Phase 1
Completed N=48
Study Evaluating Safety And Tolerability Of Meningococcal B Rlp2086 Vaccine In Healthy Adults
Meningitis, Meningococcal
Source: ClinicalTrials.gov NCT00879814 ↗
Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcomePrimary: Percentage of Participants With at Least One Adverse Event (AE) — 91.7; 91.7; 91.7; 91.7 percentage of participants
Summary
The purpose of this study is to evaluate the safety and tolerability of an investigational meningococcal B rLP2086 vaccine in healthy adults.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With at Least One Adverse Event (AE) |
91.7; 91.7; 91.7; 91.7 | — |
| PRIMARY Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Alanine Aminotransferase [ALT]) |
100.0; 91.7; 83.3; 91.7; 0; 8.3 | — |
| PRIMARY Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Aspartate Aminotransferase [AST]) |
100.0; 91.7; 100.0; 91.7; 0; 8.3 | — |
| PRIMARY Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Total Protein) |
100.0; 100.0; 100.0; 100.0; 0.0; 0.0 | — |
| PRIMARY Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Albumin) |
100.0; 100.0; 100.0; 100.0; 0.0; 0.0 | — |
| PRIMARY Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Alkaline Phosphatase [ALP]) |
100.0; 91.7; 100.0; 100.0; 0; 8.3 | — |
| PRIMARY Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Total Bilirubin) |
100.0; 91.7; 100.0; 91.7; 0; 8.3 | — |
| PRIMARY Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Creatine Phosphokinase [CPK]) |
100.0; 91.7; 91.7; 75.0; 0; 0 | — |
| PRIMARY Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Prothrombin Time [PT]) |
100.0; 100.0; 91.7; 100.0; 0; 0 | — |
| PRIMARY Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Partial Thromboplastin Time [PTT]) |
83.3; 50.0; 50.0; 75.0; 16.7; 50.0 | — |
| PRIMARY Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Fibrinogen) |
83.3; 75.0; 41.7; 83.3; 0; 16.7 | — |
| PRIMARY Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Hemoglobin) |
75.0; 83.3; 83.3; 75.0; 16.7; 8.3 | — |
| PRIMARY Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (White Blood Cell [WBC]) |
91.7; 83.3; 66.7; 83.3; 8.3; 16.7 | — |
| PRIMARY Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Lymphocytes) |
100.0; 100.0; 91.7; 100.0; 0; 0 | — |
| PRIMARY Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Neutrophils) |
100.0; 100.0; 100.0; 91.7; 0; 0 | — |
| PRIMARY Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Eosinophils) |
100.0; 91.7; 91.7; 83.3; 0; 8.3 | — |
| PRIMARY Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Platelet Count) |
100.0; 100.0; 100.0; 100.0; 0.0; 0.0 | — |
| PRIMARY Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Sodium). |
100.0; 91.7; 91.7; 83.3; 0; 8.3 | — |
| PRIMARY Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Potassium). |
91.7; 75.0; 100.0; 100.0; 0; 8.3 | — |
| PRIMARY Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Blood Urea Nitrogen [BUN]). |
100.0; 100.0; 100.0; 100.0; 0.0; 0.0 | — |
| PRIMARY Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Serum Creatinine). |
100.0; 100.0; 100.0; 100.0; 0.0; 0.0 | — |
| PRIMARY Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Red Blood Cells [RBC]). |
83.3; 100.0; 75.0; 75.0; 0; 0 | — |
| PRIMARY Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Protein). |
58.3; 50.0; 58.3; 75.0; 16.7; 16.7 | — |
| PRIMARY Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Glucose). |
100.0; 100.0; 100.0; 100.0; 0.0; 0.0 | — |
| SECONDARY Meningococcal Immunoglobulin G (IgG) Geometric Mean Titers (GMT) |
17.3; 16.8; 7.5; 7.9; 1522.7; 1933.5 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00879814). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.