Evaluation of Recombinant Norovirus Hexavalent Vaccine in Healthy Subjects (NCT05805618) | Clinical Trial Compass
UnknownEarly Phase 1
Evaluation of Recombinant Norovirus Hexavalent Vaccine in Healthy Subjects
60 participantsStarted 2024-07-01
Plain-language 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.
Who can participate
Age range18 Years – 59 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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;
What they're measuring
1
Incidence of solicited AEs within 7 days after each vaccination dose.
Timeframe: 7 Days
2
Incidence of unsolicited AEs within 28 days after each vaccination dose
Timeframe: 28 Days
3
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
Timeframe: 42 days
4
SAE, MAAE in all subjects within 12 months after the completion of the vaccination series.
✕. 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;