NorovirusPhase 1NCT05508178
Recombinant, Bivalent, Norovirus Vaccine Study
A Phase 1 study testing Norovirus GI.4 / GII.4 Bivalent VLP Vaccine (100 µg) and Norovirus GI.4 / GII.4 Bivalent VLP Vaccine (300 µg) in people with Norovirus, run by Icon Genetics GmbH at 1 site in Belgium.
Trial summary
This clinical study will evaluate the vaccine candidate rNV-2v, which is under development to prevent disease triggered by noroviruses. Noroviruses are one of the leading causes of gastrointestinal diseases in the world. Norovirus infections can cause vomiting, diarrhea, and cramping. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Norovirus
- What is being tested?
- Norovirus GI.4 / GII.4 Bivalent VLP Vaccine (100 µg) and Norovirus GI.4 / GII.4 Bivalent VLP Vaccine (300 µg)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 17 Aug 2020to 26 Oct 2021
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Male or female aged 18 to 40 years (inclusive) at Screening.
- Good general health as determined by a Screening evaluation that includes vital signs, medical history, physical examinations, and laboratory assessments within 28 days before administration of the study vaccine.
- Expressed interest, availability and understanding to fulfil the study requirements, and in the opinion of the Investigator, can and will comply with the protocol requirements.
- Female subjects of childbearing potential must be using a highly-effective licensed method of birth control for 30 days prior to the first vaccination and must agree to continue such precautions during the study until 60 days after the second vaccination. Male subjects must agree to employ barrier contraception from the day of first vaccination until 60 days after the second vaccination, if their female partner of childbearing potential doesn't use a highly effective method of birth control.
- Agrees not to participate in another clinical study with an investigational product or to use any nonregistered product (drug, vaccine, or medical device) for the duration of the study.
Who cannot join
- Any condition that may interfere with study participation or place the participant at increased risk of AEs would be excluded from the study. Additionally, subjects are excluded from the study if any of the following criteria apply:
- Positive serology test results for hepatitis C virus, human immunodeficiency virus antibody, and/or hepatitis B surface antigen at Screening.
- Pregnant or lactating women.
- History of any of the following medical illnesses, which, in the opinion of the Investigator, may interfere with study participation or place the participant at increased risk of AEs, including but not limited to: immunosuppression (disease or treatments that may affect immune system function), diabetes, cancer (malignancy other than a resolved or excised skin lesion), heart disease (hospitalisation for a heart attack, arrhythmia, or syncope), unconsciousness (excluding single and brief concussion), seizures, asthma requiring treatment with inhaler or medication in the past 2 years, neuroinflammatory disease, autoimmune disease, recurrent infections (more than 3 hospitalisations for invasive bacterial infections such as pneumonia or meningitis).
- Any current or chronic conditions requiring daily medication other than vitamins, minerals, or antihypertensives, as per the Investigator's discretion. Rescreening for acute illness that is expected to resolve quickly is allowed, as per the Investigator's discretion.
- Known or suspected allergies or hypersensitivity to any component of the study vaccine.
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- Any clinically significant abnormality detected during physical examinations or vital sign evaluations, as per the Investigator's discretion.
- Hypertension defined as a mean of triplicate sitting blood pressure measurements >150/90 mmHg.
- Any Screening hematology or biochemistry abnormalities considered clinically significant by the Investigator.
- For women of child bearing potential, positive urine/serum pregnancy test at Screening or within 24 hours of the first dose of the study vaccine.
- Body (oral) temperature >38°C or symptoms of an acute self-limited illness such as an upper respiratory infection or gastroenteritis within 3 days of administration of the first dose of the study vaccine.
- Administration of rNV-2v or any other experimental norovirus vaccine in the past.
- Planned administration of other vaccines from 14 days before the first administration of the study vaccine and 60 days after the last study administration of the study vaccine, with the exception of inactivated influenza vaccine, which can be administered up to 14 days before or from 30 days after the last administration of the study vaccine.
