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

NCT05463354 | Completed Phase 2

• 1 other identifier: WSTVC001
• Study Type: interventional
• Target: 410
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; SARS-CoV-2 Infection

Outcome Measures

Primary Outcomes (3)

• Incidence of adverse drug reactions (ADRs)

  Day 0-28 post-boost dose.

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

  Day 14 post-boost dose.

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

  Day 14 post-boost dose.

Secondary Outcomes (8)

• Incidence of adverse events (AEs)

  Day 0-7 post-boost dose

• Incidence of AEs

  Day 0-28 post-boost dose

• Incidence of serious adverse events (SAEs)

  Day 0 through 6 months post-boost dose

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

  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.

  Day 3 post-boost dose

Study Arms (6)

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)

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

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)

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

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)

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

Biological: COVID-19 Vaccine (Vero Cell), Inactivated

Interventions

Recombinant COVID-19 Vaccine (Sf9 Cell) BIOLOGICAL

1dose, Intramuscular Injection

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), Inactivated BIOLOGICAL

1dose, Intramuscular Injection

Inactivated COVID-19 vaccines cohort group 2; Viral Vector COVID-19 vaccines cohort group 2; mRNA COVID-19 vaccines cohort group 2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Participant is willing and able to give written informed consent for participation in the trial.
• \. Male or Female, aged 18 years or above and in good health as determined by a trial clinician.
• \. 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.
• \. In the Investigator's opinion, is able and willing to comply with all trial requirements.
• \. 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.
• \. Agreement to refrain from blood donation during the study.
• \. 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.

You may not qualify if:

• \. 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)
• \. 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)
• \. Positive SARS-CoV-2 RT-PCR at screening.
• \. Participants who are pregnant at enrolment or planning to become pregnant during the first 3 months following vaccination.
• \. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccines.
• \. 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).
• \. History of allergic disease or reactions likely to be exacerbated by any component of study vaccines.
• \. Any history of anaphylaxis.
• \. Current diagnosis of or treatment for cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).

Sponsors & Collaborators

• WestVac Biopharma Co., Ltd.: lead

Study Sites (1)

Iloilo Doctors Hospital

Iloilo City, Philippines

Location

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Vaccines

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2022
• First Posted: July 19, 2022
• Study Start: July 11, 2022
• Primary Completion: August 18, 2022
• Study Completion: January 26, 2024
• Last Updated: April 24, 2024

Record last verified: 2024-03

Locations

PH (1)