1.
ClinicalTrials.gov; 10/05/2023; TrialID: NCT05855408
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05855408
RESUMO
Condition:
COVID-19Intervention:
Biological: Intramuscularly administered Ad5-nCoV vaccine;Biological: Aerosolized Ad5-nCoV;Biological: DelNS1-2019-nCoV-RBD-OPT1;Biological: SYS6006Primary outcome:
The incidence of COVID-19 from 14 days to 6 months after the booster immunization.Criteria:
Inclusion Criteria:
1. Adults aged 18 years and over, including the elderly over 60 years and those with
underlying diseases.
2. Volunteers are able and willing to comply with the requirements of the clinical trial
protocol and sign the informed consent form.
3. = 4 months from the last SARS-CoV-2 infection (or never been infected), and 6 months
or more from the first booster immunization of the COVID-19 vaccine.
Exclusion Criteria:
1. Volunteers have suspected symptoms of COVID-19 when enrolled, such as dry throat, sore
throat, cough, etc.
2. The COVID-19 Antigen Quick Test Kit is positive when volunteers are enrolled.
3. Fever, temperature > 37.0°C.
4. Have received a second COVID-19 vaccine booster immunization.
5. Have a history of serious adverse reactions related to the vaccine and/or have a
history of severe allergic reactions to any component of the investigational vaccine
(only applicable to the vaccine groups).
6. Pregnant or lactating women.
7. HIV infection, tuberculosis, low immunity caused by disease or long-term medication.
8. Acute disease or acute onset of chronic disease.
9. Epilepsy and other progressive neurological disorders.
10. Other situations that are not suitable for participating in this research, according
to the judgment of the researcher.
2.
ClinicalTrials.gov; 28/03/2022; TrialID: NCT05313646
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05313646
RESUMO
Condition:
COVID-19Intervention:
Biological: batch 1 of Ad5-nCoV;Biological: batch 2 of Ad5-nCoV;Biological: batch 3 of Ad5-nCoVPrimary outcome:
GMTs of SARS-CoV-2 RBD-specific binding IgG on day 28 after vaccination.Criteria:
Inclusion Criteria:
1. healthy participants aged 18 years and above who have not received COVID-19 vaccine.
2. The subjects can provide with informed consent and sign informed consent form (ICF).
4. The subjects are able to and willing to comply with the requirements of the clinical
trial program and could complete the follow-up of the study.
5. Axillary temperature = 37.0?. 6. negative IgM and IgG against SARS-CoV-2 7. with BMI
between18.5 to 30.0 8. No history of epidemiological contact with COVID-2019 9. have not
been to medium or high risk areas in the past 21 days and have no history of departure.
10. be determined to be healthy by medical history, physical examination and clinical
examination and meet the requirements for immunization of this product.
Exclusion criteria:
1. Medical history or family history of convulsion, epilepsy, encephalopathy and
psychosis.
2. Allergic to any component of the research vaccines, or a history of hypersensitivity
or serious reactions to vaccination.
3. Women with positive urine pregnancy test, pregnant or breast-feeding, or have a
pregnancy plan in this study.
4. Suffering from acute febrile disease, infectious disease, or SARS infection history
5. Serious cardiovascular disease, such as arrhythmia, conduction block, myocardial
infarction, severe hypertension, which cannot be controlled by medication (systolic
blood pressure =180mmHg, diastolic blood pressure =110mmHg)
6. Have severe chronic diseases or unstable condition ( Grade 3 or higher as defined in
the guidelines for the classification of adverse events in clinical trials for
prophylactic vaccines), Such as diabetes, thyroid disease and so on.
7. Congenital or acquired angioedema / neuroedema.
8. had urticaria one year before this vaccination.
9. Asplenia or functional asplenia.
10. Thrombocytopenia or other clotting disorder (this may contraindicate intramuscular
injection).
11. Faintng during acupuncture treatment
12. Received immunosuppressant therapy, antiallergic therapy, cytotoxic therapy, high dose
inhaled corticosteroid over the past 6 months (excluding corticosteroid spray for
allergic rhinitis, surface corticosteroid for acute non-complicated dermatitis, and
corticosteroid with dose less than 20mg/ day)
13. Received blood products within 4 months before vaccination.
14. Received other investigational drugs within 1 month prior to receiving the
investigational vaccines.
