COVID-19Phase 2NCT05463354
Safety and Immunogenicity of Recombinant COVID-19 Vaccine (Sf9 Cell) as a Booster
A Phase 2 study testing Recombinant COVID-19 Vaccine (Sf9 Cell) and COVID-19 Vaccine (Vero Cell), Inactivated in people with COVID-19 and SARS-CoV-2 Infection, run by WestVac Biopharma Co., Ltd. at 1 site in Philippines.
Trial summary
A phase Ⅱ, observer-blind, randomized, controlled, investigator-initiated clinical trial to evaluate the safety and immunogenicity of a booster vaccination with Recombinant COVID-19 vaccine (Sf9 Cell) in a population aged 18 years and above who have completed homologous primary vaccination with either Inactivated or… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19, SARS-CoV-2 Infection
- What is being tested?
- Recombinant COVID-19 Vaccine (Sf9 Cell) and COVID-19 Vaccine (Vero Cell), Inactivated
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- 1 sitePhilippines
- Study dates
- 11 Jul 2022to 26 Jan 2024
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Participant is willing and able to give written informed consent for participation in the trial.
- 2. Male or Female, aged 18 years or above and in good health as determined by a trial clinician.
- 3. Female participants of childbearing potential must be willing to ensure that they or their partner use effective contraception from 1 month prior to first immunisation continuously until 3 months after boost immunisation. See Section "Contraception and Pregnancy" for definition of child-bearing potential and definition of effective contraception.
- 4. In the Investigator's opinion, is able and willing to comply with all trial requirements.
- 5. Willing to allow investigators to discuss the volunteer's medical history with their General Practitioner and access all medical records when relevant to study procedures.
- 6. Agreement to refrain from blood donation during the study.
- 7. Participants who have completed homologous primary vaccination with either Inactivated or mRNA or Viral Vector COVID-19 vaccines (full approval, CMA or EUA) and is at least 6 months post second vaccination.
Who cannot join
- 1. Receipt of any vaccine (licensed or investigational) other than the study intervention within 30 days before and after each study vaccination (one week for licensed seasonal influenza vaccine or pneumococcal vaccine)
- 2. Prior or planned receipt of any other investigational or licensed vaccine or product likely to impact on interpretation of the trial data (e.g. adenovirus vectored vaccines, any coronavirus vaccines)
- 3. Positive SARS-CoV-2 RT-PCR at screening.
- 4. Participants who are pregnant at enrolment or planning to become pregnant during the first 3 months following vaccination.
- 5. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccines.
- 6. Any confirmed or suspected immunosuppressive or immunodeficient state; asplenia; recurrent severe infections and use of immunosuppressant medication within the past 6 months, except topical steroids or short-term oral steroids (course lasting ≤14 days).
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- 7. History of allergic disease or reactions likely to be exacerbated by any component of study vaccines.
- 8. Any history of anaphylaxis.
- 9. Current diagnosis of or treatment for cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Immunogenicity of Recombinant COVID-19 Vaccine (Sf9 Cell) as a Booster Following Primary Vaccination of Either Inactivated or mRNA or Viral Vector COVID-19 Vaccines
A phase Ⅱ, observer-blind, randomized, controlled, investigator-initiated clinical trial to evaluate the safety and immunogenicity of a booster vaccination with Recombinant COVID-19 vaccine (Sf9 Cell) in a population aged 18 years and above who have completed homologous primary vaccination with either Inactivated or mRNA or Viral Vector COVID-19 vaccines at least 6 months prior to enrolment.
Read the detailed description
A phase Ⅱ, observer-blind, randomized, controlled, investigator-initiated clinical trial to evaluate the safety and immunogenicity of a booster vaccination with Recombinant COVID-19 vaccine (Sf9 Cell) in a population aged 18 years and above who have completed homologous primary vaccination with either Inactivated or mRNA or Viral Vector COVID-19 vaccines at least 6 months prior to enrolment. The study uses a non-inferiority design to compare between schedules with Recombinant COVID-19 Vaccine (Sf9 Cell) versus COVID-19 Vaccine (Vero Cell), Inactivated as the booster dose. Participants, laboratory and analysing statisticians will remain blind to treatment allocation.
A total of 450 participants will be enrolled (participants aged ≥ 60 years account for approximately 10%), consisting of 3 cohorts:
150 participants who received 2 doses of Inactivated COVID-19 vaccines with the second dose at least 6 months (≥180 days) prior to enrolment.
150 participants who received 2 doses of mRNA COVID-19 vaccines with the second dose at least 6 months (≥180 days) prior to enrolment.
