COVID-19Phase 2NCT04640402

A Phase Ⅱ Clinical Trial of Recombinant Corona Virus Disease-19 (COVID-19) Vaccine (Sf9 Cells)

A Phase 2 study testing Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen, Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimen and High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen in people with COVID-19, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for: COVID-19
What is being tested?: Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen, Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimen and High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen
Type of treatment: Vaccines
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 960 participants
Where: 1 siteChina
Study dates: 17 Nov 2020to 23 Nov 2021
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 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.

Who cannot join

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.

Show all 24Show fewer

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.
Patients with severe allergic reactions after the previous dose of vaccination;
Patients with serious adverse events causally related to the previous dose of vaccination.

Trial locations and contacts

1 site in 1 country.

China1 site

Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, 210009

Other trials in China

About this study

Official title: A Single-center, Randomized, Double-Blinded, Placebo-Controlled, Phase Ⅱ Clinical Trial of Recombinant COVID-19 Vaccine (Sf9 Cells), in the Subjects From Healthy Aged 18 Years and Above

Read the 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.

Conditions: COVID-19
Being tested: Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen, Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimen, High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen, High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimen, Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimen
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.

Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimenBiological
18-59 years group, two doses of low-dose (20µg/0.5ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.
Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimenBiological
18-59 years group, three doses of low-dose (20µg/0.5ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.
High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimenBiological
18-59 years group, two doses of high-dose (40µg/1.0ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.
High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimenBiological
18-59 years group, three doses of high-dose (40µg/1.0ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.
Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimenBiological
60-85 years group, two doses of low-dose (20µg/0.5ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.
Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimenBiological
60-85 years group, three doses of low-dose (20µg/0.5ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.
High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimenBiological
60-85 years group, two doses of high-dose (40µg/1.0ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.
High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimenBiological
60-85 years group, three doses of high-dose (40µg/1.0ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.
Low-dose placebo (18-59 years) & Two dose regimenBiological
18-59 years group, two doses of placebo(0.5ml) at the schedule of day 0, 21.
Low-dose placebo (18-59 years) & Three dose regimenBiological
18-59 years group, three doses of placebo(0.5ml) at the schedule of day 0, 14, 28.
High-dose placebo (18-59 years) & Two dose regimenBiological
18-59 years group, two doses of placebo(1.0ml) at the schedule of day 0, 21.
High-dose placebo (18-59 years) & Three dose regimenBiological
18-59 years group, three doses of placebo(1.0ml) at the schedule of day 0, 14, 28.
Low-dose placebo (60-85 years) & Two dose regimenBiological
60-85 years group, two doses of placebo(0.5ml) at the schedule of day 0, 21.
Low-dose placebo (60-85 years) & Three dose regimenBiological
60-85 years group, three doses of placebo(0.5ml) at the schedule of day 0, 14, 28.
High-dose placebo (60-85 years) & Two dose regimenBiological
60-85 years group, two doses of placebo(1.0ml) at the schedule of day 0, 21.
High-dose placebo (60-85 years) & Three dose regimenBiological
60-85 years group, three doses of placebo(1.0ml) at the schedule of day 0, 14, 28.

Study groups in NCT04640402
Study group	Role	What they receive
Low-dose vaccine (18-59 years) & Two dose regimen	Experimental	two doses of low-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21. Receives: Biological: Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen
Low-dose vaccine (18-59 years) & Three dose regimen	Experimental	three doses of low-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28. Receives: Biological: Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimen
High-dose vaccine (18-59 years) & Two dose regimen	Experimental	two doses of high-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21. Receives: Biological: High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen
High-dose vaccine (18-59 years) & Three dose regimen	Experimental	three doses of high-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28. Receives: Biological: High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimen
Low-dose vaccine (60-85 years) & Two dose regimen	Experimental	two doses of low-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21. Receives: Biological: Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimen
Low-dose vaccine (60-85 years) & Three dose regimen	Experimental	three doses of low-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28. Receives: Biological: Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimen
High-dose vaccine (60-85 years) & Two dose regimen	Experimental	two doses of high-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21. Receives: Biological: High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimen
High-dose vaccine (60-85 years) & Three dose regimen	Experimental	three doses of high-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28. Receives: Biological: High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimen
Low-dose placebo (18-59 years) & Two dose regimen	Placebo comparator	two doses of placebo at the schedule of day 0, 21. Receives: Biological: Low-dose placebo (18-59 years) & Two dose regimen
Low-dose placebo (18-59 years) & Three dose regimen	Placebo comparator	three doses of placebo at the schedule of day 0, 14, 28. Receives: Biological: Low-dose placebo (18-59 years) & Three dose regimen
High-dose placebo (18-59 years) & Two dose regimen	Placebo comparator	two doses of placebo at the schedule of day 0, 21. Receives: Biological: High-dose placebo (18-59 years) & Two dose regimen
High-dose placebo (18-59 years) & Three dose regimen	Placebo comparator	three doses of placebo at the schedule of day 0, 14, 28. Receives: Biological: High-dose placebo (18-59 years) & Three dose regimen
Low-dose placebo (60-85 years) & Two dose regimen	Placebo comparator	two doses of placebo at the schedule of day 0, 21. Receives: Biological: Low-dose placebo (60-85 years) & Two dose regimen
Low-dose placebo (60-85 years) & Three dose regimen	Placebo comparator	three doses of placebo at the schedule of day 0, 14, 28. Receives: Biological: Low-dose placebo (60-85 years) & Three dose regimen
High-dose placebo (60-85 years) & Two dose regimen	Placebo comparator	two doses of placebo at the schedule of day 0, 21. Receives: Biological: High-dose placebo (60-85 years) & Two dose regimen
High-dose placebo (60-85 years) & Three dose regimen	Placebo comparator	three doses of placebo at the schedule of day 0, 14, 28. Receives: Biological: High-dose placebo (60-85 years) & Three dose regimen

