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

NCT00780806 | Completed Phase 1 DMC

• 2 other identifiers: 6108A1-1003B1971003
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Meningitis, Meningococcal

Keywords

MnB; rLP2086; blood collection; vaccination

Outcome Measures

Primary Outcomes (1)

• Safety of 3 doses of MnB rLP2086 vaccine candidate assessed by frequency of solicited local and systemic reactions collected for 7 days after each study vaccination; evaluation of occurrence of AE and SAE during the duration of study

  Up to 2 years

Study Arms (1)

1

EXPERIMENTAL

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

Biological: meningococcal B rLP2086 vaccine candidate; Procedure: Blood draw

Interventions

meningococcal B rLP2086 vaccine candidate BIOLOGICAL

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

1

Blood draw PROCEDURE

Blood draw

1

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Study Sites (3)

Pfizer Investigational Site

Herston, QLD 4006, Australia

Location

Pfizer Investigational Site

North Adelaide, SA 5006, Australia

Location

Pfizer Investigational Site

Subiaco, WA 6008, Australia

Location

Related Publications (2)

• 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.

  PMID: 35164991 DERIVED

• Marshall HS, Richmond PC, Nissen MD, Wouters A, Baber J, Jiang Q, Anderson AS, Jones TR, Harris SL, Jansen KU, Perez JL. A phase 2 open-label safety and immunogenicity study of a meningococcal B bivalent rLP2086 vaccine in healthy adults. Vaccine. 2013 Mar 15;31(12):1569-75. doi: 10.1016/j.vaccine.2013.01.021. Epub 2013 Jan 24.

  PMID: 23352429 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Meningitis, Meningococcal

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Meningitis, Bacterial; Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Meningococcal Infections; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Meningitis; Neuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2008
• First Posted: October 28, 2008
• Study Start: October 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: August 23, 2011

Record last verified: 2011-08

Locations

AU (3)