Covid-19 VaccinePhase 2/3NCT05463419
A Phase II/III Study of PIKA Recombinant SARS-CoV-2 Vaccine as a Booster Dose.
A Phase 2/3 study testing PIKA COVID-19 vaccine and Inactivated Covid-19 vaccine in people with Covid-19 Vaccine, run by Yisheng Biopharma (Singapore) Pte. Ltd. at 6 sites in 2 countries.
Trial summary
This is a Phase II/III, randomized, double-blinded study in adults ≥ 18 years old who received 2 or more doses of inactivated COVID-19 vaccine to evaluate the efficacy, safety and immunogenicity of a booster dose of PIKA COVID-19 vaccine compared to the comparator inactivated COVID-19 vaccine. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid-19 Vaccine
- What is being tested?
- PIKA COVID-19 vaccine and Inactivated Covid-19 vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,860 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 3 Oct 2022to 11 Apr 2024
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject who met all of the following criteria may be enrolled.
- Age more than or equal 18 years on Screening.
- Judged by the investigator to be healthy based on medical history, physical examination and vital signs performed at screening.
- Able to provide informed consent.
- Able and willing to comply with all study procedures over follow up period of approximately 12 months.
- Received 2 or more doses of inactivated COVID-19 vaccine as primary series with their last dose at least 3 months prior to enrollment.
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- Axillary body temperature ≤37.5℃.
- SARS-COV-2 test was negative for nasopharyngeal swabs by RT PCR.
- Non-pregnant and not lactating women.
- For female subjects of childbearing potential: must agree to avoid pregnancy from Study Day 0 to Study Day 60 during 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.
- Male subjects who are sexually active with a woman of childbearing potential and have not had vasectomy must agree to practice a highly effective form of contraception with their female partners of childbearing potential during the trial, starting after screening until 60 days after receiving the last vaccination.
- Men must be willing to refrain from sperm donation, starting after screening until 60 days after receiving the last vaccination.
Who cannot join
- Subject who met any of the following criteria may not be enrolled.
- Abnormal vital signs or laboratory test results prior to D0 judged as clinically significant by investigator.
- Known allergy, hypersensitivity, or intolerance to the test vaccine (including any excipients and the antibiotics kanamycin and aminoglycosides).
- History of severe allergies to any drugs, foods or vaccines, such as anaphylactic shock, allergic laryngeal edema, allergic dyspnea, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), etc.
- Diagnosed with any serious disease, or congenital malformation, or uncontrolled chronic disease that may influence the compliance with the study including but not limited to respiratory disease such as asthma or chronic bronchitis, serious cardiovascular disease, kidney disease, autoimmune disease, thalassemia, malignant tumor, hereditary allergy, etc.
- History or family history of convulsions, seizures, encephalopathy, and mental illness.
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- History of narcolepsy.
- Known substance abuse and addiction within the past 2 years.
- Uninterrupted use of systemic immunosuppressants or other immunomodulators within 30 days prior to D0.
- Use of blood or blood-related products (e.g., blood transfusion, human albumin, human immunoglobulin, etc.) within 30 days prior to D0.
- Blood loss >400 mL within 28 days prior to D0 (e.g., donated blood or blood products or injury), or planned to donate blood or plasma before D28 of the study.
- Use of nonsteroidal anti-inflammatory drugs and/or antiallergic drugs within 3 days prior to D0
- Have symptoms of COVID-19, such as respiratory symptoms, fever, cough, shortness of breath and dyspnea.
- Bleeding disorder, or receipt of anticoagulants in the past 21 days preceding inclusion, contraindicating IM vaccination based on Investigator's judgment.
- Surgical removal of whole or part of spleen for any reason
- Received any vaccines within 28 days prior to D0 or disagree to avoid receiving any vaccines before D28 of the study except the emergent vaccination such as rabies vaccine, tetanus vaccine.
- Participating in or planning to participate in other clinical trials (drugs or vaccines) during the study period.
- Any other conditions not eligible for participating in the study at investigator's discretion.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Philippines5 sites
Health Index Multispecialty Clinic -Clinical Research
Cavite, 4104
Norzel Medical and Diagnostic Clinical
Cebu
Tropical Disease Foundation
City of Muntinlupa
St. John Hospital
Naga
UERM Research Center
Quezon City
About this study
Official title: A Phase II/III, Randomized, Double-blinded Study to Evaluate the Efficacy, Safety and Immunogenicity of a Booster Dose of PIKA Recombinant SARS-CoV-2 Vaccine in Adults Who Received 2 or More Doses of Inactivated Covid-19 Vaccine.
