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

Primary Purpose

COVID-19, SARS-CoV-2 Infection

Status

Recruiting

Phase

Phase 2

Locations

Philippines

Study Type

Interventional

Intervention

Recombinant COVID-19 Vaccine (Sf9 Cell)

COVID-19 Vaccine (Vero Cell), Inactivated

About this trial

This is an interventional prevention trial for COVID-19

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

Iloilo Doctors HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Inactivated COVID-19 vaccines cohort group 1

Inactivated COVID-19 vaccines cohort group 2

mRNA COVID-19 vaccines cohort group 1

mRNA COVID-19 vaccines cohort group 2

Viral Vector COVID-19 vaccines cohort group 1

Viral Vector COVID-19 vaccines cohort group 2

Arm Description

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)

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

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)

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

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)

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

Outcomes

Primary Outcome Measures

Incidence of adverse drug reactions (ADRs)

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

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

Secondary Outcome Measures

Incidence of adverse events (AEs)

Incidence of AEs

Incidence of serious adverse events (SAEs)

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

The percentage of participants with grading shifts in hematology, chemistry and urinalysis laboratory assessments between baseline and 3 days after the booster dose.

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

Geometric mean increase (GMI) of specific neutralizing antibody (Virus or Pseudovirus Neutralization Assay) against SARS-CoV-2

GMT and GMI of IgG antibodies against SARS-CoV-2 S protein RBD

Full Information

NCT ID

NCT05463354

First Posted

July 18, 2022

Last Updated

January 31, 2023

Sponsor

WestVac Biopharma Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05463354

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Recruiting

Study Start Date

July 11, 2022 (Actual)

Primary Completion Date

February 2023 (Anticipated)

Study Completion Date

July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

WestVac Biopharma Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

Brief Summary

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19, SARS-CoV-2 Infection

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Inactivated COVID-19 vaccines cohort group 1

Arm Type

Experimental

Arm Description

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)

Arm Title

Inactivated COVID-19 vaccines cohort group 2

Arm Type

Active Comparator

Arm Description

Arm Title

mRNA COVID-19 vaccines cohort group 1

Arm Type

Experimental

Arm Description

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)

Arm Title

mRNA COVID-19 vaccines cohort group 2

Arm Type

Active Comparator

Arm Description

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

Arm Title

Viral Vector COVID-19 vaccines cohort group 1

Arm Type

Experimental

Arm Description

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)

Arm Title

Viral Vector COVID-19 vaccines cohort group 2

Arm Type

Active Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

Recombinant COVID-19 Vaccine (Sf9 Cell)

Intervention Description

1dose, Intramuscular Injection

Intervention Type

Biological

Intervention Name(s)

COVID-19 Vaccine (Vero Cell), Inactivated

Intervention Description

1dose, Intramuscular Injection

Primary Outcome Measure Information:

Title

Incidence of adverse drug reactions (ADRs)

Time Frame

Day 0-28 post-boost dose.

Title

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

Time Frame

Day 14 post-boost dose.

Title

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 Measure Information:

Title

Incidence of adverse events (AEs)

Time Frame

Day 0-7 post-boost dose

Title

Incidence of AEs

Time Frame

Day 0-28 post-boost dose

Title

Incidence of serious adverse events (SAEs)

Time Frame

Day 0 through 6 months post-boost dose

Title

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

Time Frame

Day 3 post-boost dose

Title

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

Title

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

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Anjuli May P. Jaen, MD

Phone

(+63) 9177111064

anjulimay@yahoo.com

Facility Information:

Facility Name

Iloilo Doctors Hospital

City

Iloilo City

Country

Philippines

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anjuli May P. Jaen, MD

Phone

(+63) 9177111064

anjulimay@yahoo.com

First Name & Middle Initial & Last Name & Degree

Anjuli May P. Jaen, MD

12. IPD Sharing Statement

Learn more about this trial

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

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