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

Primary Purpose

Meningitis, Meningococcal

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

rLP2086 vaccine or control

About this trial

This is an interventional prevention trial for Meningitis, Meningococcal

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept 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

Sites / Locations

Miami Research Associates, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

rLP2086 vaccine 60 mcg

rLP2086 vaccine 120 mcg

rLP2086 vaccine 200 mcg

Tdap vaccine - normal saline - normal saline

Outcomes

Primary Outcome Measures

Percentage of Participants With at Least One Adverse Event (AE)

Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Alanine Aminotransferase [ALT])

Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Aspartate Aminotransferase [AST])

Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Total Protein)

Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Albumin)

Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Alkaline Phosphatase [ALP])

Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Total Bilirubin)

Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Creatine Phosphokinase [CPK])

Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Prothrombin Time [PT])

Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Partial Thromboplastin Time [PTT])

Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Fibrinogen)

Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Hemoglobin)

Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (White Blood Cell [WBC])

Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Lymphocytes)

Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Neutrophils)

Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Eosinophils)

Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Platelet Count)

Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Sodium).

Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Potassium).

Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Blood Urea Nitrogen [BUN]).

Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Serum Creatinine).

Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Red Blood Cells [RBC]).

Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Protein).

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00879814

First Posted

April 10, 2009

Last Updated

July 15, 2015

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00879814

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Completed

Study Start Date

April 2009 (undefined)

Primary Completion Date

July 2012 (Actual)

Study Completion Date

July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Meningitis, Meningococcal

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

rLP2086 vaccine 60 mcg

Arm Title

Arm Type

Experimental

Arm Description

rLP2086 vaccine 120 mcg

Arm Title

Arm Type

Experimental

Arm Description

rLP2086 vaccine 200 mcg

Arm Title

Arm Type

Active Comparator

Arm Description

Tdap vaccine - normal saline - normal saline

Intervention Type

Biological

Intervention Name(s)

rLP2086 vaccine or control

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

rLP2086 vaccine or control

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

rLP2086 vaccine or control

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

rLP2086 vaccine or control

Intervention Description

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

Primary Outcome Measure Information:

Title

Percentage of Participants With at Least One Adverse Event (AE)

Time Frame

Baseline up to Month 7

Title

Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Alanine Aminotransferase [ALT])

Time Frame

Baseline up to Month 7

Title

Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Aspartate Aminotransferase [AST])

Time Frame

Baseline up to Month 7

Title

Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Total Protein)

Time Frame

Baseline up to Month 7

Title

Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Albumin)

Time Frame

Baseline up to Month 7

Title

Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Alkaline Phosphatase [ALP])

Time Frame

Baseline up to Month 7

Title

Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Total Bilirubin)

Time Frame

Baseline up to Month 7

Title

Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Creatine Phosphokinase [CPK])

Time Frame

Baseline up to Month 7

Title

Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Prothrombin Time [PT])

Time Frame

Baseline up to Month 7

Title

Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Partial Thromboplastin Time [PTT])

Time Frame

Baseline up to Month 7

Title

Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Fibrinogen)

Time Frame

Baseline up to Month 7

Title

Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Hemoglobin)

Time Frame

Baseline up to Month 7

Title

Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (White Blood Cell [WBC])

Time Frame

Baseline up to Month 7

Title

Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Lymphocytes)

Time Frame

Baseline up to Month 7

Title

Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Neutrophils)

Time Frame

Baseline up to Month 7

Title

Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Eosinophils)

Time Frame

Baseline up to Month 7

Title

Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Platelet Count)

Time Frame

Baseline up to Month 7

Title

Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Sodium).

Time Frame

Baseline up to Month 7

Title

Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Potassium).

Time Frame

Baseline up to Month 7

Title

Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Blood Urea Nitrogen [BUN]).

Time Frame

Baseline up to Month 7

Title

Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Serum Creatinine).

Time Frame

Baseline up to Month 7

Title

Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Red Blood Cells [RBC]).

Time Frame

Baseline up to Month 7

Title

Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Protein).

Time Frame

Baseline up to Month 7

Title

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

Time Frame

Baseline up to Month 7

Secondary Outcome Measure Information:

Title

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

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Miami Research Associates, Inc.

City

South Miami

State/Province

Florida

ZIP/Postal Code

33143

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

35164991

Citation

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.

Results Reference

derived

PubMed Identifier

22832260

Citation

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.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=6108A1-1004&StudyName=Study%20Evaluating%20Safety%20And%20Tolerability%20Of%20Meningococcal%20B%20Rlp2086%20Vaccine%20In%20Healthy%20Adults

Description

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

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