Salmonella enterica serovar Typhi (S. Typhi) disease
Conditions
Interventions
Product Name: S. Typhi Vi-CRM Glycoconjugate vaccine
Product Code: Vi-CRM vaccine
Pharmaceutical Form: Solution for injection
Other descriptive name: Vi-CRM conjugate
Concentration unit: µg/ml microgr
Sponsors
Novartis Vaccines Institute for Global Health (NVGH)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females of age =18 to =40 years. 2. Individuals who, after the nature of the study have been explained to them, have given written consent according to local regulatory requirements. 3. Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator. 4. Individuals with negative screening tests for drug addition as follows: opiate, cocaine, amphetamine/metamphetamine and cannabinoides. 5. If women, use of birth control one month before study start, a negative pregnancy test and willingness to use birth control measures for the entire study duration. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study. 2. Individuals with any progressive or severe neurological disorder, seizure disorder or Guillain-Barré syndrome. 3. Individuals who are not able to understand and to follow all required study procedures for the whole period of the study. 4. Individuals with history of any illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study. 5. Individuals with known or suspected HIV infection or HIV related disease, with history of an autoimmune disorder or any other known or suspected impairment /alteration of the immune system, or under immunosuppressive therapy including use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids within the previous 30 days, or were in chemotherapy treatment within the past 6 months. 6. Individuals with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time. 7. Individuals with any serious chronic or progressive disease according to judgment of the investigator (e.g., neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease). 8. Individuals who have any malignancy or lymphoproliferative disorder. 9. Individuals with history of allergy to vaccine components. 10. Individuals participating in any clinical trial with another investigational product 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study. 11. Individuals who have previously received any vaccines against typhoid fever (either oral live attenuated or injectable vaccines) 12. Individuals who received any other vaccines within 4 weeks prior to enrolment in this study or who are planning to receive any vaccine within 4 weeks from the study vaccine 13. Individuals who have received blood, blood products and/or plasma derivatives including parenteral immunoglobulin preparations in the past 12 weeks. 14. Individuals who are part of study personnel or close family members to the personnel conducting this study. 15. Individuals with body temperature > 38.0 degrees Celsius within 3 days of intended study immunization. 16. BMI > 35 kg/m2. 17. Individuals with history of substance or alcohol abuse within the past 2 years. 18. Women who are pregnant or breast-feeding or of childbearing age who have not used any birth control measure one month prior to study start or do not plan to use acceptable birth control measures, for the duration of the study. 19. Females with history of stillbirth, neonatal loss, or previous infant with anomaly. 20. Individuals who have a previously ascertained or suspected disease caused by S. Typhi. 21. Individuals who have had household contact with/and or intimate exposure to an individual with laboratory confirmed S. Typhi. 22. Any condition which, in the opinion of the investigator may interfere with the evaluation of the study objectives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The goal is to evaluate the safety profile of three different dose levels of Vi-CRM197 in adults compared to that of the licensed Vi polysaccharide vaccine (Typherix, GSK), by measuring rates of post immunization reactions and adverse events. The goal is also to evaluate the immunogenicity profile of three different dose levels of Vi-CRM197 in adults compared to that of the licensed Vi polysaccharide vaccine (Typherix, GSK), by measuring enzyme-linked immunosorbent assay (ELISA), at 28 days post-immunization. ;Secondary Objective: Not applicable;Primary end point(s): Immunogenicity Endpoints The measures of immunogenicity, against the Vi antigen of S. Typhi, will include: - Geometric mean concentrations (GMCs), pre- and post-vaccination, as determined by ELISA, and applicable geometric mean ratios between post- and pre-vaccination samples. - Seroconversion rate: percentage of subjects achieving at least a four-fold rise in ELISA antibody concentration in the post-vaccination blood sample Safety Endpoints (criteria for assessing safety endpoints) The measures of safety will include: - Numbers and percentage of subjects with solicited local and systemic adverse reactions as well as numbers and percentage of subjects with reported unsolicited adverse events and serious adverse events. Solicited local reactions include erythema, induration and pain at injection site; solicited systemic reactions include headache, arthralgia, chills, fatigue, malaise, myalgia, and fever as measured by axillary temperature for Day 1 through 7 of the study. All local and systemic reactions will be collected for 7 days after immunization (i.e., days 1 to 7). All AEs will be collected throughout the study duration (28 days). | — |
Countries
Belgium
Outcome results
None listed