A Phase Ⅱ Clinical Trial of Recombinant Corona Virus Disease-19 (COVID-19) Vaccine (Sf9 Cells)
- Conditions
- COVID-19
- Interventions
- Biological: High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimenBiological: High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimenBiological: High-dose placebo (18-59 years) & Three dose regimenBiological: Low-dose placebo (60-85 years) & Three dose regimenBiological: Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimenBiological: High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimenBiological: High-dose placebo (60-85 years) & Three dose regimenBiological: Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimenBiological: Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimenBiological: High-dose placebo (60-85 years) & Two dose regimenBiological: High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimenBiological: High-dose placebo (18-59 years) & Two dose regimenBiological: Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimenBiological: Low-dose placebo (18-59 years) & Two dose regimenBiological: Low-dose placebo (18-59 years) & Three dose regimenBiological: Low-dose placebo (60-85 years) & Two dose regimen
- Registration Number
- NCT04640402
- Brief Summary
This is a phase Ⅱ, single-center, randomized, double-blind, placebo-controlled study, to evaluate the immunogenicity and safety of the recombinant COVID-19 vaccine (Sf9 cells) in the subjects from healthy adults and elderly adults aged 18 years and above (aged 18-60 and 60-85 years) with different immunization procedures (0, 21 days and 0, 14, 28 days) and doses (20μg/40μg).
- Detailed Description
This is a phase Ⅱ, single-center, randomized, double-blind, placebo-controlled study, to evaluate the immunogenicity and safety of the recombinant COVID-19 vaccine (Sf9 cells) in the subjects from healthy adults and elderly adults aged 18 years and above (aged 18-60 and 60-85 years) . The phase Ⅱ clinical trials designed 8 research group, including two immunization procedures (0, 21 days and 0, 14, 28 days), two doses (20μg/0.5ml, 40μg/1.0ml) and two ages group (adults and elder): Each group including 120 participants. Vaccination or placebo group will be randomly assigned to receive in a 5:1 ratio, 960 in total.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 960
- Aged 18 years and above.
- Able to understand the content of informed consent and willing to sign the informed consent.
- Able and willing to complete all the secluded study process during the whole study follow-up period (about 7 months).
- Axillary temperature ≤37.0℃.
- General good health as established by medical history and physical examination.
First dose exclusion criteria:
- Positive serum immunoglobulin M (IgM) and IgG to the SARS-CoV-2.
- A Known History of HIV infection
- Family history of seizure, epilepsy, brain or mental disease.
- Participant that has an allergic history to any ingredient of vaccines.
- Woman who is pregnant, breast-feeding or positive in pregnancy test on day of enrollment, or is planning to be pregnant during the next 6 months.
- Any acute fever disease or infections.
- Have a medical history of SARS.
- Have serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension and not well-controlled.
- Major chronic illness, such as asthma, diabetes, or thyroid disease, and not well-controlled.
- Hereditary angioneurotic edema or acquired angioneurotic edema.
- Urticaria in last one year.
- Asplenia or functional asplenia.
- Platelet disorder or other bleeding disorder may cause injection contraindication.
- Faint at the sight of blood or needles.
- Prior administration of immunodepressant or corticosteroids, antianaphylactics treatment, cytotoxic treatment in last 6 months.
- Prior administration of blood products in last 4 months.
- Prior administration of other research medicines in last 1 month.
- Prior administration of attenuated vaccine in last 1 month.
- Prior administration of subunit vaccine or inactivated vaccine in last 14 days.
- Being treated for tuberculosis.
- Any condition that in the opinion of the investigators may interfere with the evaluation of study objectives.
