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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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 |
|
| 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) |
|
| 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 |
|
| Viral Vector COVID-19 vaccines cohort group 1 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant COVID-19 Vaccine (Sf9 Cell) | Biological | 1dose, Intramuscular Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Iloilo Doctors Hospital | Iloilo City | Philippines |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000086663 | COVID-19 Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| 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) |
|
| 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 |
|
| COVID-19 Vaccine (Vero Cell), Inactivated | Biological | 1dose, Intramuscular Injection |
|
| 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 |
| GMT of specific neutralizing antibody (Virus or Pseudovirus Neutralization Assay) against SARS-CoV-2 | 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 | 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 | Day 14, day 28, month 3 and month 6 post-boost dose |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |