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

This study has been completed.
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by (Responsible Party):
Dr. Elizabeth Miller, Health Protection Agency, United Kingdom
ClinicalTrials.gov Identifier:
NCT00962624
First received: August 19, 2009
Last updated: March 27, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Meningococcal Meningitis, Serogroup A
Meningococcal Meningitis, Serogroup B
Meningococcal Meningitis, Serogroup C
Meningococcal Meningitis, Serogroup Y
Meningococcal Meningitis, Serogroup W
Drug: meningococcal B vaccine & meningococcal ACYW conjugate vaccine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Health Protection Agency, United Kingdom:

Primary Outcome Measures:
  • Proportion of subjects attaining putative protective antibody concentrations against meningococci in the serum bactericidal antibody assay [ Time Frame: one month following the last vaccination ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: July 2010
Study Completion Date: March 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: meningococcal B vaccine & meningococcal ACYW conjugate vaccine
    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.
    Other Name: Meningococcal ACYW vaccine- MenVeo
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00962624

Locations
United Kingdom
Manchester Medical Microbiology Partnership
Manchester, United Kingdom, M13 9WZ
Sponsors and Collaborators
Dr. Elizabeth Miller
Novartis Vaccines
Investigators
Principal Investigator: Ray Borrow, PhD Health Protection Agency, United Kingdom
  More Information

No publications provided

Responsible Party: Dr. Elizabeth Miller, Prinicipal Investigator, Health Protection Agency, United Kingdom
ClinicalTrials.gov Identifier: NCT00962624     History of Changes
Other Study ID Numbers: MenOccy, I72P1
Study First Received: August 19, 2009
Last Updated: March 27, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Health Protection Agency, United Kingdom:
Meningococcal
Vaccine
Meningitis

Additional relevant MeSH terms:
Meningitis
Meningitis, Meningococcal
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Meningitis, Bacterial
Central Nervous System Bacterial Infections
Bacterial Infections
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections

ClinicalTrials.gov processed this record on August 01, 2014