RabiesPhase 1NCT02657161
Safety and Efficacy of a PIKA Rabies Vaccine Containing the PIKA Adjuvant
A Phase 1 study testing RABIPUR®, PIKA rabies vaccine and PIKA rabies vaccine with an accelerated regimen in people with Rabies, run by Yisheng Biopharma (Singapore) Pte. Ltd. at 1 site in Singapore.
Trial summary
Phase I 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 was to assess the clinical safety of the vaccine composition in healthy adult volunteers. 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®, PIKA rabies vaccine and PIKA rabies vaccine with an accelerated regimen
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteSingapore
- Study dates
- Feb 2015to Jul 2015
- Phase
- Phase 1
- 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 16Show fewer
- Patient with clinical signs of encephalitis
- Recipient of any vaccine in the 4 weeks preceding the first trial vaccination, except for influenza vaccination
- 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
1 site in 1 country.
Singapore1 site
SingHealth Investigational Medicine Unit
Singapore, Singapore, 169608
About this study
Official title: Phase I Study to Determine the Safety and Efficacy of a PIKA Rabies Vaccine Containing the PIKA Adjuvant
Phase I 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 was to assess the clinical safety of the vaccine composition in healthy adult volunteers. The secondary objective was to evaluate the vaccine's efficacy based on an accelerated vaccine regimen.
Read the detailed description
A single-center, open label, randomized phase I study in healthy naïve adult subjects. There were three study groups; subjects were randomly assigned to groups A (12), B (12) and C (12). Group A, as a control arm of the study, had received a commercially available rabies vaccine, RABIPUR® and Group B had received doses of the investigational PIKA rabies vaccine. Group C received an accelerated vaccine regimen with the investigational PIKA rabies vaccine. Group A and B followed the same vaccine regimen of (1-1-1-1), one injection on days 0, 3, 7 and 14 was administered respectively. Group C 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 Group C 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, PIKA rabies vaccine with an accelerated regimen
- 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
PIKA rabies vaccine with an accelerated regimenBiological
Also called 'PIKA rabies vaccine with PIKA adjuvant
Biological rabies vaccine
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Comparator vaccine RABIPUR®
Healthy volunteers received rabies vaccination intramuscularly on days 0,3,7 and 14 Receives: Biological: RABIPUR® |
| Group B | Experimental | PIKA Rabies vaccine
Healthy volunteers received rabies vaccination intramuscularly on days 0,3,7 and 14 Receives: Biological: PIKA rabies vaccine |
| Group C | 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 with an accelerated regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Titer level of Rabies Virus Neutralizing Antibody (RVNA) from serum at day 14 and 42 after the first injection
To analyze the titer level of RVNA from serum at day 14 and 42 after the first injection and with RVNA titer meeting the 0.5 IU(International units) /ml World Health Organization (WHO) requirement
Measured: Day 14 and Day 42
Secondary outcomes (2)
Detectable specific T cell mediated immune response on day 7 or day 14 and 42
Assessment of efficacy was determined by the observed immune response in subjects receiving the investigational vaccine where:Detectable specific T cell mediated immune response on day 7 or day 14 and 42
Measured: Day 7, Day 14 and Day 42
Number of subjects in Group C who has higher RVNA titre level on Day 7 or Day 14 when compared to classic course.
Evaluation of the accelerated regimen is studied to check if the levels of anti-rabies antibodies (serum RVNA titer) will be higher in day 7 or 14 than a classic course with control commercialized vaccine.
Measured: Day 7 and Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2016 (estimated)
- Study startFeb 2015
- Primary completionJul 2015
- Study completionJul 2015
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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yisheng Biopharma (Singapore) Pte. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Duke-NUS Graduate Medical School
- Responsible party
- Sponsor
- Investigators
- Limin Wijaya, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02657161
- Sponsor's protocol ID
- RV001-I
- Status last verified
- Jan 2016
- First submitted
- 11 Jan 2016
- Last updated
- 15 Jan 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 37821317Wijaya L, Tham CYL, Chan YFZ, Wong AWL, Li LT, Wang LF, Bertoletti A, Low JG. An accelerated rabies vaccine schedule based on toll-like receptor 3 (TLR3) agonist PIKA adjuvant augments rabies virus specific antibody and T cell response in healthy adult volunteers. Vaccine. 2017 Feb 22;35(8):1175-1183. doi: 10.1016/j.vaccine.2016.12.031. Epub 2017 Jan 22.
