COVID-19Phase 1NCT04530656

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

A Phase 1 study testing Two doses of middle-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28, Two doses of high-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28 and Three doses of high-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 14, 28 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

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: COVID-19
What is being tested?: Two doses of middle-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28, Two doses of high-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28 and Three doses of high-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 14, 28
Type of treatment: Vaccines
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 168 participants
Where: 1 siteChina
Study dates: 28 Aug 2020to 23 Nov 2021
Phase: Phase 1
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

Subjects with a medical or family history of convulsions, epilepsy, encephalopathy, and psychosis.
Allergic to any ingredient in the study vaccine, or used to have a serious vaccine allergic reaction.
Women who are positive for urine pregnancy test. Women who are pregnant or breastfeeding or planning to be pregnant within 6 months.
Have acute febrile diseases or infectious diseases.
History of SARS, SARS-CoV-2 or MERS infection.
People with serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension and can not control using drugs.

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Patients with severe chronic diseases or progressive conditions can not be smoothly controlled, such as asthma, diabetes, and thyroid diseases.
Have congenital or acquired angioedema/neuroedema.
Had urticaria 1 year before receiving the study vaccine.
Asplenium or functional aspleen.
Have thrombocytopenia or other coagulation disorders (may cause contraindications to intramuscular injection).
Have acupuncture syncope reaction.
Have received immunosuppressant therapy, anti-allergic therapy, cytotoxic therapy, inhaled corticosteroids in the past 6 months (excluding corticosteroid spray therapy for allergic rhinitis, and surface corticosteroid therapy for acute non-complicated dermatitis).
Received blood products within 4 months before receiving the study vaccine.
Received other study drugs within 1 month before receiving the study vaccine.
Received a live attenuated vaccine within 1 month before receiving the study vaccine.
Received a subunit or inactivated vaccine within 14 days before receiving the study vaccine.
Are receiving anti-tuberculosis treatment.
According to the judgment of the researchers, due to a variety of medical, psychological, social or other conditions, it is contrary to the trial scheme, or affects the subjects to sign informed consent.
It is contrary to the trial protocol, or affects the subjects to sign informed consent due to various medical, psychological, social or other conditions, according to the investigator's judgment.
Have had a severe allergic reaction after the previous dose of vaccination.
Those with serious adverse events that are causally related to the previous dose of vaccination.
For those newly discovered or occurred after the prime vaccination that does not meet the prime-dose inclusion criteria or meets the prime-dose exclusion criteria, it is up to the investigator to determine whether to continue to participate in the study or not.
Other exclusion reasons determined by the investigators.

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: 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

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.

Read the 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.

Conditions: COVID-19
Being tested: Two doses of middle-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28, Two doses of high-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28, Three doses of high-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 14, 28, Two doses of placebo at the schedule of day 0, 28（middle-dose group）, Two doses of placebo at the schedule of day 0, 28（high-dose group）
Keywords: Safety, Tolerability, Immunogenicity, SARS-CoV-2 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.

Two doses of middle-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28Biological
Two doses of middle-dose (20µg/ 0.5ml) recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28.
Two doses of high-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28Biological
Two doses of high-dose (40µg/ 1.0ml) recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28.
Three doses of high-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 14, 28Biological
Three doses of high-dose (40µg/ 1.0ml) recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 14, 28
Two doses of placebo at the schedule of day 0, 28（middle-dose group）Biological
Two doses of placebo (0.5ml) at the schedule of day 0, 28
Two doses of placebo at the schedule of day 0, 28（high-dose group）Biological
Two doses of placebo (1.0ml) at the schedule of day 0, 28
Three doses of placebo at the schedule of day 0, 14, 28（high-dose group）Biological
Three doses of placebo (1.0ml) at the schedule of day 0, 14, 28

