Meningococcal Meningitis, Serogroup APhase 2MenOccyNCT00962624
Study of Meningococcal B Vaccine and ACWY Conjugate Vaccine in Healthy Adults
A Phase 2 study testing meningococcal B vaccine & meningococcal ACYW conjugate vaccine in people with Meningococcal Meningitis, Serogroup A and Meningococcal Meningitis, Serogroup B, run by Prof. Elizabeth Miller at 1 site in United Kingdom.
Trial summary
The study involves the measurement of immune response to vaccination with three doses of a meningococcal B vaccine and a single dose of a meningococcal ACYW conjugate vaccine in healthy adults (Laboratory workers). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningococcal Meningitis, Serogroup A, Meningococcal Meningitis, Serogroup B, Meningococcal Meningitis, Serogroup C
- What is being tested?
- meningococcal B vaccine & meningococcal ACYW conjugate vaccine
- Type of treatment
- Vaccines
- How many people
- 38 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2010to Mar 2012
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18-65 years of age
- Who have given written informed consent after the nature of the study has been explained.
- Who work within the Manchester Medical Microbiology Partnership and may be at potential occupational exposure to meningococci.
Who cannot join
- The possibility of pregnancy
- A serious chronic disease including progressive neurological disease or seizure disorder.
- Have a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
- Have a history of severe allergic reactions after previous vaccinations such as anaphylactic shock, asthma, urticaria, or other allergic reaction or hypersensitivity to any vaccine component.
- Have received another investigational agent within 90 days or before completion of the safety follow-up period in another study, whichever is longer, prior to enrollment and unwilling to refuse participation in another investigational trial through the end of the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Manchester Medical Microbiology Partnership
Manchester, M13 9WZ
About this study
Official title: A Phase 2, Open-label Study of the Safety, Tolerability and Immunogenicity of a Meningococcal B Vaccine When Administered at a 0, 2, 6 Months and of a Single Dose of Meningococcal ACWY Conjugate Vaccine in Healthy Adults Aged 18-65 Years
The study involves the measurement of immune response to vaccination with three doses of a meningococcal B vaccine and a single dose of a meningococcal ACYW conjugate vaccine in healthy adults (Laboratory workers). The study will be completed at the Manchester Medical Microbiology Partnership in the UK and will enrol staff who may be at potential occupational exposure to meningococci. Blood samples will be taken before and after each vaccination and used to determine if the vaccines induce protective responses.
Read the detailed description
Laboratory staff at the Manchester Medical Microbiology Partnership may be at potential occupational exposure to meningococci. No licensed vaccine is available against serogroup B meningococci and the available plain polysaccharide serogroup ACYW vaccine is poorly immunogenic. Novartis Vaccines have developed an investigational serogroup B vaccine and a conjugated ACYW vaccine. This study will investigate these vaccines ability to induce a protective response in laboratory staff from the Manchester Medical Microbiology Partnership. Three doses of the meningococcal B vaccine will be administered at 0, 2 and 6 months and a single dose will be administered at 0 months. Blood samples will be taken before and after each vaccination and functional antibodies determined.
- Conditions
- Meningococcal Meningitis, Serogroup A, Meningococcal Meningitis, Serogroup B, Meningococcal Meningitis, Serogroup C, Meningococcal Meningitis, Serogroup Y, Meningococcal Meningitis, Serogroup W
- Being tested
- meningococcal B vaccine & meningococcal ACYW conjugate vaccine
- Keywords
- Meningococcal, Vaccine, Meningitis
- Medical subject headings
- Meningitis, Meningococcal, Meningitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
meningococcal B vaccine & meningococcal ACYW conjugate vaccineDrug
Also called Meningococcal ACYW vaccine- MenVeo
Meningococcal B vaccine will be administered at 0, 2 and 6 months and a single dose of meningococcal ACYW vaccine will be administered at 0 months, concomitantly with the first dose of the meningococcal B vaccine.
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects attaining putative protective antibody concentrations against meningococci in the serum bactericidal antibody assay
Measured: one month following the last vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2009 (estimated)
- Study startJul 2010
- Primary completionMar 2011
- Study completionMar 2012
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 Meningococcal Meningitis, Serogroup AStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Elizabeth Miller
- Sponsor type
- Other government
- Collaborators
- Novartis Vaccines
- Responsible party
- Sponsor-investigator, Prof. Elizabeth Miller, Public Health England
- Investigators
- Ray Borrow, PhD, Principal investigator, Public Health England
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00962624
- Sponsor's protocol ID
- MenOccy
- Other IDs
- I72P1
- Acronym
- MenOccy
- Status last verified
- Sep 2018
- First submitted
- 19 Aug 2009
- Last updated
- 19 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Findlow J, Bai X, Findlow H, Newton E, Kaczmarski E, Miller E, Borrow R. Safety and immunogenicity of a four-component meningococcal group B vaccine (4CMenB) and a quadrivalent meningococcal group ACWY conjugate vaccine administered concomitantly in healthy laboratory workers. Vaccine. 2015 Jun 26;33(29):3322-30. doi: 10.1016/j.vaccine.2015.05.027. Epub 2015 May 27.
