Meningitis, MeningococcalPhase 1NCT00879814

Study Evaluating Safety And Tolerability Of Meningococcal B Rlp2086 Vaccine In Healthy Adults

A Phase 1 study of Meningitis, Meningococcal, run by Pfizer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to evaluate the safety and tolerability of an investigational meningococcal B rLP2086 vaccine in healthy adults. Read more about this study

Who is it for?: Ages 18 to 40 years
Conditions the study is for: Meningitis, Meningococcal
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 siteUnited States
Study dates: Apr 2009to Jul 2012
Phase: Phase 1
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 40 years
All sexes
No healthy volunteers
Adult

Who may be able to join

A subject must meet the following inclusion criteria at screening (visit 1) and at randomization (visit 2) to be considered for enrollment in the study:
Male or female subjects between the ages of 18 and 40.
Healthy male or female subjects as determined by medical history, physical examination, and judgment of the investigator.
Male or female subject who is considered biologically capable of having children must agree to commit to the use of a reliable method of birth control for the duration of the study and for 30 days after early discontinuation. A subject is still biologically capable of having children, even if he or she is using contraceptives or if his or her sexual partner is sterile or using contraceptives.
In addition a subject must meet the following inclusion criteria at randomization (visit 2) to be considered for enrollment in the study. The referred blood and urinalysis tests (inclusion criterion 5) will be performed on a blood and urine sample taken at visit 1:
Female subjects of childbearing potential with a negative urine pregnancy test prior to study drug administration. Note: this criterion will apply to each vaccination visit and to the last study visit.
Laboratory blood and urinalysis tests results within the per-protocol normal ranges.
Able to be contacted by telephone during the study period. Note: this criterion will apply to each study visit.

Who cannot join

None

Trial locations and contacts

1 site in 1 country.

United States1 site

Miami Research Associates, Inc.
South Miami, Florida, 33143

Other trials in United States

About this study

Official title: A Phase 1 Randomized, Open-label, Parallel-group, Active- And Placebo-controlled Study To Assess Safety And Tolerability Of 60, 120, And 200 Mcg Meningococcal Group B Rlp2086 Vaccine In Healthy Adult Subjects

The purpose of this study is to evaluate the safety and tolerability of an investigational meningococcal B rLP2086 vaccine in healthy adults.

Conditions: Meningitis, Meningococcal
Being tested: rLP2086 vaccine or control
Medical subject headings: Meningitis, Meningococcal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

rLP2086 vaccine or controlBiological
intra-muscular vaccine (solution), 0.5 mL, 3 doses, schedule: 0, 2, 6 months
rLP2086 vaccine or controlBiological
intra-muscular vaccine (solution), 0.5 mL, 3 doses, schedule: 0, 2, 6 months
rLP2086 vaccine or controlBiological
intra-muscular vaccine (solution), 0.5 mL, 3 doses, schedule: 0, 2, 6 months
rLP2086 vaccine or controlBiological
intra-muscular vaccine (solution), 0.5 mL, 3 doses, schedule: 0, 2, 6 months

Study groups in NCT00879814
Study group	Role	What they receive
1	Experimental	rLP2086 vaccine 60 mcg Receives: Biological: rLP2086 vaccine or control
2	Experimental	rLP2086 vaccine 120 mcg Receives: Biological: rLP2086 vaccine or control
3	Experimental	rLP2086 vaccine 200 mcg Receives: Biological: rLP2086 vaccine or control
4	Active comparator	Tdap vaccine - normal saline - normal saline Receives: Biological: rLP2086 vaccine or control

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With at Least One Adverse Event (AE)
Measured: Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Alanine Aminotransferase [ALT])
Measured: Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Aspartate Aminotransferase [AST])
Measured: Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Total Protein)
Measured: Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Albumin)
Measured: Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Alkaline Phosphatase [ALP])
Measured: Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Total Bilirubin)
Measured: Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Creatine Phosphokinase [CPK])
Measured: Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Prothrombin Time [PT])
Measured: Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Partial Thromboplastin Time [PTT])
Measured: Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Fibrinogen)
Measured: Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Hemoglobin)
Measured: Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (White Blood Cell [WBC])
Measured: Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Lymphocytes)
Measured: Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Neutrophils)
Measured: Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Eosinophils)
Measured: Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Platelet Count)
Measured: Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Sodium).
Measured: Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Potassium).
Measured: Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Blood Urea Nitrogen [BUN]).
Measured: Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Serum Creatinine).
Measured: Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Red Blood Cells [RBC]).
Measured: Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Protein).
Measured: Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Glucose).
Measured: Baseline up to Month 7