Study groups in NCT04530656
Study group	Role	What they receive
Middle-dose vaccine (18-55 years) & Two dose regimen	Experimental	Two doses of middle-dose experimental vaccine at the schedule of day 0, 28. Receives: Biological: Two doses of middle-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28
Middle-dose vaccine (> 55 years) & Two dose regimen	Experimental	Two doses of middle-dose experimental vaccine at the schedule of day 0, 28. Receives: Biological: Two doses of middle-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28
High-dose vaccine (18-55 years) & Two dose regimen	Experimental	Two doses of high-dose experimental vaccine at the schedule of day 0, 28. Receives: Biological: Two doses of high-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28
High-dose vaccine (> 55 years) & Two dose regimen	Experimental	Two doses of high-dose experimental vaccine at the schedule of day 0, 28. Receives: Biological: Two doses of high-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28
High-dose vaccine (18-55 years) & Three dose regimen	Experimental	Three doses of high-dose experimental vaccine at the schedule of day 0, 14, 28. Receives: Biological: Three doses of high-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 14, 28
High-dose vaccine (> 55 years) & Three dose regimen	Experimental	Three doses of high-dose experimental vaccine at the schedule of day 0, 14, 28. Receives: Biological: Three doses of high-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 14, 28
Middle-dose placebo (18-55 years) & Two dose regimen	Placebo comparator	Two doses of middle-dose placebo at the schedule of day 0, 28. Receives: Biological: Two doses of placebo at the schedule of day 0, 28（middle-dose group）
Middle-dose placebo (> 55 years) & Two dose regimen	Placebo comparator	Two doses of middle-dose placebo at the schedule of day 0, 28. Receives: Biological: Two doses of placebo at the schedule of day 0, 28（middle-dose group）
High-dose placebo (18-55 years) & Two dose regimen	Placebo comparator	Two doses of high-dose placebo at the schedule of day 0, 28. Receives: Biological: Two doses of placebo at the schedule of day 0, 28（high-dose group）
High-dose placebo (> 55 years) & Two dose regimen	Placebo comparator	Two doses of high-dose placebo at the schedule of day 0, 28. Receives: Biological: Two doses of placebo at the schedule of day 0, 28（high-dose group）
High-dose placebo (18-55 years) & Three dose regimen	Placebo comparator	Three doses of high-dose placebo at the schedule of day 0, 14, 28. Receives: Biological: Three doses of placebo at the schedule of day 0, 14, 28（high-dose group）
High-dose placebo (> 55 years) & Three dose regimen	Placebo comparator	Three doses of high-dose placebo at the schedule of day 0, 14, 28. Receives: Biological: Three doses of placebo at the schedule of day 0, 14, 28（high-dose group）

What is being measured

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

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

Secondary outcomes (12)

Occurrence of adverse events (AE) within 7 days after each dose of the recombinant SARS-CoV-2 vaccine (Sf9 cell) or placebo.
Occurrence of solicited AE in the subjects within 7 days after each dose of recombinant SARS-CoV-2 vaccine (Sf9 cell) or placebo.
Measured: 7 days after each dose.
Occurrence of AE up to 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.
Measured: Day 28 after prime and boost vaccination.
The proportion of SAEs up to Day 28 after prime and boost vaccination.
The proportion of subjects experiencing SAEs up to Day 28 after prime and boost vaccination.
Measured: Day 28 after prime and boost vaccination.
The proportion of SAEs up to Month 12 after prime and boost vaccination.
Month 12 after prime and boost vaccination.
Measured: The proportion of subjects experiencing SAEs up to Month 12 after prime and 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.
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.
Measured: 7 days before prime vaccination and Day 3 after each dose.
GMT of anti-RBD specific antibody at 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.
Measured: 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, at 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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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, at 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.
Measured: 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.
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.
Measured: 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.
Seroconversion rates of IFN-γ stimulated by the overlapping peptide library of S-RBD protein at Day 14, Day 28 after boost vaccination.
Measured: Day 14, Day 28 after boost vaccination.

Timeline

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

28 Aug 202023 Nov 2021

First posted28 Aug 2020
Study start28 Aug 2020
Primary completion28 Oct 2020
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 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 168 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04530656
Sponsor's protocol ID: JSVCT098
Status last verified: Mar 2022
First submitted: 27 Aug 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?

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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: 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
ClinicalTrials.gov ID: NCT04530656
Acronym / sponsor ID: JSVCT098
Conditions: COVID-19
Keywords: Safety, Tolerability, Immunogenicity, SARS-CoV-2 Vaccine, Recombinant vaccine
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 168 participants (actual)
Lead sponsor: Jiangsu Province Centers for Disease Control and PreventionResearch network
Collaborators: West China Hospital
Study start: 28 Aug 2020 (actual)
Primary completion: 28 Oct 2020 (actual)
Study completion: 23 Nov 2021 (actual)
First posted: 28 Aug 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

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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 12

