Meningococcal disease
Conditions
Interventions
Study group (AW135 Vacccine Candidate): 1 dose de 0,5 mL by intramuscular route in the deltoid deep every 6 weeks. Total: 2 doses. Control group (VAMENGOC BC): 1 dose de 0,5 mL by intramuscular route
Sponsors
Finlay Institute, Center for Research, and Productions of Serum and Vaccines
Norwegian Institute of Public Health (NIPH), Department of Bacteriology and Immunology
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1.Woman or men from 18 to 50 years old with a body mass index (BMI) between 18 and 29,9. 2.Good physical and mental health state, established by mean of anamnesis and physical examination as a medical criteria, as well by mean of electrocardiogram and hematology, hemochemical and urine tests, within non clinically significant reference parameters, as well as negative results in the serology of VDRL, HIV and HBV surface Ag and HCV before the beginning of the study. 3.Willfulness expressed by mean of a written informed consent.
Exclusion criteria
Exclusion criteria: 1.Occurrence of acute illness (with or without fever) within 30 days prior to the moment the subject be included in the study. 2.Chronic diseases such cancers, diabetes, heart disease, liver disease, progressive neurological disease, autoimmune disease or blood dyscrasias, signs of heart or renal failure or severe malnutrition. 3.Any suspected or confirmed condition of immunodeficiency. 4.To have suffered meningococcal disease. 5.To have been immunized with meningococcal vaccine, 6 months prior to administration of the treatments included in the study. 6.History of immunoglobulin therapy during the 30 days prior to the administration of the treatments included in the clinical trial. 7.To be under immunosuppressive treatment (more than 14 days) or other medication which modify the immune status, excluding topical or inhaled steroids. 8.Administration of a vaccine not predicted in the protocol, 30 days before the beginning of the study. 9.Pregnancy or breastfeeding. 10.Alcoholism defined as set forth in the CENATOX algorithm 11.Allergy to Thiomersal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severe Adverse Event (name of event and causality relationship). Measuring time: during the 84 days of the study. Laboratory tests (hematology and blood chemistry clinical laboratory tests results with values out of the reference range). Measuring time: 7 days after the firts dose Expected adverse events of grade 3 (name, initial date, duration time). Measuring time: daily during the 7 days after every dose. Expected adverse events of other grade (name, initial date, duration time). Measuring time: daily during the 7 days after every dose. Unexpected adverse events (name, initial date, duration time, grade, causality relationship). Measuring time: during the 84 days of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Bactericidal Serum Antibodies against meningococcal strain of the A and W135 serogroup. Measuring time: before administration of every dose, 42 days and 30 days after the administration of every dose. Seroconversion (the increment of at least four fold N. meningitidis Bactericidal Antibodies titer in Serum of the A and W135 serogroups). Measuring time: days 42 and 30 after the administration of every dose. Antibodies concentration against the Outer Membrane Protein antigen. Measuring time: before administration of every dose, at the 42 days and 30 days after the administration of every dose. | — |
Countries
Cuba
Contacts
Public ContactSonia Perez Rodriguez
National Center of Toxicology (CENATOX) “Carlos J. Finlay“ Military Hospital, MINSAP, Cuba
Outcome results
None listed