination; 14 days, 6 months, 12 months after the full vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Individual participant dataSharing planned: No
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 Phase 3 study testing Freeze-dried human rabies vaccine (Vero cells) Zhifeilongkoma - 5-dose program, Freeze-dried human rabies vaccine (Vero cells) Zhifeilongkoma - 4-dose program and Freeze-dried human rabies vaccine (Vero cells) Chengda - 5-dose program in people with Rabies Vaccine Adverse Reaction and Safety and Efficacy, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. 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 5 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 24 Nov 2023. 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?
Results are not available in the source record.
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?
Antibody positive conversion rate - Immunogenicity endpoint (time frame: 14 days after the first dose of vaccination). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Nov 2023.