Meningococcal Meningitis Clinical Trial
Official title:
A Phase 2 Double Blind Study to Evaluate Safety and Immunogenicity of Meningococcal Meningitis Serogroups A, C, Y & W-135 Polysaccharide Diphtheria Toxoid Conjugate Vaccine (NmVac4-A/C/Y/W-135-DT™) Compared With a Licensed Vaccine
The purpose of this study is to evaluate the production of antibodies to a new conjugate vaccine, NmVac4-A/C/Y/W-135-DT, as a measure of vaccine effectiveness, compared to the production of antibodies to a similar, licensed meningococcal (Groups A, C, Y, W-135) polysaccharide diphtheria toxoid (DT) conjugate vaccine. The investigators will also evaluate the safety of NmVac4-A/C/Y/W-135-DT™ conjugate vaccine compared to the licensed vaccine. The hypothesis is that the test vaccine is comparable to the licensed active control vaccine.
Meningococcal disease is a potentially life-threatening bacterial infection. The disease
most commonly is expressed as either meningococcal meningitis, an inflammation of the
membranes surrounding the brain and spinal cord, or meningococcemia, the presence of
bacteria in the blood. The most common symptoms include high fever, headache, neck
stiffness, confusion, nausea, vomiting, lethargy, and rash. If not treated the disease can
progress rapidly and can lead to shock and death, often within hours of the onset of
symptoms. The disease is fatal at a rate of 10%. Of patients who recover, 10% have permanent
hearing loss or other serious sequelae.
Neisseria meningitidis capsular polysaccharides are poor immunogens. However, conjugation of
bacterial polysaccharides to immunogenic carrier proteins generally results in conjugates
that induce strong anti-polysaccharide T-helper cell dependent immune responses, creating a
longer-lasting immune response and thus protection against meningococcal infection.
The sponsor's small size Phase 1 clinical trial comprised 60 subjects. Therefore, additional
data is needed to confirm the previous data with a statistically powered Phase 2 clinical
trial. The present study aims to evaluate subject responses to single doses, administered in
adult subjects, to determine further safety and immunogenicity of the vaccine. This study
compares safety and antibody production induced by one intramuscular injection of either
NmVac4-A/C/Y/W-135-DT or a licensed meningococcal (Groups A, C, Y, W-135) polysaccharide
diphtheria toxoid conjugate vaccine. The primary immunogenicity endpoint will be
seroresponse, based on antibody titer ≥1:8 for subjects with titer <1:8 at baseline or a
4-fold rise in antibody levels, 4 weeks after a single injection . The number and proportion
of subjects achieving seroresponse will be tabulated by serogroup for each vaccine group. A
non-inferiority test will be used to determine if the immune response elicited by NmVac4
A/C/Y/W-135-DT™ is not less than a specified difference in percent seroconversion from the
licensed control vaccine. Participants will attend a screening visit up to 6 weeks prior to
vaccination (day 0), then will attend study visits for 4 weeks. There will be a study phone
call at days 2-3, then a post-study call to subjects to assess safety at 26 weeks.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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