PubMed 26025807Ramirez-Bencomo F, Thistlethwaite A, Viviani V, Bartolini E, Pizza M, Biolchi A, Muzzi A, Delany I, Awanye AM, Chang CM, Borrow R, Derrick JP. Identification of immunogenic outer membrane vesicle vaccine antigen components using a meningococcal protein microarray. Vaccine. 2025 Apr 19;53:126953. doi: 10.1016/j.vaccine.2025.126953. Epub 2025 Mar 4.
PubMed 40043411
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-label Study of the Safety, Tolerability and Immunogenicity of a Meningococcal B Vaccine When Administered at a 0, 2, 6 Months and of a Single Dose of Meningococcal ACWY Conjugate Vaccine in Healthy Adults Aged 18-65 Years
- ClinicalTrials.gov ID
- NCT00962624
- Acronym / sponsor ID
- MenOccy / MenOccy
- Conditions
- Meningococcal Meningitis, Serogroup A, Meningococcal Meningitis, Serogroup B, Meningococcal Meningitis, Serogroup C, Meningococcal Meningitis, Serogroup Y, Meningococcal Meningitis, Serogroup W
- Keywords
- Meningococcal, Vaccine, Meningitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Prof. Elizabeth MillerOther government
- Collaborators
- Novartis Vaccines
- Study start
- Jul 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 20 Aug 2009 (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.
The study involves the measurement of immune response to vaccination with three doses of a meningococcal B vaccine and a single dose of a meningococcal ACYW conjugate vaccine in healthy adults (Laboratory workers). The study will be completed at the Manchester Medical Microbiology Partnership in the UK and will enrol staff who may be at potential occupational exposure to meningococci. Blood samples will be taken before and after each vaccination and used to determine if the vaccines induce protective responses.
Detailed description
Laboratory staff at the Manchester Medical Microbiology Partnership may be at potential occupational exposure to meningococci. No licensed vaccine is available against serogroup B meningococci and the available plain polysaccharide serogroup ACYW vaccine is poorly immunogenic. Novartis Vaccines have developed an investigational serogroup B vaccine and a conjugated ACYW vaccine. This study will investigate these vaccines ability to induce a protective response in laboratory staff from the Manchester Medical Microbiology Partnership. Three doses of the meningococcal B vaccine will be administered at 0, 2 and 6 months and a single dose will be administered at 0 months. Blood samples will be taken before and after each vaccination and functional antibodies determined.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18-65 years of age
- Who have given written informed consent after the nature of the study has been explained.
- Who work within the Manchester Medical Microbiology Partnership and may be at potential occupational exposure to meningococci.
Key exclusion criteria (5 listed)
- The possibility of pregnancy
- A serious chronic disease including progressive neurological disease or seizure disorder.
- Have a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
- Have a history of severe allergic reactions after previous vaccinations such as anaphylactic shock, asthma, urticaria, or other allergic reaction or hypersensitivity to any vaccine component.
- Have received another investigational agent within 90 days or before completion of the safety follow-up period in another study, whichever is longer, prior to enrollment and unwilling to refuse participation in another investigational trial through the end of the study.
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 & meningococcal ACYW conjugate vaccineAlso: Meningococcal ACYW vaccine- MenVeoMeningococcal B vaccine will be administered at 0, 2 and 6 months and a single dose of meningococcal ACYW vaccine will be administered at 0 months, concomitantly with the first dose of the meningococcal B vaccine. | Drug | – |
Primary outcome
Proportion of subjects attaining putative protective antibody concentrations against meningococci in the serum bactericidal antibody assay
Time frame: one month following the last 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 19 Sep 2018.
- Background: PubMed 26025807Findlow J, Bai X, Findlow H, Newton E, Kaczmarski E, Miller E, Borrow R. Safety and immunogenicity of a four-component meningococcal group B vaccine (4CMenB) and a quadrivalent meningococcal group ACWY conjugate vaccine administered concomitantly in healthy laboratory workers. Vaccine. 2015 Jun 26;33(29):3322-30. doi: 10.1016/j.vaccine.2015.05.027. Epub 2015 May 27.
- Derived from this study: PubMed 40043411Ramirez-Bencomo F, Thistlethwaite A, Viviani V, Bartolini E, Pizza M, Biolchi A, Muzzi A, Delany I, Awanye AM, Chang CM, Borrow R, Derrick JP. Identification of immunogenic outer membrane vesicle vaccine antigen components using a meningococcal protein microarray. Vaccine. 2025 Apr 19;53:126953. doi: 10.1016/j.vaccine.2025.126953. Epub 2025 Mar 4.
Related trials for Meningococcal Meningitis, Serogroup A
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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.
Ray Borrow, PhD 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 & meningococcal ACYW conjugate vaccine in people with Meningococcal Meningitis, Serogroup A and Meningococcal Meningitis, Serogroup B, run by Prof. Elizabeth Miller 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 3 inclusion and 5 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 Sep 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?
Proportion of subjects attaining putative protective antibody concentrations against meningococci in the serum bactericidal antibody assay (time frame: one month following the last vaccination). 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 NCT00962624, 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 Sep 2018.