RabiesPhase 2NCT02956421
Efficacy and Safety of a PIKA Rabies Vaccine Containing the PIKA Adjuvant With an Accelerated Regimen
A Phase 2 study testing RABIPUR® and PIKA rabies vaccine in people with Rabies, run by Yisheng Biopharma (Singapore) Pte. Ltd. at 2 sites in Singapore.
Trial summary
Phase II clinical study for an investigational PIKA(Polyinosinic Polycytidylic Acid Based Adjuvant) rabies vaccine comprising Inactivated and Purified Rabies Virus (IPRV) and the PIKA adjuvant. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Rabies
- What is being tested?
- RABIPUR® and PIKA rabies vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 2 sitesSingapore
- Study dates
- Feb 2016to Oct 2016
- Phase
- Phase 2
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informed consent form has been signed and dated
- Able to attend all scheduled visits and comply with all trial procedures.
- Never received rabies vaccine before.
- Refrain from blood donation during the course of the study.
- Able to attend all scheduled visits and comply with all trial procedures.
Who cannot join
- For women who are pregnant and breast-feeding
- Previous vaccination against rabies (in pre- or post-exposure regimen) with either the trial vaccine or another vaccine
- History of allergies to the medicine (S), convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction
- Known bleeding disorder or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth
- Participation in any other interventional clinical trial
- Donation of blood within the last 2 months or who have donated plasma within the last 14 days
Show all 17Show fewer
- Patient with clinical signs of encephalitis
- Recipient of any vaccine in the 4 weeks preceding the first trial vaccination, except for influenza vaccination
- Planned participation in another clinical trial during the present trial period
- Concomitant use or at high probability of expected concomitant use during the planned study of medication such as immune suppressants, steroids, non-study vaccine or similar substances
- Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Administration of immunoglobulins and/or any blood products within 3 months prior to the first dose of study vaccine or planned administration during the study period.
- History of allergic disease or reactions likely to be exacerbated by any component of the study vaccines.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- Uncontrolled acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history or physical examination.
- Chronic administration of immuno-suppressants or other immune-modifying drugs within 3 months prior to the first vaccine dose.
- Clinical Manifestation of Metabolic, blood system, lungs, heart, the gastrointestinal tract, nervous system, kidneys, urinary system, endocrine, liver disease or malignant tumor
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites
SingHealth Investigational Medicine Unit
Singapore, Singapore, 169608
Clinical Trials & Research Unit
Singapore, Singapore, 529889
About this study
Official title: Phase II Study to Determine the Efficacy and Safety of PIKA Rabies Vaccine Containing the PIKA Adjuvant With an Accelerated Regimen
Phase II clinical study for an investigational PIKA(Polyinosinic Polycytidylic Acid Based Adjuvant) rabies vaccine comprising Inactivated and Purified Rabies Virus (IPRV) and the PIKA adjuvant. The primary objective of the study is to evaluate the efficacy and safety profile of the vaccine composition in healthy adult volunteers under the accelerated regimen. The secondary objective is to achieve higher seroconversion of the vaccine under accelerated regimen at Day 7.
Read the detailed description
A multi-center, open labelled, randomized study in healthy naïve adult subjects. Subjects were randomly assigned to groups A (60) and B (60). Group A as a control arm of the study, had received a commercially available rabies vaccine, RABIPUR®. Group B had received doses of the investigational PIKA rabies vaccine in an accelerated regimen.
Group A followed the vaccine regimen of (1-1-1-1),one injection on days 0, 3, 7 and 14 was administered respectively. Group B received the accelerated regimen (2-2-1), two injections on both days 0 and 3 were administered in different arms; and only one injection was administered on day 7.
Each vaccine dose comprise 1.0 ml of PIKA rabies vaccine for Group B and 1.0 ml of RABIPUR® for Group A after reconstitution. The route of administration is intramuscular injection, given in the deltoid region of the arm.