What is being measured

The primary outcome is the main question the study is designed to answer.

Geometric mean (GMT) of specific antibody
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)
Measured: 1 months after immunization in each study group
The incidence of adverse reaction (AR)
The incidence of adverse reaction (AR)
Measured: 0 to 7 days after vaccination in each study group

Secondary outcomes (9)

The incidence of adverse events (AE)
The incidence of adverse events (AE)
Measured: 0 to 28 days after vaccination in each study group
The incidence of severe adverse events (SAE)
The incidence of severe adverse events (SAE)
Measured: 0 to 28 days after vaccination in each study group
The incidence of serious adverse events
The incidence of serious adverse events
Measured: 6 months after vaccination in each study group
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: 1 months after immunization in each study group
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: 14 days, 30 days after immunization in each study group
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: 14 days, 30 days after immunization in each study group
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: 14 days after immunization in each study group
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: 14 days, 30 days after immunization in each study group
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: 14 days, 30 days after immunization in each study group

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Nov 202023 Nov 2021

First posted23 Nov 2020
Study start17 Nov 2020
Primary completion18 Feb 2021
Study completion23 Nov 2021

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: 960 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04640402
Sponsor's protocol ID: JSVCT099
Status last verified: Mar 2022
First submitted: 19 Nov 2020
Last updated: 1 Jun 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19

All COVID-19 trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-center, Randomized, Double-Blinded, Placebo-Controlled, Phase Ⅱ Clinical Trial of Recombinant COVID-19 Vaccine (Sf9 Cells), in the Subjects From Healthy Aged 18 Years and Above
ClinicalTrials.gov ID: NCT04640402
Acronym / sponsor ID: JSVCT099
Conditions: COVID-19
Keywords: Safety, Immunogenicity, COVID-19 Vaccine, Recombinant vaccine
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 960 participants (actual)
Lead sponsor: Jiangsu Province Centers for Disease Control and PreventionResearch network
Collaborators: West China Hospital
Study start: 17 Nov 2020 (actual)
Primary completion: 18 Feb 2021 (actual)
Study completion: 23 Nov 2021 (actual)
First posted: 23 Nov 2020 (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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 16

Arm	Type	Receives
Low-dose vaccine (18-59 years) & Two dose regimen	Experimental	Biological: Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimentwo doses of low-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.
Low-dose vaccine (18-59 years) & Three dose regimen	Experimental	Biological: Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimenthree doses of low-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.
High-dose vaccine (18-59 years) & Two dose regimen	Experimental	Biological: High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimentwo 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	Experimental	Biological: High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimenthree doses of high-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.
Low-dose vaccine (60-85 years) & Two dose regimen	Experimental	Biological: Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimentwo doses of low-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.
Low-dose vaccine (60-85 years) & Three dose regimen	Experimental	Biological: Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimenthree doses of low-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.
High-dose vaccine (60-85 years) & Two dose regimen	Experimental	Biological: High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimentwo doses of high-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.
High-dose vaccine (60-85 years) & Three dose regimen	Experimental	Biological: High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimenthree doses of high-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.
Low-dose placebo (18-59 years) & Two dose regimen	Placebo comparator	Biological: Low-dose placebo (18-59 years) & Two dose regimentwo doses of placebo at the schedule of day 0, 21.
Low-dose placebo (18-59 years) & Three dose regimen	Placebo comparator	Biological: Low-dose placebo (18-59 years) & Three dose regimenthree doses of placebo at the schedule of day 0, 14, 28.
High-dose placebo (18-59 years) & Two dose regimen	Placebo comparator	Biological: High-dose placebo (18-59 years) & Two dose regimentwo doses of placebo at the schedule of day 0, 21.
High-dose placebo (18-59 years) & Three dose regimen	Placebo comparator	Biological: High-dose placebo (18-59 years) & Three dose regimenthree doses of placebo at the schedule of day 0, 14, 28.
Low-dose placebo (60-85 years) & Two dose regimen	Placebo comparator	Biological: Low-dose placebo (60-85 years) & Two dose regimentwo doses of placebo at the schedule of day 0, 21.
Low-dose placebo (60-85 years) & Three dose regimen	Placebo comparator	Biological: Low-dose placebo (60-85 years) & Three dose regimenthree doses of placebo at the schedule of day 0, 14, 28.
High-dose placebo (60-85 years) & Two dose regimen	Placebo comparator	Biological: High-dose placebo (60-85 years) & Two dose regimentwo doses of placebo at the schedule of day 0, 21.
High-dose placebo (60-85 years) & Three dose regimen	Placebo comparator	Biological: High-dose placebo (60-85 years) & Three dose regimenthree doses of placebo at the schedule of day 0, 14, 28.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (24 listed)

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.