15. Received other live attenuated vaccines within 1 month prior to receiving the
investigational vaccines.
16. Received subunit or inactivated vaccine within 14 days prior to receiving
investigational vaccine.
17. Be receiving anti-tuberculosis treatment
18. Have the history of SARS-CoV-2 infection or COVID-19
19. Any medical, psychological, social or other conditions that, in the investigator's
judgment, are inconsistent with the study protocol or affect the subjects' informed
consent
3.
ClinicalTrials.gov; 22/03/2022; TrialID: NCT05303584
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05303584
4.
ClinicalTrials.gov; 21/01/2022; TrialID: NCT05204589
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05204589
RESUMO
Condition:
COVID-19Intervention:
Biological: Aerosolized Ad5-nCoV;Biological: Inactivated SARS-CoV-2 vaccinePrimary outcome:
Incidence of adverse reactions within 28 days after the booster dose.;GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the booster dose in immunogenicity cohort.Criteria:
Inclusion Criteria:
- Health subjects aged =18 years.
- Have received two-dose inactivated SARS-CoV-2 vaccine before 6 months or more.
- The subject can provide with informed consent and sign informed consent form (ICF).
- The subjects are able to and willing to comply with the requirements of the clinical
trial program and could complete the 6-month follow-up of the study.
Exclusion Criteria:
- Have the medical history or family history of convulsion, epilepsy, encephalopathy and
psychosis.
- Be allergic to any component of the research vaccines, or used to have a history of
hypersensitivity or serious reactions to vaccination.
- Women with positive urine pregnancy test.
- Have acute febrile diseases and infectious diseases.
- Axillary temperature>37.0?.
- Have serious cardiovascular disease, such as arrhythmia, conduction block, myocardial
infarction, severe hypertension that cannot be controlled by medication (systolic
blood pressure =180mmHg and/or diastolic blood pressure =110mmHg when measured in the
field).
- Have severe chronic diseases or condition in progress cannot be smoothly controlled,
such as asthma, diabetes, thyroid disease.
- Congenital or acquired angioedema / neuroedema.
- Have the history of urticaria 1 year before receiving the investigational vaccine.
- Have asplenia or functional asplenia.
- Patients with chronic obstructive pulmonary disease, pulmonary fibrosis and other
pulmonary abnormalities.
- Have history of SARS-CoV-2 infection or COVID-19.
- Have symptoms of upper respiratory tract infection.
- Have traveled to medium or high risk areas or traveled abroad in the past 21 days, and
epidemiologically contacted with SARS-CoV-2.
- Any medical, psychological, social, or other conditions that, in the investigator's
judgment, are inconsistent with the protocol or affect the subject's informed consent.
5.
ClinicalTrials.gov; 03/12/2021; TrialID: NCT05148949
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05148949
6.
ClinicalTrials.gov; 13/09/2021; TrialID: NCT05043259
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05043259
7.
ClinicalTrials.gov; 03/07/2021; TrialID: NCT04952727
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04952727
8.
ClinicalTrials.gov; 10/05/2021; TrialID: NCT04892459
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04892459
RESUMO
Condition:
COVID-19Intervention:
Biological: Recombinant SARS-CoV-2 Ad5 vectored vaccine;Biological: Inactive SARS-CoV-2 vaccine (Vero cell)Primary outcome:
Incidence of adverse reactions within 28 days after the booster dose.;GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 14 after the booster dose.Criteria:
Inclusion Criteria:
- Health subjects aged 18-59 years, who have been completed two-dose regimen of inactive
SARS-CoV-2 vaccine in the past 3-6 months, or received one dose of inactive SARS-CoV-2
vaccine in the past 1-3 months.
- The subject can provide with informed consent and sign informed consent form (ICF).
- The subjects are able to and willing to comply with the requirements of the clinical
trial program and could complete the 6-month follow-up of the study.
- Axillary temperature = 37.0?.
- Individuals who are in good health condition at the time of entry into the trial as
determined by medical history, physical examination and clinical judgment of the
investigator and meet the requirements of immunization.
