Meningitis, Meningococcal, Serogroup BPhase 2B1971042NCT01768117
Study To Describe The Safety, Tolerability, And Immunogenicity Of Bivalent Rlp2086 Vaccine In Laboratory Workers ≥18 To ≤65 Years Of Age
A Phase 2 study testing rLP2086 in people with Meningitis, Meningococcal, Serogroup B, run by Pfizer at 1 site in United States.
Trial summary
This study will assess the safety, tolerability and immunogenicity of bivalent rLP2086 vaccine in laboratory workers ≥18 to ≤65 years of age administered on a Month 0, 2, and 6 schedule. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningitis, Meningococcal, Serogroup B
- What is being tested?
- rLP2086
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Feb 2014
- Phase
- Phase 2
- 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
- Laboratory personnel (inclusive of Pfizer staff) who work directly with pathogenic Neisseria meningitidis in the context of the bivalent rLP2086 vaccine development program.
- Male or female subject aged ≥18 to ≤65 years at the time of enrollment.
- Negative urine pregnancy test.
Who cannot join
- Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
- A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired defects in B cell function or those receiving immunosuppressive therapy. Subjects with terminal complement deficiency are excluded from participation in this study.
- Significant neurological disorder or history of seizure (excluding simple febrile seizure).
- Current chronic use of systemic antibiotics.
- Received any investigational drugs, vaccines, or devices within 28 days before administration of the first study vaccination.
- Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
- Prior receipt of any vaccine specifically targeting fHBP or LP2086 antigens.
- History of microbiologically proven disease caused by Neisseria meningitidis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Frontage Clinical Services (Formally ABR)
Hackensack, New Jersey, 07601
About this study
Official title: A Single-arm, Open-label Study To Describe The Safety, Tolerability, And Immunogenicity Of Bivalent Rlp2086 Vaccine In Laboratory Workers >=18 To < =65 Years Of Age
This study will assess the safety, tolerability and immunogenicity of bivalent rLP2086 vaccine in laboratory workers ≥18 to ≤65 years of age administered on a Month 0, 2, and 6 schedule. The study will recruit laboratory personnel (inclusive of Pfizer staff) who work directly with pathogenic Neisseria meningitidis in the context of the bivalent rLP2086 vaccine development program. The study will provide descriptive safety and immunogenicity data following vaccination of these individuals with bivalent rLP2086 vaccine.
- Conditions
- Meningitis, Meningococcal, Serogroup B
- Being tested
- rLP2086
- Medical subject headings
- Meningitis, Meningococcal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rLP2086Biological
0.5 ml intramuscular injection of 120 microgram bivalent rLP2085 administered at 0, 2 and 6 months
| Study group | Role | What they receive |
|---|---|---|
| rLP2086 | Experimental | Not described Receives: Biological: rLP2086 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)
Measured: 1 month after vaccination 3
Percentage of Participants With at Least One Adverse Event (AE)
Measured: Vaccination 1 up to 1 month after Vaccination 3
Secondary outcomes (3)
Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= LLOQ
Measured: 1 month after vaccination (Vac) 1, 2, Immediately prior to vaccination 3
Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= LLOQ For All 4 Primary Test Strains Combined
Measured: 1 month after vaccination 3
Number of Participants With 4-fold Increase in Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level
Measured: 1 month after vaccination 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionFeb 2014
- Study completionFeb 2014
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 Meningitis, Meningococcal, Serogroup BStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01768117
- Sponsor's protocol ID
- B1971042
- Acronym
- B1971042
- Status last verified
- Nov 2018
- First submitted
- 8 Jan 2013
- Last updated
- 20 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Beeslaar J, Mather S, Absalon J, Eiden JJ, York LJ, Crowther G, Maansson R, Maguire JD, Peyrani P, Perez JL. Safety data from the MenB-FHbp clinical development program in healthy individuals aged 10 years and older. Vaccine. 2022 Mar 15;40(12):1872-1878. doi: 10.1016/j.vaccine.2022.01.046. Epub 2022 Feb 11.
