Clinical trial NCT05198102: ZF2001 Booster Immunization Clinical Trials of 12 Months After the Completion of Basic Immunization
Official title: To Evaluate the Immunogenicity and Safety of Booster Immunization 12 Months After the Completion of Basic Immunization of Recombinant Novel Coronavirus Vaccine (CHO Cell) in People 18 Years Old and Above
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Prevention of COVID-19
Lead sponsor: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-01-20
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the immunogenicity and safety of the recombinant novel coronavirus vaccine (CHO cells) after the booster immunization. It is planned to screen 300 subjects of 18 years old and above who have completed the basic immunization of recombinant novel coronavirus vaccine (CHO cells), to evaluate the immunogenicity and safety of the booster immunization of 12 months (window period ± 3 months) after the basic immunization. Investigate the geometric mean titer (GMT), GMI and 4 times growth rate of SARS-CoV-2 neutralizing antibody and RBD protein binding antibody 14 days, 30 days, and 6 months after booster vaccination; the incidence of all AEs within 1 month after the booster vaccination, the incidence of all serious adverse events (SAE) within 6 months after the booster vaccination.

Detailed description: This study adopts an open experimental design. It is planned to screen 300 subjects of 18 years old and above who have completed the basic immunization of recombinant novel coronavirus vaccine (CHO cells), to evaluate the immunogenicity and safety of the booster immunization of 12 months (window period ± 3 months) after the basic immunization.

Immunogenicity observation: the geometric mean titer (GMT), GMI and 4 times growth rate of SARS-CoV-2 neutralizing antibody and RBD protein binding antibody 14 days, 30 days, and 6 months after booster vaccination.

Safety observation:

All adverse events (AE) were collected within 30 minutes after the booster immunization, all AEs (including both solicited and unsolicited AEs) 0-7 days after the booster immunization, and all AEs (unsolicited AEs) 8-30 days after the booster immunization.

Solicited AE (the following events occurring within 7 days of vaccination) :

Adverse events at the inoculation site (local) : pain, pruritus, redness, swelling, rash, induration; Non-inoculated site (systemic) adverse events: fever, headache, fatigue, diarrhea, nausea, vomiting, muscle pain (non-inoculated site), acute allergic reactions, cough.

All SAEs were collected within 6 months after the booster immunization.

Eligibility criteria: Inclusion Criteria:

* Participated in "A Phase III Randomized, Double-blind, Placebo-controlled Clinical Trial in 18 Years of Age and Above to Determine the Safety and Efficacy of ZF2001, a Recombinant Novel Coronavirus Vaccine (CHO cell) for Prevention of COVID-19. Protocol no.: LKM-2020-NCV-GJ01)" and has completed basic immunization with recombinant novel coronavirus vaccine (CHO cells) since 12 months (window period ± 3 months);
* The subjects voluntarily participate in the study, sign an informed consent form, and can provide valid identification, understand and comply with the requirements of the trial protocol;
* Female subjects of childbearing age agree to take effective contraceptive measures from the start of the study to 1 month after vaccination.

Exclusion Criteria:

* A confirmed case of new coronavirus infection or asymptomatic infection or a history of positive new coronavirus nucleic acid test;
* Patients with uncontrolled lymphoproliferative diseases, unresolved aplastic anemia, active primary immune thrombocytopenia (ITP), uncontrolled coagulopathy, etc;
* Patients with malignant tumors before and after surgery, patients undergoing chemotherapy, radiotherapy, immunotherapy, etc.; patients with organ transplant status;
* People with uncontrolled epilepsy and other serious neurological diseases (such as transverse myelitis, Guillain-Barre syndrome, demyelinating diseases, etc.);
* Suffering from acute diseases, or acute attacks of chronic diseases, or uncontrolled severe chronic diseases, such as hypertension that cannot be controlled by drugs (systolic blood pressure ≥150mmHg and/or diastolic blood pressure ≥100mmHg);
* Previous history of severe allergies to any vaccine, or history of severe allergies to any component of the test vaccine, including aluminum preparations, such as: anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, dyspnea, vascular nerve Sexual edema, etc.;
* Women who are breastfeeding or pregnant;
* In addition to completing the recombinant new coronavirus vaccine (CHO cell) within the past 15 months, has participated in or is participating in other COVID-19 related clinical trials;
* Researchers believe that any disease or condition in the subject may put the subject at an unacceptable risk; the subject cannot meet the requirements of the protocol; the situation that interferes with the assessment of the vaccine response.

Primary outcomes:
measure: Immunogenicity endpoint
timeFrame: 14 days after booster vaccination
measure: Immunogenicity endpoint
timeFrame: 30 days after booster vaccination
measure: Immunogenicity endpoint
timeFrame: 6 months after booster vaccination
Secondary outcomes:
measure: Immunogenicity endpoint
timeFrame: 14 days, 30 days, and 6 months after booster vaccination
measure: Safety endpoint
timeFrame: Within 1 month after booster vaccination
measure: Safety endpoint
timeFrame: Within 6 months after booster vaccination
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Provincial Center for Disease Control and Prevention
state: Hunan
Study officials:
affiliation: Hunan Provincial Center for Disease Control and Prevention
name: Tao Huang, Bachelor
role: PRINCIPAL_INVESTIGATOR
References: