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

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000056
• Date of registration: 29/07/2008
• Primary sponsor: Finlay Institute
• Public title: Clinical trial to evaluate the safety, reactogenicity and immunogenicity of the vax-TyVi vaccine in volunteers between 18 and 20 years of age.
• 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.
• Date of first enrolment: 09/01/2002
• Target sample size: 415 subjects were respectively vaccinated with vax-TyVi (146 subjects), Typhim-Vi (141) or vax-TET (128).
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000056-En
• Study type: Interventional
• Study design: Randomization: Randomized Controlled Trial Blinding: Double Blind Placebo: Active Assignment: Parallel Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: Dra Morelia Baro Suarez
• Affiliation: Finlay Institute

• Name: Dr Rolando Ochoa Azze
• Affiliation: Finlay Institute

Key inclusion & exclusion criteria

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.

Age minimum: 18 years
Age maximum: 20 years
Gender: Both

Health Condition(s) or Problem(s) studied

typhoid fever

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.

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.

Secondary ID(s)

A1212-01-01

Source(s) of Monetary Support

Finlay Institute