PubMed 35164991
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open-label Study To Describe The Safety, Tolerability, And Immunogenicity Of Bivalent Rlp2086 Vaccine In Laboratory Workers >=18 To < =65 Years Of Age
- ClinicalTrials.gov ID
- NCT01768117
- Acronym / sponsor ID
- B1971042 / B1971042
- Conditions
- Meningitis, Meningococcal, Serogroup B
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 15 Jan 2013 (estimated)
- Results
- Posted 9 Mar 2015
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 assess the safety, tolerability and immunogenicity of bivalent rLP2086 vaccine in laboratory workers ≥18 to ≤65 years of age administered on a Month 0, 2, and 6 schedule. The study will recruit laboratory personnel (inclusive of Pfizer staff) who work directly with pathogenic Neisseria meningitidis in the context of the bivalent rLP2086 vaccine development program. The study will provide descriptive safety and immunogenicity data following vaccination of these individuals with bivalent rLP2086 vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rLP2086 | Experimental | Biological: rLP2086 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Laboratory personnel (inclusive of Pfizer staff) who work directly with pathogenic Neisseria meningitidis in the context of the bivalent rLP2086 vaccine development program.
- Male or female subject aged ≥18 to ≤65 years at the time of enrollment.
- Negative urine pregnancy test.
Key exclusion criteria (8 listed)
- Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
- A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired defects in B cell function or those receiving immunosuppressive therapy. Subjects with terminal complement deficiency are excluded from participation in this study.
- Significant neurological disorder or history of seizure (excluding simple febrile seizure).
- Current chronic use of systemic antibiotics.
- Received any investigational drugs, vaccines, or devices within 28 days before administration of the first study vaccination.
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 |
|---|---|---|
| rLP20860.5 ml intramuscular injection of 120 microgram bivalent rLP2085 administered at 0, 2 and 6 months | Biological | rLP2086 |
Primary outcome
Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)
Time frame: 1 month after vaccination 3
Percentage of Participants With at Least One Adverse Event (AE)
Time frame: Vaccination 1 up to 1 month after Vaccination 3
3 secondary outcomes
Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= LLOQ
Time frame: 1 month after vaccination (Vac) 1, 2, Immediately prior to vaccination 3
Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= LLOQ For All 4 Primary Test Strains Combined
Time frame: 1 month after vaccination 3
Number of Participants With 4-fold Increase in Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level
Time frame: 1 month after vaccination 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35164991Beeslaar J, Mather S, Absalon J, Eiden JJ, York LJ, Crowther G, Maansson R, Maguire JD, Peyrani P, Perez JL. Safety data from the MenB-FHbp clinical development program in healthy individuals aged 10 years and older. Vaccine. 2022 Mar 15;40(12):1872-1878. doi: 10.1016/j.vaccine.2022.01.046. Epub 2022 Feb 11.
Related trials for Meningitis, Meningococcal, Serogroup B
Active, not recruitingPhase 4
A Study on the Immune Response and Safety of a Vaccine Against N. Meningitidis Serogroup B Infection in Healthy Infants From 2 Months of Age
Meningitis, Meningococcal
RecruitingPhase 4
Investigating Gender and Sex Differences in Immune Responses Through Vaccination of Transgender and Cisgender Persons
Meningococcal Meningitis, Serogroup B, Transgender Persons
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.
Pfizer CT.gov Call Center study director
Pfizer
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 rLP2086 in people with Meningitis, Meningococcal, Serogroup B, run by Pfizer at 1 site 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 3 inclusion and 8 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 20 Dec 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 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 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?
Yes. Results are posted in the registry (first posted 9 Mar 2015). 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?
Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) (time frame: 1 month after vaccination 3). The study lists 2 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 NCT01768117, 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 20 Dec 2018.