Evaluation of Recombinant Norovirus Hexavalent Vaccine in Healthy Subjects

NCT05805618 | Unknown Early Phase 1

• 1 other identifier: KH-CT-002-01
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the safety and immunogenicity of different dose levels of the Recombinant Norovirus Hexavalent Vaccine in healthy subjects aged 18-59 years given three doses of the vaccine at 28-day intervals.

Conditions

Gastroenteritis

Outcome Measures

Primary Outcomes (4)

• Incidence of solicited AEs within 7 days after each vaccination dose.

  Safety will be assessed through 7 days after vaccination (including the day of vaccination) via collection of solicited AEs. The solicited AEs include local AEs (injection site: pain,tenderness， induration,swelling,erythema,pruritus)and systemic AEs (Headache, Fatigue,Myalgia,Arthralgia,Vomiting, Diarrhea, Fever).

  7 Days

• Incidence of unsolicited AEs within 28 days after each vaccination dose

  Unsolicited AEs are AEs other than those designated as solicited AEs, and also include eponymous solicited AEs that occur after the solicitation period. Unsolicited AEs mainly include any AEs that have been reported by the subjects, learned from interrogation or observed by the investigator during the study visits, or discovered during review of medical records or original files. the incidence of unsolicited AEs within 28 days after each dose of the study vaccine will be calculated.

  28 Days

• Incidence of AEs related to serum chemistry, hematology, and urinalysis parameters in all subjects on day 4 after each vaccination dose and on day 14, day 42 after the first dose

  The number of participants with any markedly abnormal standard safety laboratory values (serum chemistry,hematology or urinalysis) collected.

  42 days

• SAE, MAAE in all subjects within 12 months after the completion of the vaccination series.

  The subjects will also be monitored for SAEs, MAAEs from the first dose to 12 months after the completion of the vaccination series.

  12 Months

Secondary Outcomes (13)

• GMT of Serum Anti-norovirus GI.1 and GII.2, GII.3, GII.4, GII.6, GII.17 VLP HBGA (BT50)

  12 Months

• GMFR of Serum Anti-norovirus GI.1 and GII.2, GII.3, GII.4, GII.6, GII.17 VLP HBGA

  12 Months

• SCR of Serum Anti-norovirus GI.1 and GII.2, GII.3, GII.4, GII.6, GII.17 VLP HBGA

  12 Months

• GMT of Serum Anti-norovirus GI.1 and GII.2, GII.3, GII.4, GII.6, GII.17 VLP Pan-Ig

  12 Months

• GMFR of Serum Anti-norovirus GI.1 and GII.2, GII.3, GII.4, GII.6, GII.17 VLP Pan-Ig

  12 Months

Study Arms (2)

KH002

EXPERIMENTAL

at low dose,150 mg(Cohort 1 ), 20 subjects are dosed Vaccine as experimental at high dose,300mg (Cohort 2), 20 subjects are dosed Vaccine as experimental

Biological: Recombinant Norovirus Hexavalent Vaccine

matching placebo

PLACEBO COMPARATOR

at low dose,150 mg(Cohort 1 ), 10 subjects are dosed placebo at high dose, 300mg(Cohort 2),10 subjects are dosed placebo

Other: Matching Placebo

Interventions

Recombinant Norovirus Hexavalent Vaccine BIOLOGICAL

To prevent acute gastroenteritis caused by norovirus of genotypes GI.1, GII.2, GII.3, GII.4, GII.6, and GII.17

Also known as: KH002

KH002

Matching Placebo OTHER

matching placebo for Recombinant Norovirus Hexavalent Vaccine / KH002

matching placebo

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 18-59 years (inclusive);
• Subjects with a body mass index ( 18 kg/m2 and 35 kg/m2;
• Capable and willing to give informed consent prior to any study-specific activities/procedures;
• Subjects who are able to comply with the requirements of the clinical study protocol to complete the study;
• Subjects who haven't been vaccinated or haven't plan to be vaccinated with other vaccines (including live attenuated vaccines, non-live vaccines, and novel coronavirus vaccines) within 14 days before the first dose of study vaccines;
• Subjects who are clinically determined to be healthy by the investigator after being inquired about their medical history and relevant physical examinations;
• Female subjects who are not breastfeeding; all subjects who have no childbearing plan or sperm/egg donation plan from ICF signing to 6 months after the completion of the vaccination series and agree to take effective contraceptive measures (See the appendix 3) from 4 weeks prior to the first dose to 6 months after the completion of the vaccination series.