This is a Phase II/III, randomized, double-blinded study in adults ≥ 18 years old who received 2 or more doses of inactivated COVID-19 vaccine to evaluate the efficacy, safety and immunogenicity of a booster dose of PIKA COVID-19 vaccine compared to the comparator inactivated COVID-19 vaccine. Phase II/III will be a competitive enrollment process in all participating countries. Once the target number of subjects is reached, the enrollment in all participating countries in the particular phase will be stopped.
Read the detailed description
In phase II, a total of 300 eligible subjects will be randomly allocated in a 1:1 ratio to receive PIKA COVID-19 vaccine or the comparator inactivated COVID-19 vaccine. The ratio of the GMT of neutralizing antibody on Day 14 after the booster dose of PIKA COVID-19 vaccine group and inactivated COVID-19 vaccine group will be calculated. Based on the Phase I immunogenicity data of PIKA vaccine, the proposed Phase II sample size results in nearly 100% power in a two-sample t test of the log- transformed neutralizing antibody titers with a two-sided alpha=0.05. Among 300 subjects, at least 200 subjects will be enrolled as subset of long term immunogenicity and 100 subjects will be enrolled as subset of early immunogenicity. Among the 100 early immunogenicity subset, the ratio of the GMT of neutralizing antibody on Day 7 after the booster dose of PIKA COVID-19 vaccine group and inactivated COVID-19 vaccine group will be calculated. Therefore, the 100 subjects randomized to the early immunogenicity subset will have additional blood sampling on Day 7. After completion of the 7-day safety observation following the immunization of all subjects in the Phase II trial, a Safety Monitoring Committee (SMC) meeting will be held to determine whether to initiate enrollment of participants in the Phase III trial. In phase III, total 9,000 eligible subjects will be randomly allocated in a 1:1 ratio to the PIKA COVID-19 vaccine group or the comparator inactivated COVID-19 vaccine group. The sample size provides an approximately 90% power to detect a protection rate of at least 65% by PIKA vaccine in a Poisson regression analysis with a one-sided alpha of 0.025. The calculations consider an interim analysis performed with 50% of the information collected using a Pocock boundary to adjust for multiplicity. A 1% infection rate in the control group and an approximately a 10% attrition rate are assumed. It is of note that while the actual background incidence rate can vary, the sample size requirement amounts to achieving an observation of 82 COVID-19 cases to ensure the statistical power under the 65% protection rate assumption. Similarly, the interim analysis will need to be conducted at when approximately 41 cases are observed to maintain the planned operating characteristics. Among total subjects, at least 6% subjects will be enrolled as subset of immunogenicity. Eligible subjects will receive a dose of investigational vaccine via intramuscular injection in deltoid muscle on Day 0. All subjects will be monitored for at least 30 minutes after injection. Solicited AEs will be recorded for 7 days. Unsolicited AEs and MAAEs will be recorded for 28 days following injection. SAEs, SUSARs, AESIs will be recorded for the entire duration of the study. It will take about 13 months for each subject from enrollment to the last visit. Some subjects may withdraw or discontinue from the study during the study for any reason.
- Conditions
- Covid-19 Vaccine
- Being tested
- PIKA COVID-19 vaccine, Inactivated Covid-19 vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIKA COVID-19 vaccineBiological
SARS-CoV-2 spike subunit protein (Also called "Recombinant SARS-CoV-2 S-trimer protein"), PIKA adjuvant.
Inactivated Covid-19 vaccineBiological
Inactivated SARS-CoV-2 virus
| Study group | Role | What they receive |
|---|---|---|
| PIKA COVID-19 vaccine | Experimental | One dose of the experimental vaccine should be administered on Study Day 0 in the deltoid muscle. Receives: Biological: PIKA COVID-19 vaccine |
| Inactivated Covid-19 vaccine | Active comparator | One dose of the control vaccine should be administered on Study Day 0 in the deltoid muscle. Receives: Biological: Inactivated Covid-19 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity at Phase II Study
Geometric mean titer (GMT) of neutralizing antibody against Omicron virus on D14 after the booster dose
Measured: at day 14 after booster.
Efficacy at Phase III Study
Incidence of first occurrence of Rt-PCR positive symptomatic illness after D14 of booster dose
Measured: up to 360 days after booster
Safety at Phase II and Phase III
Incidence of AE, MAAE, SAE, SUSAR and AESI after booster dose
Measured: up to 360 days after booster.
Secondary outcomes (2)
Immunogenicity at Phase II Study
GMT of neutralizing antibody against wild type SARS-CoV-2 virus on Day 7, Day 14, Day 90, Day 180, Day 360.
