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

Meningococcal Meningitis, Serogroup A Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00962624
• Other study ID #: MenOccy
• Secondary ID: I72P1
• Status: Completed
• Phase: Phase 2
• Start date: July 2010
• Est. completion date: March 2012

Study information

• Verified date: September 2018
• Source: Public Health England
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: March 2012
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Manchester Medical Microbiology Partnership	Manchester

Sponsors (2)

Lead Sponsor	Collaborator
Prof. Elizabeth Miller	Novartis Vaccines

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects attaining putative protective antibody concentrations against meningococci in the serum bactericidal antibody assay		one month following the last vaccination