RabiesPhase 3NCT05667974
A Study to Evaluate a PIKA Rabies Vaccine（Vero Cell）for Human Use,Freeze-dried
A Phase 3 study testing PIKA Rabies Vaccine (Vero Cell) for Human use, Freeze-dried and Chirorab in people with Rabies and Prevention, run by Yisheng Biopharma (Singapore) Pte. Ltd. at 7 sites in 2 countries.
Trial summary
This is a phase III, randomized, comparator-controlled, double-blind, multicenter study to evaluate lot-to-lot consistency of three lots of a PIKA Rabies Vaccine, immunogenicity and safety in healthy adults using a post-exposure prophylaxis schedule. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Rabies, Prevention
- What is being tested?
- PIKA Rabies Vaccine (Vero Cell) for Human use, Freeze-dried and Chirorab
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,500 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 22 Sep 2023to 21 Feb 2025
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Has completed the written informed consent process.
- For Singapore sites: age ≥21 and ≤ 65 years on Study Day 0; for other country sites: age ≥18 and ≤ 65 years on Screening.
- Healthy males and females.
- No history of rabies exposure, administration of rabies vaccination or rabies immunoglobulin.
- Agree to refrain from blood donation during the course of the study.
- Be able to commit to the vaccine schedule strictly.
- Has the ability and commitment to comply with requirements of the study, such as completion of diary cards, return for follow-up visits, accessible by phone and reside within the study area for the duration of study.
- For female subjects: agree to avoid pregnancy from Study Day 0 to Study Day 90 during the course of the study. Women physically capable of pregnancy (not sterilized and still menstruating or within 1 year of the last menses if menopausal) in sexual relationships with men must use an acceptable method of avoiding pregnancy during this period. Acceptable methods of avoiding pregnancy include a sterile sexual partner, sexual abstinence (not engaging in sexual intercourse), hormonal contraceptives (oral, injection, transdermal patch, or implant), vaginal ring, intrauterine device (IUD), or the combination of a condom or diaphragm with spermicide.
Who cannot join
- Pregnant and nursing female volunteers will be excluded from the study.
- Previous exposure to a suspect rabid animal within the last 12 months.
- Any subject who needs post-exposure prophylaxis against rabies.
- History of rabies infection or treatment (immunoglobulin or vaccine).
- History of previous rabies vaccination.
- History of hypersensitivity reaction to human immunoglobulin.
Show all 24Show fewer
- Received any vaccine in the past 30 days before randomization except for COVID 19 and flu vaccination.
- Received immunoglobulin or blood products within 90 days before randomization or plans to receive such products at any time during active period of the study (through Day 90).
- Received any investigational therapy (including vaccine) within 90 days before randomization, or planned participation in any other investigational study during the active study period (through Day 90).
- Used immunosuppressant medications in the past 180 days (defined as more than 14 continuous days before randomization or plans to receive any products during the active vaccination period (through Day 28). An immunosuppressant dose of a glucocorticoid will be defined as a systemic dose of ≥10mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted).
- At high risk for rabies infection during the trial: (such as veterinarians and their staff, animal handlers, rabies researchers, and certain laboratory workers, persons whose activities bring them into frequent contact with rabies virus or potentially rabid bats, raccoons, skunks, cats, dogs, or other species at risk for having rabies, people travelling where rabies is enzootic, previous bite by a rabid animal with no post-exposure treatment administered).
- History of HBV or HCV infection.
- History of any past, present, or future possible immunodeficiency state including but not limited to any laboratory indication of HIV-1 infection.
- History of treatment for depression or mental illness in the past 5 years; history of any attempt of suicide.
- Bleeding disorder, or receipt of anticoagulants in the past 21 days preceding inclusion, contraindicating IM vaccination based on Investigator's judgment.
- Donation of blood within the last 2 months or who have donated plasma within the last 14 days before Study Day 0.
- Clinical signs of encephalitis.
- History or evidence on physical examination of any systemic disease or any acute or chronic illness that, in the opinion of the investigator, may interfere with the evaluation of the safety or immunogenicity of the vaccine.
