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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
410
1dose, Intramuscular Injection
1dose, Intramuscular Injection
Iloilo Doctors Hospital
Iloilo City, Philippines
Incidence of adverse drug reactions (ADRs)
Time frame: 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.
Seroconversion rate (≥ 4 folds increase from baseline) of serum anti-SARS-CoV-2 neutralizing antibody titers
Time frame: Day 14 post-boost dose.
Incidence of adverse events (AEs)
Time frame: Day 0-7 post-boost dose
Incidence of AEs
Time frame: Day 0-28 post-boost dose
Incidence of serious adverse events (SAEs)
Time frame: 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
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
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
Geometric mean increase (GMI) of specific neutralizing antibody (Virus or Pseudovirus Neutralization Assay) against SARS-CoV-2
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Time frame: 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