Phase I Trial of a Recombinant SARS-CoV-2 Vaccine (Sf9 Cell)

Safety, Tolerability and Immunogenicity of a Recombinant SARS-CoV-2 Vaccine (Sf9 Cell) in Chinese Healthy Population Aged 18 Years and Older: A Phase I, Single-center, Randomized, Placebo-controlled, Double-blind Study

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04530656

Enrollment

168

Registered

2020-08-28

Start date

2020-08-28

Completion date

2021-11-23

Last updated

2022-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Keywords

Safety, Tolerability, Immunogenicity, SARS-CoV-2 Vaccine, Recombinant vaccine

Brief summary

This is a phase I, single-center, randomized, placebo-controlled, double-blind study, to evaluate safety, tolerability and immunogenicity of a recombinant SARS-CoV-2 vaccine (Sf9 cell) in Chinese healthy population aged 18 years and older. After randomization, the trial for each subject will last for approximately 13 months. Screening period is 1 week prior to randomization (Day -7 to Day -1), and each dose of either SARS-CoV-2 vaccine (Sf9 Cell) or placebo will be given intramuscularly (IM) on Day 0 and Day 28 for a two-dose regimen, or on Day 0, Day 14, and Day 28 for a three-dose regimen. Subjects who are ≥18 years old and ≤ 55 years old will be enrolled in adult group, and healthy elderly population who are \>55 years old will be enrolled in elderly group. After adult group completes the follow-up 7 days after first vaccination, elderly group will be recruited.

Detailed description

This is a phase I, single-center, randomized, placebo-controlled, double-blind study, to evaluate safety, tolerability and immunogenicity of a recombinant SARS-CoV-2 vaccine (Sf9 cell) in Chinese healthy population aged 18 years and older. Healthy adults who are ≥18 years old and ≤55 years old will be enrolled in the adult group and healthy elderly population who are \>55 years old will be enrolled in the elderly group. To ensure the enrollment of healthy subjects, screening tests (hematology, biochemistry, and urinalysis) will be performed prior to the vaccination. In each age group, there are three regimen cohort: middle-dose at 0, 28 schedule, high-dose at 0, 28 schedule, and high-dose at 0,14,28 schedule. The subjects in regimen cohort will be randomized to receive vaccines or placebos at a ratio of 3:1. The study will set up an Independent Data Monitoring Committee (IDMC) to conduct overall supervision. The IDMC is required to review the unblinded data when a significant event or risk occurs in the study that might cause the study to be suspended.

Interventions

BIOLOGICALTwo doses of middle-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28

Two doses of middle-dose (20µg/ 0.5ml) recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28.

BIOLOGICALTwo doses of high-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28

Two doses of high-dose (40µg/ 1.0ml) recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28.

BIOLOGICALThree doses of high-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 14, 28

Three doses of high-dose (40µg/ 1.0ml) recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 14, 28

BIOLOGICALTwo doses of placebo at the schedule of day 0, 28（middle-dose group）

Two doses of placebo (0.5ml) at the schedule of day 0, 28

BIOLOGICALTwo doses of placebo at the schedule of day 0, 28（high-dose group）

Two doses of placebo (1.0ml) at the schedule of day 0, 28

BIOLOGICALThree doses of placebo at the schedule of day 0, 14, 28（high-dose group）

Three doses of placebo (1.0ml) at the schedule of day 0, 14, 28

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Male or female subjects of ≥ 18 years old with body mass index (BMI) ≥ 18.5 and ≤ 30 at the Screening Visit. * The subject can provide with informed consent and signs and dates a written informed consent form (ICF) prior to the initiation of any trial procedures. * They must be able to understand and follow trial-related instructions. * They must be willing and able to comply with planned visits, treatment schedule, laboratory tests and other requirements of the trial. * Negative HIV antibody when screening. * Axillary temperature ≤ 37.0ºC. * Negative in nucleic acid screening of SARS-CoV-2. * Negative in antibodies (IgG and IgM) screening of SARS-CoV-2. * No imaging features of COVID-19 in chest CT. * There were no significant abnormalities in blood routine, blood biochemistry, coagulation function and urine routine, or no clinical significance was determined by doctors (including white blood cell count, lymphocyte count, neutrophil count, platelet, hemoglobin, glutamic pyruvic transaminase ALT, glutamic oxaloacetic transaminase AST, total bilirubin, fasting blood glucose, creatinine, prothrombin time, partially activated prothrombin time, urine protein, urine red blood cells). * Healthy subjects who have been examined by medical history, physical examination and clinical examination are in accordance with the immunization of this vaccine.

