Neisseria Meningitidis Serogroup BPhase 2MNB3NCT00443157
Meningococcal B Vaccination in University Students
A Phase 2 study testing Meningococcal B Vaccine NZ in people with Neisseria Meningitidis Serogroup B, run by Public Health England at 1 site in United Kingdom.
Trial summary
This study is the third in a series using the MenB vaccine from the National Institute of Public Health in Norway (NIPH). The vaccine was first made in response to a high incidence of disease using the 44/76 strain which was resopnsible for most of the disease there. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Neisseria Meningitidis Serogroup B
- What is being tested?
- Meningococcal B Vaccine NZ
- Type of treatment
- Vaccines
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2006to Mar 2007
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Informed written consent given for four immunisations (group 2 will receive 3 doses only) with MeNZB TM vaccine, as well as for eight blood draws to be taken as described in the patient information leaflet in appendix 2
- Healthy adults (university students) aged 18 up to 40 years on inclusion in the study
Who cannot join
- On enrolment:
- Previous history of bacteriologically confirmed disease caused by N. meningitidis
- Prior receipt of any group B meningococcal vaccine
- have had household contact with and/or intimate exposure to an individual with culture or PCR proven N. meningitidis serogroup B within the previous 60 days
- have either received, or for whom there is intent to immunize with, any vaccines or investigational agents within 50 days prior to enrolment, through to 50 days following the last study vaccine administration, with the exception of influenza vaccines or post-exposure tetanus vaccination
- have a history of any anaphylactic shock, urticaria or other allergic reaction after previous vaccinations or hypersensitivity to any vaccine component
Show all 23Show fewer
- have experienced significant acute or chronic infections requiring systemic antibiotic treatment within the past 14 days
- have any present or suspected serious acute or chronic disease such as: cardiac or autoimmune disease, insulin dependent diabetes or progressive neurological disease or severe malnutrition, acute or progressive hepatic disease, acute or progressive renal disease; leukaemia, lymphomas, neoplasm;
- have a known or suspected impairment of the immune function, or those receiving immunosuppressive therapy, or having received immunosuppressive therapy, including systemic steroids, or ACTH or inhaled steroids in dosages which are associated with hypothalamic-pituitary-adrenal axis suppression;
- have received blood, blood products or a parenteral immunoglobulin preparation in the past 12 weeks;
- have a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;
- have a history of seizure disorder;
- have an inherited genetic anomaly (known cytogenic disorders) e.g., Down's syndrome;
- Language difficulty sufficient to preclude adequate comprehension of the information sheet, consent form or study nurse's explanation of the study;
- The possibility of pregnancy - a pregnancy test (urine) on the scheduled day of vaccination will be offered to any female wishing to participate in the study. A positive test will result in exclusion from the study. (Agreement from each female participants will be sought prior to vaccination that they will take adequate precautions to avoid pregnancy for the duration of the vaccination phase of the study until the final blood sample appointment following their final vaccination, i.e. until the week 63 - visit 8 - blood appointment);
- Current regimen of chronic prescription medications other than oral contraceptives, or current regular use of any over-the-counter concomitant medications including antipyretics and non-steroidal anti-inflammatory agents;
- Current participation in any other clinical trial (an undertaking will be sought from participants not to enrol in any other clinical trial for the duration of this study);
- They have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives
- Current (to be checked prior to each vaccination):
- Generalised acute systemic illness on the day of immunisation
- Sublingual temperature >38,5oC on the day of immunisation
- Development of any condition specified in the initial exclusion criteria cited above will constitute a criterion for exclusion from receiving subsequent vaccine doses.
- Any serious reaction related to the study vaccines, which in the opinion of the investigator should alter the course of subsequent study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Open Label, Randomised, Single Centre Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Three or Four Doses of Meningococcal Serogroup B Outer Membrane Vesicle (OMV) Vaccine MENZBTM When Administered to Healthy Adults (University Students)
This study is the third in a series using the MenB vaccine from the National Institute of Public Health in Norway (NIPH). The vaccine was first made in response to a high incidence of disease using the 44/76 strain which was resopnsible for most of the disease there. The VEC did the first study, MNB1, using this vaccine. Since then the NIPH has formed a commercial partnership with Chiron Vaccines and has reformulated the vaccine using the NZ98/254 MenB strain for use in New Zealand.
