Safety and Immunogenicity of Three Formulations of Vi-CRM197 Vaccine Against S. Typhi in Adults (18-40 Years Old)
Condition: Typhoid Fever
MeSH terms: Typhoid Fever
Intervention: NVGH Vi-CRM197 12.5 mcg; NVGH Vi-CRM197 5.0 mcg; NVGH Vi-CRM197 1.25 mcg; Vi-polysaccharide vaccine
Intervention description: 1 dose of 0.5 mL; 1 dose of 0.5 mL; 1 dose of 0.5 mL; 1 dose of 0.5 mL containing 25 mcg of Vi polysaccharide
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 88.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Typhoid fever; Glycoconjugate vaccine; Vi polysaccharide; Immunogenicity

Summary:

      This trial is aimed to evaluate the safety and immunogenicity profiles of three formulations
      of Vi-CRM197 conjugate vaccine against S. Typhi in healthy human adults in comparison with
      the currently licensed Vi polysaccharide vaccine
    

Eligibility 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 urine screening tests for drug addition (Opiate, Cocaine,
             Amph/Metamphetamine, 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.

        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.