- Administration of immunoglobins or any blood products within 180 days prior to the first administration of the study vaccine and throughout the study duration, as per the Investigator's discretion.
- Relatives of the Sponsor, clinical research organisation, or the study centre personnel are excluded from participating in the study.
- History of psychiatric hospitalisation, alcohol abuse, or illicit drug use, which in the opinion of the Investigator, may affect the subject's participation in the study.
- Other condition that in the clinical judgement of the Investigator would jeopardise the safety or rights of a subject participating in the study, would render the subject unable to comply with the protocol, or would interfere with the evaluation of the study vaccine.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Center for Vaccinology (CEVAC), Ghent University and University Hospital
Ghent, 9000
About this study
Official title: A Phase 1 Randomised, Double-Blind, Placebo-Controlled, Safety and Immunogenicity Study of a Plant-Produced, Bivalent, Recombinant Norovirus-Like Particle Vaccine, Administered Intramuscularly to Healthy Adults Aged 18 to 40 Years
This clinical study will evaluate the vaccine candidate rNV-2v, which is under development to prevent disease triggered by noroviruses. Noroviruses are one of the leading causes of gastrointestinal diseases in the world. Norovirus infections can cause vomiting, diarrhea, and cramping. Noroviruses can spread easily, especially in hospitals, schools, military barracks and ships. At the moment, there is no vaccine available to prevent norovirus infections or disease. This clinical trial will look at the safety and tolerability of an investigational vaccine that is being developed to prevent norovirus-related disease. The trial will also look at whether the immune system produces a response to the investigational study vaccine. The study vaccine is a combination of two different types of norovirus antigens. In contrast to similar vaccines under development, the vaccine studied here adds no substances (adjuvants) to increase or modulate the immune response. The study vaccine is produced using a plant-based system rather than a typically used animal cell system. This is the first time the study vaccine will be given to humans. Two different doses of the investigational study vaccine will be tested in this trial. Either the investigational study vaccine or the placebo will be given as 2 injections. These injections will be given about 1 month apart. The trial will last about 12 months, from the time of enrollment.
Read the detailed description
The vaccine being tested in this study is rNV-2v; norovirus GI.4/GII.4 bivalent, virus-like particle (VLP) vaccine without adjuvant. Two norovirus vaccine dose levels (50 µg + 50 µg and 150 µg + 150 µg) are being tested for safety, tolerability and immunogenicity in a young adult population (18-40 years of age).
The study will enroll 60 participants. Participants will be randomly assigned to one of three treatment groups.
Norovirus GI.4/GII.4 bivalent VLP vaccine (50 µg + 50 µg), 2 administrations Norovirus GI.1/GII.4 bivalent VLP vaccine (150 µg + 150 µg), 2 administrations Placebo (norovirus vaccine vehicle without antigens), 2 administrations All participants randomized will be administered either norovirus vaccine or placebo on Day 1 and on Day 29 of the study.
Participants will be asked to record any reactions/ symptoms that may be related or not to the vaccine in a diary card for 7 days after each vaccination. Unsolicited Adverse Events (AEs) will be recorded through open-ended inquiries for 28 days after each vaccine administration. Serious AEs will be captured until Day 365.
This single-center trial will be conducted at the Center for Vaccinology (CEVAC), Ghent, Belgium. Participants will make multiple visits to the clinic including a final visit on Day 365.