You may not qualify if:

• Subjects with positive COVID-19 test by PCR for nasopharyngeal or oropharyngeal swabs (nasopharyngeal swabs are preferred) on the day of the first dose vaccination;
• Subjects who have previously participated in a clinical study of any type of norovirus vaccines within the past year before enrollment in this study;
• Subjects with a history of chronic gastrointestinal disorder or having gastroenteritis that required treatment (for example, seek medical advice, etc.) within the past year before screening; or subjects have diarrhea, vomiting, or other digestive system conditions before 2 weeks of the first dose vaccination;
• Subjects have cancer or have a history of cancer within 5 years before screening;
• Subjects with the following conditions: (1) serious congenital malformations, serious developmental disorders, serious genetic defects, serious malnutritions, etc.; (2) thrombocytopenia, coagulation disorder or receipt of anticoagulant therapy, and other contraindications to intramuscular injections; (3) congenital or acquired immunodeficiency or receipt of immunosuppressant therapy (excluding topical treatment, surface treatment for acute non-complicated dermatitis, spray treatment for allergic rhinitis, ICS use for asthma treatmen, etc.) within 6 months; (4) history of infectious diseases, such as tuberculosis; (5) history or family history of convulsions, epilepsy, encephalopathy; (6) asplenia, functional asplenia, and asplenia or splenectomy due to any cause; (7) serious cardiovascular diseases (pulmonary heart disease and pulmonary edema), serious liver and kidney diseases, type I diabetes, celiac disease, autoimmune diseases, etc.; (8) use of medications within the timeframes specified in Section 6.5.2 ;
• Subjects with a clinicallly significant history of serious hypersensitivity to any component of study vaccines, including adjuvant components and yeast, such as allergic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, and local allergic necrotic reaction (Arthus reaction); a history of serious adverse vaccine or drug reactions, such as allergy, urticaria, skin eczema(small, local rashes on a single body part are permitted), dyspnea, and angioedema;
• Subjects with abnormal and clinically significant results of laboratory tests at the discretion of Investigator, such as hematology, serum chemistry, and urinalysis;
• Subjects with abnormal and clinically significant ECG results up to the Investigator's discretion at screening;
• Females of childbearing potential with positive serum pregnancy test results;
• Subjects who are positive for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus (HCV) antibody, or anti-treponema pallidum (anti-TP) antibody at screening;
• Subjects with hypertension (systolic blood pressure 140 mmHg and/or diastolic blood pressure 90 mmHg) or hypotension (systolic blood pressure \< 90 mmHg and/or diastolic blood pressure 40 mmHg) (regardless of medication use) in the physical examination before enrollment;
• Subjects with fever (oral temperature ≥ 37.5 °C) on the day of vaccination with study vaccines or within 72 h before vaccination;
• Subjects who have donated blood or lost blood (≥ 400 mL) or received blood transfusion or used blood products within 30 days before signing the ICF or plan to donate blood during the study(from the first vaccination dose to 3 months after the completion of the vaccination series);
• Subjects who have undergone surgery within 3 months before signing the ICF or plan to undergo surgery (including cosmetic surgery, dental surgery, and oral surgery(excluding tooth filling, protaper and tooth extraction)) during the study (from the first vaccination dose to 3 months after the completion of the vaccination series);
• Smoking more than 10 cigarettes per week within 3 months prior to screening;

Sponsors & Collaborators

• Syneos Health: lead
• Chengdu Kanghua Biological Products Co., Ltd: collaborator

MeSH Terms

Conditions

Gastroenteritis

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Kristi McLendon, Dr

  Q-Pharm Pty Ltd

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fanny Hou, PM

CONTACT

+86 18502191682; fanny.hou@syneoshealth.com

Chunlin Chen, PD

CONTACT

+8613558646151; chenchunlin@kangh.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: April 10, 2023
• Study Start: July 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share