The vaccine was first produced at NIPH facilties and it was this vaccine that was used in our second study, MNB2. The current study, MNB3, will use the NZ98/254 MenB vaccine but from Chiron facilities where production has been scaled up in order to provide enough doses for the national immunisation campaign that is ongoing in New Zealand.
- Conditions
- Neisseria Meningitidis Serogroup B
- Being tested
- Meningococcal B Vaccine NZ
- Keywords
- meningococcal B vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meningococcal B Vaccine NZBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
serum bactericidal antibody
Secondary outcomes (3)
Serum antibody ELISA
Immunoblotting
Opsonophagocytosis assay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2007 (estimated)
- Study startFeb 2006
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neisseria Meningitidis Serogroup BStudies 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
- None (open label)
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Public Health England
- Sponsor type
- Other government
- Investigators
- Elizabeth Miller, MBBS FRCPath, Principal investigator, Public Health England
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00443157
- Sponsor's protocol ID
- MNB3
- Acronym
- MNB3
- Status last verified
- Sep 2007
- First submitted
- 2 Mar 2007
- Last updated
- 29 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open Label, Randomised, Single Centre Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Three or Four Doses of Meningococcal Serogroup B Outer Membrane Vesicle (OMV) Vaccine MENZBTM When Administered to Healthy Adults (University Students)
- ClinicalTrials.gov ID
- NCT00443157
- Acronym / sponsor ID
- MNB3 / MNB3
- Conditions
- Neisseria Meningitidis Serogroup B
- Keywords
- meningococcal B vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- Public Health EnglandOther government
- Study start
- Feb 2006
- Study completion
- Mar 2007 (actual)
- First posted
- 5 Mar 2007 (estimated)
- 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 study is the third in a series using the MenB vaccine from the National Institute of Public Health in Norway (NIPH). The vaccine was first made in response to a high incidence of disease using the 44/76 strain which was resopnsible for most of the disease there. The VEC did the first study, MNB1, using this vaccine. Since then the NIPH has formed a commercial partnership with Chiron Vaccines and has reformulated the vaccine using the NZ98/254 MenB strain for use in New Zealand.
The vaccine was first produced at NIPH facilties and it was this vaccine that was used in our second study, MNB2. The current study, MNB3, will use the NZ98/254 MenB vaccine but from Chiron facilities where production has been scaled up in order to provide enough doses for the national immunisation campaign that is ongoing in New Zealand.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Informed written consent given for four immunisations (group 2 will receive 3 doses only) with MeNZB TM vaccine, as well as for eight blood draws to be taken as described in the patient information leaflet in appendix 2
- Healthy adults (university students) aged 18 up to 40 years on inclusion in the study
Key exclusion criteria (23 listed)
- Previous history of bacteriologically confirmed disease caused by N. meningitidis
- Prior receipt of any group B meningococcal vaccine
- have had household contact with and/or intimate exposure to an individual with culture or PCR proven N. meningitidis serogroup B within the previous 60 days
- have either received, or for whom there is intent to immunize with, any vaccines or investigational agents within 50 days prior to enrolment, through to 50 days following the last study vaccine administration, with the exception of influenza vaccines or post-exposure tetanus vaccination
- have a history of any anaphylactic shock, urticaria or other allergic reaction after previous vaccinations or hypersensitivity to any vaccine component
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 |
|---|---|---|
| Meningococcal B Vaccine NZ | Biological | – |
Primary outcome
serum bactericidal antibody
3 secondary outcomes
Serum antibody ELISA
Immunoblotting
Opsonophagocytosis assay
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 29 Aug 2018.
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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.
Elizabeth Miller, MBBS FRCPath principal investigator
Public Health England
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 Meningococcal B Vaccine NZ in people with Neisseria Meningitidis Serogroup B, run by Public Health England at 1 site in United Kingdom.
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 2 inclusion and 23 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 29 Aug 2018. 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 United Kingdom. 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. 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?
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?
serum bactericidal antibody. 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 29 Aug 2018.