150 participants who received 2 doses of Viral Vector COVID-19 vaccines with the second dose at least 6 months (≥180 days) prior to enrolment.
Each of 3 cohorts of 150 participants will be randomized 1:1 to receive a single dose of Recombinant COVID-19 vaccine (Sf9 Cell) (test group) or the COVID-19 Vaccine (Vero Cell), Inactivated (control group).
- Conditions
- COVID-19, SARS-CoV-2 Infection
- Being tested
- Recombinant COVID-19 Vaccine (Sf9 Cell), COVID-19 Vaccine (Vero Cell), Inactivated
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant COVID-19 Vaccine (Sf9 Cell)Biological
1dose, Intramuscular Injection
COVID-19 Vaccine (Vero Cell), InactivatedBiological
1dose, Intramuscular Injection
| Study group | Role | What they receive |
|---|---|---|
| Inactivated COVID-19 vaccines cohort group 1 | Experimental | Participants who received 2 doses of Inactivated COVID-19 vaccines with the second dose at least 6 months (≥180 days) prior to enrolment. N=75 Intervention: Recombinant COVID-19 Vaccine (Sf9 Cell) Receives: Biological: Recombinant COVID-19 Vaccine (Sf9 Cell) |
| Inactivated COVID-19 vaccines cohort group 2 | Active comparator | Participants who received 2 doses of Inactivated COVID-19 vaccines with the second dose at least 6 months (≥180 days) prior to enrolment. N=75 Intervention: COVID-19 Vaccine (Vero Cell), Inactivated Receives: Biological: COVID-19 Vaccine (Vero Cell), Inactivated |
| mRNA COVID-19 vaccines cohort group 1 | Experimental | Participants who received 2 doses of mRNA COVID-19 vaccines with the second dose at least 6 months (≥180 days) prior to enrolment. N=75 Intervention: Recombinant COVID-19 Vaccine (Sf9 Cell) Receives: Biological: Recombinant COVID-19 Vaccine (Sf9 Cell) |
| mRNA COVID-19 vaccines cohort group 2 | Active comparator | Participants who received 2 doses of mRNA COVID-19 vaccines with the second dose at least 6 months (≥180 days) prior to enrolment. N=75 Intervention: COVID-19 Vaccine (Vero Cell), Inactivated Receives: Biological: COVID-19 Vaccine (Vero Cell), Inactivated |
| Viral Vector COVID-19 vaccines cohort group 1 | Experimental | Participants who received 2 doses of Viral Vector COVID-19 vaccines with the second dose at least 6 months (≥180 days) prior to enrolment. N=75 Intervention: Recombinant COVID-19 Vaccine (Sf9 Cell) Receives: Biological: Recombinant COVID-19 Vaccine (Sf9 Cell) |
| Viral Vector COVID-19 vaccines cohort group 2 | Active comparator | Participants who received 2 doses of Viral Vector COVID-19 vaccines with the second dose at least 6 months (≥180 days) prior to enrolment. N=75 Intervention: COVID-19 Vaccine (Vero Cell), Inactivated Receives: Biological: COVID-19 Vaccine (Vero Cell), Inactivated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse drug reactions (ADRs)
Measured: Day 0-28 post-boost dose.
Geometric mean titer (GMT) of specific neutralizing antibody (Virus or Pseudovirus Neutralization Assay) against SARS-CoV-2
Measured: Day 14 post-boost dose.
Seroconversion rate (≥ 4 folds increase from baseline) of serum anti-SARS-CoV-2 neutralizing antibody titers
Measured: Day 14 post-boost dose.
Secondary outcomes (8)
Incidence of adverse events (AEs)
Measured: Day 0-7 post-boost dose
Incidence of AEs
Measured: Day 0-28 post-boost dose
Incidence of serious adverse events (SAEs)
Measured: Day 0 through 6 months post-boost dose
The percentage of participants with abnormal hematology, chemistry and urinalysis laboratory values
Measured: Day 3 post-boost dose
The percentage of participants with grading shifts in hematology, chemistry and urinalysis laboratory assessments between baseline and 3 days after the booster dose.
