Phase II clinical trial, controlled, randomized, double-blind to assess the immunogenicity of live attenuated vaccine candidate against cholera CV638 .

• Register: RPCEC
• Last refreshed on: 29 April 2024
• Main ID: RPCEC00000188
• Date of registration: 06/11/2014
• Prospective Registration: Yes
• Primary sponsor: Finlay Institute, Center for Research Developing and Productions of Vaccines
• Public title: Phase II clinical trial, controlled, randomized, double-blind to assess the immunogenicity of live attenuated vaccine candidate against cholera CV638 .
• Scientific title: Phase II clinical trial, controlled, randomized, double-blind to assess the immunogenicity of the live vaccine candidate against cholera of the attenuated 638 Vibrio cholerae O1 El Tor Ogawa (CV638), in Cuban volunteers from 5 to 65 years old.
• Date of first enrolment: 10/11/2014
• Target sample size: 410
• Recruitment status: Pending
• URL: https://rpcec.sld.cu/en/trials/RPCEC00000188-En
• Study type: Interventional
• Study design: Allocation: Randomized controlled trial. Masking: Double Blind. Control group: Active. Assignment: Parallel. Purpose: Prevention
• Phase: 2

Countries of recruitment

Cuba

Contacts

• Name: Rodrigo Felipe Valera Fernandez
• Affiliation: Clinical Trials Department at the Finlay Institute Center for Research, Development and Production of Vaccines

• Name: Rodrigo Felipe Valera Fernandez
• Affiliation: Clinical Trials Department at the Finlay Institute Center for Research, Development and Production of Vaccines

Key inclusion & exclusion criteria

Inclusion criteria: 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.
Exclusion criteria: 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.

Age minimum: 5 years
Age maximum: 45 years
Gender: Male/Female

Health Condition(s) or Problem(s) studied

Cholera infection

Intervention(s)

Group 1 (Study): Vaccine Candidate 638 (CV638). A dose of CV638 will administer orally the day 0 and a dose of placebo will administer the day 14 by oral route.
Group 2 (Control): Vaccine Shanchol®. 2 doses will administer orally, day 0 and day 14.

Primary Outcome(s)

Vibriocidal serum antibodies titles against Vibrio cholerae Ogawa serotype (title value). Measuring time: 14 days.

Secondary Outcome(s)

Safety during the first 28 days.
1. Occurrence of Serious Adverse Events (yes/no). Measuring time: 28 days after the first dose.
2. Description of Serious Adverse Events (Name of the Adverse Event). Measuring time: 28 days after the first dose.
3. Causality relationship (related, unrelated). Measuring time: 28 days after the first dose.
4. Result (recovered, recovered with sequelae, remains to finish the study, death, unknown). Measuring time: 28 days after the first dose.
Reactogenicity during the first 28 days.
1. Solicited Adverse events (fever, headache, malaise, abdominal pain, meteorims, nausea, vomiting, diarrhea or dehydration) (yes/no). Measuring time: 7 days after the first dose,3 three days after the second dose.
2. Other adverse events. (yes/no). Measuring time: 28 days after the first dose.
3. Description of the reported Adverse Event (Adverse Event name). Measuring time: 28 days after the first dose.
4. Causality relationship (related, unrelated). Measuring time: 28 days after the first dose.
5. Intensity (mild, moderate, severe). Measuring time: 28 days after the first dose.
6. Beginning of the Adverse Events (beginning day). Measuring time: 28 days after the first dose.
7. Duration (difference between Adverse Event´s beginning and ending dates). Measuring time: 28 days after the first dose.
Immunogenicity
1.Vibriocidal serum antibodies title against V. Cholera Ogawa serotype. (title´s value). Measuring time: at baseline, 14 and 28 days after the first dose.
Vibrio Cholera 638 strain fecal excretion during the first 14 days
1. Detection of Vibrio cholerae 638 strain in vaccinated subject feces (yes/no). Measuring time: days 3, 7, 9 and 14 after the first dose.
Transmissibility of Vibrio cholerae 638 during the first 14 days
1. Detection of Vibrio cholerae 638 strain in the subject cohabitant feces (yes / no). Measuring time: days 3, 7, 9 and 14 the first dose.
2. Subject cohabitant vibriocidal serum antibodies title (title´s value). Measurement time: Day 0, Day 28.

Secondary ID(s)

IF/COLERA/04

Source(s) of Monetary Support

Finlay Institute, Center for Research Developing and Productions of Vaccines National Center for Scientific Research (CNIC) Ministry of Public Health of Cuba (MINSAP)

Secondary Sponsor(s)

National Center for Scientific Research (CNIC)