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CompletedNCT05463354Updated Apr 24, 2024

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

A Phase 2 interventional study of Recombinant COVID-19 Vaccine (Sf9 Cell) and COVID-19 Vaccine (Vero Cell), Inactivated in COVID-19 and SARS-CoV-2 Infection, sponsored by WestVac Biopharma Co., Ltd.. Completed at 1 site in Philippines. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-24.

Sponsored by WestVac Biopharma Co., Ltd. · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
410
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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 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).

02

Conditions studied

  • COVID-19
  • SARS-CoV-2 Infection

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03

In context

COVID-19

7,774 studies on the registry are indexed under COVID-19; 482 are open to participants now.

This study's enrollment of 410 is above the median of 100 across 4,175 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

WestVac Biopharma Co., Ltd. is the lead sponsor of 14 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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).
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
410 participants (actual)

Study arms

  • 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)

  • 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

  • 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)

  • 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

  • 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)

  • 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

Interventions

06

What researchers measure

Primary outcomes

  1. Incidence of adverse drug reactions (ADRs)

    Time frame: Day 0-28 post-boost dose.

  2. Geometric mean titer (GMT) of specific neutralizing antibody (Virus or Pseudovirus Neutralization Assay) against SARS-CoV-2

    Time frame: Day 14 post-boost dose.

  3. Seroconversion rate (≥ 4 folds increase from baseline) of serum anti-SARS-CoV-2 neutralizing antibody titers

    Time frame: Day 14 post-boost dose.

Secondary outcomes

  1. Incidence of adverse events (AEs)

    Time frame: Day 0-7 post-boost dose

  2. Incidence of AEs

    Time frame: Day 0-28 post-boost dose

  3. Incidence of serious adverse events (SAEs)

    Time frame: Day 0 through 6 months post-boost dose

  4. The percentage of participants with abnormal hematology, chemistry and urinalysis laboratory values

    Time frame: Day 3 post-boost dose

  5. 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

  6. 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

  7. 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

  8. 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

07

Study locations

1 site
  • Iloilo Doctors Hospital
    Iloilo City, Philippines
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2022 to primary completion in Aug 2022, 1 month.

Of 220 industry-sponsored phase 2 interventional studies under COVID-19, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 14. This study's 1 month is below that.

Counting every sponsor, half of 569 studies reached it within 9 months; a quarter within 5 and three quarters within 16.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 18, 2022
First posted
Jul 19, 2022
StartActual
Jul 11, 2022
Primary completionActual
Aug 18, 2022
CompletionActual
Jan 26, 2024
Last update
Apr 24, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05463354
Lead sponsor
WestVac Biopharma Co., Ltd.
Responsible party
Sponsor
First posted
Jul 19, 2022
Start date
Jul 11, 2022
Primary completion
Aug 18, 2022
Completion
Jan 26, 2024
Last update
Apr 24, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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