Norwalk GastroenteritisPhase 1NCT04188691
A Clinical Trial to Evaluate the Safety and Immunogenicity of Norovirus Bivalent Vaccine
A Phase 1 study testing Norovirus Bivalent (GI.1 / GII.4) Vaccine（low）, Norovirus Bivalent (GI.1 / GII.4) Vaccine（middle） and Norovirus Bivalent (GI.1 / GII.4) Vaccine（high） in people with Norwalk Gastroenteritis and Norovirus Infections, run by National Vaccine and Serum Institute, China at 1 site in China.
Trial summary
A total of 450 subjects were enrolled, divided into four age groups, including 18-59 years, 6-17 years, 3-5 years, and 6-35 months. There are three types of the test vaccine component in each age group. Read more about this study
- Who is it for?
- Ages 6 months to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Norwalk Gastroenteritis, Norovirus Infections
- What is being tested?
- Norovirus Bivalent (GI.1 / GII.4) Vaccine（low）, Norovirus Bivalent (GI.1 / GII.4) Vaccine（middle） and Norovirus Bivalent (GI.1 / GII.4) Vaccine（high）
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 510 participants
- Where
- 1 siteChina
- Study dates
- 28 Nov 2019to 13 Dec 2020
- Phase
- Phase 1
- 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
- Aged 6 months to 59 years old, can provide legal identification of Chinese population;
- Based on medical history and physical examination, determined by the researcher as healthy;
- Volunteer legal guardians or trustees have the ability to understand (non-illiterate) research procedures, sign informed consent voluntarily with informed consent, and be able to comply with the requirements of clinical research protocols;
- Female subjects of childbearing age were not pregnant at the time of enrollment (negative urine pregnancy test), were not breastfeeding, and had no birth plan within the first 3 months after enrollment; effective contraceptive measures were taken within 2 weeks before enrollment.
Who cannot join
- Axillary body temperature before inoculation on the day of entry> 37.0 ℃;
- Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc .;
- Have a history of epilepsy, convulsions or convulsions, or a family history of mental illness;
- Those who received immunoenhancement or inhibitor therapy within 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;
- No spleen or spleen function defect caused by any situation;
Show all 16Show fewer
- Severe liver and kidney disease, drug-uncontrollable hypertension (systolic blood pressure> 140mmHg, diastolic blood pressure> 90mmHg), diabetic complications, malignant tumors, various acute diseases or chronic attacks of acute diseases;
- Have a history of chronic gastrointestinal diseases, diarrhea or other digestive system diseases, and have had 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; are allergic to any component of the test vaccine;
- Live attenuated vaccine within14 days; other vaccines received within 7 days;
- Participating in other clinical trials in the near future;
- The investigator judges other circumstances that are not suitable for participation in this clinical trial.
- In addition to the general exclusion criteria, specific populations should also adhere to the following exclusion criteria:
- Premature birth (delivery before the 37th week of pregnancy), low weight (birth <2300g) infants under 24 months of age;
- History of salvage, birth apnea, or other causes of salvage, neurological damage, severe chronic disease (such as Down syndrome, sickle cell anemia, or neurological disorders) in children under 24 months of age.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Blind, Placebo-controlled Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Norovirus Bivalent (GI. 1 / GII. 4) Vaccine (Hansenulapolymorpha) in Healthy People Aged 6 Months to 59 Years
A total of 450 subjects were enrolled, divided into four age groups, including 18-59 years, 6-17 years, 3-5 years, and 6-35 months. There are three types of the test vaccine component in each age group. A total of 30 people in each dose group were vaccinated with the test vaccine or placebo 1 or placebo 2, respectively, in a ratio of 3: 1: 1.
The 18-59-year-old, 6-17-year-old, and 3-5-year-old age groups were vaccinated 2 times at a time interval of 28 days. The 6-35 month age group is divided into two groups, Group 1 is inoculated with 2 doses interval of 28 days each, and Group 2 is inoculated with 3 doses interval of 28 days.
Read the detailed description
From January to April 2020, this study was affected by the COVID-19 epidemic, which caused the two groups（6-17-year-old，3-5-year-old） of subjects to vaccinate beyond the window and deviate from the experimental plan. After communication between the researcher, the sponsor and the statistician, it was decided to restart the Phase I clinical trials of these two groups.