Exclusion Criteria:
- have the medical history or family history of convulsion, epilepsy, encephalopathy and
psychosis.
- be allergic to any component of the research vaccines, or used to have a history of
hypersensitivity or serious reactions to vaccination.
- women with positive urine pregnancy test, pregnant or breast-feeding, or have a
pregnancy plan within six months.
- have acute febrile diseases and infectious diseases.
- have severe chronic diseases or condition in progress cannot be controlled.
- congenital or acquired angioedema / neuroedema
- have the history of urticaria 1 year before receiving the investigational vaccine.
- have asplenia or functional asplenia.
- have thrombocytopenia or other coagulation disorders (which may cause
contraindications for intramuscular injection).
- have needle sickness.
- have the history of immunosuppressive therapy, anti-allergy therapy, cytotoxic therapy
or inhaled corticosteroids (excluding corticosteroid spray therapy for allergic
rhinitis, and acute corticosteroid therapy without dermatitis) over the past 6 months.
- have received blood products within 4 months before injection of investigational
vaccines.
- under anti-tuberculosis treatment.
- not be able to follow the protocol, or not be able to understand the informed consent
according to the researcher's judgment, due to various medical, psychological, social
or other conditions.
9.
ClinicalTrials.gov; 06/05/2021; TrialID: NCT04887207
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04887207
RESUMO
Condition:
COVID-19Intervention:
Biological: Recombinant COVID-19 vaccine (Sf9 cells);Other: Placebo controlPrimary outcome:
Virologically confirmed (polymerase chain reaction(PCR) positive) symptomatic COVID-19 cases first occurring, regardless of severity.;The incidence of serious adverse events(SAEs).;The incidence of adverse event of special interests(AESIs).;The incidence of medically attended adverse events(MAAEs).;The incidence of solicited adverse events(AEs).;The incidence of unsolicited adverse events(AEs) .Criteria:
Inclusion Criteria:
- Aged 18 years and older.
- Able and willing (in the investigator's opinion) to comply with all study
requirements.
- Willing to allow the investigators to discuss the volunteer's medical history with
their general practitioner/personal doctor and access all medical records which are
relevant to study procedures.
- Healthy adults, or stable-healthy adults who may have a pre-existing medical condition
that does not meet any exclusion criteria. A stable medical condition is defined as a
disease not requiring significant change in therapy or hospitalization for worsening
disease during the 3 months before enrollment.
- For females of childbearing potential only, willingness to practice continuous
effective contraception (see glossary) for 90 days after completion of 3 doses
vaccination, and have negative pregnancy tests before each dose vaccination.
Note: Nonchildbearing potential is defined as surgically sterile (history of bilateral
tubal ligation, bilateral oophorectomy, hysterectomy) or postmenopausal (defined as
amenorrhea for = 12 consecutive months prior to Screening without an alternative medical
cause). A follicle-stimulating hormone (FSH) level may be measured at the discretion of the
investigator to confirm postmenopausal status.
- Males participating in this study who are involved in heterosexual sexual activity
must agree to practice adequate contraception (see glossary) and refrain from donating
sperm for 90 days after receiving the study vaccination.
- Agreement to refrain from blood donation during the study.
- Provide a written informed consent form (ICF).
Exclusion Criteria:
Exclusion criteria for the first dose
- Participation in any other COVID-19 prophylactic drug trials during the duration of
the study. Note: Participation in COVID-19 treatment trials is allowed in the event of
hospitalization due to COVID-19. The study team should be informed as soon as
possible.
- Positive HIV antibody testing results.
- Participation in SARS-CoV-2 serological surveys where participants are informed of
their serostatus during the duration of the study.
Note: Disclosure of serostatus post enrolment may accidentally unblind participants to
group allocation. Participation in this trial can only be allowed if volunteers are kept
blinded to their serology results from local/national serological surveys
- Planned receipt of any licensed or investigational vaccine, other than the study
intervention, within 14 days before and after study vaccination.
- Prior receipt of an investigational or licensed COVID-19 vaccine.
- Administration of immunoglobulins and/or any blood products within three months prior
to the planned administration of the investigational products (IPs).
- Any confirmed or suspected immunosuppressive or immunodeficient state; positive HIV
status; asplenia; recurrent severe infections and chronic use (more than 14 days) of
immunosuppressant medication within the past 6 months. Topical steroids or short-term
(course lasting =14 days) oral steroids are not exclusion criteria.
- History of allergic disease or reactions likely to be exacerbated by any component of
Recombinant COVID-19 Vaccine (Sf9 cells).
- Any history of angioedema
- Pregnancy, lactation, or willingness/intention to become pregnant within 90 days after
receiving study vaccine
- Current diagnosis or treatment of cancer (except basal cell carcinoma of the skin and
cervical carcinoma in situ)
- History of serious psychiatric condition likely to affect participation in the study
- A bleeding disorder (e.g. factor deficiency, coagulopathy, or platelet disorder), or
prior history of significant bleeding or bruising following IM injections or
venipuncture
- Suspected or known current alcohol or drug dependency
- Severe and/or uncontrolled cardiovascular disease, respiratory disease,
gastrointestinal disease, liver disease, renal disease, an endocrine disorder, and
neurological illness (mild/moderate well-controlled comorbidities are allowed)
- History of laboratory-confirmed COVID-19
- Continuous use of anticoagulants, such as coumarins and related anticoagulants (i.e.
warfarin) or novel oral anticoagulants (i.e. apixaban, rivaroxaban, dabigatran, and
edoxaban)
- Any other significant disease, disorder, or finding which may significantly increase
the risk to the volunteer because of participation in the study, affect the ability of
the volunteer to participate in the study, or impair interpretation of the study data.
Exclusion criteria for the second/third dose In this trial, the second/third dose
vaccination may be terminated in some cases. These include systemic allergic reactions,
severe hypersensitivity reactions, or intolerable grade 3 or higher adverse reactions after
the previous vaccination/placebo. If these reactions occur, the participants should not
continue to receive the second/third vaccination.
10.
ClinicalTrials.gov; 03/04/2021; TrialID: NCT04833101
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04833101
RESUMO
Condition:
COVID-19Intervention:
Biological: recombinant Ad5 vectored COVID-19 vaccine;Biological: RBD-based protein subunit vaccine (ZF2001) against COVID-19;Biological: trivalent split influenza vaccinePrimary outcome:
Incidence of solicited adverse events within 7 days after vaccination.;GMT of neutralizing antibodies against live SARS-CoV-2 virus at Day 14 after the booster vaccination.Criteria:
Inclusion Criteria:
- The subjects = 18 years old who has completed one dose of recombinant Ad5 vectored
COVID-19 vaccine.
- The subjects can provide with informed consent and sign informed consent form (ICF).
- The subjects are able to and willing to comply with the requirements of the clinical
trial program and can complete the 6-month follow-up of the study.
- Axillary temperature = 37.0 ?
- Individuals who are in good health condition at the time of entry into the trial as
determined by medical history, physical examination and clinical judgment of the
investigator and meet the requirements of these products immunization.
Exclusion Criteria:
- have a medical history or family history of convulsion, epilepsy, encephalopathy and
psychosis.
- be allergic to any component of the research vaccines, or used to have a history of
hypersensitivity or serious reactions to vaccination.
- Women with positive urine pregnancy test, pregnant or breast-feeding, or have a
pregnancy plan within six months.
- have acute febrile diseases and infectious diseases.
- have severe chronic diseases or condition in progress cannot be smoothly controlled,
such as asthma, diabetes, thyroid disease
- Congenital or acquired angioedema / neuroedema.
- have the history of urticaria 1 year before receiving the trial vaccine.
- have asplenia or functional asplenia.
- have thrombocytopenia or other coagulation disorders (which may cause
contraindications for intramuscular injection).
- have needle sickness.
- have the history of immunosuppressive therapy, anti allergy therapy, cytotoxic therapy
or inhaled corticosteroids (excluding corticosteroid spray therapy for allergic
rhinitis, and acute corticosteroid therapy without dermatitis) over the past 6 months.
- have received blood products within 4 months before injection of trial vaccines.
- have received another investigational product within one month before injection of
trial vaccine.