- Conditions
- Norovirus
- Being tested
- Norovirus GI.4 / GII.4 Bivalent VLP Vaccine (100 µg), Norovirus GI.4 / GII.4 Bivalent VLP Vaccine (300 µg), Placebo
- Keywords
- Norovirus, Vaccine, Adults, Safety, Immunogenicity, First-in-human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Norovirus GI.4 / GII.4 Bivalent VLP Vaccine (100 µg)Biological
Also called rNV-2v
Norovirus: 50 µg GI.4 VLP + 50 µg GII.4 VLP without adjuvant
Norovirus GI.4 / GII.4 Bivalent VLP Vaccine (300 µg)Biological
Also called rNV-2v
Norovirus: 150 µg GI.4 VLP + 150 µg GII.4 VLP without adjuvant
PlaceboDrug
Also called Vehicle
Norovirus vaccine (rNV-2v) vehicle without antigen
| Study group | Role | What they receive |
|---|---|---|
| Norovirus GI.4 / GII.4 Bivalent VLP Vaccine (100 µg) | Experimental | Participants 18-40 years of age, 2-dose regimen: Norovirus bivalent GI.4 (50 μg) / GII.4 (50 μg) virus-like particle (VLP) vaccine, intramuscularly (IM), on Day 1 and Day 29 Receives: Biological: Norovirus GI.4 / GII.4 Bivalent VLP Vaccine (100 µg) |
| Norovirus GI.4 / GII.4 Bivalent VLP Vaccine (300 µg) | Experimental | Participants 18-40 years of age, 2-dose regimen: Norovirus bivalent GI.4 (150 μg) / GII.4 (150 μg) virus-like particle (VLP) vaccine, intramuscularly (IM), on Day 1 and Day 29 Receives: Biological: Norovirus GI.4 / GII.4 Bivalent VLP Vaccine (300 µg) |
| Placebo | Placebo comparator | Participants 18-40 years of age, 2-dose regimen: Placebo (norovirus vaccine vehicle without antigens), intramuscularly (IM), on Day 1 and Day 29 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety, tolerability, and reactogenicity of rNV-2v administered intramuscularly (IM) to healthy subjects
Safety and tolerability as determined by:
- The occurrence of adverse events (AEs) consisting of local and systemic signs and symptoms within 7 days after vaccination. Local and systemic signs and symptoms, assessed as typical and expected reactions to study vaccine administration including pain, redness, and swelling at the injection site; fever, fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhea, and/or abdominal pain), headache, myalgia, shivering, and arthralgia.
- Incidence of abnormal hematology and serum chemistry laboratory values.
- Occurrence of serious adverse events (SAEs).
- Onset of any significant new medical conditions following the first administration of study vaccine.
Measured: within 7 days after each administration of the vaccine
To assess the safety, tolerability, and reactogenicity of rNV-2v administered intramuscularly (IM) to healthy subjects
Safety and tolerability as determined by:
- Incidence of abnormal hematology and serum chemistry laboratory values.
- Occurrence of serious adverse events (SAEs).
- Onset of any significant new medical conditions following the first administration of study vaccine.
Measured: until 28 days after second administration of study vaccine (Day 57)
To assess the safety, tolerability, and reactogenicity of rNV-2v administered intramuscularly (IM) to healthy subjects
Safety and tolerability as determined by:
- Occurrence of serious adverse events (SAEs).
- Onset of any significant new medical conditions following the first administration of study vaccine.
Measured: for 364 days following the first administration of study vaccine
Secondary outcomes (1)
To assess the humoral immune response elicited by rNV-2v by measuring binding antibodies against the GI.4 and GII.4 components of the bivalent vaccine
virus-like particle (VLP) antigens, relative to Baseline:
- Anti-GI.4 and GII.4 VLP immunoglobulin (Ig) G titer by enzyme-linked immunosorbent assay (ELISA) in serum
Measured: Pre-dose, Week 1, Week 4, Week 8, Week 26, and Week 52.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start17 Aug 2020
- Primary completion26 Oct 2021
- Study completion26 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for NorovirusStudies 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icon Genetics GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital, Ghent
- Responsible party
- Sponsor
- Investigators
- Principal Investigator, Principal investigator, Center for Vaccinology (CEVAC), Ghent University and University Hospital, Ghent, Belgium.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05508178
- Sponsor's protocol ID
- rNV-2v-001
- Status last verified
- Aug 2022
- First submitted
- 17 Aug 2022
- Last updated
- 19 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Waerlop G, Janssens Y, Jacobs B, Jarczowski F, Diessner A, Leroux-Roels G, Klimyuk V, Leroux-Roels I, Thieme F. Immune responses in healthy adults elicited by a bivalent norovirus vaccine candidate composed of GI.4 and GII.4 VLPs without adjuvant. Front Immunol. 2023 Jun 26;14:1188431. doi: 10.3389/fimmu.2023.1188431. eCollection 2023.
