COVID-19 PandemicPhase 1NCT05305300
A Phase I Study to Evaluate Safety, Tolerability, and Immunogenicity of a PIKA COVID-19 Vaccine in Healthy Individuals
A Phase 1 study testing PIKA COVID-19 Vaccine (CHO cell, S-protein), Arm A and PIKA COVID-19 Vaccine (CHO cell, S-protein), Arm B in people with COVID-19 Pandemic, run by Yisheng Biopharma (Singapore) Pte. Ltd. at 1 site in United Arab Emirates.
Trial summary
This is a Phase I, open label, dose-escalation study of three dose levels of the SARS-CoV-2 spike antigen administered intramuscularly (IM) in combination with a fixed dosage of PIKA adjuvant vaccine to evaluate the safety, tolerability, and immunogenicity of PIKA COVID-19 vaccine candidate in healthy individuals aged… 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 Pandemic
- What is being tested?
- PIKA COVID-19 Vaccine (CHO cell, S-protein), Arm A and PIKA COVID-19 Vaccine (CHO cell, S-protein), Arm B
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 18 Oct 2021to 15 Sep 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female healthy volunteers.
- Age ≥18 years on Study Day 0.
- Judged by the investigator to be healthy on the basis of 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 6 months.
- For more inclusion criteria, please contact the investigator or sponsor.
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- Male and female healthy volunteers.
- Received complete primary series of COVID-19 Inactivated Vaccines not less than 6 months or Received complete primary series of COVID-19 mRNA Vaccines not less than 6 month.
- Age ≥18 years on Study Day 0.
- Judged by the investigator to be healthy on the basis of 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 6 months.
- For more inclusion criteria, please contact the investigator or sponsor.
Who cannot join
- History of COVID-19 of less than 6 months prior to enrollment
- Received partial or complete course of any type of COVID-19 vaccine.
- History of close contact with a person infected or suspected of COVID-19 not less than 14 days prior to study enrollment.
- Positive test for SARS-CoV-2 infection, including but not limited to RT-PCR /Rapid Antigen Test at screening, before the first dose (Day 0) and before the second dose (Day 7).
- For more exclusion criteria, please contact the investigator or sponsor.
- History of close contact with a person infected or suspected of COVID-19 not less than 14 days prior to study enrollment.
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- Positive test for SARS-CoV-2 infection, including but not limited to RT-PCR/RAT at screening, before the first dose (Day 0) .
- Have received three and more doses of COVID-19 vaccine.
- Pregnant or breastfeeding or intending to become pregnant or father children within the projected duration of the trial.
- For more exclusion criteria, please contact the investigator or sponsor.
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
Al Kuwait Hospital (Al Baraha Hospital)
Dubai
About this study
Official title: A Phase I Study to Evaluate the Safety, Tolerability, and Immunogenicity of a PIKA COVID-19 Vaccine in Healthy Adults Who is COVID-19 naïve or Had Previous COVID-19 Infection or Completed Inactivated or mRNA COVID-19 Vaccination.
This is a Phase I, open label, dose-escalation study of three dose levels of the SARS-CoV-2 spike antigen administered intramuscularly (IM) in combination with a fixed dosage of PIKA adjuvant vaccine to evaluate the safety, tolerability, and immunogenicity of PIKA COVID-19 vaccine candidate in healthy individuals aged 18 years and above. The study will comprise of two arms. Arm A will include subjects who never been infected with COVID-19 or with a history of COVID-19 infection for not less than 6 months prior to study participation and Arm B will include subjects who will be receiving PIKA vaccine as a booster vaccination dose to COVID-19 primary vaccination of inactivated or mRNA Covid 19 vaccines.
Read the detailed description
This is a Phase I, open label, dose-escalation study of three dose levels of the SARS-CoV-2 spike antigen administered intramuscularly (IM) in combination with a fixed dosage of PIKA adjuvant vaccine to evaluate the safety, tolerability, and immunogenicity of PIKA COVID-19 vaccine candidate in healthy individuals aged 18 years and above. The study will comprise of two arms. Arm A will include subjects who had never been infected with COVID-19 or with a history of COVID-19 infection for not less than 6 months prior to study participation and Arm B will include subjects who will be receiving PIKA vaccine as a booster vaccination dose to COVID-19 primary vaccination of inactivated or mRNA Covid 19 vaccines.