Design outcomes

Primary

Measure	Time frame	Description
Occurrence of adverse reactions (AR) within 7 days after each dose of the recombinant SARS-CoV-2 vaccine (Sf9 cell) or placebo.	7 days after each dose.	Occurrence of solicited AR in the subjects within 7 days after each dose of recombinant SARS-CoV-2 vaccine (Sf9 cell) or placebo.

Secondary

Measure	Time frame	Description
Occurrence of AE up to Day 28 after prime and boost vaccination.	Day 28 after prime and boost vaccination.	Occurrence of subjects experiencing AE associated with recombinant SARS-CoV-2 vaccine (Sf9 cell) up to Day 28.
The proportion of SAEs up to Day 28 after prime and boost vaccination.	Day 28 after prime and boost vaccination.	The proportion of subjects experiencing SAEs up to Day 28 after prime and boost vaccination.
The proportion of SAEs up to Month 12 after prime and boost vaccination.	The proportion of subjects experiencing SAEs up to Month 12 after prime and boost vaccination.	Month 12 after prime and boost vaccination.
Four-fold increase in anti-RBD specific antibody titers, at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.	Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.	Four-fold increase in anti-RBD specific antibody titers, as compared to baseline, at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.
GMFI of anti-RBD specific antibody at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.	Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.	Geometric mean fold increase (GMFI) of anti-RBD specific antibody at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.
Occurrence of adverse events (AE) within 7 days after each dose of the recombinant SARS-CoV-2 vaccine (Sf9 cell) or placebo.	7 days after each dose.	Occurrence of solicited AE in the subjects within 7 days after each dose of recombinant SARS-CoV-2 vaccine (Sf9 cell) or placebo.
GMT of anti-RBD specific antibody at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.	Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.	Geometric mean titer (GMT) of anti-RBD specific antibody at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.
GMT of SARS-CoV-2 neutralizing antibody at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.	Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.	Geometric mean titer (GMT) of SARS-CoV-2 neutralizing antibody (including pseudovirus and live virus-based SARS-CoV-2 neutralizing antibody assay) at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after prime and boost vaccination.
Four-fold increase in SARS-CoV-2 neutralizing antibody titers, at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.	Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.	Four-fold increase in SARS-CoV-2 neutralizing antibody titers (including pseudovirus and live virus-based SARS-CoV-2 neutralizing antibody assay), as compared to baseline, at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.
GMFI of SARS-CoV-2 neutralizing antibody at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after prime and boost vaccination.	Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.	Geometric mean fold increase (GMFI) of SARS-CoV-2 neutralizing antibody (including pseudovirus and live virus-based SARS-CoV-2 neutralizing antibody assay) at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.
Seroconversion rates of IFN-γ stimulated by the overlapping peptide library of S-RBD protein at Day 14, Day 28 after boost vaccination.	Day 14, Day 28 after boost vaccination.	Seroconversion rates of IFN-γ stimulated by the overlapping peptide library of S-RBD protein at Day 14, Day 28 after boost vaccination.
The proportion of abnormal markers of hematology, blood chemistry and urine analysis within 7 days before prime vaccination and at Day 3 after each dose of recombinant SARS-CoV-2 vaccine (Sf9 cell) or placebo.	7 days before prime vaccination and Day 3 after each dose.	The proportion of subjects experiencing abnormal markers of hematology, blood chemistry and urine analysis within 7 days before prime vaccination and at Day 3 after each dose of recombinant SARS-CoV-2 vaccine (Sf9 cell) or placebo.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026