Arm	Type	Receives
Middle-dose vaccine (18-55 years) & Two dose regimen	Experimental	Biological: Two doses of middle-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28Two doses of middle-dose experimental vaccine at the schedule of day 0, 28.
Middle-dose vaccine (> 55 years) & Two dose regimen	Experimental	Biological: Two doses of middle-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28Two doses of middle-dose experimental vaccine at the schedule of day 0, 28.
High-dose vaccine (18-55 years) & Two dose regimen	Experimental	Biological: Two doses of high-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28Two doses of high-dose experimental vaccine at the schedule of day 0, 28.
High-dose vaccine (> 55 years) & Two dose regimen	Experimental	Biological: Two doses of high-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28Two doses of high-dose experimental vaccine at the schedule of day 0, 28.
High-dose vaccine (18-55 years) & Three dose regimen	Experimental	Biological: Three doses of high-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 14, 28Three doses of high-dose experimental vaccine at the schedule of day 0, 14, 28.
High-dose vaccine (> 55 years) & Three dose regimen	Experimental	Biological: Three doses of high-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 14, 28Three doses of high-dose experimental vaccine at the schedule of day 0, 14, 28.
Middle-dose placebo (18-55 years) & Two dose regimen	Placebo comparator	Biological: Two doses of placebo at the schedule of day 0, 28（middle-dose group）Two doses of middle-dose placebo at the schedule of day 0, 28.
Middle-dose placebo (> 55 years) & Two dose regimen	Placebo comparator	Biological: Two doses of placebo at the schedule of day 0, 28（middle-dose group）Two doses of middle-dose placebo at the schedule of day 0, 28.
High-dose placebo (18-55 years) & Two dose regimen	Placebo comparator	Biological: Two doses of placebo at the schedule of day 0, 28（high-dose group）Two doses of high-dose placebo at the schedule of day 0, 28.
High-dose placebo (> 55 years) & Two dose regimen	Placebo comparator	Biological: Two doses of placebo at the schedule of day 0, 28（high-dose group）Two doses of high-dose placebo at the schedule of day 0, 28.
High-dose placebo (18-55 years) & Three dose regimen	Placebo comparator	Biological: Three doses of placebo at the schedule of day 0, 14, 28（high-dose group）Three doses of high-dose placebo at the schedule of day 0, 14, 28.
High-dose placebo (> 55 years) & Three dose regimen	Placebo comparator	Biological: Three doses of placebo at the schedule of day 0, 14, 28（high-dose group）Three doses of high-dose placebo at the schedule of day 0, 14, 28.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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.

Key exclusion criteria (24 listed)

Subjects with a medical or family history of convulsions, epilepsy, encephalopathy, and psychosis.
Allergic to any ingredient in the study vaccine, or used to have a serious vaccine allergic reaction.
Women who are positive for urine pregnancy test. Women who are pregnant or breastfeeding or planning to be pregnant within 6 months.
Have acute febrile diseases or infectious diseases.
History of SARS, SARS-CoV-2 or MERS infection.

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
Two doses of middle-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28Two doses of middle-dose (20µg/ 0.5ml) recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28.	Biological	Middle-dose vaccine (18-55 years) & Two dose regimen, Middle-dose vaccine (> 55 years) & Two dose regimen
Two doses of high-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28Two doses of high-dose (40µg/ 1.0ml) recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28.	Biological	High-dose vaccine (18-55 years) & Two dose regimen, High-dose vaccine (> 55 years) & Two dose regimen
Three doses of high-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 14, 28Three doses of high-dose (40µg/ 1.0ml) recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 14, 28	Biological	High-dose vaccine (18-55 years) & Three dose regimen, High-dose vaccine (> 55 years) & Three dose regimen
Two 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	Biological	Middle-dose placebo (18-55 years) & Two dose regimen, Middle-dose placebo (> 55 years) & Two dose regimen
Two 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	Biological	High-dose placebo (18-55 years) & Two dose regimen, High-dose placebo (> 55 years) & Two dose regimen
Three 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	Biological	High-dose placebo (18-55 years) & Three dose regimen, High-dose placebo (> 55 years) & Three dose regimen

Primary outcome

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

12 secondary outcomes

Occurrence of adverse events (AE) within 7 days after each dose of the recombinant SARS-CoV-2 vaccine (Sf9 cell) or placebo.
Time frame: 7 days after each dose.
Occurrence of AE up to Day 28 after prime and boost vaccination.
Time frame: Day 28 after prime and boost vaccination.
The proportion of SAEs up to Day 28 after prime and boost vaccination.
Time frame: Day 28 after prime and boost vaccination.
The proportion of SAEs up to Month 12 after prime and boost vaccination.
Time frame: The proportion of subjects experiencing SAEs up to Month 12 after prime and 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.
Time frame: 7 days before prime vaccination and Day 3 after each dose.
GMT of anti-RBD specific antibody at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.
Time frame: 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, at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.
Time frame: 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.
Time frame: 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.
Time frame: 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, at Day 7, Day 14, Day 28, Month 3, Month 6, and Month 12 after boost vaccination.
Time frame: 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.
Time frame: 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.
Time frame: Day 14, Day 28 after boost vaccination.

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.

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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 11 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Occurrence of adverse reactions (AR) within 7 days after each dose of the recombinant SARS-CoV-2 vaccine (Sf9 cell) or placebo. (time frame: 7 days after each dose.). 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 NCT04530656.

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.