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

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ClinicalTrials.gov Identifier: NCT05463354
Recruitment Status : Recruiting
First Posted : July 19, 2022
Last Update Posted : February 2, 2023
Sponsor:
Information provided by (Responsible Party):
WestVac Biopharma Co., Ltd.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
COVID-19 SARS-CoV-2 Infection Biological: Recombinant COVID-19 Vaccine (Sf9 Cell) Biological: COVID-19 Vaccine (Vero Cell), Inactivated Phase 2

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : July 11, 2022
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05463354


Contacts
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Contact: Anjuli May P. Jaen, MD (+63) 9177111064 anjulimay@yahoo.com

Locations
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Philippines
Iloilo Doctors Hospital Recruiting
Iloilo City, Philippines
Contact: Anjuli May P. Jaen, MD    (+63) 9177111064    anjulimay@yahoo.com   
Principal Investigator: Anjuli May P. Jaen, MD         
Sponsors and Collaborators
WestVac Biopharma Co., Ltd.
More Information
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Responsible Party: WestVac Biopharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT05463354    
Other Study ID Numbers: WSTVC001
First Posted: July 19, 2022    Key Record Dates
Last Update Posted: February 2, 2023
Last Verified: July 2022

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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
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs