NCT00962624

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Prof. Elizabeth Miller · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-07-01
• Primary completion: 2011-03-01
• Completion: 2012-03-01
• First posted: 2009-08-20
• Last updated: 2018-09-19

Locations

1 site across 1 country: United Kingdom