Clinical Trials of the Consistency and Non-inferiority Bridging Between Batches of Recombinant New Coronavirus Vaccine (CHO Cells)

  • STATUS
    Recruiting
  • days left to enroll
    86
  • participants needed
    1680
  • sponsor
    Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Updated on 31 October 2021
Accepts healthy volunteers

Summary

Popular topic:Clinical trials of the consistency and non-inferiority bridging between batches of recombinant new coronavirus vaccine (CHO cells) Research purpose:Main purpose:1)To evaluate the interbatch consistency of immunogenicity of three batches of recombinant Novel Coronavirus vaccine (CHO cells) following process validation in 18-59 year olds. 2)To evaluate the non-inferiority of immunogenicity of recombinant Novel Coronavirus vaccine (CHO cells) from the combined batch and pilot scale batch after process validation in 18-59 years of age. Secondary purpose:1)To evaluate the safety of each batch of recombinant Novel Coronavirus vaccine (CHO cells) in patients aged 18-59 years.2)To evaluate the non-inferiority of immunogenicity of recombinant Novel Coronavirus vaccine (CHO cells) from the combined batch and commercial batch after process validation in 18-59 years of age.

Overall design:This trial adopts a randomized, double-blind, parallel controlled trial design. Study population:The study involved people aged 18-59. Test groups:A total of 1680 subjects were enrolled in this clinical trial and randomly divided into 4 groups at 1:1:1:1 (pilot scale batch: process verification batch 1: process verification batch 2: process verification batch 3) , 420 cases per group.

Description

Overall design: In this study, a randomized, double-blind, parallel-controlled trial design was used to evaluate the inter-batch consistency of immunogenicity of the three batches of recombinant Novel Coronavirus vaccine (CHO cells) after process validation in 18-59 year olds and the non-inferiority of immunogenicity between the three batches after process validation and the pilot scale batches. Non-inferiority of immunogenicity between the three batches after process validation and the commercial scale batches (clinical trials have been conducted), and the safety of each vaccine batch after vaccination was evaluated.

Intervention: Group A: 3 doses of experimental vaccine (pilot scale batch) were given at day 0, 30 and 60; Group B: 3 doses of experimental vaccine (process validation lot 1) at day 0, 30 and 60; Group C: 3 doses of experimental vaccine (process validation lot 2) at day 0, 30 and 60; Group D: 3 doses of experimental vaccine (process validation lot 3) at day 0, 30 and 60;

Immunogenicity observation:Blood samples were collected before the first dose and 14 days after the whole immunization, and the serum was separated for detection of live virus neutralizing antibodies (CPE method).

Safety observation:

(1) All adverse events (AE) were collected 30 minutes after each dose, all AE (including both solicitation and non-solicitation AE) at 0-7 days, and all AE (non-solicitation AE) at 8-30 days.

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

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

(2) All SAE were collected from the first dose to 12 months after full immunization.

Details
Condition Coronavirus Disease 2019
Treatment Recombinant new coronavirus vaccine (CHO cell) group
Clinical Study IdentifierNCT05091411
SponsorAnhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Last Modified on31 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Persons aged 18-59 with full capacity for civil conduct
Subjects voluntarily participate in the study, sign informed consent, provide valid identification, understand and comply with the requirements of the study protocol
Female subjects of reproductive age agree to use effective contraceptive measures from the beginning of the study to 12 months after full vaccination

Exclusion Criteria

Suspected or confirmed fever within 72 hours before enrollment, or armpit temperature 37.3 on the day of enrollment
Diastolic blood pressure 100mmHg and/or systolic blood pressure 160mmHg before screening
people who currently have or have a history of COVID-19
Persons suffering from the following diseases
have thrombocytopenia, any coagulation dysfunction or receive anticoagulant
treatment, etc
history of congenital or acquired immune deficiency or autoimmune disease
Received immunomodulators within 6 months, such as immunosuppressive doses of
glucocorticoids (dose reference: equivalent to prednisone 20mg/ day, over a
week); Or monoclonal antibodies; Or thymosin; Or interferon; However, topical
use (such as ointments, eye drops, inhalants or nasal sprays) is allowed
Cancer patients (except basal cell carcinoma)
Patients with active tuberculosis, viral hepatitis and/or HIV antibody
positive or syphilis specific antibody positive
Neurological disease or family history (e.g., migraines, epilepsy, stroke
seizures in the last three years, encephalopathy, focal neurological deficits
Guillain-Barre syndrome, encephalomyelitis or transverse myelitis); History of
mental illness or family history
Functional absence of spleen, and absence of spleen or splenectomy caused by
any reason
Serious chronic diseases or diseases in the advanced stage can not be
controlled smoothly, such as diabetes, thyroid diseases
Severe liver and kidney diseases; Any current respiratory illness requiring
routine medication (e.g., chronic obstructive pulmonary disease [COPD]
asthma) or any exacerbation of respiratory illness (e.g., exacerbation of
asthma) within the last 5 years; A history of serious cardiovascular disease
(e.g., congestive heart failure, cardiomyopathy, ischemic heart disease
arrhythmia, conduction block, myocardial infarction, cor pulmonale) or
myocarditis or pericarditis
\. A history of severe allergy to any vaccine, or to any component of the
test vaccine, including aluminum preparations, such as anaphylactic shock
allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, dyspnea
angiopantic edema, etc
\. Subunit vaccine and inactivated vaccine should be administered within 14
days before the first dose of vaccine, and live attenuated vaccine should be
administered within 30 days
\. Have received blood or blood-related products, including immunoglobulin
within 3 months; Or planned use from the beginning of the study to 1 month
after full vaccination
\. Those who have participated in or are participating in other CLINICAL
trials related to COVID-19, or who have received COVID-19 vaccines
\. Lactating women or pregnant women (including women of childbearing age
with positive urine pregnancy test)
\. The Investigator believes that the subject has any disease or condition
that may place the subject at unacceptable risk; Subjects cannot meet the
requirements of the program; Conditions that interfere with the assessment of
vaccine response
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