- have received attenuated vaccine within 1 month before injection of trial vaccine
except the recombinant Ad5 vectored COVID-19 vaccine.
- have received subunit or inactivated vaccine within 14 days before the vaccination
with trial vaccine.
- under anti tuberculosis treatment.
- not be able to follow the protocol, or not be able to understand the informed consent
according to the researcher's judgment, due to various medical, psychological, social
or other conditions.
11.
ClinicalTrials.gov; 19/03/2021; TrialID: NCT04813562
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04813562
RESUMO
Condition:
COVID-19Intervention:
Biological: a middle-dose recombinant COVID-19 vaccine (CHO Cell) (18-59 years) at the schedule of day 0, 28, 56;Biological: a high-dose recombinant COVID-19 vaccine (CHO Cell) (18-59 years) at the schedule of day 0, 28, 56;Biological: a middle-dose recombinant COVID-19 vaccine (CHO Cell) (60-85 years) at the schedule of day 0, 28, 56;Biological: a high-dose recombinant COVID-19 vaccine (CHO Cell) (60-85 years) at the schedule of day 0, 28, 56;Biological: a middle-dose placebo (18-59 years) at the schedule of day 0, 28, 56;Biological: a high-dose placebo (18-59 years) at the schedule of day 0, 28, 56;Biological: a middle-dose placebo (60-85 years) at the schedule of day 0, 28, 56;Biological: a high-dose placebo (60-85 years) at the schedule of day 0, 28, 56Primary outcome:
The positive conversion rate of anti-SARS-CoV-2 specific neutralizing antibody (eucivirus neutralization assays);The incidence of adverse reaction (AR)Criteria:
Inclusion Criteria:
- Healthy subjects of = 18 years old.
- The subject can understand and voluntarily sign the informed consent.
- Axillary temperature =37.0?.
- General good health as established by medical history and physical examination
Exclusion Criteria:
- Have a history of close contact with a confirmed case of SARS-CoV-2, an asymptomatic
infection in the previous 14 days, or a travel history/residential history in a
community where a case has been reported.
- Have a history of contact with a person infected with SARS-CoV-2(a person with a
positive nucleic acid test) in the previous 14 days.
- Patients with fever or respiratory symptoms who have been to middle or high-risk areas
in the past 14 days or have exit history, or come from communities with case reports.
- In the past 14 days, there have been 2 or more cases of fever and/or respiratory
symptoms in small areas such as homes, offices, school classes, etc.
- Have a history of SARS.
- Have a history of SARS-CoV-2 infection or history of Coronavirus Vaccination
(including Emergency Vaccine and Experimental Vaccine).
- Positive in SARS-CoV-2 IgG or IgM antibody screening.
- Have a history of HIV infection;
- Women who are breastfeeding, pregnant, or planning to become pregnant during 6 months
after full-course vaccination (based on the subject's self-report and blood pregnancy
test results for women of childbearing age).
- Have a history of asthma, a history of vaccine or vaccine component allergy, have
serious adverse reactions to the vaccine, such as urticaria, dyspnea, angioedema.
- Subjects with congenital malformations or developmental disorders, genetic defects,
severe malnutrition, etc.
- Subjects with autoimmune diseases or immunodeficiency/immunosuppression.
- Subjects with severe chronic diseases, severe cardiovascular diseases,
hypertension(sbp=160mmHg and/or dbp=100mmHg) and diabetes that cannot be controlled by
drugs, liver and kidney diseases, malignant tumors, etc.
- Subjects with severe neurological disease (epilepsy, convulsions or convulsions) or
mental illness.
- Subjects with thyroid disease or history of thyroidectomy, no spleen, functional
asthenia, and any spleen or splenectomy caused by any condition.
- Abnormal blood coagulation function diagnosed by a doctor (such as coagulation factor
deficiency, coagulopathy, abnormal platelet) or obvious bruise or coagulation
disorder.
- Have received immunosuppressant therapy, cytotoxic therapy, and 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 3 months before receiving trial vaccine.
- Received other study drugs within 30 days before receiving the trail vaccine.
- Received a live attenuated vaccine within 14 days before receiving the experimental
vaccine.
