Meningococcal InfectionsPhase 4NCT02569632
Investigating the Immunogenicity of a U.S.-Licensed Meningococcal Serogroup B Vaccine (Trumenba)
A Phase 4 study testing Trumenba Vaccine (Wyeth/Pfizer Pharmaceuticals) in people with Meningococcal Infections, run by UCSF Benioff Children's Hospital Oakland at 2 sites in United States.
Trial summary
This study will investigate the breadth of protection against meningococcal disease in humans immunized with a newly FDA approved meningococcal B vaccine, trade name "Trumenba®" manufactured by Pfizer Vaccines. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningococcal Infections
- What is being tested?
- Trumenba Vaccine (Wyeth/Pfizer Pharmaceuticals)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2015to Dec 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adults in the following risk groups: physicians, nurses, respiratory therapists, microbiology laboratory personnel working at UCSF Benioff Children's Hospital Oakland or the University of Massachusetts Medical School as well as medical students attending accredited U.S. medical schools
- Able to comprehend and follow all required study procedures
- In good health as determined by a brief medical history
- For females of child bearing age a negative urine pregnancy test will be required
Who cannot join
- Are not in the risk groups summarized above
- Have not given or are unable to give written informed consent to participate in the study
- Females of child bearing potential who are pregnant, or planning on becoming pregnant during the study period.
- Persons with a past history of having Guillain-Barré Syndrome (GBS), or a family history of GBS in a parent or sibling.
- Persons with presence or suspected presence of serious chronic disease including but not limited to: chronic cardiac disease, autoimmune disease, diabetes, hepatitis B/C, HIV, progressive neurological disease or seizure, leukemia, lymphomas, or neoplasm.
- Have participated in any other investigational drug or received any other vaccine within the last 30 days.
Show all 12Show fewer
- Received a dose of a meningococcal serogroups A, C, Y, W conjugate vaccine within the previous 30 days or wish to receive a dose of this vaccine during the six month study period.
- Have a history of anaphylactic shock, asthma, urticaria or other allergic reaction after previous dose of Trumenba
- Have experienced fever (oral temperature above 38.0°C) within the past 3 days or are suffering from a present acute infectious disease
- Are planning to leave the area of the study site before the end of the study period
- Have obesity (BMI higher than 33); or 11.
- With any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UCSF Benioff Children's Hospital Oakland
Oakland, California, 94609
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
About this study
Official title: Immunogenicity of a U.S.-Licensed Meningococcal Serogroup B Vaccine (Trumenba) in Adults at Increased Risk of Meningococcal Disease Because of Occupational Exposure
This study will investigate the breadth of protection against meningococcal disease in humans immunized with a newly FDA approved meningococcal B vaccine, trade name "Trumenba®" manufactured by Pfizer Vaccines. As a secondary goal the investigators will investigate underlying mechanisms by which human anti-FHbp antibodies elicit complement-mediated bactericidal activity.
Read the detailed description
Neisseria meningitidis causes meningitis and severe infections of the blood stream. The incidence of serogroup B meningococcal disease however is too low to conduct a randomized, controlled trial to determine the actual efficacy of the new serogroup B vaccines. Instead vaccine efficacy was inferred from serum bactericidal antibody responses using four test strains. However, because of strain variability of FHbp amino acid sequence (there are more than 800 sequence variants described) and strain variability of FHbp expression, bactericidal data on only four strains are unlikely to be sufficient to predict the actual strain coverage by the vaccine. There also are gaps in knowledge about the underlying mechanisms by which human antibodies to FHbp elicit complement mediated bactericidal activity. For example, binding of FH to FHbp is specific for human FH. Therefore in vaccinated humans the vaccine antigen is expected to form a complex with FH right after immunization. The investigators' hypothesis is that binding of human FH to the vaccine antigen skews the antibody repertoire to FHbp epitopes located outside of the FH combining site. The resulting antibodies would be expected not to inhibit binding of FH to the bacteria. This hypothesis will be investigated in Trumenba-immunized humans as part of studies in Aim 1 (and in future studies of recombinant human anti-FHbp Fabs that will be enabled by obtaining DNA from individual B cells, described in Aim 2).
