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

Primary Purpose

Typhoid Fever

Status
Completed
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
Typherix
NVGH Vi-CRM197
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Typhoid Fever focused on measuring Typhoid fever, Glycoconjugate vaccine, Carrier protein, Immunogenicity

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Center for the Evaluation of Vaccination (CEV)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NVGH Vi-CRM197 conjugate vaccine

Vi-polysaccharide vaccine

Arm Description

Outcomes

Primary Outcome Measures

Number of Subjects Reporting Any Post Immunization Reactions
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
Number of Subjects Reporting Serious Adverse Events (SAEs)

Secondary Outcome Measures

Anti-Vi ELISA Geometric Mean Concentration (GMC)

Full Information

First Posted
May 13, 2010
Last Updated
December 16, 2013
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT01123941
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Typhoid Fever
Keywords
Typhoid fever, Glycoconjugate vaccine, Carrier protein, Immunogenicity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NVGH Vi-CRM197 conjugate vaccine
Arm Type
Experimental
Arm Title
Vi-polysaccharide vaccine
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Typherix
Intervention Description
1 dose, 0.5 mL containing 25 mcg of Vi polysaccharide
Intervention Type
Biological
Intervention Name(s)
NVGH Vi-CRM197
Intervention Description
1 dose of 0.5 mL containing 25 mcg of Vi-CRM
Primary Outcome Measure Information:
Title
Number of Subjects Reporting Any Post Immunization Reactions
Description
Solicited reactions collected during the 7-day period after vaccination are pain, erythema, induration, chills, malaise, myalgia, headache, arthralgia and fatigue.
Time Frame
During the 7-day period after vaccination
Title
Number of Subjects Reporting Adverse Events
Time Frame
During the 28-day period after vaccination
Title
Number of Subjects Reporting Serious Adverse Events (SAEs)
Time Frame
During the 6-month period after vaccination
Secondary Outcome Measure Information:
Title
Anti-Vi ELISA Geometric Mean Concentration (GMC)
Time Frame
At 28 days after vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Males and females of age ≥18 to ≤40 years. Individuals who, after the nature of the study has been explained to them, have given written consent according to local regulatory requirements. 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. If women, a negative pregnancy test and willingness to use birth control measures for the entire study duration Exclusion Criteria: 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. Individuals with any progressive or severe neurological disorder, seizure disorder or Guillain-Barré syndrome. Individuals who are not able to understand and to follow all required study procedures for the whole period of the study. 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. 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. Individuals with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time. Individuals with any serious chronic or progressive disease according to judgment of the investigator. Individuals who have any malignancy or lymphoproliferative disorder. Individuals with history of allergy to vaccine components. 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. Individuals who have previously received any vaccines against typhoid fever. 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. Individuals who have received blood, blood products and/or plasma derivatives including parenteral immunoglobulin preparations in the past 12 weeks. Individuals with body temperature > 38.0 degrees Celsius within 3 days of intended study immunization. BMI > 35 kg/m2. Individuals with history of substance or alcohol abuse within the past 2 years. 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. Females with history of stillbirth, neonatal loss, or previous infant with anomaly. Individuals who have a previously ascertained or suspected disease caused by S. Typhi. Individuals who have had household contact with/and or intimate exposure to an individual with laboratory confirmed S. Typhi.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre VanDamme, Dr.
Organizational Affiliation
Center for the Evaluation of Vaccination (CEV)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for the Evaluation of Vaccination (CEV)
City
Antwerp
State/Province
Wilrijk (Antwerp)
ZIP/Postal Code
2610
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
21980445
Citation
van Damme P, Kafeja F, Anemona A, Basile V, Hilbert AK, De Coster I, Rondini S, Micoli F, Qasim Khan RM, Marchetti E, Di Cioccio V, Saul A, Martin LB, Podda A. Safety, immunogenicity and dose ranging of a new Vi-CRM(1)(9)(7) conjugate vaccine against typhoid fever: randomized clinical testing in healthy adults. PLoS One. 2011;6(9):e25398. doi: 10.1371/journal.pone.0025398. Epub 2011 Sep 30.
Results Reference
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Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adult (18-40 Years Old)

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