- Conditions
- Norwalk Gastroenteritis, Norovirus Infections
- Being tested
- Norovirus Bivalent (GI.1 / GII.4) Vaccine（low）, Norovirus Bivalent (GI.1 / GII.4) Vaccine（middle）, Norovirus Bivalent (GI.1 / GII.4) Vaccine（high）, Normal saline, Aluminum adjuvant
- Medical subject headings
- Caliciviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Norovirus Bivalent (GI.1 / GII.4) Vaccine（low）Biological
Norovirus Bivalent (GI.1 / GII.4) Vaccine（low）administered intramuscularly according to a 0, 28，（56） day vaccination schedule
Norovirus Bivalent (GI.1 / GII.4) Vaccine（middle）Biological
Norovirus Bivalent (GI.1 / GII.4) Vaccine（middle）administered intramuscularly according to a 0, 28，（56） day vaccination schedule
Norovirus Bivalent (GI.1 / GII.4) Vaccine（high）Biological
Norovirus Bivalent (GI.1 / GII.4) Vaccine（high）administered intramuscularly according to a 0, 28，（56）day vaccination schedule
Normal salineBiological
Normal saline administered intramuscularly according to a 0, 28 ，（56）day vaccination schedule
Aluminum adjuvantBiological
Aluminum adjuvant administered intramuscularly according to a 0, 28，（56） day vaccination schedule
| Study group | Role | What they receive |
|---|---|---|
| vaccine group 1 | Experimental | vaccine produced by NVSI , Specification: GI.1 / GII.4 (low), 0.5ml / dose Receives: Biological: Norovirus Bivalent (GI.1 / GII.4) Vaccine（low） |
| vaccine group 2 | Experimental | vaccine produced by NVSI , Specification: GI.1 / GII.4 (middle), 0.5ml / dose Receives: Biological: Norovirus Bivalent (GI.1 / GII.4) Vaccine（middle） |
| vaccine group 3 | Experimental | vaccine produced by NVSI , Specification: GI.1 / GII.4 (high), 0.5ml / dose Receives: Biological: Norovirus Bivalent (GI.1 / GII.4) Vaccine（high） |
| Normal saline | Placebo comparator | （0.5ml / dose）produced by NVSI Receives: Biological: Normal saline |
| Aluminum adjuvant | Placebo comparator | （0.5ml / dose）produced by NVSI Receives: Biological: Aluminum adjuvant |
What is being measured
The primary outcome is the main question the study is designed to answer.
AE of local and systemic reactions within 30 minutes after each dose
Measured: 30 minutes
All active AEs within 0-7 days after each dose
Active AE: Local and systemic adverse reactions occurring within 0-7 days after each dose of vaccination
Measured: 7 days
All non-active collection AEs within 0-28（30） days after each dose
Adverse events other than active AE include solicitation adverse events reported in addition to the specified solicitation time window
Measured: 28（30） days
All SAEs within 6 months after the last dose is vaccinated
Measured: 6 months
Secondary outcomes (4)
Calculate geometric mean titer (GMT) of NoV GI.1 and GII.4 IgG antibodies
Measured: 28 days after the full vaccination
Calculate positive rate of NoV GI.1 and GII.4 IgG antibodies
Measured: 28 days after the full vaccination
Calculate NoV GI.1 and GII.4 HBGA-blocking antibody titers
Measured: 28 days after the full vaccination
Calculate NoV GI.1 and GII.4 HBGA-blocking antibody positive rates
Measured: 28 days after the full vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study start28 Nov 2019
- Primary completion13 Dec 2020
- Study completion13 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Norwalk GastroenteritisStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 510 participants (actual)
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
- NCT04188691
- Sponsor's protocol ID
- CXSL1700011-I
- Status last verified
- Apr 2020
- First submitted
- 27 Nov 2019
- Last updated
- 22 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 22 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blind, Placebo-controlled Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Norovirus Bivalent (GI. 1 / GII. 4) Vaccine (Hansenulapolymorpha) in Healthy People Aged 6 Months to 59 Years
- ClinicalTrials.gov ID
- NCT04188691
- Acronym / sponsor ID
- CXSL1700011-I
- Conditions
- Norwalk Gastroenteritis, Norovirus Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 510 participants (actual)
- 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
- 28 Nov 2019 (actual)
- Primary completion
- 13 Dec 2020 (actual)
- Study completion
- 13 Dec 2020 (actual)
- First posted
- 6 Dec 2019 (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.
A total of 450 subjects were enrolled, divided into four age groups, including 18-59 years, 6-17 years, 3-5 years, and 6-35 months. There are three types of the test vaccine component in each age group. A total of 30 people in each dose group were vaccinated with the test vaccine or placebo 1 or placebo 2, respectively, in a ratio of 3: 1: 1.
The 18-59-year-old, 6-17-year-old, and 3-5-year-old age groups were vaccinated 2 times at a time interval of 28 days. The 6-35 month age group is divided into two groups, Group 1 is inoculated with 2 doses interval of 28 days each, and Group 2 is inoculated with 3 doses interval of 28 days.