Arm A: There will be 3 dose groups, 1 to 3 with escalating antigen dose with PIKA adjuvant in sequential cohorts. A total of 45 subjects will be enrolled in Arm A. Subjects in Group 1-3 will receive two doses of PIKA COVID-19 vaccine via IM administration on Days 0 and 7. Fifteen eligible subjects in each dose group.
Arm B: There will be 3 dose groups, 1 to 3 with escalating antigen dose with PIKA adjuvant in sequential cohorts. A total of 90 subjects will be enrolled in Arm B which will be divided into Arm B1 (45 subjects) and Arm B2 (45 subjects). Arm B1 will enroll subjects who received Inactivated vaccines and will comprise of 15 subjects per dose (45 subjects). Arm B2 will enroll subjects who received mRNA vaccines and will comprise of 15 subjects per dose (45 subjects). Subjects in Group 1-3 of Arm B1 and Arm B2 will receive one booster dose of PIKA COVID-19 vaccine via IM administration on Days 0.
- Conditions
- COVID-19 Pandemic
- Being tested
- PIKA COVID-19 Vaccine (CHO cell, S-protein), Arm A, PIKA COVID-19 Vaccine (CHO cell, S-protein), Arm B
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIKA COVID-19 Vaccine (CHO cell, S-protein), Arm ABiological
receive two doses of PIKA COVID-19 vaccine (5 μg S protein/1mg PIKA, 10μg S protein/1mg PIKA and 20μg S protein/1mg PIKA) via IM administration on Days 0 and 7.
PIKA COVID-19 Vaccine (CHO cell, S-protein), Arm BBiological
receive one dose of PIKA COVID-19 vaccine (5 μg S protein/1mg PIKA, 10μg S protein/1mg PIKA and 20μg S protein/1mg PIKA) via IM administration on Days 0.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Primary Immunization | Experimental | There will be 3 dose groups, 1 to 3 with escalating antigen dose with PIKA adjuvant in sequential cohorts. A total of 45 subjects will be enrolled in Arm A. Subjects in Group 1-3 will receive two doses of PIKA COVID-19 vaccine via IM administration on Days 0 and 7. Receives: Biological: PIKA COVID-19 Vaccine (CHO cell, S-protein), Arm A |
| Arm B1: Booster Immunization 1 | Experimental | There will be 3 dose groups, 1 to 3 with escalating antigen dose with PIKA adjuvant in sequential cohorts. Arm B1 will enroll subjects who received Inactivated vaccines and will comprise of 15 subjects per dose. In arm B1, fifteen eligible subjects in each dose group will receive the study vaccine on Study Days 0 via intramuscular injection in alternative deltoid muscles. Receives: Biological: PIKA COVID-19 Vaccine (CHO cell, S-protein), Arm B |
| Arm B2: Booster Immunization 2 | Experimental | There will be 3 dose groups, 1 to 3 with escalating antigen dose with PIKA adjuvant in sequential cohorts. Arm B2 will enroll subjects who received mRNA vaccines and will comprise of 15 subjects per dose. In arm B2, fifteen eligible subjects in each dose group will receive the study vaccine on Study Days 0 via intramuscular injection in alternative deltoid muscles. Receives: Biological: PIKA COVID-19 Vaccine (CHO cell, S-protein), Arm B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Solicited local adverse events,
Incidence of solicited local adverse events (AEs).
Measured: 7 days after each vaccination.
Solicited systemic AEs
Incidence of solicited systemic AEs.
Measured: 7 days after each vaccination.
Unsolicited AEs
Incidence of unsolicited AEs.
Measured: 28 days after each vaccination.
Serious adverse events (SAEs) including Suspected Unexpected Serious Adverse Reaction (SUSARs)
Incidence of serious adverse events (SAEs) including Suspected Unexpected Serious Adverse Reaction (SUSARs).
Measured: through study completion, an average of 6 months.
Medically Attended AEs (MAAEs)
Incidence of Medically Attended AEs (MAAEs).
Measured: through study completion, an average of 6 months.
AEs of special interest (AESIs)
Incidence of AEs of special interest (AESIs).