Exclusion criteria for subsequent doses:
- Patients with severe allergic reactions after the previous dose of vaccination;
- Patients with serious adverse events causally related to the previous dose of vaccination.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High-dose vaccine (18-59 years) & Two dose regimen High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen two doses of high-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21. High-dose vaccine (18-59 years) & Three dose regimen High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimen three doses of high-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28. High-dose placebo (18-59 years) & Three dose regimen High-dose placebo (18-59 years) & Three dose regimen three doses of placebo at the schedule of day 0, 14, 28. Low-dose placebo (60-85 years) & Three dose regimen Low-dose placebo (60-85 years) & Three dose regimen three doses of placebo at the schedule of day 0, 14, 28. Low-dose vaccine (18-59 years) & Two dose regimen Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen two doses of low-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21. High-dose vaccine (60-85 years) & Three dose regimen High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimen three doses of high-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28. High-dose placebo (60-85 years) & Three dose regimen High-dose placebo (60-85 years) & Three dose regimen three doses of placebo at the schedule of day 0, 14, 28. Low-dose vaccine (18-59 years) & Three dose regimen Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimen three doses of low-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28. Low-dose vaccine (60-85 years) & Two dose regimen Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimen two doses of low-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21. High-dose placebo (60-85 years) & Two dose regimen High-dose placebo (60-85 years) & Two dose regimen two doses of placebo at the schedule of day 0, 21. High-dose vaccine (60-85 years) & Two dose regimen High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimen two doses of high-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21. High-dose placebo (18-59 years) & Two dose regimen High-dose placebo (18-59 years) & Two dose regimen two doses of placebo at the schedule of day 0, 21. Low-dose vaccine (60-85 years) & Three dose regimen Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimen three doses of low-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28. Low-dose placebo (18-59 years) & Two dose regimen Low-dose placebo (18-59 years) & Two dose regimen two doses of placebo at the schedule of day 0, 21. Low-dose placebo (18-59 years) & Three dose regimen Low-dose placebo (18-59 years) & Three dose regimen three doses of placebo at the schedule of day 0, 14, 28. Low-dose placebo (60-85 years) & Two dose regimen Low-dose placebo (60-85 years) & Two dose regimen two doses of placebo at the schedule of day 0, 21.
- Primary Outcome Measures
Name Time Method Geometric mean (GMT) of specific antibody 1 months after immunization in each study group Geometric mean (GMT) of specific antibody against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Spike protein Receptor-binding domain(S-RBD) protein (ELISA)
The incidence of adverse reaction (AR) 0 to 7 days after vaccination in each study group The incidence of adverse reaction (AR)
- Secondary Outcome Measures
Name Time Method The incidence of adverse events (AE) 0 to 28 days after vaccination in each study group The incidence of adverse events (AE)
The incidence of severe adverse events (SAE) 0 to 28 days after vaccination in each study group The incidence of severe adverse events (SAE)
The incidence of serious adverse events 6 months after vaccination in each study group The incidence of serious adverse events
Geometric mean (GMT) of anti-SARS-CoV-2-specific neutralizing antibodies 14 days after immunization in each study group Geometric mean (GMT) of anti-SARS-CoV-2-specific neutralizing antibodies (euvirus and pseudovirus-neutralizing assays)
The positive conversion rate of S-RBD protein-specific antibody 14 days, 30 days after immunization in each study group The positive conversion rate of S-RBD protein-specific antibody (ELISA) against SARS-CoV-2
Geometric mean fold increase (GMI) of S-RBD protein-specific antibody 14 days, 30 days after immunization in each study group Geometric mean fold increase (GMI) of S-RBD protein-specific antibody (ELISA) against SARS-CoV-2
The positive conversion rate of anti-SARS-CoV-2 specific neutralizing antibody 14 days, 30 days after immunization in each study group The positive conversion rate of anti-SARS-CoV-2 specific neutralizing antibody (euvirus and pseudovirus neutralization test)
Geometric mean fold increase (GMI) of anti-SARS-CoV-2 specific neutralizing antibodies 14 days, 30 days after immunization in each study group Geometric mean fold increase (GMI) of anti-SARS-CoV-2 specific neutralizing antibodies (eucivirus and pseudovirus neutralization assays)
Trial Locations
- Locations (1)
Jiangsu Provincial Center for Diseases Control and Prevention
🇨🇳Nanjing, Jiangsu, China