Safety And Blood Collection Study Of Meningococcal B Rlp2086 Vaccine In Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the safety of an investigational meningococcal B rLP2086 vaccine in adults and to obtain blood samples from immunized subjects for use in assay development.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study Evaluating the Safety, Immunogenicity and Tolerability of Meningococcal Group B Vaccine in Healthy Adults

NCT00297687

Meningitis, Meningococcal

COMPLETED PHASE1

Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Healthy Toddlers

NCT00387569

Healthy

COMPLETED PHASE1

Safety and Blood Donations in Adults Vaccinated With rMenB+OMV NZ.

NCT02305446

Meningitis, Meningococcal, Serogroup B

COMPLETED PHASE3

Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Adolescents

NCT00387725

Healthy

COMPLETED PHASE2

A Study Evaluating Safety And Immunogenicity Of Meningococcal B Rlp2086 Vaccine In Adolescents

NCT00808028

Meningitis, Meningococcal

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Meningitis, Meningococcal

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Immunization with one dose of MnB rLP2086 vaccine at 0, 1 and 6 months

Group Type EXPERIMENTAL

meningococcal B rLP2086 vaccine candidate

Intervention Type BIOLOGICAL

vaccine, 0.5 mL, 3 doses, 0 - 2 - 6 to 9 months

Blood draw

Intervention Type PROCEDURE

Blood draw

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

meningococcal B rLP2086 vaccine candidate

vaccine, 0.5 mL, 3 doses, 0 - 2 - 6 to 9 months

Intervention Type BIOLOGICAL

Blood draw

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy male or female subject between the ages of \>=18 and \<=40 years
* Negative urine pregnancy test for all female subjects of childbearing potential prior to test article administration and at the completion of the study.
* All female or male subjects who are biologically capable of having children must agree to abstinence or commit to the use of a reliable method of birth control during for the duration of the study and for 30 days after early discontinuation. 4. Hemoglobin levels \>=12.0 and \<=16.5 g/dL for female subjects and \>=13.0 and \<=18.5 g/dL for male subjects.
* Blood pressure: Systolic blood pressure \>90 and \<160 mm Hg; Diastolic blood pressure \>60 and \<95 mm Hg.
* Body weight \>=45 and \<=120 kg.
* Able to be contacted by telephone during the study period.

Exclusion Criteria

* Pregnancy or breastfeeding women
* Prior vaccination with a serogroup B meningococcal vaccine.
* A previous anaphylactic or severe vaccine-associated adverse reaction.
* A known hypersensitivity to any study vaccine components.
* A known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids (excluding topical, inhalation and intra-articular corticosteroids).
* Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
* Receipt of any blood products, including gamma globulin, in the period from 6 months before study vaccination through the study conclusion.
* Receipt of an inactivated vaccine within 14 days before study vaccinations and live attenuated vaccine within 28 days before study vaccination. This will apply throughout the study until the last vaccination.
* Any clinically significant chronic disease that, in the investigator's judgment may be worsened by blood draw.
* Received any investigational drug, vaccine or device within the 30-day period before study visit 1 and during the conduct of the study.
* History of culture-proven invasive disease caused by N meningitidis or N gonorrhoea.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes