Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adult (18-40 Years Old)

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Brief Title

Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adult (18-40 Years Old)

Official Title

A Phase I, Randomized, Single-Blind, Controlled, Single Center Study to Evaluate the Safety and Immunogenicity of the NVGH Glycoconjugate Vaccine Against S. Typhi in Adult Subjects 18 to 40 Years of Age.

Brief Summary

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

Study Phase

Phase 1

Study Type


Primary Outcome

Number of Subjects Reporting Any Post Immunization Reactions

Secondary Outcome

 Anti-Vi ELISA Geometric Mean Concentration (GMC)


Typhoid Fever



Study Arms / Comparison Groups

 NVGH Vi-CRM197 conjugate vaccine


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

May 2010

Completion Date

November 2010

Primary Completion Date

June 2010

Eligibility Criteria

        Inclusion Criteria:

          1. Males and females of age ≥18 to ≤40 years.

          2. Individuals who, after the nature of the study has 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, hematological / hematochemical blood tests and urinalysis and clinical
             judgment of the investigator.

          4. If women, 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.

          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.

         12. Individuals who received any other vaccines within 4 weeks prior to enrollment in this
             study or who are planning to receive any vaccine within 4 weeks from the study

         13. Individuals who have received blood, blood products and/or plasma derivatives
             including parenteral immunoglobulin preparations in the past 12 weeks.

         14. Individuals with body temperature > 38.0 degrees Celsius within 3 days of intended
             study immunization.

         15. BMI > 35 kg/m2.

         16. Individuals with history of substance or alcohol abuse within the past 2 years.

         17. Women who are pregnant or breast-feeding or of childbearing age who have not used or
             do not plan to use acceptable birth control measures, for the duration of the study.

         18. Females with history of stillbirth, neonatal loss, or previous infant with anomaly.

         19. Individuals who have a previously ascertained or suspected disease caused by S. Typhi.

         20. Individuals who have had household contact with/and or intimate exposure to an
             individual with laboratory confirmed S. Typhi.




18 Years - 40 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers


Pierre VanDamme, Dr., , 

Location Countries


Location Countries


Administrative Informations



Organization ID


Responsible Party


Study Sponsor


Study Sponsor

Pierre VanDamme, Dr., Principal Investigator, Center for the Evaluation of Vaccination (CEV)

Verification Date

December 2013