- Received a subunit or inactivated vaccine within 7 days before receiving the
experimental vaccine.
- Various acute or chronic diseases occurred in the past 7 days.
- Have a long history of alcohol or drug abuse.
- Had urticaria one year before receiving the experimental vaccine;
- congenital or acquired angioedema/neuroedema;
- According to the judgment of the investigator, the subject has any other factors that
are not suitable for participating in the clinical trial, or Or influence the subject
to sign the informed consent.
Exclusion criteria of subsequent dose:
- Patients with severe allergic reactions after the previous dose of vaccination;
- Patients with serious adverse reactions causally related to the previous dose of
vaccination.
- For those newly discovered or newly discovered after the first vaccination that does
not meet the first-dose selection criteria or meets the first-dose exclusion criteria,
the investigator will determine whether to continue participating in the study.
- Other exclusion reasons suggested by the researchers.
12.
ClinicalTrials.gov; 20/01/2021; TrialID: NCT04718467
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04718467
RESUMO
Condition:
COVID-19Intervention:
Biological: Recombinant COVID-19 vaccine (Sf9 cells);Biological: PlaceboPrimary outcome:
The incidence of adverse reaction (AR);The incidence of Adverse Events of Special Interest (AESI)Criteria:
Inclusion Criteria:
- 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?
Exclusion Criteria:
- 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.
- 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.
Exclusion criteria for subsequent doses:
- 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.
13.
ClinicalTrials.gov; 19/11/2020; TrialID: NCT04640402
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04640402
RESUMO
Condition:
COVID-19Intervention:
Biological: Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen;Biological: Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimen;Biological: High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen;Biological: High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimen;Biological: Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimen;Biological: Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimen;Biological: High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimen;Biological: High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimen;Biological: Low-dose placebo (18-59 years) & Two dose regimen;Biological: Low-dose placebo (18-59 years) & Three dose regimen;Biological: High-dose placebo (18-59 years) & Two dose regimen;Biological: High-dose placebo (18-59 years) & Three dose regimen;Biological: Low-dose placebo (60-85 years) & Two dose regimen;Biological: Low-dose placebo (60-85 years) & Three dose regimen;Biological: High-dose placebo (60-85 years) & Two dose regimen;Biological: High-dose placebo (60-85 years) & Three dose regimenPrimary outcome:
Geometric mean (GMT) of specific antibody;The incidence of adverse reaction (AR)Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
First dose exclusion criteria:
- Positive serum immunoglobulin M (IgM) and IgG to the SARS-CoV-2.
- A Known History of HIV infection
- Family history of seizure, epilepsy, brain or mental disease.
- Participant that has an allergic history to any ingredient of vaccines.
- Woman who is pregnant, breast-feeding or positive in pregnancy test on day of
enrollment, or is planning to be pregnant during the next 6 months.
- Any acute fever disease or infections.
- Have a medical history of SARS.
- Have serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial
infarction, severe hypertension and not well-controlled.
- Major chronic illness, such as asthma, diabetes, or thyroid disease, and not
well-controlled.
- Hereditary angioneurotic edema or acquired angioneurotic edema.
- Urticaria in last one year.
- Asplenia or functional asplenia.
- Platelet disorder or other bleeding disorder may cause injection contraindication.
- Faint at the sight of blood or needles.
- Prior administration of immunodepressant or corticosteroids, antianaphylactics
treatment, cytotoxic treatment in last 6 months.
- Prior administration of blood products in last 4 months.
- Prior administration of other research medicines in last 1 month.
- Prior administration of attenuated vaccine in last 1 month.
- Prior administration of subunit vaccine or inactivated vaccine in last 14 days.
- Being treated for tuberculosis.
- Any condition that in the opinion of the investigators may interfere with the
evaluation of study objectives.
Exclusion criteria for subsequent doses:
- Patients with severe allergic reactions after the previous dose of vaccination;
- Patients with serious adverse events causally related to the previous dose of
vaccination.
14.
