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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: RPCEC
Last refreshed on: 4 March 2024
Main ID:  RPCEC00000228
Date of registration: 29/12/2016
Prospective Registration: Yes
Primary sponsor: Finlay Institute of Vaccines (IFV)
Public title: CV638 ability to protect against homologous Vibrio cholerae 3008 virulent strain
Scientific title: A randomized, double blind, phase III clinical trial, to evaluate the ability of the CV638 attenuated live vaccine candidate Vibrio cholerae 638 O1 El Tor Ogawa strain, to prevent clinical cholera disease caused by the challenge with the virulent strain Vibrio cholerae 3008 . - PVSVCHO
Date of first enrolment: 06/03/2017
Target sample size: 120
Recruitment status: Pending
URL:  https://rpcec.sld.cu/en/trials/RPCEC00000228-En
Study type:  Interventional
Study design:  Allocation: Randomized controlled trial. Masking: Double Blind. Control group: Placebo. Assignment: Parallel. Purpose: Prevention  
Phase:  3
Countries of recruitment
Cuba
Contacts
Name: Rafael    Fando Calzada
Address:  Ave 25 y 158 N0 15202. Cubanacan, Playa. PO 6414 12100 Havana Cuba
Telephone: rafael.fando@cnic.sld.cu
Email:
Affiliation:  Director of the Infectious Diseases Area and Director of Research, National Center for Scientific Research
Name: Rodrigo  Felipe   Valera Fernandez
Address:  Ave. 21 No. 19810 e/ 198 y 200, Atabey, Playa, 1600 Havana Cuba
Telephone:
Email: rvalera@finlay.edu.cu
Affiliation:  Clinical Investigational Design and Implementation Unit, Department of Clinical Research, Clinical Research and Impact Assessment (DIC & EI), Finlay Institute of Vaccines
Key inclusion & exclusion 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: 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.


Age minimum: 18 years
Age maximum: 45 years
Gender: Male/Female
Health Condition(s) or Problem(s) studied
cholera infection
Vibrio Infections
Gram-Negative Bacterial Infections
Waterborne Diseases
Environmental Illness
Bacterial Infections
Cholera
Intervention(s)
Administration, Oral
Cholera Vaccines
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 live V. cholerae O1 El Tor Ogawa strain 638. Second intervention: Fifteen (15) days after the first intervention, 20 subjects will receive 50 ml oral suspension containing one dose virulent strain 3008 V. cholerae O1 El Tor Ogawa, with a concentration of 1– 9,00E+06 CFU. Ninety (90) days after the first intervention other 20 subjects will receive 50 ml of an oral suspension containing one dose V. cholerae O1 El Tor Ogawa virulent strain 3008, with a concentration of 1 – 9,00E+06 CFU. The 20 subjects remaining will not receive the second intervention.
Group 2 (control): First intervention: All subjects will receive a 50 ml oral dose of Placebo. Second intervention: Fifteen (15) days after the first intervention 20 subjects will receive 50 ml of an oral suspension containing one dose virulent strain 3008 V. cholerae O1 El Tor Ogawa, with a concentration of 1– 9,00E+06 CFU. Ninety (90) days after the first intervention other 20 subjects will receive 50 ml of an oral suspension containing one dose V. cholerae O1 El Tor Ogawa virulent strain 3008, with a concentration of 1 – 9,00E+06 CFU. The 20 subjects remaining will not receive the second intervention.
Placebos
Vaccines, Attenuated
Vibrio cholerae O1
Primary Outcome(s)
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 Outcome(s)
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).
• Measurement time: before, and at 14 days after first intervention.
12. Seroconversion
• (number of volunteers increasing 4 times the values of serum vibriocidal antibody titres against V. cholerae O1 Ogawa)
• Measurement time: before, and at 14 days after first intervention.
Tolerability Endpoints
13. Severity of meteorism, headache, nausea, abdominal cramps, malaise, vomiting and fever.
• (Absence of severe symptoms).
• Measurement time: during the first 14 days after the first intervention.
14. Severity of unsolicited adverse events
• (Absence of severe symptoms).
• Measurement time: during the first 14 days after the first intervention.
Other endpoints
15. Title of serum vibriocidal antibodies against V. cholerae O1 Ogawa.
• (title value).
• Measurement time: before, and 21 days after the second intervention.
16. Title of Cholera IgG Antibody Measured by ELISA
• (title value by optical density (O.D.)).
• Measurement time: before and at 21 days after the second intervention.
Secondary ID(s)
If/colera/05
Source(s) of Monetary Support
Finlay Institute of Vaccines (IFV) National Fund for Science and Innovation (FONCI)
Secondary Sponsor(s)
Not applicable
Ethics review
Status:
Approval date:
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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