- History of neurological disorder, either congenital or acquired (e.g. seizures, meningitis, encephalitis, Guillain-Barre syndrome, dementia, vasculitis, hereditary CNS disorders).
- History of cancer (malignancy) in the past 10 years (exception is non-melanomatous skin CA).
- A history of alcohol or drug addiction in the past 2 years.
- History of hypersensitivity or serious reactions (eg. anaphylaxis, urticarial, other significant reaction) to previous vaccinations.
- Plans to permanently move from the catchment area during trial conduct.
- Concerns of compliance with protocol or social condition that makes the subject a poor candidate for the trial as determined by the PI.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Philippines4 sites
TDF-Lakeview，Muntinlupa
City of Muntinlupa
Las Pinas Doctor's Hospital
Las Piñas
PGH
Manila
TDF - San Pablo, Laguna
San Pablo
Pakistan3 sites
Al-Shifa Trust Eye Hospital
Islamabad
Ziauddin University
Karachi
Central Park Teaching Hospital
Lahore
About this study
Official title: A Phase III, Randomized, Comparator-Controlled, Double-Blind, Multicenter Study to Evaluate the Immunogenicity, Safety and Lot to Lot Consistency of Three Lots of a PIKA Rabies Vaccine（Vero Cell）for Human Use,Freeze-dried in Healthy Adults Using a Post-Exposure Prophylaxis Schedule
This is a phase III, randomized, comparator-controlled, double-blind, multicenter study to evaluate lot-to-lot consistency of three lots of a PIKA Rabies Vaccine, immunogenicity and safety in healthy adults using a post-exposure prophylaxis schedule. It is also the aim of this study to evaluate non-inferiority and superiority of the PIKA Rabies Vaccine compared to the rabies vaccine comparator ChiroRab.
Read the detailed description
This is a phase III, randomized, comparator-controlled, double-blind, multicenter study to evaluate lot-to-lot consistency of three lots of a PIKA Rabies Vaccine, immunogenicity and safety in healthy adults using a post-exposure prophylaxis schedule. It is also the aim of this study to evaluate non-inferiority and superiority of the PIKA Rabies Vaccine compared to the rabies vaccine comparator ChiroRab.
A total of 4,500 subjects will be enrolled in the study randomized into 2:1 with 3000 subjects allocated to PIKA rabies vaccine and 1,500 allocated to receive the comparator rabies vaccine ChiroRab . There will be two study Groups: Group 1 (20%) and Group 2 (80%).
Within each study group, subjects will be randomly allocated in a 2:2:2:3 ratios to receive 1 of the 3 lots of PIKA rabies vaccine or ChiroRab. The ChiroRab group will receive the classic Essen 5 dose regimen (1-1-1-1-1 schedule on Days 0, 3, 7, 14 and 28), whilst the PIKA rabies vaccine group will receive an accelerated regimen (2-2-1 schedule with a double-dose injection on Days 0 and 3 and a single-dose injection on Day 7). For blinding purposes, normal saline will be injected on Days 14 and 28 for PIKA rabies group and Days 0 and 3 for ChiroRab group.
Group 1 will enrol a total of 900 subjects, approximately 20% of the total sample population. Subjects will be randomized at 2:2:2:3 ratio (PIKA lot #1: 200 subjects, PIKA lot #2: 200 subjects, PIKA lot #3: 200 and 300 will be randomized to receive ChiroRab). Blood will be collected pre-vaccination (Day 0) and post-vaccination on Days 7, 14, 28, 90, 180 and 365 to evaluate the primary immunogenicity, safety and secondary immunogenicity endpoints. Subjects will be followed up for the whole study period through clinic visits or phone calls.
The first 50 participants randomized in each of the 3 PIKA lots and that for the ChiroRab in Goup 1 (200 in total) will form the safety subset and will have additional blood draw for safety laboratory parameters for CBC platelet, urinalysis, serum chemistry and coagulation on Day 0 (prior to vaccination), Day 7 and Day 28.
