An interventional study of Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells) and Recombinant novel coronavirus protein vaccine (CHO cells) in Coronavirus, sponsored by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-06.
Sponsored by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. (part of Chongqing Zhifei Biological Products Co., Ltd.) · Not applicable, Interventional, and Prevention
Popular title: Clinical study of Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells).
Purpose of the study: Main objectives: To evaluate the immunogenicity and safety of Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells) against the new coronavirus prototype strain and Omicron variant (XBB, BA.5, BF.7) after receiving 2 doses according to different immunization schedules in people aged 18 years and older. Secondary purposes: To evaluate the immune persistence of Omicron BA.4/5-Delta recombinant novel coronavirus protein vaccine (CHO cells) against the new coronavirus prototype strain and Omicron variant (XBB, BA.5, BF.7) after receiving 2 doses according to different immunization schedules in people aged 18 years and older.
Overall design: Studies were randomized, double-blind, active-controlled study design.
Study group: There were 160 participants aged 18 years and older, including 80 people aged 60 years and older.
Study group：Among them, 80 subjects were from the "randomized, double-blind, active-controlled clinical study to evaluate the immunogenicity and safety of Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells) in people aged 18 years and older, protocol number: LKM-2023-NCV-02", 40 cases in the study group and 40 cases in the control group, and completed the second dose of vaccine at the 6th month visit to observe immunogenicity and safety. The remaining 80 subjects were randomly blinded to the 1:1 ratio into the research group and the control group and received 2 doses of the experimental vaccine according to the 0-1-month procedure to observe immunogenicity and safety.
1,112 studies on the registry are indexed under Coronavirus Infections; 52 are open to participants now.
This study's planned enrollment of 160 is above the median of 120 across 655 interventional studies indexed under Coronavirus Infections.
Browse Coronavirus Infections studies →Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. is the lead sponsor of 49 studies on the registry; 4 are 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:
Participants were not eligible for study if they had any of the following:
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.
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
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.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
According to the 0-1-month immunization schedule, two doses of 25 μg/0.5 ml Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells) were injected into the deltoid muscle of the upper arm.
Biological: Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells)
According to the 0-1-month immunization schedule, two doses of 25 μg/0.5 ml recombinant novel coronavirus protein vaccine (CHO cells) were injected into the deltoid muscle of the upper arm.
Biological: Recombinant novel coronavirus protein vaccine (CHO cells)
The subjects were from the "LKM-2023-NCV-02" project and were vaccinated on a voluntary basis with 25 μg/0.5 ml Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells) at the visit 6 months after the exemption.
Biological: Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells)
The subjects were from the "LKM-2023-NCV-02" project and were vaccinated on a voluntary basis with 25 μg/0.5 ml recombinant novel coronavirus protein vaccine (CHO cells) at the visit 6 months after the exemption.
Biological: Recombinant novel coronavirus protein vaccine (CHO cells)
Drug page: CHO Cells
Intramuscular injection of deltoid muscle of upper arm of 25μg/0.5ml/person dose Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells).
Intramuscular injection of deltoid muscle of upper arm of 25μg/0.5ml/person dose Recombinant new coronavirus vaccine (CHO cells).
Number of adverse events after 2 doses given intramuscularly according to different immunization programs
The observation of adverse events mainly come from vital sign detection and laboratory examination (including blood routine/urine routine/blood biochemistry/electrocardiogram and chest X-ray), local reactions and systemic reactions after injection.
Time frame: 6 months after 2 doses of vaccine
Laboratory markers of immunity after 2 doses given intramuscularly according to different immunization programs
Geometric mean titer (GMT) of neutralizing antibodies against the Omicron variant (XBB) after vaccination with the investigational vaccine.
Time frame: 14 days after 2 doses of vaccine
Immunogenic end points
Positive conversion rate of the Omicron variant (XBB) of the new coronavirus after vaccination with the investigational vaccine.
Time frame: 14 days after 2 doses of vaccine
Laboratory markers of immunity
Geometric mean titer (GMT) of neutralizing antibodies against the prototype novel coronavirus strain, Omicron strain (BA.4/5, BF.7) after 2 doses of vaccine candidate.
Time frame: 14 days after 2 doses of vaccine
Laboratory markers of immunity
Growth multiples (GMI) of the prototype new coronavirus strain and the Omicron variant (BA.4/5, BF.7) after 2 doses of investigational vaccine.
Time frame: 14 days after 2 doses of vaccine
Immunogenic end points
Positive conversion rate against the prototype Omicron variant (BA.4/5, BF.7) after 2 doses of study vaccine.
Time frame: 14 days after 2 doses of vaccine
Laboratory markers of immunity
Growth multiple (GMI) of the new coronavirus Omicron variant (XBB) after 2 doses of investigational vaccine.
Time frame: 14 days after 2 doses of vaccine
Laboratory markers of immunity
Geometric mean titer (GMT) of neutralizing antibodies against the prototype novel coronavirus strain, Omicron strain (XBB, BA.4/5, BF.7) after 2 doses of vaccine candidate.
Time frame: 6 months after 2 doses of vaccine
Laboratory markers of immunity
Growth multiples (GMI) of the prototype new coronavirus strain and the Omicron variant (XBB, BA.4/5, BF.7) after 2 doses of investigational vaccine.
Time frame: 6 months after 2 doses of vaccine
Immunogenic end points
Positive conversion rate against the prototype Omicron variant (XBB, BA.4/5, BF.7) after 2 doses of study vaccine.
Time frame: 6 months after 2 doses of vaccine
No study locations are listed for this record.
Start is estimated for Sep 2023; primary completion for May 2024, 7 months later.
Of 133 interventional studies with no phase under Coronavirus Infections, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 14. This study's planned 7 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: CHO Cells
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