- GMT of neutralizing antibody against Omicron virus on Day 7.
- Seroconversion rate of neutralizing antibody against wild type SARS-CoV-2 virus from Day 0 to Day 7.
- Seroconversion rate of neutralizing antibody against Omicron virus from Day 0 to Day 7.
- Mean geometric titers fold growth of neutralizing antibody against wild type SARS-CoV-2 virus from Day 0 to Day 7.
- Mean geometric titers fold growth of neutralizing antibody against Omicron virus from Day 0 to Day 7.
- GMT of serum IgG antibody on Day 7.
- Seroconversion rate of serum IgG antibody from Day 0 to Day 7.
Measured: at day 7, day 14, day 90, day 180, day 360 after booster.
Efficacy at Phase III Study
Incidence of the first occurrence of either COVID-19 or SARS CoV-2 infection regardless of symptomatology or severity starting 14 days after the booster dose.
For immunogenicity subset (6% of Phase III):
- GMT of neutralizing antibody against Omicron virus on Day 7 and Day 14.
- Seroconversion rate of neutralizing antibody against Omicron virus from Day 0 to Day 7 and Day 14.
- Mean geometric titersfold growth of neutralizing antibody against Omicron virus from Day 0 to Day 7 and Day 14.
- GMT of serum IgG antibody on Day 7 and Day 14.
- Seroconversion rate of serum IgG antibody from Day 0 to Day 7, Day 14
Measured: from day 14 to day 360 after booster.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start3 Oct 2022
- Primary completion28 Dec 2023
- Study completion11 Apr 2024
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 Covid-19 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 5,860 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
- NCT05463419
- Sponsor's protocol ID
- YS302
- Status last verified
- Oct 2023
- First submitted
- 29 Jun 2022
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lim RJ, Qiu X, Alberto E, Capeding MR, Carlos J, Leong RN, Gutierrez JL, Trillana M, Liu Y, Mojares Z. Safety and immunogenicity of PIKA-adjuvanted recombinant SARS-CoV-2 spike protein subunit vaccine as a booster against SARS-CoV-2: a phase II, open-label, randomized, double-blinded study. Clin Exp Vaccine Res. 2024 Oct;13(4):329-337. doi: 10.7774/cevr.2024.13.4.329. Epub 2024 Oct 31.
PubMed 39525672
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 II/III, Randomized, Double-blinded Study to Evaluate the Efficacy, Safety and Immunogenicity of a Booster Dose of PIKA Recombinant SARS-CoV-2 Vaccine in Adults Who Received 2 or More Doses of Inactivated Covid-19 Vaccine.
- ClinicalTrials.gov ID
- NCT05463419
- Acronym / sponsor ID
- YS302
- Conditions
- Covid-19 Vaccine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,860 participants (actual)
- Lead sponsor
- Yisheng Biopharma (Singapore) Pte. Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 28 Dec 2023 (actual)
- Study completion
- 11 Apr 2024 (actual)
- First posted
- 19 Jul 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 II/III, randomized, double-blinded study in adults ≥ 18 years old who received 2 or more doses of inactivated COVID-19 vaccine to evaluate the efficacy, safety and immunogenicity of a booster dose of PIKA COVID-19 vaccine compared to the comparator inactivated COVID-19 vaccine. Phase II/III will be a competitive enrollment process in all participating countries. Once the target number of subjects is reached, the enrollment in all participating countries in the particular phase will be stopped.
