v3.0.7
Please consider this website is continuously evolving and still under development
to harmonize automatic data extraction and integrate manual data annotation.
Column | Value |
---|---|
Trial registration number | NCT05939648 |
Full text link
Last imported at : July 12, 2023, 8 p.m. Source : ClinicalTrials.gov |
|
First author
Last imported at : July 12, 2023, 8 p.m. Source : ClinicalTrials.gov |
|
Contact
Last imported at : July 12, 2023, 8 p.m. Source : ClinicalTrials.gov |
fan.zhang@aimbio.com |
Registration date
Last imported at : July 12, 2023, 8 p.m. Source : ClinicalTrials.gov |
2023-07-11 |
Recruitment status
Last imported at : July 12, 2023, 8 p.m. Source : ClinicalTrials.gov |
Not recruiting |
Study design
Last imported at : July 12, 2023, 8 p.m. Source : ClinicalTrials.gov |
RCT |
Allocation
Last imported at : July 12, 2023, 8 p.m. Source : ClinicalTrials.gov |
Randomized |
Design
Last imported at : July 12, 2023, 8 p.m. Source : ClinicalTrials.gov |
Parallel |
Masking
Last imported at : July 12, 2023, 8 p.m. Source : ClinicalTrials.gov |
Blind label |
Center
Last imported at : July 12, 2023, 8 p.m. Source : ClinicalTrials.gov |
single-center |
Study aim
Last imported at : July 12, 2023, 8 p.m. Source : ClinicalTrials.gov |
Prevention |
Inclusion criteria
Last imported at : July 12, 2023, 8 p.m. Source : ClinicalTrials.gov |
inclusion criteria: healthy adults aged 18 years and older, both male and female, who can provide legal identity certificate of participants; the subject understands the contents of the informed consent form and the vaccination situation of this vaccination, voluntarily signs the informed consent form, and has the ability to use the thermometer, scale and fill in the diary card and contact card as required (if the subject is unable to sign the informed consent form by himself/herself due to limited reading and writing ability, the informed consent form and signature of the informed consent form can be completed under the witness' s witness); able to communicate well with investigators and understand and comply with the requirements of this trial; completion of basic immunization with sars-cov-2 vaccine ≥ 6 months; negative nucleic acid test for sars-cov-2 within 3 days prior to vaccination; women who have used effective contraception within 2 weeks prior to inclusion in this trial, have a negative pregnancy test (pregnancy test can be exempted for those who have been amenorrheic for at least 1 year or have a documented history of surgical sterilization), and voluntarily agree to continue using at least 1 effective contraception within 6 months after vaccination [effective contraception includes: oral contraceptives, injected or implanted contraception, sustained-release local contraceptives, hormonal patches, intrauterine device (iud), sterilization, abstinence, condoms (men), diaphragms, cervical caps, etc.]; healthy participants or participants with mild underlying disease [stable condition without worsening (requiring no hospitalization or major modification of treatment regimen, etc.) for at least 3 months prior to inclusion in this trial]. |
Exclusion criteria
Last imported at : July 12, 2023, 8 p.m. Source : ClinicalTrials.gov |
abnormal blood pressure indicators in the screening period, and the investigator determines that the health condition is uncertain and further diagnosis is required, or the investigator determines that the vaccination is not suitable in combination with the medical history and clinical manifestations; body mass index (bmi) <18 kg/m 2 or >30 kg/m 2; individuals with any infectious disease, acute infection, acute phase of chronic infection (such as active untreated pulmonary tuberculosis, etc.) or any advanced immune disease (inquiry); infected within last 6 months or likely infected with sars-cov-2; positive hiv test result at screening; fever on the day of investigational vaccination (axillary temperature ≥ 37.3℃) or within 3 days, or use of antipyretic and analgesic drugs within 3 days; women with a positive pregnancy test (surgical sterilizers who are menstruating or amenorrheic for at least 1 year or have medical records may be exempted from pregnancy testing), or breastfeeding women, or women planning to become pregnant from screening through 6 months after booster vaccination, men whose partners plan to become pregnant, or plan to donate sperm and eggs; previous history of allergic or allergic reactions to vaccines or drugs, such as urticaria, severe skin eczema, dyspnea, laryngeal edema, angioneurotic edema, etc.; administration of any vaccine within 28 days prior to booster vaccination with investigational vaccine; have participated within 28 days prior to booster vaccination with investigational vaccine or plan to participate in other drug clinical trials within 12 months after booster vaccination; patients with a history of thrombocytopenia or other coagulation disorders, which may cause contraindications to subcutaneous blood sampling or injection, and patients with a history of thrombosis; known history or diagnosis of diseases affecting immune system function, such as cancer (except basal cell carcinoma of the skin), congenital or acquired immunodeficiency, uncontrolled autoimmune diseases, etc. (such as systemic lupus erythematosus, autoimmune thyroid disease, multiple sclerosis); absence of spleen or functional absence of spleen; chronic use (≥14 consecutive days) of immunosuppressants or other immunomodulatory drugs (eg, corticosteroids: prednisone or drugs of the same class) within 6 months prior to booster vaccination with the investigational vaccine, but topical medications (eg, ointments, eye drops, inhalers, or nasal sprays) are allowed and should not exceed the dose recommended in the package insert; immunoglobulins and/or blood products received within 3 months prior to the investigational booster vaccination; suspected or known alcohol dependence or drug abuse that could compromise the safety evaluation or subject compliance; other conditions that the investigator considers inappropriate for participation in this trial. |
Number of arms
Last imported at : July 12, 2023, 8 p.m. Source : ClinicalTrials.gov |
3 |
Funding
Last imported at : July 12, 2023, 8 p.m. Source : ClinicalTrials.gov |
AIM Vaccine Co., Ltd. |
Inclusion age min
Last imported at : July 12, 2023, 8 p.m. Source : ClinicalTrials.gov |
18 |
Inclusion age max
Last imported at : July 12, 2023, 8 p.m. Source : ClinicalTrials.gov |
100 |
Countries
Last imported at : July 12, 2023, 8 p.m. Source : ClinicalTrials.gov |
China |
Type of patients
Last imported at : July 12, 2023, 8 p.m. Source : ClinicalTrials.gov |
Healthy volunteers |
Severity scale
Last imported at : July 12, 2023, 8 p.m. Source : ClinicalTrials.gov |
N/A |
Total sample size
Last imported at : July 12, 2023, 8 p.m. Source : ClinicalTrials.gov |
600 |
primary outcome
Last imported at : July 12, 2023, 8 p.m. Source : ClinicalTrials.gov |
GMT, SCR of neutralizing antibodys against SARS-CoV-2 (original strain, delta strain, Omicron BA.5, XBB strains and current major circulating strains).;Incidence of solicited and unsolicited adverse events |
Notes
Last imported at : July 12, 2023, 8 p.m. Source : ClinicalTrials.gov |
None |
Phase
Last imported at : July 12, 2023, 8 p.m. Source : ClinicalTrials.gov |
Phase 2 |
Arms
Last imported at : July 12, 2023, 8 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "nan", "treatment_id": 1154, "treatment_name": "Sars-cov-2 recombinant protein vaccine", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "nan", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "nan", "treatment_id": 2611, "treatment_name": "Lvrna021", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}] |