- Conditions
- Rabies
- Being tested
- RABIPUR®, PIKA rabies vaccine
- Medical subject headings
- Rabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RABIPUR®Biological
Biological rabies vaccine
PIKA rabies vaccineBiological
Also called PIKA rabies vaccine with PIKA adjuvant
Biological rabies vaccine
| Study group | Role | What they receive |
|---|---|---|
| RABIPUR® | Active comparator | Comparator vaccine RABIPUR® Healthy volunteers received rabies vaccination intramuscularly on days 0,3,7 and 14 Receives: Biological: RABIPUR® |
| PIKA Rabies vaccine | Experimental | PIKA Rabies vaccine with an accelerated regimen Healthy volunteers received rabies vaccination intramuscularly on days 0 (2 Doses), 3 (2 Doses), and day 7 (1 Dose) Receives: Biological: PIKA rabies vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Titer level of Rabies Virus Neutralizing Antibody (RVNA) from serum at accelerated regimen
Evaluation of the accelerated regimen is studied to check if the levels of anti-rabies antibodies (serum RVNA titer) will be better than a classic course with control commercialized vaccine.
Measured: 42 days
Identification of any adverse events for all the treatment groups
Assessment of safety based on the identification of any adverse events for all the treatment groups, Group A, Group B and Group C through to the end of the study at day 42.
Measured: 42 days
Secondary outcomes (1)
Number of subjects in Group B who has higher RVNA titre level on Day 7 when compared to classic course.
To analyze the titer level of RVNA from serum at day 7 after the first injection and with RVNA titer meeting the 0.5 IU(International units) /ml World Health Organization (WHO) requirement
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2016 (estimated)
- Study startFeb 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yisheng Biopharma (Singapore) Pte. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Limin Wijaya, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02956421
- Sponsor's protocol ID
- RV001-II
- Status last verified
- Nov 2016
- First submitted
- 3 Nov 2016
- Last updated
- 8 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Yu P, Liu Y, Tao X, He Y, Liu Q, Wang B, Zheng H, Zhang N, Bi S, Zhu W, Zhang Y. Potential option for rabies post-exposure prophylaxis: New vaccine with PIKA adjuvant against diverse Chinese rabies strains. Vaccine. 2023 Nov 2;41(46):6852-6862. doi: 10.1016/j.vaccine.2023.10.001. Epub 2023 Oct 9.
PubMed 37821317Kalimuddin S, Wijaya L, Chan YFZ, Wong AWL, Oh HML, Wang LF, Kassim JA, Zhao J, Shi Z, Low JG. A phase II randomized study to determine the safety and immunogenicity of the novel PIKA rabies vaccine containing the PIKA adjuvant using an accelerated regimen. Vaccine. 2017 Dec 18;35(51):7127-7132. doi: 10.1016/j.vaccine.2017.10.097. Epub 2017 Nov 22.
PubMed 29174316
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study to Determine the Efficacy and Safety of PIKA Rabies Vaccine Containing the PIKA Adjuvant With an Accelerated Regimen
- ClinicalTrials.gov ID
- NCT02956421
- Acronym / sponsor ID
- RV001-II
- Conditions
- Rabies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Yisheng Biopharma (Singapore) Pte. Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 7 Nov 2016 (estimated)
- 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.
Phase II clinical study for an investigational PIKA(Polyinosinic Polycytidylic Acid Based Adjuvant) rabies vaccine comprising Inactivated and Purified Rabies Virus (IPRV) and the PIKA adjuvant. The primary objective of the study is to evaluate the efficacy and safety profile of the vaccine composition in healthy adult volunteers under the accelerated regimen. The secondary objective is to achieve higher seroconversion of the vaccine under accelerated regimen at Day 7.
Detailed description
A multi-center, open labelled, randomized study in healthy naïve adult subjects. Subjects were randomly assigned to groups A (60) and B (60). Group A as a control arm of the study, had received a commercially available rabies vaccine, RABIPUR®. Group B had received doses of the investigational PIKA rabies vaccine in an accelerated regimen.
