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

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

Official Title
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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

Conditions
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Meningitis, Meningococcal

Intervention / Treatment
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* Biological: rLP2086 vaccine or control
* Biological: rLP2086 vaccine or control
* Biological: rLP2086 vaccine or control
* Biological: rLP2086 vaccine or control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>rLP2086 vaccine 60 mcg | Biological: rLP2086 vaccine or control<br>* intra-muscular vaccine (solution), 0.5 mL, 3 doses, schedule: 0, 2, 6 months<br>|
| Experimental: 2<br>rLP2086 vaccine 120 mcg | Biological: rLP2086 vaccine or control<br>* intra-muscular vaccine (solution), 0.5 mL, 3 doses, schedule: 0, 2, 6 months<br>|
| Experimental: 3<br>rLP2086 vaccine 200 mcg | Biological: rLP2086 vaccine or control<br>* intra-muscular vaccine (solution), 0.5 mL, 3 doses, schedule: 0, 2, 6 months<br>|
| Active Comparator: 4<br>Tdap vaccine - normal saline - normal saline | Biological: rLP2086 vaccine or control<br>* intra-muscular vaccine (solution), 0.5 mL, 3 doses, schedule: 0, 2, 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Meningococcal Immunoglobulin G (IgG) Geometric Mean Titers (GMT) |  | Before Dose 1, 1 month after Dose 2, before Dose 3, 1 month after Dose 3 |