cholera infection
Conditions
Interventions
Each group will compound by 60 subjects
Group 1 (experimental): First intervention: All subjects will receive a 50 ml oral dose of CV638 with a concentration of 5,00E+08-5,00E+09 CFU of the attenuated
Administration, Oral
Placebos
Sponsors
Finlay Institute of Vaccines (IFV)
Not applicable
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Woman or man from 18 to 45 years of age. 2. Voluntariness expressed through written informed consent signed by the volunteer. 3. Good physical and mental state established by medical criteria by means of anamnesis and physical examination, as well as by electrocardiogram and the following complementary ones: complete blood count with erythrocyte sedimentation, hemoglobin: glycemia, creatinine, urea, uric acid, TGO, TGP, GGT, Alkaline phosphatase, and urine (cituria), within the reference parameters which were not clinically significant, before starting the study. 4. Women of childbearing age who meet the following criteria: A.Negative pregnancy rapid test in the previous checkup, before vaccination and before the challenge, B. Agree to practice sexual abstinence or use an approved effective method of birth control within 2 months after vaccination, C. Agree to continue these precautions during the study and up to 30 days after the challenge. 5. Man of childbearing age who agrees not to conceive a child within 30 days of vaccination. 6. Subject that agrees not to participate in another clinical trial during the period.
Exclusion criteria
Exclusion criteria: 1. Volunteers with VC titers greater than or equal to 320, five days before administration of CV638 or Placebo. 2. Volunteers seropositive to cholera antitoxin IgG by ELISA 10 days before CV638 or Placebo administration. 3. Acute disease detected in the week prior to the administration of CV638, Placebo. 4. Axillary temperature = 37.5 ° C immediately prior to administration of CV638 or Placebo. 5. Personal history of chronic illness, except compensated asthma and hypertension. 6. History of immunosuppressive therapy (systemic steroids, cytostatics, etc.) or immunostimulants (interferons, transfer factor, gammaglobulins, levamisole, etc.) in the previous 30 days, excluding topical steroids or by inhalation. 7. History of therapy with immunoglobulins or blood products during the 6 months prior to administration of CV638 or Placebo. 8. History of antibiotic therapy, current or during the 10 days prior to administration of CV638, or Placebo. 9. History of cholera in the last 3 years. 10. History of immunization with cholera vaccines prior to the first intervention. 11. History of allergic reactions to any of the components of research or antacids, as well as to milk or lactose intolerance. 12. History of allergic reactions to doxycycline, azithromycin and ciprofoxacin. 13. History of Guillain-Barre syndrome. 14. Gestation. 15. Breastfeeding. 16. Clinically abnormal electrocardiogram at the previous check-up, defined as pathological Q waves or significant changes in the ST-T waves; Criteria of left ventricular hypertrophy; And any non-sinus rhythm, excluding isolated contractions. 17. Significant clinical abnormality detected on physical examination, including but not limited to pathological murmur, lymphadenopathy, hepatosplenomegaly, or abdominal scar of doubtful origin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of clinical cholera disease cases with positive culture of V. cholerae O1 (celA negative). (mild, moderate, severe): Measurement time: Daily up to 10 days after the second intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy endpoints 1. Number of cases with clinical cholera disease with positive culture of V. cholerae O1 (celA negative). • (moderate, severe): • Measurement time: Daily up to 10 days after the second intervention. 2. Number of cases with subclinical cholera diseases per group • (positive culture of V. cholerae O1 (negative celA)). • Measurement time: Daily up to 10 days after the second intervention. 3. Number of subjects not formed by volunteer and group • (amount of bowel movements (grades 3-5) in 48 hours) • Measurement time: Daily up to 10 days after the second intervention. 4. Total weight of unformed stools (grades 3-5) • (value of weight converted to volume, 1 g = 1 mL) • Measurement time: Daily up to 10 days after the second intervention. 5. Number of volunteers with fecal excretion of the virulent strain of V. cholerae O1 (binary variable: +/-) Measurement time: Daily up to 10 days after the second intervention. 6. Concentration of V. cholerae O1 (negative celA) in feces per day, volunteer and group • (value of V. cholerae concentration in CFU) • Measuring time: for 10 days after the second intervention. Safety Endpoints 7. Frequency of meteorism, headache, nausea, abdominal cramps, malaise, vomiting and fever • Number of volunteers with symptoms in 24 hours) • Measurement time: for 14 days after the first intervention. 8. Frequency of unsolicited adverse events • (Number of volunteers with symptoms in 24 hours) • Measurement time: for 14 days after the first intervention. 9. Intense meteors, headache, nausea, abdominal cramps, malaise, vomiting and fever • (mild, moderate, severe) • Measurement time: for 14 days after the first intervention 10. Intensity of unsolicited adverse events • (mild, moderate, severe) • Measurement time: for 14 days after the first intervention. Immunogenicity endpoints 11. Geometric mean of the titers of vibriocidal antibodies against V. cholerae O1 Ogawa • (title value). • Measuremen | — |
Countries
Cuba
Contacts
Public ContactRodrigo Valera Fernandez
Clinical Investigational Design and Implementation Unit, Department of Clinical Research, Clinical Research and Impact Assessment (DIC & EI), Finlay Institute of Vaccines
Outcome results
None listed