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

NCT00879814 | Completed Phase 1 Results

• 2 other identifiers: 6108A1-1004B1971004
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Meningitis, Meningococcal

Outcome Measures

Primary Outcomes (24)

• 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 Outcomes (1)

• Meningococcal Immunoglobulin G (IgG) Geometric Mean Titers (GMT)

  Before Dose 1, 1 month after Dose 2, before Dose 3, 1 month after Dose 3

Study Arms (4)

1

EXPERIMENTAL

rLP2086 vaccine 60 mcg

Biological: rLP2086 vaccine or control

2

EXPERIMENTAL

rLP2086 vaccine 120 mcg

Biological: rLP2086 vaccine or control

3

EXPERIMENTAL

rLP2086 vaccine 200 mcg

Biological: rLP2086 vaccine or control

4

ACTIVE COMPARATOR

Tdap vaccine - normal saline - normal saline

Biological: rLP2086 vaccine or control

Interventions

rLP2086 vaccine or control BIOLOGICAL

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

1

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Miami Research Associates, Inc.

South Miami, Florida, 33143, United States

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

• Sheldon EA, Schwartz H, Jiang Q, Giardina PC, Perez JL. A phase 1, randomized, open-label, active-controlled trial to assess the safety of a meningococcal serogroup B bivalent rLP2086 vaccine in healthy adults. Hum Vaccin Immunother. 2012 Jul;8(7):888-95. doi: 10.4161/hv.19983. Epub 2012 Jul 1.

  PMID: 22832260 DERIVED

Related Links

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

MeSH Terms

Conditions

Meningitis, Meningococcal

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

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2009
• First Posted: April 13, 2009
• Study Start: April 1, 2009
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: August 6, 2015
• Results First Posted: November 25, 2014

Record last verified: 2015-07

Locations

US (1)