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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00879814

Enrollment

Registered

2009-04-13

Start date

2009-04-30

Completion date

2012-07-31

Last updated

2015-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Meningitis, Meningococcal

Brief summary

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

Interventions

BIOLOGICALrLP2086 vaccine or control

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Glucose).	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 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 (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 (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 (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

Secondary

Measure	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

Countries

United States

Participant flow

Recruitment details

Of the 189 participants who signed informed consent form, 134 were screen failures (mainly because of laboratory abnormalities) and 7 participants withdrew before the first vaccination. Total 48 participants were randomized into 4 groups.

Participants by arm

Arm	Count
rLP2086 60mcg Given on a 0, 2-, 6- month schedule	12
rLP2086 120 mcg Given on a 0, 2-, 6- month schedule	12
rLP2086 200 mcg Given on a 0, 2-, 6- month schedule	12
Tdap/Normal Saline (Control) Tdap was given at month 0 and Saline was given at Month 2 and 6	12
Total	48

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003
Overall Study	Adverse Event	0	1	0	0
Overall Study	Lost to Follow-up	1	0	0	2
Overall Study	Other	0	0	1	0
Overall Study	Participant Failed to Return	0	0	0	1
Overall Study	Physician Decision	0	0	1	0
Overall Study	Withdrawal by Subject	3	1	1	2

Baseline characteristics

Characteristic	Tdap/Normal Saline (Control)	rLP2086 60mcg	rLP2086 120 mcg	rLP2086 200 mcg	Total
Age, Continuous	27.2 years STANDARD_DEVIATION 5.77	29.3 years STANDARD_DEVIATION 7.4	31.0 years STANDARD_DEVIATION 7.65	27.8 years STANDARD_DEVIATION 6.05	28.8 years STANDARD_DEVIATION 6.72
Sex: Female, Male Female	7 Participants	6 Participants	6 Participants	10 Participants	29 Participants
Sex: Female, Male Male	5 Participants	6 Participants	6 Participants	2 Participants	19 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —
other Total, other adverse events	11 / 12	11 / 12	11 / 12	11 / 12
serious Total, serious adverse events	0 / 12	0 / 12	0 / 12	0 / 12