ClinicalTrials.gov; 17/11/2020; TrialID: NCT04636333
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04636333
RESUMO
Condition:
COVID-19Intervention:
Biological: Two doses of middle-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14;Biological: Three doses of middle-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28;Biological: Two doses of high-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14;Biological: Three doses of high-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28;Biological: Two doses of placebo at the schedule of day 0, 14 #middle-dose group; Biological: Three doses of placebo at the schedule of day 0, 14, 28 #middle-dose group; Biological: Two doses of placebo at the schedule of day 0, 14 #High-dose group; Biological: Three doses of placebo at the schedule of day 0, 14, 28 #High-dose group#Primary outcome:
The proportion of adverse reactions (AR) up to Day 28 after prime and boost vaccination of the recombinant SARS-CoV-2 vaccine (CHO cell) or placebo.Criteria:
Inclusion Criteria:
- Healthy subjects of = 18 years old.
- The subject can understand and voluntarily sign the informed consent.
- The subject can The subject canprovide legal identification.
Exclusion Criteria:
- Have a history of close contact with a confirmed case of SARS-CoV-2, an asymptomatic
infection in the previous 14 days, or a travel history/residential history in a
community where a case has been reported.
- Have a history of contact with a person infected with SARS-CoV-2(a person with a
positive nucleic acid test) in the previous 14 days.
- Patients with fever or respiratory symptoms who have been to middle or high-risk areas
in the past 14 days or have exit history, or come from communities with case reports.
- In the past 14 days, there have been 2 or more cases of fever and/or respiratory
symptoms in small areas such as homes, offices, school classes, etc.
- Have a history of SARS.
- Have a history of SARS-CoV-2 infection.
- Positive in SARS-CoV-2 IgG or IgM antibody screening.
- Positive in RT-PCR test of SARS-CoV-2 in throat swab.
- Positive in HIVantibody screening.
- Women who are breastfeeding, pregnant, or planning to become pregnant during the study
period (based on the subject's self-report and blood pregnancy test results for women
of childbearing age), or men who plan to conceive their partners during the study
period.
- Subjects with body mass index (BMI) =35 kg/m2.
- Have a history of asthma, a history of vaccine or vaccine component allergy, have
serious adverse reactions to the vaccine, such as urticaria, dyspnea, angioedema.
- Subjects with congenital malformations or developmental disorders, genetic defects,
severe malnutrition, etc.
- Subjects with autoimmune diseases or immunodeficiency/immunosuppression.
- Subjects with severe chronic diseases, severe cardiovascular diseases, hypertension
and diabetes that cannot be controlled by drugs, liver and kidney diseases, malignant
tumors, etc.
- Subjects with severe neurological disease (epilepsy, convulsions or convulsions) or
mental illness.
- Subjects with thyroid disease or history of thyroidectomy, no spleen, functional
asthenia, and any spleen or splenectomy caused by any condition.
- Abnormal blood coagulation function diagnosed by a doctor (such as coagulation factor
deficiency, coagulopathy, abnormal platelet) or obvious bruise or coagulation
disorder.
- Have received immunosuppressant therapy, cytotoxic therapy, and inhaled
corticosteroids in the past 6 months (excluding corticosteroid spray therapy for
allergic rhinitis and surface corticosteroid therapy for acute non-complicated
dermatitis).
- Physical examination or chest CT imaging reveals clinically significant abnormalities.
- Abnormal laboratory test results such as hematology and biochemistry that are beyond
the reference value range and have clinical significance.
1. Routine blood test: white blood cell count, hemoglobin, platelet count.
2. Blood biochemical index detection: alanine aminotransferase (ALT), aspartate
aminotransferase (AST), fasting blood glucose, C-reactive protein, total
bilirubin (TBIL), creatinine (CR), creatine phosphokinase (CPK).
3. Urine routine indicators: urine protein (PRO), urine sugar, urine red blood
cells.
4. Coagulation function test: prothrombin time (PT), activated partial
thromboplastin time (APTT), thrombin time (TT), fibrinogen (FIB).
- Have a long history of alcohol or drug abuse.
- Received blood products within 3 months before receiving trial vaccine.
- Received other study drugs within 30 days before receiving the trail vaccine.
- Received a live attenuated vaccine within 14 days before receiving the experimental
vaccine.
- Received a subunit or inactivated vaccine within 7 days before receiving the
experimental vaccine.
- Various acute or chronic diseases occurred in the past 7 days.