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
Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen18-59 years group, two doses of low-dose (20µg/0.5ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.	Biological	Low-dose vaccine (18-59 years) & Two dose regimen
Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimen18-59 years group, three doses of low-dose (20µg/0.5ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.	Biological	Low-dose vaccine (18-59 years) & Three dose regimen
High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen18-59 years group, two doses of high-dose (40µg/1.0ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.	Biological	High-dose vaccine (18-59 years) & Two dose regimen
High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimen18-59 years group, three doses of high-dose (40µg/1.0ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.	Biological	High-dose vaccine (18-59 years) & Three dose regimen
Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimen60-85 years group, two doses of low-dose (20µg/0.5ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.	Biological	Low-dose vaccine (60-85 years) & Two dose regimen
Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimen60-85 years group, three doses of low-dose (20µg/0.5ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.	Biological	Low-dose vaccine (60-85 years) & Three dose regimen
High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimen60-85 years group, two doses of high-dose (40µg/1.0ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.	Biological	High-dose vaccine (60-85 years) & Two dose regimen
High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimen60-85 years group, three doses of high-dose (40µg/1.0ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.	Biological	High-dose vaccine (60-85 years) & Three dose regimen
Low-dose placebo (18-59 years) & Two dose regimen18-59 years group, two doses of placebo(0.5ml) at the schedule of day 0, 21.	Biological	Low-dose placebo (18-59 years) & Two dose regimen
Low-dose placebo (18-59 years) & Three dose regimen18-59 years group, three doses of placebo(0.5ml) at the schedule of day 0, 14, 28.	Biological	Low-dose placebo (18-59 years) & Three dose regimen
High-dose placebo (18-59 years) & Two dose regimen18-59 years group, two doses of placebo(1.0ml) at the schedule of day 0, 21.	Biological	High-dose placebo (18-59 years) & Two dose regimen
High-dose placebo (18-59 years) & Three dose regimen18-59 years group, three doses of placebo(1.0ml) at the schedule of day 0, 14, 28.	Biological	High-dose placebo (18-59 years) & Three dose regimen
Low-dose placebo (60-85 years) & Two dose regimen60-85 years group, two doses of placebo(0.5ml) at the schedule of day 0, 21.	Biological	Low-dose placebo (60-85 years) & Two dose regimen
Low-dose placebo (60-85 years) & Three dose regimen60-85 years group, three doses of placebo(0.5ml) at the schedule of day 0, 14, 28.	Biological	Low-dose placebo (60-85 years) & Three dose regimen
High-dose placebo (60-85 years) & Two dose regimen60-85 years group, two doses of placebo(1.0ml) at the schedule of day 0, 21.	Biological	High-dose placebo (60-85 years) & Two dose regimen
High-dose placebo (60-85 years) & Three dose regimen60-85 years group, three doses of placebo(1.0ml) at the schedule of day 0, 14, 28.	Biological	High-dose placebo (60-85 years) & Three dose regimen

Primary outcome

Geometric mean (GMT) of specific antibody
Time frame: 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)
Time frame: 0 to 7 days after vaccination in each study group
The incidence of adverse reaction (AR)

9 secondary outcomes

The incidence of adverse events (AE)
Time frame: 0 to 28 days after vaccination in each study group
The incidence of severe adverse events (SAE)
Time frame: 0 to 28 days after vaccination in each study group
The incidence of serious adverse events
Time frame: 6 months after vaccination in each study group
Geometric mean (GMT) of anti-SARS-CoV-2-specific neutralizing antibodies
Time frame: 1 months after immunization in each study group
The positive conversion rate of S-RBD protein-specific antibody
Time frame: 14 days, 30 days after immunization in each study group
Geometric mean fold increase (GMI) of S-RBD protein-specific antibody
Time frame: 14 days, 30 days after immunization in each study group
Geometric mean (GMT) of anti-SARS-CoV-2-specific neutralizing antibodies
Time frame: 14 days after immunization in each study group
The positive conversion rate of anti-SARS-CoV-2 specific neutralizing antibody
Time frame: 14 days, 30 days after immunization in each study group
Geometric mean fold increase (GMI) of anti-SARS-CoV-2 specific neutralizing antibodies
Time frame: 14 days, 30 days after immunization in each study group

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.

Related trials for COVID-19

Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19

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?

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 5 inclusion and 24 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: finished, as of the sponsor's last update on 1 Jun 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Geometric mean (GMT) of specific antibody (time frame: 1 months after immunization in each study group). 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?

On the ClinicalTrials.gov record for NCT04640402.

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 1 Jun 2022.