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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01193907
First received: September 1, 2010
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
Typhoid Fever
Biological: NVGH Vi-CRM197 12.5 mcg
Biological: NVGH Vi-CRM197 5.0 mcg
Biological: NVGH Vi-CRM197 1.25 mcg
Biological: Vi-polysaccharide vaccine
Phase 2

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 2, Randomized, Observer-blind, Controlled, Single Center Study to Evaluate the Safety and Immunogenicity of Three Formulations of the Novartis Vaccines Institute for Global Health (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 ]
  • Anti-Vi ELISA (Enzyme Linked Immunosorbent Assay) Geometric Mean Concentration (GMC) [ Time Frame: At 28 days after vaccination ] [ Designated as safety issue: No ]
  • Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer [ Time Frame: At 28 days after vaccination ] [ Designated as safety issue: No ]

Enrollment: 88
Study Start Date: October 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NVGH Vi-CRM197 conjugate vaccine 12.5 mcg
1 dose of 0.5 mL containing 12.5 mcg of Vi-CRM
Biological: NVGH Vi-CRM197 12.5 mcg
1 dose of 0.5 mL
Experimental: NVGH Vi-CRM197 conjugate vaccine 5 mcg
1 dose of 0.5 mL containing 5 mcg of Vi-CRM
Biological: NVGH Vi-CRM197 5.0 mcg
1 dose of 0.5 mL
Experimental: NVGH Vi-CRM197 conjugate vaccine 1.25 mcg
1 dose of 0.5 mL containing 1.25 mcg of Vi-CRM
Biological: NVGH Vi-CRM197 1.25 mcg
1 dose of 0.5 mL
Active Comparator: Typherix
1 dose of 0.5 mL containing 25 mcg of Vi-polysaccharide
Biological: Vi-polysaccharide vaccine
1 dose of 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 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.
  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: NCT01193907

Locations
Belgium
Center for the Evaluation of Vaccination (CEV)
Antwerp, Wilrijk (Antwerp), Belgium, 2610
Sponsors and Collaborators
Novartis
  More Information

Publications:
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01193907     History of Changes
Other Study ID Numbers: H01_04TP, 2010-021874-12
Study First Received: September 1, 2010
Results First Received: March 6, 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
Vi polysaccharide
Immunogenicity

Additional relevant MeSH terms:
Typhoid Fever
Salmonella Infections
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on September 30, 2014