Detailed description
In phase II, a total of 300 eligible subjects will be randomly allocated in a 1:1 ratio to receive PIKA COVID-19 vaccine or the comparator inactivated COVID-19 vaccine. The ratio of the GMT of neutralizing antibody on Day 14 after the booster dose of PIKA COVID-19 vaccine group and inactivated COVID-19 vaccine group will be calculated. Based on the Phase I immunogenicity data of PIKA vaccine, the proposed Phase II sample size results in nearly 100% power in a two-sample t test of the log- transformed neutralizing antibody titers with a two-sided alpha=0.05. Among 300 subjects, at least 200 subjects will be enrolled as subset of long term immunogenicity and 100 subjects will be enrolled as subset of early immunogenicity. Among the 100 early immunogenicity subset, the ratio of the GMT of neutralizing antibody on Day 7 after the booster dose of PIKA COVID-19 vaccine group and inactivated COVID-19 vaccine group will be calculated. Therefore, the 100 subjects randomized to the early immunogenicity subset will have additional blood sampling on Day 7. After completion of the 7-day safety observation following the immunization of all subjects in the Phase II trial, a Safety Monitoring Committee (SMC) meeting will be held to determine whether to initiate enrollment of participants in the Phase III trial. In phase III, total 9,000 eligible subjects will be randomly allocated in a 1:1 ratio to the PIKA COVID-19 vaccine group or the comparator inactivated COVID-19 vaccine group. The sample size provides an approximately 90% power to detect a protection rate of at least 65% by PIKA vaccine in a Poisson regression analysis with a one-sided alpha of 0.025. The calculations consider an interim analysis performed with 50% of the information collected using a Pocock boundary to adjust for multiplicity. A 1% infection rate in the control group and an approximately a 10% attrition rate are assumed. It is of note that while the actual background incidence rate can vary, the sample size requirement amounts to achieving an observation of 82 COVID-19 cases to ensure the statistical power under the 65% protection rate assumption. Similarly, the interim analysis will need to be conducted at when approximately 41 cases are observed to maintain the planned operating characteristics. Among total subjects, at least 6% subjects will be enrolled as subset of immunogenicity. Eligible subjects will receive a dose of investigational vaccine via intramuscular injection in deltoid muscle on Day 0. All subjects will be monitored for at least 30 minutes after injection. Solicited AEs will be recorded for 7 days. Unsolicited AEs and MAAEs will be recorded for 28 days following injection. SAEs, SUSARs, AESIs will be recorded for the entire duration of the study. It will take about 13 months for each subject from enrollment to the last visit. Some subjects may withdraw or discontinue from the study during the study for any reason.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PIKA COVID-19 vaccine | Experimental | Biological: PIKA COVID-19 vaccineOne dose of the experimental vaccine should be administered on Study Day 0 in the deltoid muscle. |
| Inactivated Covid-19 vaccine | Active comparator | Biological: Inactivated Covid-19 vaccineOne dose of the control vaccine should be administered on Study Day 0 in the deltoid muscle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subject who met all of the following criteria may be enrolled.
- Age more than or equal 18 years on Screening.
- Judged by the investigator to be healthy based on medical history, physical examination and vital signs performed at screening.
- Able to provide informed consent.
- Able and willing to comply with all study procedures over follow up period of approximately 12 months.
Key exclusion criteria (18 listed)
- Subject who met any of the following criteria may not be enrolled.
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 COVID-19 vaccineSARS-CoV-2 spike subunit protein (Also called "Recombinant SARS-CoV-2 S-trimer protein"), PIKA adjuvant. | Biological | PIKA COVID-19 vaccine |
| Inactivated Covid-19 vaccineInactivated SARS-CoV-2 virus | Biological | Inactivated Covid-19 vaccine |
Primary outcome
Immunogenicity at Phase II Study
Time frame: at day 14 after booster.
Geometric mean titer (GMT) of neutralizing antibody against Omicron virus on D14 after the booster dose
Efficacy at Phase III Study
Time frame: up to 360 days after booster
Incidence of first occurrence of Rt-PCR positive symptomatic illness after D14 of booster dose
Safety at Phase II and Phase III
Time frame: up to 360 days after booster.
Incidence of AE, MAAE, SAE, SUSAR and AESI after booster dose
2 secondary outcomes
Immunogenicity at Phase II Study
Time frame: at day 7, day 14, day 90, day 180, day 360 after booster.
Efficacy at Phase III Study
Time frame: from day 14 to day 360 after booster.
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 23 Jul 2024.
- Derived from this study: PubMed 39525672Lim RJ, Qiu X, Alberto E, Capeding MR, Carlos J, Leong RN, Gutierrez JL, Trillana M, Liu Y, Mojares Z. Safety and immunogenicity of PIKA-adjuvanted recombinant SARS-CoV-2 spike protein subunit vaccine as a booster against SARS-CoV-2: a phase II, open-label, randomized, double-blinded study. Clin Exp Vaccine Res. 2024 Oct;13(4):329-337. doi: 10.7774/cevr.2024.13.4.329. Epub 2024 Oct 31.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing PIKA COVID-19 vaccine and Inactivated Covid-19 vaccine in people with Covid-19 Vaccine, run by Yisheng Biopharma (Singapore) Pte. Ltd. at 6 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 12 inclusion and 18 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 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 6 sites in Philippines, United Arab Emirates. 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 combined 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.
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?
Immunogenicity at Phase II Study (time frame: at day 14 after booster.). The study lists 3 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 NCT05463419, 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 23 Jul 2024; AzTrials last refreshed its copy on 6 Nov 2026.