Detailed description
From January to April 2020, this study was affected by the COVID-19 epidemic, which caused the two groups（6-17-year-old，3-5-year-old） of subjects to vaccinate beyond the window and deviate from the experimental plan. After communication between the researcher, the sponsor and the statistician, it was decided to restart the Phase I clinical trials of these two groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| vaccine group 1 | Experimental | Biological: Norovirus Bivalent (GI.1 / GII.4) Vaccine（low）vaccine produced by NVSI , Specification: GI.1 / GII.4 (low), 0.5ml / dose |
| vaccine group 2 | Experimental | Biological: Norovirus Bivalent (GI.1 / GII.4) Vaccine（middle）vaccine produced by NVSI , Specification: GI.1 / GII.4 (middle), 0.5ml / dose |
| vaccine group 3 | Experimental | Biological: Norovirus Bivalent (GI.1 / GII.4) Vaccine（high）vaccine produced by NVSI , Specification: GI.1 / GII.4 (high), 0.5ml / dose |
| Normal saline | Placebo comparator | Biological: Normal saline（0.5ml / dose）produced by NVSI |
| Aluminum adjuvant | Placebo comparator | Biological: Aluminum adjuvant（0.5ml / dose）produced by NVSI |
Who may qualify
- Ages
- 6 months to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Aged 6 months to 59 years old, can provide legal identification of Chinese population;
- Based on medical history and physical examination, determined by the researcher as healthy;
- Volunteer legal guardians or trustees have the ability to understand (non-illiterate) research procedures, sign informed consent voluntarily with informed consent, and be able to comply with the requirements of clinical research protocols;
- Female subjects of childbearing age were not pregnant at the time of enrollment (negative urine pregnancy test), were not breastfeeding, and had no birth plan within the first 3 months after enrollment; effective contraceptive measures were taken within 2 weeks before enrollment.
Key exclusion criteria (16 listed)
- Axillary body temperature before inoculation on the day of entry> 37.0 ℃;
- Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc .;
- Have a history of epilepsy, convulsions or convulsions, or a family history of mental illness;
- Those who received immunoenhancement or inhibitor therapy within 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 |
|---|---|---|
| Norovirus Bivalent (GI.1 / GII.4) Vaccine（low）Norovirus Bivalent (GI.1 / GII.4) Vaccine（low）administered intramuscularly according to a 0, 28，（56） day vaccination schedule | Biological | vaccine group 1 |
| Norovirus Bivalent (GI.1 / GII.4) Vaccine（middle）Norovirus Bivalent (GI.1 / GII.4) Vaccine（middle）administered intramuscularly according to a 0, 28，（56） day vaccination schedule | Biological | vaccine group 2 |
| Norovirus Bivalent (GI.1 / GII.4) Vaccine（high）Norovirus Bivalent (GI.1 / GII.4) Vaccine（high）administered intramuscularly according to a 0, 28，（56）day vaccination schedule | Biological | vaccine group 3 |
| Normal salineNormal saline administered intramuscularly according to a 0, 28 ，（56）day vaccination schedule | Biological | Normal saline |
| Aluminum adjuvantAluminum adjuvant administered intramuscularly according to a 0, 28，（56） day vaccination schedule | Biological | Aluminum adjuvant |
Primary outcome
AE of local and systemic reactions within 30 minutes after each dose
Time frame: 30 minutes
All active AEs within 0-7 days after each dose
Time frame: 7 days
Active AE: Local and systemic adverse reactions occurring within 0-7 days after each dose of vaccination
All non-active collection AEs within 0-28（30） days after each dose
Time frame: 28（30） days
Adverse events other than active AE include solicitation adverse events reported in addition to the specified solicitation time window
All SAEs within 6 months after the last dose is vaccinated
Time frame: 6 months
4 secondary outcomes
Calculate geometric mean titer (GMT) of NoV GI.1 and GII.4 IgG antibodies
Time frame: 28 days after the full vaccination
Calculate positive rate of NoV GI.1 and GII.4 IgG antibodies
Time frame: 28 days after the full vaccination
Calculate NoV GI.1 and GII.4 HBGA-blocking antibody titers
Time frame: 28 days after the full vaccination
Calculate NoV GI.1 and GII.4 HBGA-blocking antibody positive rates
Time frame: 28 days after the full vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2021.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Norovirus Bivalent (GI.1 / GII.4) Vaccine（low）, Norovirus Bivalent (GI.1 / GII.4) Vaccine（middle） and Norovirus Bivalent (GI.1 / GII.4) Vaccine（high） in people with Norwalk Gastroenteritis and Norovirus Infections, 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 16 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: finished, as of the sponsor's last update on 22 Apr 2021. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AE of local and systemic reactions within 30 minutes after each dose (time frame: 30 minutes). The study lists 4 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 22 Apr 2021.