After completion of enrolment in Group 1, Group 2 will enrol the remaining 3,600 subjects at 2:2:2:3 randomization ratio (PIKA lot #1: 800 subjects, PIKA lot #2: 800 subjects, PIKA lot #3: 800 and 1,200 will be randomized to receive ChiroRab). Blood will be collected pre-vaccination on Day 0, 7 and 365 to evaluate key secondary immunogenicity endpoints of superiority, persistence and durability of immune response as well as co-primary safety objective. Subjects will be followed up for the whole study period through clinic visits or phone calls.
After each vaccination, all subjects will be observed in the clinical site for at least 30 minutes for immediate reactions and will be followed up for solicited AEs by diary cards 7 days post each vaccination and unsolicited AEs will be collected through Day 41 post first vaccination. All subjects will be monitored for SAEs, SUSARs, AESIs, and AEs leading to study withdrawal for the whole study period.
- Conditions
- Rabies, Prevention
- Being tested
- PIKA Rabies Vaccine (Vero Cell) for Human use, Freeze-dried, Chirorab
- Keywords
- Rabies, vaccine, prophylactic
- Medical subject headings
- Rabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIKA Rabies Vaccine (Vero Cell) for Human use, Freeze-driedBiological
PIKA rabies vaccine
ChirorabBiological
Active Comparator
| Study group | Role | What they receive |
|---|---|---|
| PIKA Rabies | Experimental | Receive 1 of the 3 lots of PIKA rabies vaccine via IM administration that 2-2-1 schedule with a double-dose injection on Day 0 and 3 and a single-dose injection on Day 7 Receives: Biological: PIKA Rabies Vaccine (Vero Cell) for Human use, Freeze-dried |
| Control | Active comparator | Receive ChiroRab via IM administration that the classic Essen 5-dose regimen 1-1-1-1-1 schedule on Days 0, 3, 7, 14 and 28 Receives: Biological: Chirorab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Immunogenicity
GMTs of rabies virus neutralizing antibodies (RVNA) at Day 14 to demonstrate lot-to-lot consistency in all subjects enrolled in Group 1
Measured: 14 days post-vaccination
Primary Immunogenicity
RVNA seroconversion rate differences at Day 14 in all subjects enrolled in Group 1.
Measured: 14 days post-vaccination
Co-primary Safety(solicited AEs)
Incidence of solicited local and systemic reactions on the day of each study vaccination
Measured: 7 days after each vaccination.
Co-primary Safety(unsolicited AEs)
Incidence of unsolicited adverse events
Measured: From day of first vaccination through 14 days after the last vaccination
Co-primary Safety(SAEs)
Incidence of serious adverse events (SAEs), suspected unexpected serious adverse reactions (SUSARs), adverse events of special interest (AESIs) and AEs leading to withdrawal
Measured: through study completion, an average of 1 year
Co-primary Safety
Incidence of significant changes in the clinical laboratory test results, vital signs and physical examination by study visits.
Measured: through study completion, an average of 1 year
Secondary outcomes (5)
Secondary Immunogenicity
RVNA seroconversion rate differences at Day 28 and Day 42 in all subjects enrolled in Group 1
Measured: Day 28 and Day 42
Secondary Immunogenicity
RVNA seroconversion rate differences at Day 7 in all subjects (Group 1 and Group 2)
Measured: Day 7
Secondary Immunogenicity
GMTs of rabies virus neutralizing antibodies (RVNA) on Day 14, 28 and 42(Group 1)
Measured: Day 14, 28 and 42
Secondary Immunogenicity
GMTs of rabies virus neutralizing antibodies (RVNA) on Day 90 and 180 for Group 1 only and Day 365 for all subjects (Group 1 and Group 2) subjects (Group 1 and Group 2).
Measured: Day 90 and 180 for Group 1 only and Day 365 for all subjects (Group 1 and Group 2).