PubMed 37435073Leroux-Roels I, Maes C, Joye J, Jacobs B, Jarczowski F, Diessner A, Janssens Y, Waerlop G, Tamminen K, Heinimaki S, Blazevic V, Leroux-Roels G, Klimyuk V, Adachi H, Hiruta K, Thieme F. A randomized, double-blind, placebo-controlled, dose-escalating phase I trial to evaluate safety and immunogenicity of a plant-produced, bivalent, recombinant norovirus-like particle vaccine. Front Immunol. 2022 Oct 7;13:1021500. doi: 10.3389/fimmu.2022.1021500. eCollection 2022.
PubMed 36275772
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomised, Double-Blind, Placebo-Controlled, Safety and Immunogenicity Study of a Plant-Produced, Bivalent, Recombinant Norovirus-Like Particle Vaccine, Administered Intramuscularly to Healthy Adults Aged 18 to 40 Years
- ClinicalTrials.gov ID
- NCT05508178
- Acronym / sponsor ID
- rNV-2v-001
- Conditions
- Norovirus
- Keywords
- Norovirus, Vaccine, Adults, Safety, Immunogenicity, First-in-human
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Icon Genetics GmbHIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital, Ghent
- Study start
- 17 Aug 2020 (actual)
- Primary completion
- 26 Oct 2021 (actual)
- Study completion
- 26 Oct 2021 (actual)
- First posted
- 19 Aug 2022 (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.
This clinical study will evaluate the vaccine candidate rNV-2v, which is under development to prevent disease triggered by noroviruses. Noroviruses are one of the leading causes of gastrointestinal diseases in the world. Norovirus infections can cause vomiting, diarrhea, and cramping. Noroviruses can spread easily, especially in hospitals, schools, military barracks and ships. At the moment, there is no vaccine available to prevent norovirus infections or disease. This clinical trial will look at the safety and tolerability of an investigational vaccine that is being developed to prevent norovirus-related disease. The trial will also look at whether the immune system produces a response to the investigational study vaccine. The study vaccine is a combination of two different types of norovirus antigens. In contrast to similar vaccines under development, the vaccine studied here adds no substances (adjuvants) to increase or modulate the immune response. The study vaccine is produced using a plant-based system rather than a typically used animal cell system. This is the first time the study vaccine will be given to humans. Two different doses of the investigational study vaccine will be tested in this trial. Either the investigational study vaccine or the placebo will be given as 2 injections. These injections will be given about 1 month apart. The trial will last about 12 months, from the time of enrollment.
Detailed description
The vaccine being tested in this study is rNV-2v; norovirus GI.4/GII.4 bivalent, virus-like particle (VLP) vaccine without adjuvant. Two norovirus vaccine dose levels (50 µg + 50 µg and 150 µg + 150 µg) are being tested for safety, tolerability and immunogenicity in a young adult population (18-40 years of age).
The study will enroll 60 participants. Participants will be randomly assigned to one of three treatment groups.
Norovirus GI.4/GII.4 bivalent VLP vaccine (50 µg + 50 µg), 2 administrations Norovirus GI.1/GII.4 bivalent VLP vaccine (150 µg + 150 µg), 2 administrations Placebo (norovirus vaccine vehicle without antigens), 2 administrations All participants randomized will be administered either norovirus vaccine or placebo on Day 1 and on Day 29 of the study.
