Norovirus InfectionsPhase 2NCT04941261
Clinical Trial to Evaluate the Recombinant Norovirus Bivalent (GI. 1 / GII. 4) Vaccine (Hansenula Polymorpha)
A Phase 2 study testing middle-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine and high-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine in people with Norovirus Infections and Norwalk Gastroenteritis, run by National Vaccine and Serum Institute, China at 1 site in China.
Trial summary
Phase II clinical study will explore dose and safety, immunogenicity in 4 age groups, including 18-59 years old group, 6-17 years old group, 3-5 years old group, 6-35 months old group, with a total of 1716 subjects. Read more about this study
- Who is it for?
- Ages 6 months to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Norovirus Infections, Norwalk Gastroenteritis
- What is being tested?
- middle-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine and high-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,716 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2021to 30 Mar 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 59 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age range: healthy people aged 6 months -59 years and and older who can provide legal identification;
- Inquired about medical history and physical examination, the investigator judged that the health condition is good;
- The subject and/or his legal guardian and/or his entrusted person can understand the study procedures and informed consent, voluntarily sign informed consent form, and be able to comply with the requirements of the clinical study protocol;
- Females of childbearing age (menarche to menopause) are not pregnant at the time of enrollment (negative urine pregnancy test), not breastfeeding, and have no birth plan within 12 months after enrollment; effective contraception will be taken within 2 weeks before enrollment;
Who cannot join
- First Dose Exclusion Criteria：
- Axillary body temperature is not less than 37.3℃ (older than 14 years) before vaccination, and axillary body temperature is not less than 37.5℃ (14 years or younger) before vaccination;
- Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc;
- Have received immune enhancement or inhibitor therapy within 3 months (continuous oral or instillation for more than 14 days);
- Have been diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases;
- Having serious congenital malformations or chronic diseases (including but not limited to:Down syndrome, thalassemia, heart disease, kidney disease, diabetes, autoimmune disease, genetic allergies, Guillain Barre syndrome, etc.);
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- Asthenia or splenectomy, functional asthenia caused by any situation;
- Severe liver and kidney disease, severe cardiovascular disease, drug-uncontrollable hypertension (systolic blood pressure is not less than 140mmHg, diastolic blood pressure is not less than 90mmHg), high blood glucose, diabetic complications , Malignant tumors, various acute diseases or acute attacks of chronic diseases;
- Have a history of chronic gastrointestinal disease, current diarrhea or other digestive system diseases, gastroenteritis requiring treatment in the past 7 days;
- Have a history of abnormal coagulation function (such as coagulation factor deficiency, coagulopathy);
- Have a history of severe allergic reactions to vaccination; allergic to any component of the experimental vaccine
- Have received a live attenuated vaccine within 28 days before vaccination, or received other vaccines（Recombinant vaccine, subunit vaccine, inactivated vaccine） within 14 days before vaccination;
- Received within 6 months before vaccination or plan to receive other study drugs in the near future
- Plan to move before the end of the study or leave the local area for a long time during the scheduled study visit; Other conditions considered by the investigator to be inappropriate for participation in the study.
- In addition to the general exclusion criteria, specific populations should also follow the following exclusion criteria:
- -Children aged 24 months and under are born prematurely (delivered before the 37th week of pregnancy), low-weight (birth weight for girls <2300g, boys <2500g) infants; Children 24 months of age and younger have a history of dystocia, birth asphyxia or other reasons, a history of neurological damage, severe chronic diseases (such as Down syndrome, sickle cell anemia, or neurological disorders).
- Subsequent doses of vaccination Exclusion criteria：
- Have a high fever (axillary temperature is not less than 39.0℃) for three days and severe allergic reaction after the previous dose of vaccination;
- Severe adverse reactions that are causally related to the previous dose of vaccination;
- For those newly discovered or newly identified after the previous dose of vaccine that does not meet the first dose selection criteria or meets the first dose exclusion criteria, the investigator will determine whether to continue participating in the study;
- Other exclusion reasons considered by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
qixian Center for Disease Control and Prevention
Hebi, Henan
dacheng zhan, 15803925825
About this study
Official title: Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Recombinant Norovirus Bivalent (GI. 1 / GII. 4) Vaccine(Hansenula Polymorpha) in Healthy People Aged Aged From 6 Months to 59 Years
Phase II clinical study will explore dose and safety, immunogenicity in 4 age groups, including 18-59 years old group, 6-17 years old group, 3-5 years old group, 6-35 months old group, with a total of 1716 subjects.
