Clinical Trial of Quadrivalent Recombinant Norovirus Vaccine (Pichia Pastoris)

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    580
  • sponsor
    Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Send
Updated on 7 October 2022
See if I qualify
Accepts healthy volunteers

Summary

The purpose of the research is to evaluate the safety and tolerability of the tetravalent recombinant Norovirus vaccine at different doses, to initially explore the immunogenicity of the vaccine, and to determine the appropriate dose of the product for later clinical trials.This trial adopts the seamless design of phase I/IIa, which is carried out in two phases, phase I and phase IIa, phase I is the age/dose climbing phase, and phase IIa is the dose expansion phase.It is planned to enroll 580 subjects, divided into 5 age groups, including: young adults (18-59 years old, 60 people), adolescents (6 -17 years old, 60 people), and elderly (≥60 years old, 160 people) , Toddlers (2-5 years old, 140), infants (6 weeks to 23 months old, 160).The test vaccine contains recombinant HuNoV GI.1-VP1 protein, HuNoV GII.3-VP1 protein, HuNoV GII.4-VP1 protein, HuNoV GII.17-VP1 protein, and each dose contains 12.5μg/type/0.5ml/bottle (Low dose), 25μg/type/0.5ml/piece (high dose).

Description

A single-center, randomized, blinded, multi-cohort, placebo-controlled trial design was adopted.This trial adopts the seamless design of phase I/IIa, which is carried out in two phases, phase I and phase IIa, phase I is the age/dose climbing phase, and phase IIa is the dose expansion phase.It is planned to enroll 580 subjects, divided into 5 age groups, including: young adults (18-59 years old, 60 people), adolescents (6 -17 years old, 60 people), and elderly (≥60 years old, 160 people) , Toddlers (2-5 years old, 140), infants (6 weeks to 23 months old, 160).Research phase and trial grouping: age/dose climbing phase: 340 subjects are planned to be enrolled in Liuzhou City, and they will be enrolled in the group according to the age order of young adults → adolescents and old people → toddlers → infants and young children. There are 10 cohorts, randomly divided into experimental group (low-dose or high-dose), placebo group (containing aluminum), and the random ratio of each entry stage is 2:1. Among them, infants and the elderly will be added a placebo group without aluminum adjuvant, test group (low dose or high dose), placebo group (aluminum), placebo (aluminum-free), the random ratio is 2:1:1; Dose expansion stage: It is planned to enroll 240 subjects in Rong'an County. The elderly, infants, and infants will be divided into 3 cohorts, and each age group will be randomly divided into low-dose or high-dose groups, with a random ratio of 1:1.According to the order of young adults → adolescents and elderly → toddlers → infants and young children, the dose is from low to high, and the investigator (including the main investigator and the field investigator) will review the safety of the low-dose/placebo group 7 days after the first dose. After the safety data is confirmed, you can enter the high-dose/placebo group for this age group to explore. After DSMB examines the safety data of the first dose of young and middle-aged people to 30 days after the full exemption and confirms safety, they can enter the adolescent and elderly age group; DSMB examines the safety and confirms the safety of the first dose of adolescents and the elderly to 30 days after the full exemption After that, you can enter the infant age group; the investigator (including the main investigator and the field investigator) will review the safety data 7 days after the first dose of the infant low-dose/placebo group and confirm the safety, then you can enter the infant age group explore. The three age groups (cohorts 4 and 6, 7 and 8, 9 and 10) of the elderly, toddlers, and infants can be entered into the corresponding age after the DSMB reviews the safety data of the first dose to 30 days after the full exemption and confirms the safety. In the dose expansion phase (cohorts 11, 12, 13), 80 subjects were enrolled in each cohort (of which, 40 were vaccinated with low-dose trial vaccine and 40 were vaccinated with high-dose trial vaccine).