Participants will be asked to record any reactions/ symptoms that may be related or not to the vaccine in a diary card for 7 days after each vaccination. Unsolicited Adverse Events (AEs) will be recorded through open-ended inquiries for 28 days after each vaccine administration. Serious AEs will be captured until Day 365.
This single-center trial will be conducted at the Center for Vaccinology (CEVAC), Ghent, Belgium. Participants will make multiple visits to the clinic including a final visit on Day 365.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Norovirus GI.4 / GII.4 Bivalent VLP Vaccine (100 µg) | Experimental | Biological: Norovirus GI.4 / GII.4 Bivalent VLP Vaccine (100 µg)Participants 18-40 years of age, 2-dose regimen: Norovirus bivalent GI.4 (50 μg) / GII.4 (50 μg) virus-like particle (VLP) vaccine, intramuscularly (IM), on Day 1 and Day 29 |
| Norovirus GI.4 / GII.4 Bivalent VLP Vaccine (300 µg) | Experimental | Biological: Norovirus GI.4 / GII.4 Bivalent VLP Vaccine (300 µg)Participants 18-40 years of age, 2-dose regimen: Norovirus bivalent GI.4 (150 μg) / GII.4 (150 μg) virus-like particle (VLP) vaccine, intramuscularly (IM), on Day 1 and Day 29 |
| Placebo | Placebo comparator | Drug: PlaceboParticipants 18-40 years of age, 2-dose regimen: Placebo (norovirus vaccine vehicle without antigens), intramuscularly (IM), on Day 1 and Day 29 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Male or female aged 18 to 40 years (inclusive) at Screening.
- Good general health as determined by a Screening evaluation that includes vital signs, medical history, physical examinations, and laboratory assessments within 28 days before administration of the study vaccine.
- Expressed interest, availability and understanding to fulfil the study requirements, and in the opinion of the Investigator, can and will comply with the protocol requirements.
- Female subjects of childbearing potential must be using a highly-effective licensed method of birth control for 30 days prior to the first vaccination and must agree to continue such precautions during the study until 60 days after the second vaccination. Male subjects must agree to employ barrier contraception from the day of first vaccination until 60 days after the second vaccination, if their female partner of childbearing potential doesn't use a highly effective method of birth control.
Key exclusion criteria (17 listed)
- Any condition that may interfere with study participation or place the participant at increased risk of AEs would be excluded from the study. Additionally, subjects are excluded from the study if any of the following criteria apply:
- Positive serology test results for hepatitis C virus, human immunodeficiency virus antibody, and/or hepatitis B surface antigen at Screening.
- Pregnant or lactating women.
- History of any of the following medical illnesses, which, in the opinion of the Investigator, may interfere with study participation or place the participant at increased risk of AEs, including but not limited to: immunosuppression (disease or treatments that may affect immune system function), diabetes, cancer (malignancy other than a resolved or excised skin lesion), heart disease (hospitalisation for a heart attack, arrhythmia, or syncope), unconsciousness (excluding single and brief concussion), seizures, asthma requiring treatment with inhaler or medication in the past 2 years, neuroinflammatory disease, autoimmune disease, recurrent infections (more than 3 hospitalisations for invasive bacterial infections such as pneumonia or meningitis).
- Any current or chronic conditions requiring daily medication other than vitamins, minerals, or antihypertensives, as per the Investigator's discretion. Rescreening for acute illness that is expected to resolve quickly is allowed, as per the Investigator's discretion.
