COVID-19Phase 2NCT04718467
Phase IIb Clinical Trial of Recombinant Novel Coronavirus Pneumonia (COVID-19) Vaccine (Sf9 Cells)
A Phase 2 study testing Recombinant COVID-19 vaccine (Sf9 cells) in people with COVID-19, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.
Trial summary
This is a phase Ⅱb, 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 18-59 and 60-85 years) with immunization procedures 0… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Recombinant COVID-19 vaccine (Sf9 cells)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2021to 15 Mar 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18-85 years old
- 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 14 months).
- Axillary temperature ≤37.0℃
Who cannot join
- Positive serum immunoglobulin M (IgM) and immunoglobulin G (IgG) to the SARS-CoV-2.
- SARS-CoV-2 nucleic acid testing positive.
- History of SARS-CoV-2 infection or vaccination
- 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.
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- Woman who is pregnant, breast-feeding or positive in pregnancy test on day of enrollment, or is planning to be pregnant during the next 14 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.
- Malignant tumor, activity or have been treated tumor and no clear have cured, or during the study period is likely to relapse.
- 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.
- Nearly 7 days, all sorts of acute onset of disease or chronic diseases, such as receiving anti-tuberculosis treatment, history of asthma.
- According to the investigator's judgment, due to various medical, psychological, social or other conditions, it is contrary to the trial protocol or affects the subjects to sign informed consent.
- Appear systemic allergic reaction, severe allergic reactions.
- Appear difficult to tolerate more than grade 3 adverse reactions.
- New discovery or a new happened after the first vaccination does not conform to the first dose of the inclusion criteria or conform to the first dose of exclusion criteria, determine whether or not to continue to participate in the study by the investigators.
- Investigators think of other reasons.
Trial locations and contacts
1 site in 1 country.
China1 site
Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, 210009
About this study
Official title: A Single-center, Randomized, Double-Blinded, Placebo-Controlled, Phase Ⅱb Clinical Trial of Recombinant COVID-19 Vaccine (Sf9 Cells), in the Subjects From Healthy Aged 18 to 85 Years Old
This is a phase Ⅱb, 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 18-59 and 60-85 years) with immunization procedures 0, 21, 42 days and doses 40μg.
Read the detailed description
This is a phase Ⅱb, 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 18-59 and 60-85 years) . The phase Ⅱb clinical trials designed two research group, including adults group (aged 18-59 years) and elderly adults group (aged 60-85 years). Each group including 2000 participants. Vaccination or placebo group will be randomly assigned to receive in a 3:1 ratio, 4000 in total.
- Conditions
- COVID-19
- Being tested
- Recombinant COVID-19 vaccine (Sf9 cells), Placebo
- Keywords
- Safety, Immunogenicity, COVID-19 Vaccine, Recombinant vaccine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant COVID-19 vaccine (Sf9 cells)Biological
Three doses of Recombinant COVID-19 vaccine (Sf9 cells) (40μg) at the schedule of day 0, 21, 42.
PlaceboBiological
Three doses of Placebo (1.0ml) at the schedule of day 0, 21, 42.
| Study group | Role | What they receive |
|---|---|---|
| adults group (aged 18-59 years) & vaccine | Experimental | three doses of 40μg Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21, 42. Receives: Biological: Recombinant COVID-19 vaccine (Sf9 cells) |
| adults group (aged 18-59 years) & placebo | Placebo comparator | three doses of placebo at the schedule of day 0, 21, 42. Receives: Biological: Placebo |
| elderly adults group (aged 60-85 years) & vaccine | Experimental | three doses of 40μg Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21, 42. Receives: Biological: Recombinant COVID-19 vaccine (Sf9 cells) |
| elderly adults group (aged 60-85 years) & placebo | Placebo comparator | three doses of placebo at the schedule of day 0, 21, 42. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of adverse reaction (AR)
The incidence of adverse reaction (AR)
Measured: 0 to 7 days after each dose
The incidence of Adverse Events of Special Interest (AESI)
The incidence of Adverse Events of Special Interest (AESI)
Measured: from day 0 to day 60 after last dose
Secondary outcomes (9)
The incidence of adverse events (AE)
The incidence of adverse events (AE)
Measured: from day 0 to day 30 after last dose
The incidence of grade 3 adverse events (AE)
The incidence of grade 3 adverse events (AE)
Measured: from day 0 to day 30 after last dose
The incidence of severe adverse events (SAE)
The incidence of severe adverse events (SAE)
Measured: Month 12 after the whole process of vaccination
Geometric mean (GMT) of specific antibody
Geometric mean (GMT) of specific antibody against Severe Acute Respiratory Syndrome Coronavirus 2 (SARSCoV-2) Spike protein Receptor-binding domain(S-RBD) protein (ELISA) in immunogenicity subgroup.