Secondary Immunogenicity
RVNA seroconversion rate differences on Day 90 and 180 for Group 1 only and Day 365 for all subjects (Group 1 and Group 2)
Measured: Day 90 and 180 for Group 1 only and Day 365 for all subjects (Group 1 and Group 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2022
- Study start22 Sep 2023
- Primary completion22 Mar 2024
- Study completion21 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 4,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yisheng Biopharma (Singapore) Pte. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05667974
- Sponsor's protocol ID
- YS-002
- Status last verified
- Nov 2023
- First submitted
- 6 Dec 2022
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Comparator-Controlled, Double-Blind, Multicenter Study to Evaluate the Immunogenicity, Safety and Lot to Lot Consistency of Three Lots of a PIKA Rabies Vaccine（Vero Cell）for Human Use,Freeze-dried in Healthy Adults Using a Post-Exposure Prophylaxis Schedule
- ClinicalTrials.gov ID
- NCT05667974
- Acronym / sponsor ID
- YS-002
- Conditions
- Rabies, Prevention
- Keywords
- Rabies, vaccine, prophylactic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,500 participants (actual)
- Lead sponsor
- Yisheng Biopharma (Singapore) Pte. Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Sep 2023 (actual)
- Primary completion
- 22 Mar 2024 (actual)
- Study completion
- 21 Feb 2025 (estimated)
- First posted
- 29 Dec 2022 (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 is a phase III, randomized, comparator-controlled, double-blind, multicenter study to evaluate lot-to-lot consistency of three lots of a PIKA Rabies Vaccine, immunogenicity and safety in healthy adults using a post-exposure prophylaxis schedule. It is also the aim of this study to evaluate non-inferiority and superiority of the PIKA Rabies Vaccine compared to the rabies vaccine comparator ChiroRab.
Detailed description
This is a phase III, randomized, comparator-controlled, double-blind, multicenter study to evaluate lot-to-lot consistency of three lots of a PIKA Rabies Vaccine, immunogenicity and safety in healthy adults using a post-exposure prophylaxis schedule. It is also the aim of this study to evaluate non-inferiority and superiority of the PIKA Rabies Vaccine compared to the rabies vaccine comparator ChiroRab.
A total of 4,500 subjects will be enrolled in the study randomized into 2:1 with 3000 subjects allocated to PIKA rabies vaccine and 1,500 allocated to receive the comparator rabies vaccine ChiroRab . There will be two study Groups: Group 1 (20%) and Group 2 (80%).
Within each study group, subjects will be randomly allocated in a 2:2:2:3 ratios to receive 1 of the 3 lots of PIKA rabies vaccine or ChiroRab. The ChiroRab group will receive the classic Essen 5 dose regimen (1-1-1-1-1 schedule on Days 0, 3, 7, 14 and 28), whilst the PIKA rabies vaccine group will receive an accelerated regimen (2-2-1 schedule with a double-dose injection on Days 0 and 3 and a single-dose injection on Day 7). For blinding purposes, normal saline will be injected on Days 14 and 28 for PIKA rabies group and Days 0 and 3 for ChiroRab group.
Group 1 will enrol a total of 900 subjects, approximately 20% of the total sample population. Subjects will be randomized at 2:2:2:3 ratio (PIKA lot #1: 200 subjects, PIKA lot #2: 200 subjects, PIKA lot #3: 200 and 300 will be randomized to receive ChiroRab). Blood will be collected pre-vaccination (Day 0) and post-vaccination on Days 7, 14, 28, 90, 180 and 365 to evaluate the primary immunogenicity, safety and secondary immunogenicity endpoints. Subjects will be followed up for the whole study period through clinic visits or phone calls.
The first 50 participants randomized in each of the 3 PIKA lots and that for the ChiroRab in Goup 1 (200 in total) will form the safety subset and will have additional blood draw for safety laboratory parameters for CBC platelet, urinalysis, serum chemistry and coagulation on Day 0 (prior to vaccination), Day 7 and Day 28.
After completion of enrolment in Group 1, Group 2 will enrol the remaining 3,600 subjects at 2:2:2:3 randomization ratio (PIKA lot #1: 800 subjects, PIKA lot #2: 800 subjects, PIKA lot #3: 800 and 1,200 will be randomized to receive ChiroRab). Blood will be collected pre-vaccination on Day 0, 7 and 365 to evaluate key secondary immunogenicity endpoints of superiority, persistence and durability of immune response as well as co-primary safety objective. Subjects will be followed up for the whole study period through clinic visits or phone calls.