- Conditions
- Meningococcal Infections
- Being tested
- Trumenba Vaccine (Wyeth/Pfizer Pharmaceuticals)
- Keywords
- Meningococcal Vaccines, Neisseria Meningitidis, Factor H-binding Protein
- Medical subject headings
- Meningococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trumenba Vaccine (Wyeth/Pfizer Pharmaceuticals)Biological
Also called MenB-FHbp
All subjects will receive three doses of a Trumenba, a U.S.-licensed meningococcal vaccine. Each 0.5 mL dose contains 60 micrograms of each FHbp variant (total of 120 micrograms of protein), 0.018 mg of PS80 and 0.25 mg of Al³+ as AlPO4 in 10 mM histidine buffered saline at pH 6.0. Trumenba is administered as a three dose series (0.5 mL each) according to a 0-, 2-, and 6-month schedule.
| Study group | Role | What they receive |
|---|---|---|
| Open Label: MenB-FHbp | Experimental | Trumenba Meningococcal Group B Vaccine (Wyeth/Pfizer Pharmaceuticals) Receives: Biological: Trumenba Vaccine (Wyeth/Pfizer Pharmaceuticals) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breadth of Protective Activity of Serum Anti-FHbp Antibody Responses of Adults Immunized With Trumenba Vaccine as Assessed by Serum Bactericidal Titers
Determine the percentage of subjects achieving serum bactericidal titers of 1:4 or greater in serum obtained 1 month after doses 2 and 3 as measured against a panel of 15 genetically diverse meningococcal strains.
Measured: 18 months
Secondary outcomes (1)
Antibody Repertoire to FHbp
Determine the percentage of recombinant anti-FHbp Fabs isolated from B cells of each subject that react with 3 FHbp amino acid sequence variants representative of FHbp variant groups 1, 2 and 3
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Meningococcal 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 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCSF Benioff Children's Hospital Oakland
- Sponsor type
- University, hospital or other
- Collaborators
- University of Massachusetts, Worcester
- Responsible party
- Sponsor
- Investigators
- Dan Granoff, MD, Principal investigator, Children's Hospital Oakland Research Institute, Center for Immunobiology and Vaccine Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02569632
- Sponsor's protocol ID
- ChildrensHRCOakland
- Status last verified
- Feb 2021
- First submitted
- 30 Sep 2015
- Last updated
- 2 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lujan E, Partridge E, Giuntini S, Ram S, Granoff DM. Breadth and Duration of Meningococcal Serum Bactericidal Activity in Health Care Workers and Microbiologists Immunized with the MenB-FHbp Vaccine. Clin Vaccine Immunol. 2017 Aug 4;24(8):e00121-17. doi: 10.1128/CVI.00121-17. Print 2017 Aug.
PubMed 28566335
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity of a U.S.-Licensed Meningococcal Serogroup B Vaccine (Trumenba) in Adults at Increased Risk of Meningococcal Disease Because of Occupational Exposure
- ClinicalTrials.gov ID
- NCT02569632
- Acronym / sponsor ID
- ChildrensHRCOakland
- Conditions
- Meningococcal Infections
- Keywords
- Meningococcal Vaccines, Neisseria Meningitidis, Factor H-binding Protein
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- UCSF Benioff Children's Hospital OaklandUniversity, hospital or other
- Collaborators
- University of Massachusetts, Worcester
- Study start
- Jan 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 7 Oct 2015 (estimated)
- Results
- Posted 2 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate the breadth of protection against meningococcal disease in humans immunized with a newly FDA approved meningococcal B vaccine, trade name "Trumenba®" manufactured by Pfizer Vaccines. As a secondary goal the investigators will investigate underlying mechanisms by which human anti-FHbp antibodies elicit complement-mediated bactericidal activity.