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 GI.4 / GII.4 Bivalent VLP Vaccine (100 µg)Also: rNV-2vNorovirus: 50 µg GI.4 VLP + 50 µg GII.4 VLP without adjuvant | Biological | Norovirus GI.4 / GII.4 Bivalent VLP Vaccine (100 µg) |
| Norovirus GI.4 / GII.4 Bivalent VLP Vaccine (300 µg)Also: rNV-2vNorovirus: 150 µg GI.4 VLP + 150 µg GII.4 VLP without adjuvant | Biological | Norovirus GI.4 / GII.4 Bivalent VLP Vaccine (300 µg) |
| PlaceboAlso: VehicleNorovirus vaccine (rNV-2v) vehicle without antigen | Drug | Placebo |
Primary outcome
To assess the safety, tolerability, and reactogenicity of rNV-2v administered intramuscularly (IM) to healthy subjects
Time frame: within 7 days after each administration of the vaccine
Safety and tolerability as determined by: * The occurrence of adverse events (AEs) consisting of local and systemic signs and symptoms within 7 days after vaccination. Local and systemic signs and symptoms, assessed as typical and expected reactions to study vaccine administration including pain, redness, and swelling at the injection site; fever, fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhea, and/or abdominal pain), headache, myalgia, shivering, and arthralgia. * Incidence of abnormal hematology and serum chemistry laboratory values. * Occurrence of serious adverse events (SAEs). * Onset of any significant new medical conditions following the first administration of study vaccine.
To assess the safety, tolerability, and reactogenicity of rNV-2v administered intramuscularly (IM) to healthy subjects
Time frame: until 28 days after second administration of study vaccine (Day 57)
Safety and tolerability as determined by: * Incidence of abnormal hematology and serum chemistry laboratory values. * Occurrence of serious adverse events (SAEs). * Onset of any significant new medical conditions following the first administration of study vaccine.
To assess the safety, tolerability, and reactogenicity of rNV-2v administered intramuscularly (IM) to healthy subjects
Time frame: for 364 days following the first administration of study vaccine
Safety and tolerability as determined by: * Occurrence of serious adverse events (SAEs). * Onset of any significant new medical conditions following the first administration of study vaccine.
1 secondary outcome
To assess the humoral immune response elicited by rNV-2v by measuring binding antibodies against the GI.4 and GII.4 components of the bivalent vaccine
Time frame: Pre-dose, Week 1, Week 4, Week 8, Week 26, and Week 52.
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 19 Aug 2022.
- Derived from this study: PubMed 37435073Waerlop G, Janssens Y, Jacobs B, Jarczowski F, Diessner A, Leroux-Roels G, Klimyuk V, Leroux-Roels I, Thieme F. Immune responses in healthy adults elicited by a bivalent norovirus vaccine candidate composed of GI.4 and GII.4 VLPs without adjuvant. Front Immunol. 2023 Jun 26;14:1188431. doi: 10.3389/fimmu.2023.1188431. eCollection 2023.
- Derived from this study: PubMed 36275772Leroux-Roels I, Maes C, Joye J, Jacobs B, Jarczowski F, Diessner A, Janssens Y, Waerlop G, Tamminen K, Heinimaki S, Blazevic V, Leroux-Roels G, Klimyuk V, Adachi H, Hiruta K, Thieme F. A randomized, double-blind, placebo-controlled, dose-escalating phase I trial to evaluate safety and immunogenicity of a plant-produced, bivalent, recombinant norovirus-like particle vaccine. Front Immunol. 2022 Oct 7;13:1021500. doi: 10.3389/fimmu.2022.1021500. eCollection 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.
Principal Investigator principal investigator
Center for Vaccinology (CEVAC), Ghent University and University Hospital, Ghent, Belgium.
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 GI.4 / GII.4 Bivalent VLP Vaccine (100 µg) and Norovirus GI.4 / GII.4 Bivalent VLP Vaccine (300 µg) in people with Norovirus, run by Icon Genetics GmbH at 1 site in Belgium.
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 6 inclusion and 17 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 19 Aug 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 Belgium. 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?
To assess the safety, tolerability, and reactogenicity of rNV-2v administered intramuscularly (IM) to healthy subjects (time frame: within 7 days after each administration of the vaccine). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05508178, which also lists 2 linked publications.
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 19 Aug 2022.