Group A followed the vaccine regimen of (1-1-1-1),one injection on days 0, 3, 7 and 14 was administered respectively. Group B received the accelerated regimen (2-2-1), two injections on both days 0 and 3 were administered in different arms; and only one injection was administered on day 7.
Each vaccine dose comprise 1.0 ml of PIKA rabies vaccine for Group B and 1.0 ml of RABIPUR® for Group A after reconstitution. The route of administration is intramuscular injection, given in the deltoid region of the arm.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RABIPUR® | Active comparator | Biological: RABIPUR®Comparator vaccine RABIPUR® Healthy volunteers received rabies vaccination intramuscularly on days 0,3,7 and 14 |
| PIKA Rabies vaccine | Experimental | Biological: PIKA rabies vaccinePIKA Rabies vaccine with an accelerated regimen Healthy volunteers received rabies vaccination intramuscularly on days 0 (2 Doses), 3 (2 Doses), and day 7 (1 Dose) |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed consent form has been signed and dated
- Able to attend all scheduled visits and comply with all trial procedures.
- Never received rabies vaccine before.
- Refrain from blood donation during the course of the study.
- Able to attend all scheduled visits and comply with all trial procedures.
Key exclusion criteria (17 listed)
- For women who are pregnant and breast-feeding
- Previous vaccination against rabies (in pre- or post-exposure regimen) with either the trial vaccine or another vaccine
- History of allergies to the medicine (S), convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction
- Known bleeding disorder or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth
- Participation in any other interventional clinical trial
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 |
|---|---|---|
| RABIPUR®Biological rabies vaccine | Biological | RABIPUR® |
| PIKA rabies vaccineAlso: PIKA rabies vaccine with PIKA adjuvantBiological rabies vaccine | Biological | PIKA Rabies vaccine |
Primary outcome
Titer level of Rabies Virus Neutralizing Antibody (RVNA) from serum at accelerated regimen
Time frame: 42 days
Evaluation of the accelerated regimen is studied to check if the levels of anti-rabies antibodies (serum RVNA titer) will be better than a classic course with control commercialized vaccine.
Identification of any adverse events for all the treatment groups
Time frame: 42 days
Assessment of safety based on the identification of any adverse events for all the treatment groups, Group A, Group B and Group C through to the end of the study at day 42.
1 secondary outcome
Number of subjects in Group B who has higher RVNA titre level on Day 7 when compared to classic course.
Time frame: Day 7
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 8 Nov 2016.
- Derived from this study: PubMed 37821317Yu P, Liu Y, Tao X, He Y, Liu Q, Wang B, Zheng H, Zhang N, Bi S, Zhu W, Zhang Y. Potential option for rabies post-exposure prophylaxis: New vaccine with PIKA adjuvant against diverse Chinese rabies strains. Vaccine. 2023 Nov 2;41(46):6852-6862. doi: 10.1016/j.vaccine.2023.10.001. Epub 2023 Oct 9.
- Derived from this study: PubMed 29174316Kalimuddin S, Wijaya L, Chan YFZ, Wong AWL, Oh HML, Wang LF, Kassim JA, Zhao J, Shi Z, Low JG. A phase II randomized study to determine the safety and immunogenicity of the novel PIKA rabies vaccine containing the PIKA adjuvant using an accelerated regimen. Vaccine. 2017 Dec 18;35(51):7127-7132. doi: 10.1016/j.vaccine.2017.10.097. Epub 2017 Nov 22.
- Individual participant dataSharing planned: No
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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.
Limin Wijaya principal investigator
Singapore General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RABIPUR® and PIKA rabies vaccine in people with Rabies, run by Yisheng Biopharma (Singapore) Pte. Ltd. at 2 sites in Singapore.
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 17 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 8 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Titer level of Rabies Virus Neutralizing Antibody (RVNA) from serum at accelerated regimen (time frame: 42 days). The study lists 2 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 NCT02956421, which also lists 2 linked publications.
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 8 Nov 2016.