Cholera infection
Conditions
Interventions
Study Group: Name of the intervention: Vaccinal candidate 638, Dose to be used: single dose (5,00E+08-5,00E+09 UFC), Administration route: oral.
Control Group: Name of the intervention: Placebo, Dose
Sponsors
Center for Research and Production of Sera and Vaccines (Finlay Institute)
National Center for Scientific Research (CNIC)
Eligibility
Sex/Gender
All
Age
5 Years to 17 Years
Inclusion criteria
Inclusion criteria: 1. Female and male adolescents and children aged from 5 to 17 years old, located between the 10th and 90th percentile, according to the Cuban population nutritional evaluation tables. 2. Good physical and mental health criteria established by anamnesia, physical examination, and results of the hematology, hemochemistry and urine laboratory tests within reference parameters, before the beginning of the study. 3. Expressed willfulness by means of a written Informed Consent, signed either by the father, the mother or the legal tutor of the girls and boys, and by the approval of the children of 10 or more years old..
Exclusion criteria
Exclusion criteria: The participant should not be included if complies with at least one of the following criteria: 1. Transmissible or non-transmissible chronic disease referenced or detected during a clinical examination. 2. Acute illness detected in the previous week when the investigational product be fed, with or without fever. 3. Anemia with hemoglobin levels below 10 g / dl, according to the WHO criteria. 4. Axiliary temperature = 37.5°C immediately previous to the Investigational products be fed. 5. Congenital or acquired immunodeficiency. 6. To be under immunosuppressive therapy (more than 14 days before administration of the Investigational Products) or other medication that modifies the immune status, excluding topical or inhaled steroids. 7. History of therapy with immunoglobulin or blood products within 6 months prior to the administration of the vaccine candidate or placebo. 8. History of antibiotic therapy during the 28 days prior to the administration of the Investigational Products or benzathine penicillin therapy. 9. Allergy to medications under study. 10. Change in the normal stool pattern of the volunteers in the month previous to the study. 11. History of acute diarrhea event 30 days before the clinical trial starts or history of chronic diarrhea events. 12. At least one episode of abdominal pain for more than 2 weeks in the last 30 days and (or) anorexia, nausea, malaise or vomiting in the last 24 hours. 13. Antecedent of cholera disease in the last three years. 14. Previous history of immunization with vaccines against cholera. 15. V. cholerae O1 Positive stool culture. 16. Volunteers with vibriocidal antibody titer more than 20, seven days before the investigational products feeding. 17. Volunteers with IgG antibody titers by ELISA cholera antitoxin, seven days previous to the investigational products feeding. 18. History of allergic reactions to any component of the vaccine candidate, placebo or antacid as well as milk intolerance. 19. Positive pregnancy test in menstruant girls .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety 1.Serious adverse event (description of the event and relationship causality). Measurement time : during the 14 days after of the Investigational Products feeding. 2.Laboratory tests (out of range values of the results of the clinical laboratory tests of hematology and hemochemistry). Measurement time: 5 days after of the Investigational Products feeding. Reactogenicity 1.Degree 3 expected adverse events (frequency, onset and duration of the event). Measurement time: during 5 days after of the Investigational Products feeding. 2.Expected adverse event of any other intensity (frequency, onset and duration ). Measurement time: during 5 days after of the Investigational Products feeding. 3.Unexpected adverse event (frequency, onset, duration, intensity and relationship causality with the administration of the IP). Measurement time: during the 14 days of the Investigational Products feeding. Inmunogenicity 1.Vibriocidal antibody titers in serum against serotype Ogawa of V. cholerae. Measurement time: befote the administration of the IP, 5 and 14 days after of the Investigational Products feeding. 2.Seroconversion (increase of at least 4 times the titer of vibriocidal antibodies of V. cholerae against Ogawa serotype). Measurement time: during 5 and 14 days of the Investigational Products feeding. | — |
Secondary
| Measure | Time frame |
|---|---|
| Acceptability of IP 1.Difficulty when taking of the Investigational Products, related to the organoleptic characteristics of the product. Measurement time: immediately after of the Investigational Products feeding. 2.Volume of the Investigational Products taken by volunteers. Measurement time: immediately after being fed. Reactogenicity and volume (greater than or equal to 50% or less than 50%) of taken IP Adverse events (frequency , onser and duration of the event). Measurement time: during the 5 days after of the Investigational Products feeding. Inmunogenicity according to volume (greater than or equal to 50% or less than 50%) of taken IP 1.Vibriocidal antibody titers inserum against serotype Ogawa from V. cholerae. Measurement time: before the administration of IP, 5 and 14 days of the Investigational Products feeding. 2.Seroconversion (increase of at least 4 times the vibriocidal antibody titers of V. cholerae against serotype Ogawa). Measurement time: 5 and 14 days of the Investigational Products feeding: Excretion of V. cholerae strains 1.Excretion of strains of V. cholerae 638 in heces samples of volunteers in both study groups, (by isolation, identification or CFU counting). Measurement time: Between the 3rd and 5th day of the Investigational Products feeding (before the administration of antibiotics). 2.Concentration in CFU of strain 638 quantified in volunteers' feces. Measurement time: Between the 3rd and 5th day of the Investigational Products feeding (before the administration of antibiotics). 3.Excretion of other strains of V. cholerae O1 in simples of volunteers' feces of both study groups (by isolation, identification or CFU counting). Measurement time: Between the 3rd and 5th day of the Investigational Products feeding (before the administration of antibiotics). 4.Concentration of strain 638 excreted by volunteers, according to the volume of IP taken in both groups. Measurement time: Between the 3rd and 5th day of the Investiga | — |
Countries
Cuba
Contacts
Public ContactHilda Garcia Sanchez
Clinical Trial Department, Commercial Vice-presidency. Finlay Institute
Outcome results
None listed