PubMed 28118938
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study to Determine the Safety and Efficacy of a PIKA Rabies Vaccine Containing the PIKA Adjuvant
- ClinicalTrials.gov ID
- NCT02657161
- Acronym / sponsor ID
- RV001-I
- Conditions
- Rabies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Yisheng Biopharma (Singapore) Pte. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Duke-NUS Graduate Medical School
- Study start
- Feb 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 15 Jan 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 I 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 was to assess the clinical safety of the vaccine composition in healthy adult volunteers. The secondary objective was to evaluate the vaccine's efficacy based on an accelerated vaccine regimen.
Detailed description
A single-center, open label, randomized phase I study in healthy naïve adult subjects. There were three study groups; subjects were randomly assigned to groups A (12), B (12) and C (12). Group A, as a control arm of the study, had received a commercially available rabies vaccine, RABIPUR® and Group B had received doses of the investigational PIKA rabies vaccine. Group C received an accelerated vaccine regimen with the investigational PIKA rabies vaccine. Group A and B followed the same vaccine regimen of (1-1-1-1), one injection on days 0, 3, 7 and 14 was administered respectively. Group C 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 Group C 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
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Biological: RABIPUR®Comparator vaccine RABIPUR® Healthy volunteers received rabies vaccination intramuscularly on days 0,3,7 and 14 |
| Group B | Experimental | Biological: PIKA rabies vaccinePIKA Rabies vaccine Healthy volunteers received rabies vaccination intramuscularly on days 0,3,7 and 14 |
| Group C | Experimental | Biological: PIKA rabies vaccine with an accelerated regimenPIKA 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 (16 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 | Group A |
| PIKA rabies vaccineAlso: 'PIKA rabies vaccine with PIKA adjuvantBiological rabies vaccine | Biological | Group B |
| PIKA rabies vaccine with an accelerated regimenAlso: 'PIKA rabies vaccine with PIKA adjuvantBiological rabies vaccine | Biological | Group C |
Primary outcome
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.
Titer level of Rabies Virus Neutralizing Antibody (RVNA) from serum at day 14 and 42 after the first injection
Time frame: Day 14 and Day 42
To analyze the titer level of RVNA from serum at day 14 and 42 after the first injection and with RVNA titer meeting the 0.5 IU(International units) /ml World Health Organization (WHO) requirement
2 secondary outcomes
Detectable specific T cell mediated immune response on day 7 or day 14 and 42
Time frame: Day 7, Day 14 and Day 42
Number of subjects in Group C who has higher RVNA titre level on Day 7 or Day 14 when compared to classic course.
Time frame: Day 7 and Day 14
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 15 Jan 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 28118938Wijaya L, Tham CYL, Chan YFZ, Wong AWL, Li LT, Wang LF, Bertoletti A, Low JG. An accelerated rabies vaccine schedule based on toll-like receptor 3 (TLR3) agonist PIKA adjuvant augments rabies virus specific antibody and T cell response in healthy adult volunteers. Vaccine. 2017 Feb 22;35(8):1175-1183. doi: 10.1016/j.vaccine.2016.12.031. Epub 2017 Jan 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RABIPUR®, PIKA rabies vaccine and PIKA rabies vaccine with an accelerated regimen in people with Rabies, run by Yisheng Biopharma (Singapore) Pte. Ltd. at 1 site 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 16 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 15 Jan 2016. 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 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Identification of any adverse events for all the treatment groups (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 NCT02657161, 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 15 Jan 2016.