A Phase 1 interventional study of medium dosage inactivated SARS-CoV-2 vaccine and high dosage inactivated SARS-CoV-2 vaccine in COVID-19, sponsored by Beijing Minhai Biotechnology Co., Ltd. Status unknown at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-17.
Sponsored by Beijing Minhai Biotechnology Co., Ltd · Phase 1, Interventional, and Prevention
This study is a randomized, double-blinded, and placebo controlled phase Ⅰ clinical trial of the SARS-CoV-2 inactivated vaccine to evaluate the safety and immunogenicity of the experimental vaccine in healthy adults ⩾18 years.
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's enrollment of 180 is above the median of 102 across 4,364 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Beijing Minhai Biotechnology Co., Ltd is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two doses of medium dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,14
Biological: medium dosage inactivated SARS-CoV-2 vaccine
Two doses of high dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,14
Biological: high dosage inactivated SARS-CoV-2 vaccine
Two doses of placebo on the schedule of day 0,14
Biological: Placebo
Three doses of medium dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,28,56
Biological: medium dosage inactivated SARS-CoV-2 vaccine
Three doses of high dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,28,56
Biological: high dosage inactivated SARS-CoV-2 vaccine
Three doses of placebo on the schedule of day 0,28,56
Biological: Placebo
Three doses of medium dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,28,56
Biological: medium dosage inactivated SARS-CoV-2 vaccine
Three doses of high dosage inactivated SARS-CoV-2 vaccine on the schedule of day 0,28,56
Biological: high dosage inactivated SARS-CoV-2 vaccine
Three doses of placebo on the schedule of day 0,28,56
Biological: Placebo
medium dosage
high dosage
placebo
Incidence of adverse reactions/events
Time frame: 0-28 days after each dose of vaccination
Serious Adverse Events (SAE)
Time frame: within 12 months post full vaccination
Incidence of abnormal indicators of laboratory safety examinations(including blood routine, blood biochemistry, urine routine and coagulation function)
Time frame: Day 3 after each dose of vaccination
The seropositive rates of SARS-CoV-2 neutralizing antibody
Time frame: Day 14 and day 28 after each dose of vaccination, and 3, 6 and 12 months post full vaccination
The seropositive level of SARS-CoV-2 neutralizing antibody
Time frame: Day 14 and day 28 after each dose of vaccination, and 3, 6 and 12 months post full vaccination
The seropositive rates of SARS-CoV-2 IgG antibody(tested by ELISA)
Time frame: Day 14 and day 28 after each dose of vaccination, and 3, 6 and 12 months post full vaccination
The seropositive level of SARS-CoV-2 IgG antibody(tested by ELISA)
Time frame: Day 14 and day 28 after each dose of vaccination, and 3, 6 and 12 months post full vaccination
The proportion of IFN-γ positive cells (by ELISpot)
Time frame: Before second and third vaccination, day 28 post full vaccination(18~59years, 3 doses group); before second vaccination and day 14 post full vaccination(18~59years, 2 doses group); 3, 6 and 12 months post full vaccination(18~59years, both group）
Level of IL-2、IL-4、IL-5、IL-6、TNFα、IFN-γ (by ELISA)
Time frame: Before second and third vaccination, day 28 post full vaccination(18~59years, 3 doses group); before second vaccination and day 14 post full vaccination(18~59years, 2 doses group); 3, 6 and 12 months post full vaccination(18~59years, both group）
The SARS-CoV-2 antibody level of IgG1, IgG2, IgG3, IgG4 and Nucleoprotein
Time frame: Day 14 and 28 after each dose, and 3, 6, 12 months post full vaccination(18~59years)
Started Oct 2020 (actual). Primary completion is estimated for Jun 2021, 8 months after the start.
Of 233 industry-sponsored phase 1 interventional studies under COVID-19, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 12. This study's planned 8 months is above that.
Counting every sponsor, half of 384 studies reached it within 7 months; a quarter within 3 and three quarters within 15.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Beijing Minhai Biotechnology Co., Ltd