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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01123941
First received: May 13, 2010
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Typhoid Fever
Biological: Typherix
Biological: NVGH Vi-CRM197
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
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.

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Number of Subjects Reporting Any Post Immunization Reactions [ Time Frame: During the 7-day period after vaccination ] [ Designated as safety issue: Yes ]
    Solicited reactions collected during the 7-day period after vaccination are pain, erythema, induration, chills, malaise, myalgia, headache, arthralgia and fatigue.

  • Number of Subjects Reporting Adverse Events [ Time Frame: During the 28-day period after vaccination ] [ Designated as safety issue: Yes ]
  • Number of Subjects Reporting Serious Adverse Events (SAEs) [ Time Frame: During the 6-month period after vaccination ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Anti-Vi ELISA Geometric Mean Concentration (GMC) [ Time Frame: At 28 days after vaccination ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: May 2010
Study Completion Date: November 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NVGH Vi-CRM197 conjugate vaccine Biological: NVGH Vi-CRM197
1 dose of 0.5 mL containing 25 mcg of Vi-CRM
Active Comparator: Vi-polysaccharide vaccine Biological: Typherix
1 dose, 0.5 mL containing 25 mcg of Vi polysaccharide

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 vaccine.
  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01123941

Locations
Belgium
Center for the Evaluation of Vaccination (CEV)
Antwerp, Wilrijk (Antwerp), Belgium, 2610
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Pierre VanDamme, Dr. Center for the Evaluation of Vaccination (CEV)
  More Information

Publications:
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01123941     History of Changes
Other Study ID Numbers: H01_01TP
Study First Received: May 13, 2010
Results First Received: February 29, 2012
Last Updated: December 16, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Novartis:
Typhoid fever
Glycoconjugate vaccine
Carrier protein
Immunogenicity

Additional relevant MeSH terms:
Fever
Typhoid Fever
Body Temperature Changes
Signs and Symptoms
Salmonella Infections
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on July 23, 2014