Immunogenicity and Safety of Group A, C, Y & W-135 Meningococcal Polysaccharide Diphtheria Toxoid Conjugate 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.
Biological: Test Vaccine
Biological: US Licensed Vaccine
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|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|
- Seroresponse (Percent Seroconversion). [ Time Frame: Week 4 after injection ] [ Designated as safety issue: No ]Rise in antibody titers in serum at 4 weeks after vaccination, compared to baseline titer for meningococcal serogroups A, C, Y, and W-135. Serum Bactericidal Assay with human complement: Antibody titer ≥1:8 for subjects with titer <1:8 at baseline or a 4-fold rise in antibody levels.
- Solicited Adverse Events From Diary Cards [ Time Frame: Day 0 to Day 7 after vaccination ] [ Designated as safety issue: Yes ]Local and systemic rates from Diary Cards filled by the participants.
- Non Solicited Adverse Events [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]Non solicited local and systemic adverse Event (AE) rates throughout the course of the study, based on laboratory test results, vital signs, examination and questioning the subjects.
|Study Start Date:||July 2013|
|Study Completion Date:||December 2014|
|Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Experimental: Test Vaccine
NmVac4-A/C/Y/W-135-DT™ conjugate vaccine
Biological: Test Vaccine
NmVac4-A/C/Y/W-135-DT™ conjugate is a vaccine in liquid form composed of purified polysaccharides (PS) conjugated to diphtheria toxoid. Single intramuscular 0.5 mL dose contains 4 µg each of Serogroup A, C, W-135, and Y PS conjugated to approximately 26 µg total diphtheria toxoid.
Active Comparator: US Licensed Vaccine
Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Biological: US Licensed Vaccine
Meningococcal (Groups A,C,Y,W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine 0.5 mL dose, intramuscular. Single dose contains 4 µg each Serogroup A, C, W-135 and Y conjugated to approximately 48 µg total diphtheria toxoid.
Other Name: meningococcal meningitis conjugate vaccine, quadrivalent
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01897402
|United States, Maryland|
|Mid Atlantic Urology Associates LLC|
|Greenbelt, Maryland, United States, 20770|
|Chesapeake Research Group|
|Pasadena, Maryland, United States, 21122|
|Towson, Maryland, United States, 21204|
|Principal Investigator:||Alberto Yataco, MD||IRC Clinics,|
|Principal Investigator:||Jeffrey E Atkinson, MD||Chesapeake Research Group|
|Principal Investigator:||Myron I Murdock, MD||Mid Atlantic Urology Associates LLC|