- Axillary body temperature>37.0? before vaccination.
- According to the judgment of the investigator, the subject has any other factors that
are not suitable for participating in the clinical trial.
Exclusion criteria of subsequent dose:
If one of the following (1) to (4) adverse events (AE) occurs, the vaccination is
prohibited, but other research steps can be continued according to the investigator's
judgment; if one of the following (5), (6) adverse events occurs , The investigator will
judge whether to inoculate; if one of the following events (7) to (10) occurs, the
vaccination can be postponed within the time window specified in the plan.
- (1)The subjects used the same vaccine other than the experimental vaccine during the
study.
- (2)Any serious adverse reactions that are causally related to vaccination.
- (3)Severe allergic or hypersensitivity reactions after vaccination (including
urticaria/skin rash within 30 minutes after vaccination).
- (4)Any confirmed or suspected autoimmune disease or immunodeficiency disease,
including human immunodeficiency virus (HIV) infection.
- (5)Acute or new-onset chronic disease after vaccination.
- (6)Other reactions (including severe pain, severe swelling, severe activity
limitation, persistent high fever, severe headache, or other systemic or local
reactions) are judged by the investigator.
- (7)Acute illness at the time of vaccination (Acute illness refers to moderate or
severe illness with or without fever).
- (8)Axillary temperature >37.0? before vaccination.
- (9)Vaccination of subunit vaccine or inactivated vaccine within 7 days, live
attenuated vaccine within 14 days.
- (10)According to the investigator's judgment, the subject has any other factors that
are not suitable for vaccination.
15.
ClinicalTrials.gov; 28/09/2020; TrialID: NCT04568811
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04568811
RESUMO
Condition:
Adenovirus Type-5 Vectored COVID-19 VaccineIntervention:
Biological: Adenovirus Type-5 Vectored COVID-19 VaccinePrimary outcome:
Occurrence of adverse reactions within 14 days after booster vaccinationCriteria:
Inclusion Criteria:
- Participants who has received prime vaccination of adenovirus type-5 vectored COVID-19
vaccine
- Able to understand the content of informed consent and willing to sign the informed
consent
- Negative in HIV diagnostic test.
- Axillary temperature =37.0°C.
- General good health as established by medical history and physical examination.
- Able to complete 12 months visit
Exclusion Criteria:
- Family history of seizure, epilepsy, brain or mental disease
- Subject allergic to any component of the investigational vaccine, or a more severe
allergic reaction and history of allergies in the past.
- Woman who is pregnant, breast-feeding on day of enrollment, or become pregnant during
the next 12 months
- Any acute fever disease or infections.
- History of SARS
- Major congenital defects or not well-controlled chronic illness, such as asthma,
diabetes, or thyroid disease.
- Serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial
infarction, severe hypertension without controllable drugs, etc.
- Hereditary angioneurotic edema or acquired angioneurotic edema
- Urticaria in last one year
- No spleen or functional spleen.
- Platelet disorder or other bleeding disorder may cause injection contraindication
- Faint at the sight of needles.
- Prior administration of immunodepressant or corticosteroids, antianaphylaxis
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 inactivated vaccine in last 14 days
- Current anti-tuberculosis prophylaxis or therapy
- According to the judgement of investigator,various medical, psychological, social or
other conditions, those could affect the subjects to sign informed consent.
16.
ClinicalTrials.gov; 27/08/2020; TrialID: NCT04530656
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04530656
RESUMO
Condition:
COVID-19Intervention:
Biological: Two doses of middle-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28;Biological: Two doses of high-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28;Biological: Three doses of high-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 14, 28;Biological: Two doses of placebo at the schedule of day 0, 28(middle-dose group);Biological: Two doses of placebo at the schedule of day 0, 28(high-dose group);Biological: Three doses of placebo at the schedule of day 0, 14, 28(high-dose group)Primary outcome:
Occurrence of adverse reactions (AR) within 7 days after each dose of the recombinant SARS-CoV-2 vaccine (Sf9 cell) or placebo.Criteria:
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
Exclusion criteria of prime dose:
- 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.
- 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.
Exclusion criteria of subsequent dose:
- 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.