Clinical trial to evaluate the safety, reactogenicity and immunogenicity of the vax-TyVi vaccine in volunteers between 18 and 20 years of age.

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:

Double-blind, randomized, controlled study to evaluate the safety, reactogenicity and immunogenicity of a single dose of vax-TyVi vaccine, given intramuscularly, compared to one intramuscular dose of control vaccines Typhim-Vi and vax-TET in young male and female adults between 18 and 20 years of age.

Secondary indentifying numbers:

A1212-01-01

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 :

14/11/2001

Reference number:

04-034-01-B

Principal investigator

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

First name:

Telma

Last name:

Triana Rodriguez

Medical Specialty :

Specialist in Epidemiology

Affiliation:

Provincial Center of Hygiene and Epidemiology

Postal address:

Ave 31 no. 7617 entre 76 y 82. Marianao

City:

La Habana

Country:

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:

Not applicable

Research ethics committees:

Basic Science Institute "Victoria de Giron". Havana. 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:

09/01/2002

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

Salmonella Infections

Enterobacteriaceae Infections

Gram-Negative Bacterial Infections

Bacterial Infections

Gastrointestinal Diseases

Waterborne Diseases

Environmental Illness

Intervention(s):

The volunteers 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):

Objectives: To evaluate safety, reactogenicity and immunogenicity of the typhoid vaccine – vax-TyVi – in young male and female adults between 18 to 20 years of age, 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 33 randomly selected subjects. 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:

18 years

Maximum age:

20 years

Inclusion criteria:

1-A male or female between, and including, 18 and 20 years of age at the time of the vaccination. 2-Free from obvious health problems as established by medical history and clinical examination before entering into the study. 3-Written informed consent obtained from the parents or guardians.

Exclusion criteria:

1-Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, metabolic or renal functional abnormality, as determined by physical examination. 2-History of typhoid fever. 3- 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. 4-Use of other typhoid vaccine within 2 years preceding the study. 5-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. 6-Any hematological disease. 7-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. 8-Possibility of administration of any blood by-products during the study period. 9-Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. 10-A family history of congenital immunodeficiency. 11-History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. 12-History of any neurological disorders or seizures. 13-Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. 14-Axillary temperature of >= 37.5°C before vaccination. 15-History of chronic alcohol consumption. 16-Pregnancy (checked by rapid test). 17-breastfeeding mother. 18-Administration of radiotherapy or chemotherapy. 19-Neoplasic disease.

Type of population:

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:

1-2

Target sample size:

415 subjects were respectively vaccinated with vax-TyVi (146 subjects), Typhim-Vi (141) or vax-TET (128).

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:

Ave 27, No 19805, La Lisa. AP 16017

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

72731218

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

Middle Name:

Felipe

Last Name:

Ochoa Azze

Specialty:

II Degree Specialist in Immunology

Affiliation:

Finlay Institute

Postal Address:

Ave 27, No 19805, La Lisa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

72731218

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:

RPCEC00000056

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]