Measured: Day 3 post-boost dose
GMT of specific neutralizing antibody (Virus or Pseudovirus Neutralization Assay) against SARS-CoV-2
Measured: Day 28, month 3 and month 6 post-boost dose
Geometric mean increase (GMI) of specific neutralizing antibody (Virus or Pseudovirus Neutralization Assay) against SARS-CoV-2
Measured: Day 14, day 28, month 3 and month 6 post-boost dose
GMT and GMI of IgG antibodies against SARS-CoV-2 S protein RBD
Measured: Day 14, day 28, month 3 and month 6 post-boost dose
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 start11 Jul 2022
- Primary completion18 Aug 2022
- Study completion26 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 410 participants (actual)
Sponsor and investigators
- Lead sponsor
- WestVac Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05463354
- Sponsor's protocol ID
- WSTVC001
- Status last verified
- Mar 2024
- First submitted
- 18 Jul 2022
- Last updated
- 24 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of Recombinant COVID-19 Vaccine (Sf9 Cell) as a Booster Following Primary Vaccination of Either Inactivated or mRNA or Viral Vector COVID-19 Vaccines
- ClinicalTrials.gov ID
- NCT05463354
- Acronym / sponsor ID
- WSTVC001
- Conditions
- COVID-19, SARS-CoV-2 Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 410 participants (actual)
- Lead sponsor
- WestVac Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Jul 2022 (actual)
- Primary completion
- 18 Aug 2022 (actual)
- Study completion
- 26 Jan 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.
A phase Ⅱ, observer-blind, randomized, controlled, investigator-initiated clinical trial to evaluate the safety and immunogenicity of a booster vaccination with Recombinant COVID-19 vaccine (Sf9 Cell) in a population aged 18 years and above who have completed homologous primary vaccination with either Inactivated or mRNA or Viral Vector COVID-19 vaccines at least 6 months prior to enrolment.
Detailed description
A phase Ⅱ, observer-blind, randomized, controlled, investigator-initiated clinical trial to evaluate the safety and immunogenicity of a booster vaccination with Recombinant COVID-19 vaccine (Sf9 Cell) in a population aged 18 years and above who have completed homologous primary vaccination with either Inactivated or mRNA or Viral Vector COVID-19 vaccines at least 6 months prior to enrolment. The study uses a non-inferiority design to compare between schedules with Recombinant COVID-19 Vaccine (Sf9 Cell) versus COVID-19 Vaccine (Vero Cell), Inactivated as the booster dose. Participants, laboratory and analysing statisticians will remain blind to treatment allocation.
A total of 450 participants will be enrolled (participants aged ≥ 60 years account for approximately 10%), consisting of 3 cohorts:
150 participants who received 2 doses of Inactivated COVID-19 vaccines with the second dose at least 6 months (≥180 days) prior to enrolment.
150 participants who received 2 doses of mRNA COVID-19 vaccines with the second dose at least 6 months (≥180 days) prior to enrolment.
150 participants who received 2 doses of Viral Vector COVID-19 vaccines with the second dose at least 6 months (≥180 days) prior to enrolment.
Each of 3 cohorts of 150 participants will be randomized 1:1 to receive a single dose of Recombinant COVID-19 vaccine (Sf9 Cell) (test group) or the COVID-19 Vaccine (Vero Cell), Inactivated (control group).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Inactivated COVID-19 vaccines cohort group 1 | Experimental | Biological: Recombinant COVID-19 Vaccine (Sf9 Cell)Participants who received 2 doses of Inactivated COVID-19 vaccines with the second dose at least 6 months (≥180 days) prior to enrolment. N=75 Intervention: Recombinant COVID-19 Vaccine (Sf9 Cell) |
| Inactivated COVID-19 vaccines cohort group 2 | Active comparator | Biological: COVID-19 Vaccine (Vero Cell), InactivatedParticipants who received 2 doses of Inactivated COVID-19 vaccines with the second dose at least 6 months (≥180 days) prior to enrolment. N=75 Intervention: COVID-19 Vaccine (Vero Cell), Inactivated |
| mRNA COVID-19 vaccines cohort group 1 | Experimental | Biological: Recombinant COVID-19 Vaccine (Sf9 Cell)Participants who received 2 doses of mRNA COVID-19 vaccines with the second dose at least 6 months (≥180 days) prior to enrolment. N=75 Intervention: Recombinant COVID-19 Vaccine (Sf9 Cell) |
| mRNA COVID-19 vaccines cohort group 2 | Active comparator | Biological: COVID-19 Vaccine (Vero Cell), InactivatedParticipants who received 2 doses of mRNA COVID-19 vaccines with the second dose at least 6 months (≥180 days) prior to enrolment. N=75 Intervention: COVID-19 Vaccine (Vero Cell), Inactivated |
| Viral Vector COVID-19 vaccines cohort group 1 | Experimental | Biological: Recombinant COVID-19 Vaccine (Sf9 Cell)Participants who received 2 doses of Viral Vector COVID-19 vaccines with the second dose at least 6 months (≥180 days) prior to enrolment. N=75 Intervention: Recombinant COVID-19 Vaccine (Sf9 Cell) |
| Viral Vector COVID-19 vaccines cohort group 2 | Active comparator | Biological: COVID-19 Vaccine (Vero Cell), InactivatedParticipants who received 2 doses of Viral Vector COVID-19 vaccines with the second dose at least 6 months (≥180 days) prior to enrolment. N=75 Intervention: COVID-19 Vaccine (Vero Cell), Inactivated |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1. Participant is willing and able to give written informed consent for participation in the trial.