Measured: through study completion, an average of 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start18 Oct 2021
- Primary completion15 May 2022
- Study completion15 Sep 2022
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 PandemicStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yisheng Biopharma (Singapore) Pte. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuan Liu, Ph.D, Study director, Yisheng Biopharma CO., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05305300
- Sponsor's protocol ID
- YS-009
- Status last verified
- Mar 2022
- First submitted
- 20 Mar 2022
- Last updated
- 22 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lim RJ, Qiu X, Leong RN, Gutierrez JL, Halima A, Mostafa M, Ghoneim Y, Abdrabo M, Rashad M, Hannawi S, Liu Y, Mojares Z. Safety, tolerability, and immunogenicity of PIKA-adjuvanted recombinant SARS-CoV-2 spike protein subunit vaccine in healthy adults: an open-label randomized phase I clinical trial. Clin Exp Vaccine Res. 2024 Oct;13(4):315-328. doi: 10.7774/cevr.2024.13.4.315. Epub 2024 Oct 31.
PubMed 39525677
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety, Tolerability, and Immunogenicity of a PIKA COVID-19 Vaccine in Healthy Adults Who is COVID-19 naïve or Had Previous COVID-19 Infection or Completed Inactivated or mRNA COVID-19 Vaccination.
- ClinicalTrials.gov ID
- NCT05305300
- Acronym / sponsor ID
- YS-009
- Conditions
- COVID-19 Pandemic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Yisheng Biopharma (Singapore) Pte. Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 31 Mar 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 I, open label, dose-escalation study of three dose levels of the SARS-CoV-2 spike antigen administered intramuscularly (IM) in combination with a fixed dosage of PIKA adjuvant vaccine to evaluate the safety, tolerability, and immunogenicity of PIKA COVID-19 vaccine candidate in healthy individuals aged 18 years and above. The study will comprise of two arms. Arm A will include subjects who never been infected with COVID-19 or with a history of COVID-19 infection for not less than 6 months prior to study participation and Arm B will include subjects who will be receiving PIKA vaccine as a booster vaccination dose to COVID-19 primary vaccination of inactivated or mRNA Covid 19 vaccines.
Detailed description
This is a Phase I, open label, dose-escalation study of three dose levels of the SARS-CoV-2 spike antigen administered intramuscularly (IM) in combination with a fixed dosage of PIKA adjuvant vaccine to evaluate the safety, tolerability, and immunogenicity of PIKA COVID-19 vaccine candidate in healthy individuals aged 18 years and above. The study will comprise of two arms. Arm A will include subjects who had never been infected with COVID-19 or with a history of COVID-19 infection for not less than 6 months prior to study participation and Arm B will include subjects who will be receiving PIKA vaccine as a booster vaccination dose to COVID-19 primary vaccination of inactivated or mRNA Covid 19 vaccines.
Arm A: There will be 3 dose groups, 1 to 3 with escalating antigen dose with PIKA adjuvant in sequential cohorts. A total of 45 subjects will be enrolled in Arm A. Subjects in Group 1-3 will receive two doses of PIKA COVID-19 vaccine via IM administration on Days 0 and 7. Fifteen eligible subjects in each dose group.
Arm B: There will be 3 dose groups, 1 to 3 with escalating antigen dose with PIKA adjuvant in sequential cohorts. A total of 90 subjects will be enrolled in Arm B which will be divided into Arm B1 (45 subjects) and Arm B2 (45 subjects). Arm B1 will enroll subjects who received Inactivated vaccines and will comprise of 15 subjects per dose (45 subjects). Arm B2 will enroll subjects who received mRNA vaccines and will comprise of 15 subjects per dose (45 subjects). Subjects in Group 1-3 of Arm B1 and Arm B2 will receive one booster dose of PIKA COVID-19 vaccine via IM administration on Days 0.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A: Primary Immunization | Experimental | Biological: PIKA COVID-19 Vaccine (CHO cell, S-protein), Arm AThere will be 3 dose groups, 1 to 3 with escalating antigen dose with PIKA adjuvant in sequential cohorts. A total of 45 subjects will be enrolled in Arm A. Subjects in Group 1-3 will receive two doses of PIKA COVID-19 vaccine via IM administration on Days 0 and 7. |
| Arm B1: Booster Immunization 1 | Experimental | Biological: PIKA COVID-19 Vaccine (CHO cell, S-protein), Arm BThere will be 3 dose groups, 1 to 3 with escalating antigen dose with PIKA adjuvant in sequential cohorts. Arm B1 will enroll subjects who received Inactivated vaccines and will comprise of 15 subjects per dose. In arm B1, fifteen eligible subjects in each dose group will receive the study vaccine on Study Days 0 via intramuscular injection in alternative deltoid muscles. |
| Arm B2: Booster Immunization 2 | Experimental | Biological: PIKA COVID-19 Vaccine (CHO cell, S-protein), Arm BThere will be 3 dose groups, 1 to 3 with escalating antigen dose with PIKA adjuvant in sequential cohorts. Arm B2 will enroll subjects who received mRNA vaccines and will comprise of 15 subjects per dose. In arm B2, fifteen eligible subjects in each dose group will receive the study vaccine on Study Days 0 via intramuscular injection in alternative deltoid muscles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male and female healthy volunteers.
