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

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General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

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.

Secondary indentifying numbers:

IF/COLERA/04

Issuing authority of the secondary identifying numbers:

Finlay Institute, Center for Research Developing and Productions of Vaccines

Source(s) of monetary or material support:

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

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Authorization date :

29/10/2014

Reference number:

05-11-14-BA

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Jorge

Midle name:

Ernesto

Last name:

Perez Lastre

Medical Specialty :

Specialist of first degree in Pediatrics

Affiliation:

Pedro Kouri Tropical Medicine Institute (IPK)

Postal address:

Autopista Novia del Mediodia Km 6½, La Lisa.

City:

Havana

País:

Cuba

Zip Code:

601

Telephone:

+53-72553226

+53-72553286

Email address:

jorgee@ipk.sld.cu

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Havana, "Humberto Pulido Humarán" Policlinic, from La Lisa municipality. Rafael Martinez Lopetegui, MD, First degree Specialist in General Integral Medicine

Havana, "26 de Julio" from Playa Polyclinic municipality. Martha Martinez Ulla, MD, First degree Specialist in General Integral Medicine

Havana, Victoria Cuba-Angola Polyclinic, from Rancho Boyeros municipality. Rosayma Rivero Mendez,Lic. Master in Medical Emergencies.

Research ethics committees:

“Pedro Kourí” Tropical Medicine Institute (centralized),Septembrer 9th, 2014

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

10/11/2014

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

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.

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

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

Key secondary outcomes:

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.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

5 years

Maximum age:

45 years

Inclusion criteria:

1.Volunteer of whatever sex, apparently healthy from 5 to 65 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.

Type of population:

Children and Adults

Type of participant:

Healthy volunteers

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Prevention

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Active

Study design:

Parallel

Phase:

2

Target sample size:

410

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Rodrigo

Middle Name:

Felipe

Last Name:

Valera Fernandez

Specialty:

Physichian, specialist of second degree in Microbiology

Affiliation:

Clinical Trials Department at the Finlay Institute Center for Research, Development and Production of Vaccines

Postal Address:

Ave 27, No.19805, La Lisa.

City:

Havana

País:

Cuba.

Zip Code:

11600

Telephone:

+53 (7) 271 7911; +53 (7) 208 0986

Email :

rvalera@finlay.edu.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Rodrigo

Middle Name:

Felipe

Last Name:

Valera Fernandez

Specialty:

Physichian, specialist of second degree in Microbiology

Affiliation:

Clinical Trials Department at the Finlay Institute Center for Research, Development and Production of Vaccines

Postal Address:

Ave 27, No.19805, La Lisa.

City:

Havana

País:

Cuba

Zip Code:

11600

Telephone:

+53 (7) 271 7911; +53 (7) 208 0986

Email :

rvalera@finlay.edu.cu

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000188

Date of Registration in Primary Registry:

06/11/2014

Record Verification Date:

2017/01/09

Next update date:

2018/01/09

Link to the spanish version:

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Ensayos Registrados

Proceso de Registro

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

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