Secondary outcomes (1)

Meningococcal Immunoglobulin G (IgG) Geometric Mean Titers (GMT)
Measured: Before Dose 1, 1 month after Dose 2, before Dose 3, 1 month after Dose 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2009Jul 2012

First posted13 Apr 2009 (estimated)
Study startApr 2009
Primary completionJul 2012
Study completionJul 2012

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 (2)Papers the sponsor has linked to this study.
Other trials for Meningitis, MeningococcalStudies 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 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00879814
Sponsor's protocol ID: 6108A1-1004
Other IDs: B1971004
Status last verified: Jul 2015
First submitted: 10 Apr 2009
Last updated: 6 Aug 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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
Sheldon EA, Schwartz H, Jiang Q, Giardina PC, Perez JL. A phase 1, randomized, open-label, active-controlled trial to assess the safety of a meningococcal serogroup B bivalent rLP2086 vaccine in healthy adults. Hum Vaccin Immunother. 2012 Jul;8(7):888-95. doi: 10.4161/hv.19983. Epub 2012 Jul 1.
PubMed 22832260

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Meningitis, Meningococcal trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Randomized, Open-label, Parallel-group, Active- And Placebo-controlled Study To Assess Safety And Tolerability Of 60, 120, And 200 Mcg Meningococcal Group B Rlp2086 Vaccine In Healthy Adult Subjects
ClinicalTrials.gov ID: NCT00879814
Acronym / sponsor ID: 6108A1-1004
Conditions: Meningitis, Meningococcal
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Apr 2009
Primary completion: Jul 2012 (actual)
Study completion: Jul 2012 (actual)
First posted: 13 Apr 2009 (estimated)
Results: Posted 25 Nov 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the safety and tolerability of an investigational meningococcal B rLP2086 vaccine in healthy adults.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
1	Experimental	Biological: rLP2086 vaccine or controlrLP2086 vaccine 60 mcg
2	Experimental	Biological: rLP2086 vaccine or controlrLP2086 vaccine 120 mcg
3	Experimental	Biological: rLP2086 vaccine or controlrLP2086 vaccine 200 mcg
4	Active comparator	Biological: rLP2086 vaccine or controlTdap vaccine - normal saline - normal saline

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (8 listed)

A subject must meet the following inclusion criteria at screening (visit 1) and at randomization (visit 2) to be considered for enrollment in the study:
Male or female subjects between the ages of 18 and 40.
Healthy male or female subjects as determined by medical history, physical examination, and judgment of the investigator.
Male or female subject who is considered biologically capable of having children must agree to commit to the use of a reliable method of birth control for the duration of the study and for 30 days after early discontinuation. A subject is still biologically capable of having children, even if he or she is using contraceptives or if his or her sexual partner is sterile or using contraceptives.
In addition a subject must meet the following inclusion criteria at randomization (visit 2) to be considered for enrollment in the study. The referred blood and urinalysis tests (inclusion criterion 5) will be performed on a blood and urine sample taken at visit 1:

Key exclusion criteria (1 listed)

None

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
rLP2086 vaccine or controlintra-muscular vaccine (solution), 0.5 mL, 3 doses, schedule: 0, 2, 6 months	Biological	1
rLP2086 vaccine or controlintra-muscular vaccine (solution), 0.5 mL, 3 doses, schedule: 0, 2, 6 months	Biological	2
rLP2086 vaccine or controlintra-muscular vaccine (solution), 0.5 mL, 3 doses, schedule: 0, 2, 6 months	Biological	3
rLP2086 vaccine or controlintra-muscular vaccine (solution), 0.5 mL, 3 doses, schedule: 0, 2, 6 months	Biological	4