Details
Condition Acute Gastroenteritis
Treatment Low-dose vaccine, High-dose vaccine, Placebo (containing aluminum), Placebo (without aluminum)
Clinical Study IdentifierNCT04563533
SponsorAnhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Last Modified on7 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Compliance with this clinical trial observation age is 6 weeks old and above, and can provide legal identification
The suspected and/or violating legal guardian has the ability to understand the research procedures and sign an informed consent form
Correct and/or prevent the legal guardian who has the ability to read, understand, fill in the diary card/contact card, and promise to participate regularly in accordance with the research requirements
The armpit body temperature of all people on the day of entry was <37.3℃
Standards for some groups of people:<12 months of age: singleton full-term pregnancy (37-42 weeks gestational week) and birth weight 2.5-4.0kg; women of childbearing age: agree to take effective contraceptive measures within 6 months after the first dose is implanted to the full exemption

Exclusion Criteria

The population laboratory test indicators specified in the plan are abnormal and have clinical significance
A history of severe allergies to any component of the test vaccine, including L-histidine, sodium chloride, aluminum hydroxide, such as: anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergies Necrotic reaction (Arthus reaction); or any previous history of severe side effects of vaccines or drugs, such as: allergies, urticaria, skin eczema, dyspnea, angioedema, etc
3 days before vaccination, suffering from acute disease or in the acute attack of chronic disease (such as asthma, diabetes, thyroid disease, etc.)
Have taken antipyretic or analgesics within 24 hours before the first dose of vaccination
Inoculate the inactivated vaccine within 7 days before the first dose of vaccine, and the live attenuated vaccine within 14 days
People suffering from the following diseases:①Suffered from digestive system diseases (such as diarrhea, abdominal pain, vomiting, etc.) in the past 7 days;② Suffer from severe congenital malformations, severe developmental disorders, severe genetic defects, severe malnutrition, etc.;③ Suffering from thrombocytopenia, any coagulation disorders or receiving anticoagulant treatment and other intramuscular injection contraindications;④ Congenital or acquired immunodeficiency, or receive immunosuppressive therapy within 6 months (for example, systemic glucocorticoid prednisone or similar drugs have been used for more than 2 consecutive weeks within 6 months). Local medications (such as ointments, eye drops, inhalants or nasal sprays) should not exceed the recommended dose in the instructions or show any signs of systemic exposure;⑤ Has been diagnosed with infectious diseases, such as tuberculosis, viral hepatitis and/or human immunodeficiency virus (HIV) infection;⑥ Having convulsions, epilepsy, encephalopathy (such as congenital brain hypoplasia, brain trauma, brain tumor, cerebral hemorrhage, cerebral obstruction, infection, chemical drug poisoning, etc. caused brain nerve tissue damage, etc.) and a history of mental illness or family history;⑦ No spleen, functional asthenia, as well as any cause of asthenia or splenectomy;⑧ Suffering from severe cardiovascular disease (pulmonary heart disease, pulmonary edema), severe liver and kidney disease, diabetes with complications
Have received blood or blood-related products, including immunoglobulins, within 3 months, or plan to use them during the study period (within 1 month after enrollment and full exemption)
Any research or unregistered products (drugs, vaccines, biological products or devices) have been used within 3 months before enrollment, or planned to be used during the research period
Plan to move or leave the local area for a long time during the research period
Any situation that the researcher believes may interfere with the evaluation of the research purpose
Standards for certain groups of people:①<12 months old: IVF, multiple fetuses, currently suffering from perianal abscess, severe eczema, pathological jaundice, parents with HIV infection;② Persons ≥18 years of age: Physical examination before enrollment is hypertension (systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg) or hypotension (systolic blood pressure <89mmHg) (regardless of medication);③Women of childbearing age: are breast-feeding or pregnant (including a positive urine pregnancy test) or have a pregnancy plan during the study period (in the group to within 6 months after the full exemption)
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

Accepts healthy volunteers

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name
Edit Delete

Added by • 

 • 

Private

Edit Delete

Reply by • • Private
Edit Delete

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note