- Age ≥18 years on Study Day 0.
- Judged by the investigator to be healthy on the basis of 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 6 months.
Key exclusion criteria (10 listed)
- History of COVID-19 of less than 6 months prior to enrollment
- Received partial or complete course of any type of COVID-19 vaccine.
- History of close contact with a person infected or suspected of COVID-19 not less than 14 days prior to study enrollment.
- Positive test for SARS-CoV-2 infection, including but not limited to RT-PCR /Rapid Antigen Test at screening, before the first dose (Day 0) and before the second dose (Day 7).
- For more exclusion criteria, please contact the investigator or sponsor.
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 Vaccine (CHO cell, S-protein), Arm Areceive two doses of PIKA COVID-19 vaccine (5 μg S protein/1mg PIKA, 10μg S protein/1mg PIKA and 20μg S protein/1mg PIKA) via IM administration on Days 0 and 7. | Biological | Arm A: Primary Immunization |
| PIKA COVID-19 Vaccine (CHO cell, S-protein), Arm Breceive one dose of PIKA COVID-19 vaccine (5 μg S protein/1mg PIKA, 10μg S protein/1mg PIKA and 20μg S protein/1mg PIKA) via IM administration on Days 0. | Biological | Arm B1: Booster Immunization 1, Arm B2: Booster Immunization 2 |
Primary outcome
Solicited local adverse events,
Time frame: 7 days after each vaccination.
Incidence of solicited local adverse events (AEs).
Solicited systemic AEs
Time frame: 7 days after each vaccination.
Incidence of solicited systemic AEs.
Unsolicited AEs
Time frame: 28 days after each vaccination.
Incidence of unsolicited AEs.
Serious adverse events (SAEs) including Suspected Unexpected Serious Adverse Reaction (SUSARs)
Time frame: through study completion, an average of 6 months.
Incidence of serious adverse events (SAEs) including Suspected Unexpected Serious Adverse Reaction (SUSARs).
Medically Attended AEs (MAAEs)
Time frame: through study completion, an average of 6 months.
Incidence of Medically Attended AEs (MAAEs).
AEs of special interest (AESIs)
Time frame: through study completion, an average of 6 months.
Incidence of AEs of special interest (AESIs).
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 22 Dec 2022.
- Derived from this study: PubMed 39525677Lim RJ, Qiu X, Leong RN, Gutierrez JL, Halima A, Mostafa M, Ghoneim Y, Abdrabo M, Rashad M, Hannawi S, Liu Y, Mojares Z. Safety, tolerability, and immunogenicity of PIKA-adjuvanted recombinant SARS-CoV-2 spike protein subunit vaccine in healthy adults: an open-label randomized phase I clinical trial. Clin Exp Vaccine Res. 2024 Oct;13(4):315-328. doi: 10.7774/cevr.2024.13.4.315. 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.
Yuan Liu, Ph.D study director
Yisheng Biopharma CO., Ltd.
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 PIKA COVID-19 Vaccine (CHO cell, S-protein), Arm A and PIKA COVID-19 Vaccine (CHO cell, S-protein), Arm B in people with COVID-19 Pandemic, run by Yisheng Biopharma (Singapore) Pte. Ltd. at 1 site in United Arab Emirates.
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 13 inclusion and 10 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 22 Dec 2022. 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 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 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?
Solicited local adverse events, (time frame: 7 days after each 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?
On the ClinicalTrials.gov record for NCT05305300, 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 22 Dec 2022.