Primary outcome

Percentage of Participants With at Least One Adverse Event (AE)
Time frame: Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Alanine Aminotransferase [ALT])
Time frame: Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Aspartate Aminotransferase [AST])
Time frame: Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Total Protein)
Time frame: Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Albumin)
Time frame: Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Alkaline Phosphatase [ALP])
Time frame: Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Total Bilirubin)
Time frame: Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Creatine Phosphokinase [CPK])
Time frame: Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Prothrombin Time [PT])
Time frame: Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Partial Thromboplastin Time [PTT])
Time frame: Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Fibrinogen)
Time frame: Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Hemoglobin)
Time frame: Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (White Blood Cell [WBC])
Time frame: Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Lymphocytes)
Time frame: Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Neutrophils)
Time frame: Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Eosinophils)
Time frame: Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Platelet Count)
Time frame: Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Sodium).
Time frame: Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Potassium).
Time frame: Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Blood Urea Nitrogen [BUN]).
Time frame: Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Serum Creatinine).
Time frame: Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Red Blood Cells [RBC]).
Time frame: Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Protein).
Time frame: Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Glucose).
Time frame: Baseline up to Month 7

1 secondary outcome

Meningococcal Immunoglobulin G (IgG) Geometric Mean Titers (GMT)
Time frame: Before Dose 1, 1 month after Dose 2, before Dose 3, 1 month after Dose 3

Results and safety

Results posted to the registry on 25 Nov 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
rLP2086 60mcg	12	8
rLP2086 120 mcg	12	10
rLP2086 200 mcg	12	9
Tdap/Normal Saline (Control)	12	7

Primary outcome: Percentage of Participants With at Least One Adverse Event (AE)

Time frame: Baseline up to Month 7. Number. Unit: percentage of participants

Measure	rLP2086 60mcg n = 12	rLP2086 120 mcg n = 12	rLP2086 200 mcg n = 12	Tdap/Normal Saline (Control) n = 12
Value	91.7	91.7	91.7	91.7

Primary outcome: Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Alanine Aminotransferase [ALT])

Time frame: Baseline up to Month 7. Number. Unit: percentage of participants

Measure	rLP2086 60mcg n = 12	rLP2086 120 mcg n = 12	rLP2086 200 mcg n = 12	Tdap/Normal Saline (Control) n = 12
Baseline: Normal, Post-Baseline: Normal	100.0	91.7	83.3	91.7
Baseline: Normal, Post-Baseline: Mild	0	8.3	16.7	8.3

Primary outcome: Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Aspartate Aminotransferase [AST])

Time frame: Baseline up to Month 7. Number. Unit: percentage of participants

Measure	rLP2086 60mcg n = 12	rLP2086 120 mcg n = 12	rLP2086 200 mcg n = 12	Tdap/Normal Saline (Control) n = 12
Baseline: Normal, Post-Baseline: Normal	100.0	91.7	100.0	91.7
Baseline: Normal, Post-Baseline: Mild	0	8.3	0	0
Baseline: Normal, Post-Baseline: Moderate	0	0	0	8.3

Primary outcome: Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Total Protein)

Time frame: Baseline up to Month 7. Number. Unit: percentage of participants

Measure	rLP2086 60mcg n = 12	rLP2086 120 mcg n = 12	rLP2086 200 mcg n = 12	Tdap/Normal Saline (Control) n = 12
Baseline: Normal, Post-Baseline: Normal	100.0	100.0	100.0	100.0
Baseline:Normal,Post Baseline:Mild/Moderate/Severe	0.0	0.0	0.0	0.0

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Baseline up to Month 7. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
rLP2086 60mcg	0 of 12 (0%)	11 of 12 (91.7%)	Not reported
rLP2086 120 mcg	0 of 12 (0%)	11 of 12 (91.7%)	Not reported
rLP2086 200 mcg	0 of 12 (0%)	11 of 12 (91.7%)	Not reported
Tdap/Normal Saline (Control)	0 of 12 (0%)	11 of 12 (91.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2015.
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.
Derived from this study: PubMed 22832260Sheldon EA, Schwartz H, Jiang Q, Giardina PC, Perez JL. A phase 1, randomized, open-label, active-controlled trial to assess the safety of a meningococcal serogroup B bivalent rLP2086 vaccine in healthy adults. Hum Vaccin Immunother. 2012 Jul;8(7):888-95. doi: 10.4161/hv.19983. Epub 2012 Jul 1.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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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.

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 1 study of Meningitis, Meningococcal, 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 8 inclusion and 1 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 6 Aug 2015. 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 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?

Yes. Results are posted in the registry (first posted 25 Nov 2014). 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?

Percentage of Participants With at Least One Adverse Event (AE) (time frame: Baseline up to Month 7). The study lists 24 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 NCT00879814, 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 6 Aug 2015.