- Conditions
- Norovirus Infections, Norwalk Gastroenteritis
- Being tested
- middle-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine, high-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine, placebo
- Medical subject headings
- Caliciviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
middle-dose Norovirus Bivalent (GI.1 / GII.4) VaccineBiological
Intramuscular injection of middle-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine in the deltoid muscle of the upper arm
high-dose Norovirus Bivalent (GI.1 / GII.4) VaccineBiological
Intramuscular injection of high-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine in the deltoid muscle of the upper arm
placeboBiological
Intramuscular injection of placebo in the deltoid muscle of the upper arm
| Study group | Role | What they receive |
|---|---|---|
| 18-59 years old group A | Experimental | Not described Receives: Biological: middle-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine |
| 18-59 years old group B | Experimental | Not described Receives: Biological: high-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine |
| 18-59 years old group C | Placebo comparator | Not described Receives: Biological: placebo |
| 6-17 years old group A | Experimental | Not described Receives: Biological: middle-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine |
| 6-17 years old group B | Experimental | Not described Receives: Biological: high-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine |
| 6-17 years old group C | Placebo comparator | Not described Receives: Biological: placebo |
| 3-5 years old group A | Experimental | Not described Receives: Biological: middle-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine |
| 3-5 years old group B | Experimental | Not described Receives: Biological: high-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine |
| 3-5 years old group C | Placebo comparator | Not described Receives: Biological: placebo |
| 6-35 months old group A | Experimental | Not described Receives: Biological: middle-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine |
| 6-35 months old group B | Experimental | Not described Receives: Biological: high-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine |
| 6-35 months old group C | Placebo comparator | Not described Receives: Biological: placebo |
| 6-35 months old group D | Experimental | Not described Receives: Biological: middle-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine |
| 6-35 months old group E | Experimental | Not described Receives: Biological: high-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine |
| 6-35 months old group F | Placebo comparator | Not described Receives: Biological: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence and severity of any adverse reactions/events within 30 minutes after each dose of vaccination
Measured: through 30 minutes after each dose
the incidence and severity of adverse reactions/events within 0-7 days after each dose of vaccination
Measured: through 7 days after each dose
the incidence and severity of non-collective adverse reactions/events within 30 days after each dose of vaccination
If there is still next vaccination ，collect the incidence and severity of non-collective adverse reactions/events within vaccination interval（28 days） after vaccination
Measured: through 30 days after each dose
the incidence of SAE from the first dose of vaccination to 6 months after the full course of vaccination
Measured: up to 6 months after the full course of vaccination
Antibody titer of HBGA-blocking antibody on the 14th day after the full course of vaccination
Measured: 14th day after the full course of vaccination
4-fold Seroconversion rate on the 14th day after the full course of vaccination
Measured: 14th day after the full course of vaccination
Antibody titer of（NoV GI.1 and GII.4 HBGA-blocking antibody）on the 14th day after the full course of vaccination
Measured: 14th day after the full course of vaccination
Secondary outcomes (4)
Geometric mean Titer of（NoV GI.1 and GII.4 HBGA-blocking antibody）on the 14th day after the full course of vaccination
Measured: 14th day after the full course of vaccination
Immune response（compared with before vaccination, the antibody increased by 4 times or more） rate of（NoV GI.1 and GII.4 HBGA-blocking antibody）on the 14th day after the full course of vaccination
Measured: 14th day after the full course of vaccination
Antibody titer of（NoV GI.1 and GII.4 HBGA-blocking antibody）on 90th,180th,270th,360th,540th,720th day after the full course of vaccination
Measured: 90th,180th,270th,360th,540th,720th day after the full course of vaccination
Binding Antibody (IgG) on 90th,180th,270th,360th,540th,720th day after the full course of vaccination
Measured: 90th,180th,270th,360th,540th,720th day after the full course of vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start30 Jun 2021
- Primary completion28 Feb 2024 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Norovirus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,716 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Vaccine and Serum Institute, China
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lanzhou Institute of Biological Products Co., Ltd, Beijing Zhong Sheng Heng Yi Pharmaceutical Technology Co., Ltd., Zhengzhou University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04941261
- Sponsor's protocol ID
- CXSL1700011-Ⅱ
- Status last verified
- May 2022
- First submitted
- 18 Jun 2021
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Recombinant Norovirus Bivalent (GI. 1 / GII. 4) Vaccine(Hansenula Polymorpha) in Healthy People Aged Aged From 6 Months to 59 Years
- ClinicalTrials.gov ID
- NCT04941261
- Acronym / sponsor ID
- CXSL1700011-Ⅱ
- Conditions
- Norovirus Infections, Norwalk Gastroenteritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,716 participants (estimated)
- Lead sponsor
- National Vaccine and Serum Institute, ChinaIndustry (pharma, biotech, devices)
- Collaborators
- Lanzhou Institute of Biological Products Co., Ltd, Beijing Zhong Sheng Heng Yi Pharmaceutical Technology Co., Ltd., Zhengzhou University
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 28 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase II clinical study will explore dose and safety, immunogenicity in 4 age groups, including 18-59 years old group, 6-17 years old group, 3-5 years old group, 6-35 months old group, with a total of 1716 subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 15