Measured: day 30, day 60, month 6, month 12 after last dose
Geometric mean (GMT) of anti-SARS-CoV-2-specific neutralizing antibodies
Geometric mean (GMT) of anti-SARS-CoV-2-specific neutralizing antibodies (euvirus and pseudovirus-neutralizing assays)
Measured: day 30, day 60, month 6, month 12 after last dose
The positive conversion rate of S-RBD protein-specific antibody
The positive conversion rate of S-RBD protein-specific antibody (ELISA) against SARS-CoV-2
Measured: day 30, day 60, month 6, month 12 after last dose
Geometric mean fold increase (GMI) of S-RBD protein-specific antibody
Geometric mean fold increase (GMI) of S-RBD protein-specific antibody (ELISA) against SARS-CoV-2
Measured: day 30, day 60, month 6, month 12 after last dose
The positive conversion rate of anti-SARS-CoV-2 specific neutralizing antibody
The positive conversion rate of anti-SARS-CoV-2 specific neutralizing antibody (euvirus and pseudovirus neutralization test)
Measured: day 30, day 60, month 6, month 12 after last dose
Geometric mean fold increase (GMI) of anti-SARS-CoV-2 specific neutralizing antibodies
Geometric mean fold increase (GMI) of anti-SARS-CoV-2 specific neutralizing antibodies (eucivirus and pseudovirus neutralization assays)
Measured: day 30, day 60, month 6, month 12 after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Feb 2021 (estimated)
- Primary completion15 May 2021 (estimated)
- Study completion15 Mar 2022 (estimated)
Why it stopped: Sponsor decided to cancel this trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Province Centers for Disease Control and Prevention
- Sponsor type
- Research network
- Collaborators
- West China Hospital
- Responsible party
- Sponsor
- Investigators
- Fengcai Zhu, Doctor, Principal investigator, Jiangsu Province Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04718467
- Sponsor's protocol ID
- JSVCT107
- Status last verified
- May 2021
- First submitted
- 20 Jan 2021
- Last updated
- 25 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Double-Blinded, Placebo-Controlled, Phase Ⅱb Clinical Trial of Recombinant COVID-19 Vaccine (Sf9 Cells), in the Subjects From Healthy Aged 18 to 85 Years Old
- ClinicalTrials.gov ID
- NCT04718467
- Acronym / sponsor ID
- JSVCT107
- Conditions
- COVID-19
- Keywords
- Safety, Immunogenicity, COVID-19 Vaccine, Recombinant vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decided to cancel this trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jiangsu Province Centers for Disease Control and PreventionResearch network
- Collaborators
- West China Hospital
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 15 May 2021 (estimated)
- Study completion
- 15 Mar 2022 (estimated)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase Ⅱb, 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 18-59 and 60-85 years) with immunization procedures 0, 21, 42 days and doses 40μg.
Detailed description
This is a phase Ⅱb, 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 18-59 and 60-85 years) . The phase Ⅱb clinical trials designed two research group, including adults group (aged 18-59 years) and elderly adults group (aged 60-85 years). Each group including 2000 participants. Vaccination or placebo group will be randomly assigned to receive in a 3:1 ratio, 4000 in total.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| adults group (aged 18-59 years) & vaccine | Experimental | Biological: Recombinant COVID-19 vaccine (Sf9 cells)three doses of 40μg Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21, 42. |
| adults group (aged 18-59 years) & placebo | Placebo comparator | Biological: Placebothree doses of placebo at the schedule of day 0, 21, 42. |
| elderly adults group (aged 60-85 years) & vaccine | Experimental | Biological: Recombinant COVID-19 vaccine (Sf9 cells)three doses of 40μg Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21, 42. |
| elderly adults group (aged 60-85 years) & placebo | Placebo comparator | Biological: Placebothree doses of placebo at the schedule of day 0, 21, 42. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18-85 years old
- 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 14 months).
- Axillary temperature ≤37.0℃
Key exclusion criteria (28 listed)
- Positive serum immunoglobulin M (IgM) and immunoglobulin G (IgG) to the SARS-CoV-2.
- SARS-CoV-2 nucleic acid testing positive.
- History of SARS-CoV-2 infection or vaccination
- A Known History of HIV infection
- Family history of seizure, epilepsy, brain or mental disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant COVID-19 vaccine (Sf9 cells)Three doses of Recombinant COVID-19 vaccine (Sf9 cells) (40μg) at the schedule of day 0, 21, 42. | Biological | adults group (aged 18-59 years) & vaccine, elderly adults group (aged 60-85 years) & vaccine |
| PlaceboThree doses of Placebo (1.0ml) at the schedule of day 0, 21, 42. | Biological | adults group (aged 18-59 years) & placebo, elderly adults group (aged 60-85 years) & placebo |
Primary outcome
The incidence of adverse reaction (AR)
Time frame: 0 to 7 days after each dose
The incidence of adverse reaction (AR)
The incidence of Adverse Events of Special Interest (AESI)
Time frame: from day 0 to day 60 after last dose
The incidence of Adverse Events of Special Interest (AESI)
9 secondary outcomes
The incidence of adverse events (AE)
Time frame: from day 0 to day 30 after last dose
The incidence of grade 3 adverse events (AE)
Time frame: from day 0 to day 30 after last dose
The incidence of severe adverse events (SAE)
Time frame: Month 12 after the whole process of vaccination
Geometric mean (GMT) of specific antibody
Time frame: day 30, day 60, month 6, month 12 after last dose
Geometric mean (GMT) of anti-SARS-CoV-2-specific neutralizing antibodies
Time frame: day 30, day 60, month 6, month 12 after last dose
The positive conversion rate of S-RBD protein-specific antibody
Time frame: day 30, day 60, month 6, month 12 after last dose
Geometric mean fold increase (GMI) of S-RBD protein-specific antibody
Time frame: day 30, day 60, month 6, month 12 after last dose
The positive conversion rate of anti-SARS-CoV-2 specific neutralizing antibody
Time frame: day 30, day 60, month 6, month 12 after last dose
Geometric mean fold increase (GMI) of anti-SARS-CoV-2 specific neutralizing antibodies
Time frame: day 30, day 60, month 6, month 12 after last dose
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fengcai Zhu, Doctor principal investigator
Jiangsu Province Centers for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Recombinant COVID-19 vaccine (Sf9 cells) in people with COVID-19, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of adverse reaction (AR) (time frame: 0 to 7 days after each dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2021.