A phase I/II study to evaluate the Salmonella Typhi Vi polysaccharide vaccine – vax-TyVi

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:

A phase I/II, double-blind, randomized, controlled study to evaluate the safety, reactogenicity and immunogenicity of a single dose of the Cuban Salmonella Typhi Vi polysaccharide vaccine – vax-TyVi –, and the control vaccines – Typhim-Vi and vax-TET – , intramuscularly applied to children and teenagers.

Secondary indentifying numbers:

A1212-02-02

Issuing authority of the secondary identifying numbers:

Finlay Institute

Source(s) of monetary or material support:

Finlay Institute

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 the Quality of Drugs(CECMED)

Authorization date :

04/02/2002

Reference number:

05-003-02-B

Principal investigator

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

First name:

Katiuska

Last name:

Fernandez Jerez

Medical Specialty :

Specialist I Degree in Epidemiology

Affiliation:

Medical Position of the '' Ciudad Escolar Libertad '', Marianao. Provincial Center for Hygiene and Epidemiology

Postal address:

Ave 31 no. 7617 entre 76 y 82. Marianao

City:

La Habana

País:

Cuba

Zip Code:

11400

Email address:

email@not.entered [1]

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:

Four elementary schools and one High junior school in "Ciudad Escolar Libertad", Mariano, Havana. Dra. Katiuska Fernandez Jerez. Specialist in Epidemiology. Provincial Center of Hygiene and Epidemiology.

Research ethics committees:

Basic Science Institute "Victoria de Giron". Havana City. September 28, 2001.

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

12/02/2002

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:

typhoid fever

Health condition(s) code:

Typhoid Fever/prevention

Salmonella Infections

Enterobacteriaceae Infections

Gram-Negative Bacterial Infections

Bacterial Infections

Gastrointestinal Diseases

Waterborne Diseases

Environmental Illness

Intervention(s):

The children and teenagers were randomly distributed in three groups. They were immunized with the candidate vaccine - vax-TyVi -, or the control vaccines Typhim-Vi and vax-TET. A single dose of 0,5 mL by intramuscular route was used. The study vaccine – vax-TyVi – was developed by Finlay Institute and has 25 µg of purified Salmonella Typhi Vi polysaccharide, without adjuvant, and with a similar composition to other Vi polysaccharide vaccines.

Intervention code:

Typhoid-Paratyphoid Vaccines

Polysaccharides, Bacterial

Salmonella typhi

Injections, Intramuscular

Intervention keyword:

vax-TyVi, Typhim-Vi, vax-TET

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):

Objective: To evaluate safety, reactogenicity and immunogenicity of a single dose of the Cuban Salmonella Typhi Vi polysaccharide vaccine, intramuscularly applied to children and teenagers, and demonstrating that the immune response elicited by vax-TyVi is not lower than that induced by the control vaccine Typhim-Vi. Endpoints: Safety and reactogenicity: 1-Occurrence of any grade 3 expected symptoms within 7 days following vaccination. 2-Occurrence of expected local symptoms taking place within 7 days after vaccination. 3-Occurrence of expected general symptoms taking place within 7 days after vaccination. 4-Nature, incidence, intensity and relationship to vaccination of unexpected serious adverse events within 30 days after vaccination. 5-Nature, incidence, intensity and relationship to vaccination of unexpected non-serious adverse events within 30 days after vaccination. 6-Incidence of clinically relevant out-of-range tests for routine hematology (red blood cells, hemoglobin, hematocrit, leukocytes, differential blood count, platelets), routine microscopic urine examination (red blood cells, leukocytes, epithelial cells), serum creatinine and liver enzymes (aspartate aminotransferase – AST or SGOT, alanine aminotransferase – ALT or SGPT), immediately before and 7 days after vaccination. These laboratory tests were carried out in 45 randomly selected teenagers. Immunogenicity: 1-Anti-Vi antibody levels were detected by ELISA prior and 21 days after vaccination in all groups. Seroconversion was defined as 2-fold increase of anti-Vi antibody titers over pre-immunization levels.

Key secondary outcomes:

Not applicable

Selection criterias

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

Gender:

Male/Female

Minimum age:

9 years

Maximum age:

13 years

Inclusion criteria:

1-A male or female between, and including, 9 and 13 years of age at the time of the vaccination. 2-Written informed consent obtained from the parents or guardians. 3-Free from obvious health problems as established by medical history and clinical examination before entering into the study. 4-If the subject is a female of childbearing potential; she must be abstinent or have to use adequate contraceptive precautions during the study. Negative pregnancy tests have to be obtained before vaccination.

Exclusion criteria:

1-Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, metabolic or renal functional abnormality, as determined by physical examination. 2- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs prior to the vaccination. Inhaled and topical steroids are allowed. 3-Use of other typhoid vaccine within 2 years preceding the study. 4-Planned administration / administration of a vaccine not foreseen by the study protocol during the period starting one month before the application of the study vaccine and ending one month after that application. 5-Any hematological disease. 6-Administration of immunoglobulins and/or any blood products within the three months preceding the single dose of the candidate vaccine or planned administration during the study period. 7-Possibility of administration of any blood by-products during the study period. 8-Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. 9-A family history of congenital immunodeficiency. 10-History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. 11-History of any neurological disorders or seizures. 12-Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. 13-Use of any investigational or non-registered drug other than the study vaccine within 30 days preceding the single dose of study vaccine, or planned use during the study period. 14-Axillary temperature of >=37.5°C before vaccination. 15-Administration of immunosuppressants, other immune-modifying drugs or radiotherapy during the study period. Inhaled and topical steroids are allowed. 16-Pregnancy. 17-Difficulties to obtain a blood sample of a subject.

Type of population:

Children

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:

1-2

Target sample size:

347 subjects, which were respectively vaccinated with vax-TyVi (143 subjects), Typhim-Vi (139) or vax-TET (65).

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:

Morelia

Last Name:

Baro Suarez

Affiliation:

Finlay Institute.

Postal Address:

Casa F. Ave 27, No 19805, La Lisa.

City:

Havana

País:

Cuba

Zip Code:

AP 16017, Cod. 11600

Telephone:

2731218

Email :

mbaro@finlay.edu.cu [2]

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:

Rolando

Last Name:

Ochoa Azze

Specialty:

II Degree Specialist in Immunology

Affiliation:

Finlay Institute

Postal Address:

Casa F. Ave 27, No 19805, La Lisa

City:

Havana

País:

Cuba

Zip Code:

AP 16017, Cod. 11600

Telephone:

2731218

Email :

ochoa@finlay.edu.cu [3]

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:

RPCEC00000055

Date of Registration in Primary Registry:

2008-07-29

Record Verification Date:

2008-07-24 20:00

Link to the spanish version:

Click here [4]

A phase I/II study to evaluate the Salmonella Typhi Vi polysaccharide vaccine – vax-TyVi – in children and teenagers.