Phase II clinical trial, controlled, randomized, double-blind to assess the immunogenicity of live attenuated vaccine candidate against cholera CV638 .
- Conditions
- Cholera infection
- Registration Number
- RPCEC00000188
- Lead Sponsor
- Finlay Institute, Center for Research Developing and Productions of Vaccines
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 410
1.Volunteer of whatever sex, apparently healthy from 5 to 45 years old, whose health condition has been established by medical criteria by mean of anamnesis and physical examination before the beginning of the study.
2.Expressed willfulness by mean of written informed consent signed by the adult subjet (from 18 or more years old).
3.Expressed willfulness by mean of written informed consent signed by the adolescent or child subject´s father, mother or legal tutor from 5 to 17 years old.
4.Expressed willfulness by mean of the signed assent by the adolescent subject from 10 to 17 years old.
1.Volunteers with serum vibriocidal antibodies titer major or equal to 320, five days before the administration of CV638 or Shanchol® vaccine.
2. Seropositive volunteer to IgG cholera antitoxin by mean the ELISA test, five days before the administration of CV638 or Shanchol® vaccine.
3. Acute disease detected in the previous week to the administration of CV638 or Shanchol® vaccine.
4. Axillary temperature like or higher than 37.5 ° C immediately before the administration of CV638 or Shanchol® vaccine.
5. Personal history of chronic disease.
6. Personal history of immunosuppressive treatment (systemic steroids, cytostatics, etc.) or immunostimulants medicines (interferons, transfer factor, gamma globulins, levamisole, etc.) in the 30 days prior, excluding steroids given topicaly or by inhalation.
7. History of therapy with immunoglobulin or blood derived products, during the 6 months prior to administration of CV638 or Shanchol® vaccine.
8. History of antibiotic therapy, current or during the 10 days prior to the administration of CV638 or Shanchol® vaccine.
9. History of cholera infection in the last 3 years.
10. Previous history of immunization with cholera vaccine.
11. To be a food handler.
12. Childcare workers of children under 5 years old.
13. History of allergy reactions to any component of the investigational product or antacid and intolerance to milk or lactose.
14. History of allergic reactions to formaldehyde or thiomersal.
15. Positive pregnancy test in women, adolescents and post menstruant girls.
16. Pregnancy.
17. Breastfeeding.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Vibriocidal serum antibodies titles against Vibrio cholerae Ogawa serotype (title value). Measuring time: 14 days.
- Secondary Outcome Measures
Name Time Method