| Arm | Type | Receives |
|---|---|---|
| 18-59 years old group A | Experimental | Biological: middle-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine |
| 18-59 years old group B | Experimental | Biological: high-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine |
| 18-59 years old group C | Placebo comparator | Biological: placebo |
| 6-17 years old group A | Experimental | Biological: middle-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine |
| 6-17 years old group B | Experimental | Biological: high-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine |
| 6-17 years old group C | Placebo comparator | Biological: placebo |
| 3-5 years old group A | Experimental | Biological: middle-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine |
| 3-5 years old group B | Experimental | Biological: high-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine |
| 3-5 years old group C | Placebo comparator | Biological: placebo |
| 6-35 months old group A | Experimental | Biological: middle-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine |
| 6-35 months old group B | Experimental | Biological: high-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine |
| 6-35 months old group C | Placebo comparator | Biological: placebo |
| 6-35 months old group D | Experimental | Biological: middle-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine |
| 6-35 months old group E | Experimental | Biological: high-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine |
| 6-35 months old group F | Placebo comparator | Biological: placebo |
Who may qualify
- Ages
- 6 months to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age range: healthy people aged 6 months -59 years and and older who can provide legal identification;
- Inquired about medical history and physical examination, the investigator judged that the health condition is good;
- The subject and/or his legal guardian and/or his entrusted person can understand the study procedures and informed consent, voluntarily sign informed consent form, and be able to comply with the requirements of the clinical study protocol;
- Females of childbearing age (menarche to menopause) are not pregnant at the time of enrollment (negative urine pregnancy test), not breastfeeding, and have no birth plan within 12 months after enrollment; effective contraception will be taken within 2 weeks before enrollment;
Key exclusion criteria (21 listed)
- First Dose Exclusion Criteria：
- Axillary body temperature is not less than 37.3℃ (older than 14 years) before vaccination, and axillary body temperature is not less than 37.5℃ (14 years or younger) before vaccination;
- Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc;
- Have received immune enhancement or inhibitor therapy within 3 months (continuous oral or instillation for more than 14 days);
- Have been diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| middle-dose Norovirus Bivalent (GI.1 / GII.4) VaccineIntramuscular injection of middle-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine in the deltoid muscle of the upper arm | Biological | 18-59 years old group A, 3-5 years old group A, 6-17 years old group A, 6-35 months old group A, 6-35 months old group D |
| high-dose Norovirus Bivalent (GI.1 / GII.4) VaccineIntramuscular injection of high-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine in the deltoid muscle of the upper arm | Biological | 18-59 years old group B, 3-5 years old group B, 6-17 years old group B, 6-35 months old group B, 6-35 months old group E |
| placeboIntramuscular injection of placebo in the deltoid muscle of the upper arm | Biological | 18-59 years old group C, 3-5 years old group C, 6-17 years old group C, 6-35 months old group C, 6-35 months old group F |
Primary outcome
the incidence and severity of any adverse reactions/events within 30 minutes after each dose of vaccination
Time frame: through 30 minutes after each dose
the incidence and severity of adverse reactions/events within 0-7 days after each dose of vaccination
Time frame: through 7 days after each dose
the incidence and severity of non-collective adverse reactions/events within 30 days after each dose of vaccination
Time frame: through 30 days after each dose
If there is still next vaccination ，collect the incidence and severity of non-collective adverse reactions/events within vaccination interval（28 days） after vaccination
the incidence of SAE from the first dose of vaccination to 6 months after the full course of vaccination
Time frame: up to 6 months after the full course of vaccination
Antibody titer of HBGA-blocking antibody on the 14th day after the full course of vaccination
Time frame: 14th day after the full course of vaccination
4-fold Seroconversion rate on the 14th day after the full course of vaccination
Time frame: 14th day after the full course of vaccination
Antibody titer of（NoV GI.1 and GII.4 HBGA-blocking antibody）on the 14th day after the full course of vaccination
Time frame: 14th day after the full course of vaccination
4 secondary outcomes
Geometric mean Titer of（NoV GI.1 and GII.4 HBGA-blocking antibody）on the 14th day after the full course of vaccination
Time frame: 14th day after the full course of vaccination
Immune response（compared with before vaccination, the antibody increased by 4 times or more） rate of（NoV GI.1 and GII.4 HBGA-blocking antibody）on the 14th day after the full course of vaccination
Time frame: 14th day after the full course of vaccination
Antibody titer of（NoV GI.1 and GII.4 HBGA-blocking antibody）on 90th,180th,270th,360th,540th,720th day after the full course of vaccination
Time frame: 90th,180th,270th,360th,540th,720th day after the full course of vaccination
Binding Antibody (IgG) on 90th,180th,270th,360th,540th,720th day after the full course of vaccination
Time frame: 90th,180th,270th,360th,540th,720th day after the full course of vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing middle-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine and high-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine in people with Norovirus Infections and Norwalk Gastroenteritis, run by National Vaccine and Serum Institute, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xia shengli, bachelor (（+86）13592610137, 1792865518@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence and severity of any adverse reactions/events within 30 minutes after each dose of vaccination (time frame: through 30 minutes after each dose). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2022.