Detailed description
Neisseria meningitidis causes meningitis and severe infections of the blood stream. The incidence of serogroup B meningococcal disease however is too low to conduct a randomized, controlled trial to determine the actual efficacy of the new serogroup B vaccines. Instead vaccine efficacy was inferred from serum bactericidal antibody responses using four test strains. However, because of strain variability of FHbp amino acid sequence (there are more than 800 sequence variants described) and strain variability of FHbp expression, bactericidal data on only four strains are unlikely to be sufficient to predict the actual strain coverage by the vaccine. There also are gaps in knowledge about the underlying mechanisms by which human antibodies to FHbp elicit complement mediated bactericidal activity. For example, binding of FH to FHbp is specific for human FH. Therefore in vaccinated humans the vaccine antigen is expected to form a complex with FH right after immunization. The investigators' hypothesis is that binding of human FH to the vaccine antigen skews the antibody repertoire to FHbp epitopes located outside of the FH combining site. The resulting antibodies would be expected not to inhibit binding of FH to the bacteria. This hypothesis will be investigated in Trumenba-immunized humans as part of studies in Aim 1 (and in future studies of recombinant human anti-FHbp Fabs that will be enabled by obtaining DNA from individual B cells, described in Aim 2).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label: MenB-FHbp | Experimental | Biological: Trumenba Vaccine (Wyeth/Pfizer Pharmaceuticals)Trumenba Meningococcal Group B Vaccine (Wyeth/Pfizer Pharmaceuticals) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults in the following risk groups: physicians, nurses, respiratory therapists, microbiology laboratory personnel working at UCSF Benioff Children's Hospital Oakland or the University of Massachusetts Medical School as well as medical students attending accredited U.S. medical schools
- Able to comprehend and follow all required study procedures
- In good health as determined by a brief medical history
- For females of child bearing age a negative urine pregnancy test will be required
Key exclusion criteria (12 listed)
- Are not in the risk groups summarized above
- Have not given or are unable to give written informed consent to participate in the study
- Females of child bearing potential who are pregnant, or planning on becoming pregnant during the study period.
- Persons with a past history of having Guillain-Barré Syndrome (GBS), or a family history of GBS in a parent or sibling.
- Persons with presence or suspected presence of serious chronic disease including but not limited to: chronic cardiac disease, autoimmune disease, diabetes, hepatitis B/C, HIV, progressive neurological disease or seizure, leukemia, lymphomas, or neoplasm.
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 |
|---|---|---|
| Trumenba Vaccine (Wyeth/Pfizer Pharmaceuticals)Also: MenB-FHbpAll subjects will receive three doses of a Trumenba, a U.S.-licensed meningococcal vaccine. Each 0.5 mL dose contains 60 micrograms of each FHbp variant (total of 120 micrograms of protein), 0.018 mg of PS80 and 0.25 mg of Al³+ as AlPO4 in 10 mM histidine buffered saline at pH 6.0. Trumenba is administered as a three dose series (0.5 mL each) according to a 0-, 2-, and 6-month schedule. | Biological | Open Label: MenB-FHbp |
Primary outcome
Breadth of Protective Activity of Serum Anti-FHbp Antibody Responses of Adults Immunized With Trumenba Vaccine as Assessed by Serum Bactericidal Titers
Time frame: 18 months
Determine the percentage of subjects achieving serum bactericidal titers of 1:4 or greater in serum obtained 1 month after doses 2 and 3 as measured against a panel of 15 genetically diverse meningococcal strains.
1 secondary outcome
Antibody Repertoire to FHbp
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28566335Lujan E, Partridge E, Giuntini S, Ram S, Granoff DM. Breadth and Duration of Meningococcal Serum Bactericidal Activity in Health Care Workers and Microbiologists Immunized with the MenB-FHbp Vaccine. Clin Vaccine Immunol. 2017 Aug 4;24(8):e00121-17. doi: 10.1128/CVI.00121-17. Print 2017 Aug.
- 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.
Dan Granoff, MD principal investigator
Children's Hospital Oakland Research Institute, Center for Immunobiology and Vaccine Development
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Trumenba Vaccine (Wyeth/Pfizer Pharmaceuticals) in people with Meningococcal Infections, run by UCSF Benioff Children's Hospital Oakland at 2 sites in United States.
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 12 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 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Breadth of Protective Activity of Serum Anti-FHbp Antibody Responses of Adults Immunized With Trumenba Vaccine as Assessed by Serum Bactericidal Titers (time frame: 18 months). 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 NCT02569632, which also lists 1 linked publication.
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 2 Feb 2021.