After each vaccination, all subjects will be observed in the clinical site for at least 30 minutes for immediate reactions and will be followed up for solicited AEs by diary cards 7 days post each vaccination and unsolicited AEs will be collected through Day 41 post first vaccination. All subjects will be monitored for SAEs, SUSARs, AESIs, and AEs leading to study withdrawal for the whole study period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PIKA Rabies | Experimental | Biological: PIKA Rabies Vaccine (Vero Cell) for Human use, Freeze-driedReceive 1 of the 3 lots of PIKA rabies vaccine via IM administration that 2-2-1 schedule with a double-dose injection on Day 0 and 3 and a single-dose injection on Day 7 |
| Control | Active comparator | Biological: ChirorabReceive ChiroRab via IM administration that the classic Essen 5-dose regimen 1-1-1-1-1 schedule on Days 0, 3, 7, 14 and 28 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Has completed the written informed consent process.
- For Singapore sites: age ≥21 and ≤ 65 years on Study Day 0; for other country sites: age ≥18 and ≤ 65 years on Screening.
- Healthy males and females.
- No history of rabies exposure, administration of rabies vaccination or rabies immunoglobulin.
- Agree to refrain from blood donation during the course of the study.
Key exclusion criteria (24 listed)
- Pregnant and nursing female volunteers will be excluded from the study.
- Previous exposure to a suspect rabid animal within the last 12 months.
- Any subject who needs post-exposure prophylaxis against rabies.
- History of rabies infection or treatment (immunoglobulin or vaccine).
- History of previous rabies 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 |
|---|---|---|
| PIKA Rabies Vaccine (Vero Cell) for Human use, Freeze-driedPIKA rabies vaccine | Biological | PIKA Rabies |
| ChirorabActive Comparator | Biological | Control |
Primary outcome
Primary Immunogenicity
Time frame: 14 days post-vaccination
GMTs of rabies virus neutralizing antibodies (RVNA) at Day 14 to demonstrate lot-to-lot consistency in all subjects enrolled in Group 1
Primary Immunogenicity
Time frame: 14 days post-vaccination
RVNA seroconversion rate differences at Day 14 in all subjects enrolled in Group 1.
Co-primary Safety(solicited AEs)
Time frame: 7 days after each vaccination.
Incidence of solicited local and systemic reactions on the day of each study vaccination
Co-primary Safety(unsolicited AEs)
Time frame: From day of first vaccination through 14 days after the last vaccination
Incidence of unsolicited adverse events
Co-primary Safety(SAEs)
Time frame: through study completion, an average of 1 year
Incidence of serious adverse events (SAEs), suspected unexpected serious adverse reactions (SUSARs), adverse events of special interest (AESIs) and AEs leading to withdrawal
Co-primary Safety
Time frame: through study completion, an average of 1 year
Incidence of significant changes in the clinical laboratory test results, vital signs and physical examination by study visits.
5 secondary outcomes
Secondary Immunogenicity
Time frame: Day 28 and Day 42
Secondary Immunogenicity
Time frame: Day 7
Secondary Immunogenicity
Time frame: Day 14, 28 and 42
Secondary Immunogenicity
Time frame: Day 90 and 180 for Group 1 only and Day 365 for all subjects (Group 1 and Group 2).
Secondary Immunogenicity
Time frame: Day 90 and 180 for Group 1 only and Day 365 for all subjects (Group 1 and Group 2)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PIKA Rabies Vaccine (Vero Cell) for Human use, Freeze-dried and Chirorab in people with Rabies and Prevention, run by Yisheng Biopharma (Singapore) Pte. Ltd. at 7 sites in 2 countries.
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 8 inclusion and 24 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 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Philippines, Pakistan. 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?
Primary Immunogenicity (time frame: 14 days post-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?
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 23 Jul 2024.