- 2. Male or Female, aged 18 years or above and in good health as determined by a trial clinician.
- 3. Female participants of childbearing potential must be willing to ensure that they or their partner use effective contraception from 1 month prior to first immunisation continuously until 3 months after boost immunisation. See Section "Contraception and Pregnancy" for definition of child-bearing potential and definition of effective contraception.
- 4. In the Investigator's opinion, is able and willing to comply with all trial requirements.
- 5. Willing to allow investigators to discuss the volunteer's medical history with their General Practitioner and access all medical records when relevant to study procedures.
Key exclusion criteria (9 listed)
- 1. Receipt of any vaccine (licensed or investigational) other than the study intervention within 30 days before and after each study vaccination (one week for licensed seasonal influenza vaccine or pneumococcal vaccine)
- 2. Prior or planned receipt of any other investigational or licensed vaccine or product likely to impact on interpretation of the trial data (e.g. adenovirus vectored vaccines, any coronavirus vaccines)
- 3. Positive SARS-CoV-2 RT-PCR at screening.
- 4. Participants who are pregnant at enrolment or planning to become pregnant during the first 3 months following vaccination.
- 5. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccines.
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 |
|---|---|---|
| Recombinant COVID-19 Vaccine (Sf9 Cell)1dose, Intramuscular Injection | Biological | Inactivated COVID-19 vaccines cohort group 1, Viral Vector COVID-19 vaccines cohort group 1, mRNA COVID-19 vaccines cohort group 1 |
| COVID-19 Vaccine (Vero Cell), Inactivated1dose, Intramuscular Injection | Biological | Inactivated COVID-19 vaccines cohort group 2, Viral Vector COVID-19 vaccines cohort group 2, mRNA COVID-19 vaccines cohort group 2 |
Primary outcome
Incidence of adverse drug reactions (ADRs)
Time frame: Day 0-28 post-boost dose.
Geometric mean titer (GMT) of specific neutralizing antibody (Virus or Pseudovirus Neutralization Assay) against SARS-CoV-2
Time frame: Day 14 post-boost dose.
Seroconversion rate (≥ 4 folds increase from baseline) of serum anti-SARS-CoV-2 neutralizing antibody titers
Time frame: Day 14 post-boost dose.
8 secondary outcomes
Incidence of adverse events (AEs)
Time frame: Day 0-7 post-boost dose
Incidence of AEs
Time frame: Day 0-28 post-boost dose
Incidence of serious adverse events (SAEs)
Time frame: Day 0 through 6 months post-boost dose
The percentage of participants with abnormal hematology, chemistry and urinalysis laboratory values
Time frame: Day 3 post-boost dose
The percentage of participants with grading shifts in hematology, chemistry and urinalysis laboratory assessments between baseline and 3 days after the booster dose.
Time frame: Day 3 post-boost dose
GMT of specific neutralizing antibody (Virus or Pseudovirus Neutralization Assay) against SARS-CoV-2
Time frame: Day 28, month 3 and month 6 post-boost dose
Geometric mean increase (GMI) of specific neutralizing antibody (Virus or Pseudovirus Neutralization Assay) against SARS-CoV-2
Time frame: Day 14, day 28, month 3 and month 6 post-boost dose
GMT and GMI of IgG antibodies against SARS-CoV-2 S protein RBD
Time frame: Day 14, day 28, month 3 and month 6 post-boost dose
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 24 Apr 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Recombinant COVID-19 Vaccine (Sf9 Cell) and COVID-19 Vaccine (Vero Cell), Inactivated in people with COVID-19 and SARS-CoV-2 Infection, run by WestVac Biopharma Co., Ltd. at 1 site in Philippines.
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 7 inclusion and 9 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 24 Apr 2024. 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 Philippines. 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?
Incidence of adverse drug reactions (ADRs) (time frame: Day 0-28 post-boost dose.). 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?
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 24 Apr 2024.