Popular topic:Multi-center safety observation of recombinant Novel Coronavirus proteinvaccine (CHO cells) in a large population Study population:People aged 18 and above
Overall design:The aim of this study is to carry out safety studies in the large scale
healthy population and special population of recombinant New Coronavirus protein vaccine
(CHO cell) in China. It will be included in 100 thousand subjects, including 20 thousand
special populations. It is planned to enroll 50000 cases in Hunan (including no less than
10000 special people), 40000 cases in Guizhou (including no less than 8000 special
people), and 10000 cases in Hainan (including no less than 2000 special people).
Special groups include but are not limited to obesity, chronic metabolic diseases,
chronic lung diseases, chronic cardiovascular diseases, tumors, acquired immunodeficiency
syndrome, chronic kidney disease, etc. If the researcher determines that it is necessary,
the special population shall provide the medical diagnosis certificate or the drug
prescription certificate issued by the doctor.
Immunization program: Subjects who have not received any Novel Coronavirus vaccine or the
full dose of recombinant Novel Coronavirus protein vaccine (CHO cells) shall receive 3
doses of the experimental vaccine intramuscular in the deltoid muscle of the upper arm or
complete the remaining doses of the experimental vaccine as per the vaccination schedule
at 0, 1, and 2 months, with a dose of 0.5ml for each person.
Immunized subjects: intramuscular injection of one dose of the experimental vaccine into
the deltoid muscle of the upper arm, 0.5ml for each person.
Follow up and record:
1. Passive monitoring:
After all subjects have been vaccinated, the researcher shall conduct safety
education and issue contact cards to the subjects, so that the subjects can contact
the researcher in time in case of any discomfort. The researcher shall timely
standardize the treatment and collect the AESI or SAE information of the subjects.
2. Active monitoring:
All subjects installed customized APP or Wechat applet through mobile phones on the first
7 days and 30 days after each dose of vaccination, and 3, 6, 9 and 12 months after the
last dose of vaccination, and recorded and collected the occurrence of adverse events: ①
the first dose of vaccination - 30 days after the whole dose of vaccination, and 30 days
after the enhanced vaccination, including the occurrence of all adverse events, including
solicited AE (vaccination site (local adverse events) Non inoculated sites (systemic
adverse events)) and non solicited AEs; ② First dose - SAE, AESI and pregnancy events
within 12 months after full vaccination and 12 months after booster immunization.
The solicitation AE is:
Adverse events at the inoculation site (local): pain, pruritus, erythema, swelling, rash
and induration; Non inoculated site (systemic) adverse events: fever, headache, fatigue /
fatigue, diarrhea, nausea, vomiting, muscle pain (non inoculated site), acute allergic
reaction and cough.
Safety assessment:
AE, AESI and SAE:
1. Collect adverse events of special concern (AESI) from the first dose of vaccination
to one year after the whole course of vaccination and one year after intensive
immunization, including myocarditis / pericarditis, thrombosis, thrombocytopenia,
immune related diseases (psoriasis, rheumatoid arthritis, etc.), nervous system
related diseases (glibali syndrome, peripheral neuropathy, bell facial paralysis);
2. Collect serious adverse events (SAE) from the first dose of vaccination to 1 year
after the whole course of vaccination and 1 year after intensive immunization;
3. Collect all AEs from the first dose to 30 days after the whole course of vaccination
and 30 days after booster immunization.
Pregnancy events:
The pregnancy events from the first dose of vaccination to one year after the whole
course of vaccination and one year after the booster vaccination were collected (at the
same time, the safety and pregnancy outcome of pregnant women's accidental vaccination
were analyzed).
ADE/ VED risk monitoring:
After vaccination (at least one dose of test vaccine) (at each visit), remind the
subjects to contact the investigator in time for fever and / or respiratory symptoms
(such as dyspnea, sore throat, etc.) and covid-19 suspected or confirmed cases during the
study. If the subject is suspected or confirmed to be infected with SARS-COV-2 during the
test, he must go to the local Xinguan designated hospital for hospitalization diagnosis
and treatment. For confirmed cases, detailed case investigation shall be carried out. In
case of aggregated new coronavirus infection or severe, critical and death cases after
sars-cov-2 infection during the trial, special investigation shall be carried out.
According to the analysis of special investigation results, if there is ADE/ VED
phenomenon, an expert meeting shall be held to evaluate whether there is ADE / VED risk.
Biological: Recombinant new coronavirus vaccine (CHO cell)
Subjects who have not received any Novel Coronavirus vaccine or the full dose of
recombinant Novel Coronavirus protein vaccine (CHO cells) shall receive 3 doses of the
experimental vaccine intramuscular in the deltoid muscle of the upper arm or complete the
remaining doses of the experimental vaccine as per the vaccination schedule at 0, 1, and
2 months, with a dose of 0.5ml for each person.
Immunized subjects: intramuscular injection of one dose of the experimental vaccine into
the deltoid muscle of the upper arm, 0.5ml for each person.
Inclusion Criteria:
1. Healthy people or special people aged 18 and above who meet the requirements of
national new coronavirus vaccination (including but not limited to obesity (BMI ≥
28kg/ m²). Chronic metabolic diseases, chronic lung diseases, chronic cardiovascular
diseases, tumors, acquired immunodeficiency syndrome, chronic kidney disease, etc.);
If the researcher determines that it is necessary, the special population shall
provide relevant written diagnosis certificates, records or drug prescription
certificates issued by doctors;
2. The subjects voluntarily participated in the study, signed the informed consent,
understood and complied with the requirements of the clinical trial scheme, and were
able to understand the research procedures.
Exclusion Criteria:
1. Patients with uncontrolled lymphoproliferative diseases, unresponsive aplastic
anemia, active primary immune thrombocytopenia (ITP), uncontrolled bleeding and
coagulation diseases, etc;
2. People with uncontrolled epilepsy and other serious neurological diseases (such as
transverse myelitis, Guillain Barre syndrome, demyelinating disease, etc.);
3. Patients suffering from acute disease, or acute attack of chronic disease, or
uncontrolled severe chronic disease;
4. Previous history of severe allergy to any vaccine or any component of the test
vaccine, including aluminum preparation, such as anaphylactic shock, allergic
laryngeal edema, Henoch Schonlein purpura, thrombocytopenic purpura, dyspnea,
angioneuroedema, etc;
5. The researchers believe that the subject has any disease or condition that may put
the subject at unacceptable risk; The subjects could not meet the protocol
requirements; Interference with the evaluation of vaccine response.
Hunan Provincial Center for Disease Control and Prevention
Changsha, Hunan, China
Investigator: Lidong Gao
Contact: 0731-84305911
Lidong Gao
0731-84305911
810173358@qq.com
Lidong Gao, Study Chair
Hunan Provincial Center for Disease Control and Prevention