Safety and Immunogenicity of Recombinant COVID-19 Vaccine (Sf9 Cell) as a Booster

April 23, 2024 updated by: WestVac Biopharma Co., Ltd.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
410

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Philippines
      • Iloilo City, Philippines
        • Iloilo Doctors Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).
  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Inactivated COVID-19 vaccines cohort group 1
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)
Biological: Recombinant COVID-19 Vaccine (Sf9 Cell)
1dose, Intramuscular Injection
Active Comparator: Inactivated COVID-19 vaccines cohort group 2
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
Biological: COVID-19 Vaccine (Vero Cell), Inactivated
1dose, Intramuscular Injection
Experimental: mRNA COVID-19 vaccines cohort group 1
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)
Biological: Recombinant COVID-19 Vaccine (Sf9 Cell)
1dose, Intramuscular Injection
Active Comparator: mRNA COVID-19 vaccines cohort group 2
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
Biological: COVID-19 Vaccine (Vero Cell), Inactivated
1dose, Intramuscular Injection
Experimental: Viral Vector COVID-19 vaccines cohort group 1
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)
Biological: Recombinant COVID-19 Vaccine (Sf9 Cell)
1dose, Intramuscular Injection
Active Comparator: Viral Vector COVID-19 vaccines cohort group 2
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
Biological: COVID-19 Vaccine (Vero Cell), Inactivated
1dose, Intramuscular Injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Incidence of adverse drug reactions (ADRs)
Time Frame: Day 0-28 post-boost dose.
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.
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.
Day 14 post-boost dose.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Incidence of adverse events (AEs)
Time Frame: Day 0-7 post-boost dose
Day 0-7 post-boost dose
Incidence of AEs
Time Frame: Day 0-28 post-boost dose
Day 0-28 post-boost dose
Incidence of serious adverse events (SAEs)
Time Frame: Day 0 through 6 months post-boost dose
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
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
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
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
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
Day 14, day 28, month 3 and month 6 post-boost dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
WestVac Biopharma Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 11, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 18, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 26, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 18, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 19, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WSTVC001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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