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Study of Meningococcal B Vaccine and ACWY Conjugate Vaccine in Healthy Adults (MenOccy)

Primary Purpose

Meningococcal Meningitis, Serogroup A, Meningococcal Meningitis, Serogroup B, Meningococcal Meningitis, Serogroup C

Status

Completed

Phase

Phase 2

Locations

United Kingdom

Study Type

Interventional

Intervention

meningococcal B vaccine & meningococcal ACYW conjugate vaccine

About this trial

This is an interventional prevention trial for Meningococcal Meningitis, Serogroup A focused on measuring Meningococcal, Vaccine, Meningitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Aged 18-65 years of age
Who have given written informed consent after the nature of the study has been explained.
Who work within the Manchester Medical Microbiology Partnership and may be at potential occupational exposure to meningococci.

Exclusion Criteria:

The possibility of pregnancy
A serious chronic disease including progressive neurological disease or seizure disorder.
Have a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
Have a history of severe allergic reactions after previous vaccinations such as anaphylactic shock, asthma, urticaria, or other allergic reaction or hypersensitivity to any vaccine component.
Have received another investigational agent within 90 days or before completion of the safety follow-up period in another study, whichever is longer, prior to enrollment and unwilling to refuse participation in another investigational trial through the end of the study.

Sites / Locations

Manchester Medical Microbiology Partnership

Outcomes

Primary Outcome Measures

Proportion of subjects attaining putative protective antibody concentrations against meningococci in the serum bactericidal antibody assay

Secondary Outcome Measures

Full Information

NCT ID

NCT00962624

First Posted

August 19, 2009

Last Updated

September 17, 2018

Sponsor

Prof. Elizabeth Miller

Collaborators

Novartis Vaccines

1. Study Identification

Unique Protocol Identification Number

NCT00962624

Brief Title

Study of Meningococcal B Vaccine and ACWY Conjugate Vaccine in Healthy Adults

Acronym

MenOccy

Official Title

A Phase 2, Open-label Study of the Safety, Tolerability and Immunogenicity of a Meningococcal B Vaccine When Administered at a 0, 2, 6 Months and of a Single Dose of Meningococcal ACWY Conjugate Vaccine in Healthy Adults Aged 18-65 Years

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Completed

Study Start Date

July 2010 (undefined)

Primary Completion Date

March 2011 (Actual)

Study Completion Date

March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Prof. Elizabeth Miller

Collaborators

Novartis Vaccines

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The study involves the measurement of immune response to vaccination with three doses of a meningococcal B vaccine and a single dose of a meningococcal ACYW conjugate vaccine in healthy adults (Laboratory workers). The study will be completed at the Manchester Medical Microbiology Partnership in the UK and will enrol staff who may be at potential occupational exposure to meningococci. Blood samples will be taken before and after each vaccination and used to determine if the vaccines induce protective responses.

Detailed Description

Laboratory staff at the Manchester Medical Microbiology Partnership may be at potential occupational exposure to meningococci. No licensed vaccine is available against serogroup B meningococci and the available plain polysaccharide serogroup ACYW vaccine is poorly immunogenic. Novartis Vaccines have developed an investigational serogroup B vaccine and a conjugated ACYW vaccine. This study will investigate these vaccines ability to induce a protective response in laboratory staff from the Manchester Medical Microbiology Partnership. Three doses of the meningococcal B vaccine will be administered at 0, 2 and 6 months and a single dose will be administered at 0 months. Blood samples will be taken before and after each vaccination and functional antibodies determined.

6. Conditions and Keywords

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

Meningococcal Meningitis, Serogroup A, Meningococcal Meningitis, Serogroup B, Meningococcal Meningitis, Serogroup C, Meningococcal Meningitis, Serogroup Y, Meningococcal Meningitis, Serogroup W

Keywords

Meningococcal, Vaccine, Meningitis

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

meningococcal B vaccine & meningococcal ACYW conjugate vaccine

Other Intervention Name(s)

Meningococcal ACYW vaccine- MenVeo

Intervention Description

Meningococcal B vaccine will be administered at 0, 2 and 6 months and a single dose of meningococcal ACYW vaccine will be administered at 0 months, concomitantly with the first dose of the meningococcal B vaccine.

Primary Outcome Measure Information:

Title

Proportion of subjects attaining putative protective antibody concentrations against meningococci in the serum bactericidal antibody assay

Time Frame

one month following the last vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Aged 18-65 years of age Who have given written informed consent after the nature of the study has been explained. Who work within the Manchester Medical Microbiology Partnership and may be at potential occupational exposure to meningococci. Exclusion Criteria: The possibility of pregnancy A serious chronic disease including progressive neurological disease or seizure disorder. Have a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time. Have a history of severe allergic reactions after previous vaccinations such as anaphylactic shock, asthma, urticaria, or other allergic reaction or hypersensitivity to any vaccine component. Have received another investigational agent within 90 days or before completion of the safety follow-up period in another study, whichever is longer, prior to enrollment and unwilling to refuse participation in another investigational trial through the end of the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ray Borrow, PhD

Organizational Affiliation

Public Health England

Official's Role

Principal Investigator

Facility Information:

Facility Name

Manchester Medical Microbiology Partnership

City

Manchester

ZIP/Postal Code

M13 9WZ

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

26025807

Citation

Findlow J, Bai X, Findlow H, Newton E, Kaczmarski E, Miller E, Borrow R. Safety and immunogenicity of a four-component meningococcal group B vaccine (4CMenB) and a quadrivalent meningococcal group ACWY conjugate vaccine administered concomitantly in healthy laboratory workers. Vaccine. 2015 Jun 26;33(29):3322-30. doi: 10.1016/j.vaccine.2015.05.027. Epub 2015 May 27.

Results Reference

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Study of Meningococcal B Vaccine and ACWY Conjugate Vaccine in Healthy Adults

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