Immunogenicity and Safety of Group A, C, Y & W-135 Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine
|ClinicalTrials.gov Identifier: NCT01897402|
Recruitment Status : Completed
First Posted : July 12, 2013
Results First Posted : April 23, 2015
Last Update Posted : April 23, 2015
|Condition or disease||Intervention/treatment||Phase|
|Meningococcal Meningitis Meningococcal Infections||Biological: Test Vaccine Biological: US Licensed Vaccine||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||525 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||December 2014|
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
- Seroresponse (Percent Seroconversion). [ Time Frame: Week 4 after injection ]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 ]Local and systemic rates from Diary Cards filled by the participants.
- Non Solicited Adverse Events [ Time Frame: up to 6 months ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|