NCT01193907

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2010

Completed
29 days until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

April 3, 2012

Completed
Last Updated

January 17, 2014

Status Verified

December 1, 2013

Enrollment Period

1 month

First QC Date

September 1, 2010

Results QC Date

March 6, 2012

Last Update Submit

December 16, 2013

Conditions

Typhoid Fever

Keywords

Typhoid feverGlycoconjugate vaccineVi polysaccharideImmunogenicity

Outcome Measures

Primary Outcomes (4)

  • 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

    During the 7-day period after vaccination

  • Number of Subjects Reporting Adverse Events

    During the 28-day period after vaccination

  • Anti-Vi ELISA (Enzyme Linked Immunosorbent Assay) Geometric Mean Concentration (GMC)

    At 28 days after vaccination

  • Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer

    At 28 days after vaccination

Study Arms (4)

NVGH Vi-CRM197 conjugate vaccine 12.5 mcg

EXPERIMENTAL

1 dose of 0.5 mL containing 12.5 mcg of Vi-CRM

Biological: NVGH Vi-CRM197 12.5 mcg

NVGH Vi-CRM197 conjugate vaccine 5 mcg

EXPERIMENTAL

1 dose of 0.5 mL containing 5 mcg of Vi-CRM

Biological: NVGH Vi-CRM197 5.0 mcg

NVGH Vi-CRM197 conjugate vaccine 1.25 mcg

EXPERIMENTAL

1 dose of 0.5 mL containing 1.25 mcg of Vi-CRM

Biological: NVGH Vi-CRM197 1.25 mcg

Typherix

ACTIVE COMPARATOR

1 dose of 0.5 mL containing 25 mcg of Vi-polysaccharide

Biological: Vi-polysaccharide vaccine

Interventions

NVGH Vi-CRM197 1.25 mcgBIOLOGICAL

1 dose of 0.5 mL

NVGH Vi-CRM197 conjugate vaccine 1.25 mcg
NVGH Vi-CRM197 5.0 mcgBIOLOGICAL

1 dose of 0.5 mL

NVGH Vi-CRM197 conjugate vaccine 5 mcg
Vi-polysaccharide vaccineBIOLOGICAL

1 dose of 0.5 mL containing 25 mcg of Vi polysaccharide

Typherix

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Males and females of age ≥18 to ≤40 years.
  • Individuals who, after the nature of the study have 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 and clinical judgment of the investigator.
  • Individuals with negative urine screening tests for drug addition (Opiate, Cocaine, Amph/Metamphetamine, Cannabinoides )
  • 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.

You may not qualify if:

  • 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 (e.g., neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease).
  • 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 (either oral live attenuated or injectable vaccines).
  • 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.
  • Individuals who have received blood, blood products and/or plasma derivatives including parenteral immunoglobulin preparations in the past 12 weeks.
  • Individuals who are part of study personnel or close family members to the personnel conducting this study.
  • Individuals with body temperature \> 38.0 degrees Celsius within 3 days of intended study immunization.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for the Evaluation of Vaccination (CEV)

Antwerp, Wilrijk (Antwerp), 2610, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 21980445RESULT

MeSH Terms

Conditions

Typhoid Fever

Interventions

Vi polysaccharide vaccine, typhoid

Condition Hierarchy (Ancestors)

Salmonella InfectionsEnterobacteriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Results Point of Contact

Title
Dr. Audino Podda
Organization
Novartis Vaccines Institute for Global Health
audino.podda@novartis.com
+39 0577 243496

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2010

First Posted

September 2, 2010

Study Start

October 1, 2010

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

January 17, 2014

Results First Posted

April 3, 2012

Record last verified: 2013-12

Locations

BE(1)