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

NCT01123941 | Completed Phase 1 Results

• 1 other identifier: H01_01TP
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Typhoid Fever

Keywords

Typhoid fever; Glycoconjugate vaccine; Carrier protein; Immunogenicity

Outcome Measures

Primary Outcomes (3)

• 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

• Number of Subjects Reporting Serious Adverse Events (SAEs)

  During the 6-month period after vaccination

Secondary Outcomes (1)

• Anti-Vi ELISA Geometric Mean Concentration (GMC)

  At 28 days after vaccination

Study Arms (2)

NVGH Vi-CRM197 conjugate vaccine

EXPERIMENTAL

Biological: NVGH Vi-CRM197

Vi-polysaccharide vaccine

ACTIVE COMPARATOR

Biological: Typherix

Interventions

Typherix BIOLOGICAL

1 dose, 0.5 mL containing 25 mcg of Vi polysaccharide

Vi-polysaccharide vaccine

NVGH Vi-CRM197 BIOLOGICAL

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

NVGH Vi-CRM197 conjugate vaccine

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

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.
• 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.

Sponsors & Collaborators

• Novartis: lead

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: 21980445 RESULT

MeSH Terms

Conditions

Typhoid Fever

Condition Hierarchy (Ancestors)

Salmonella Infections; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Dr. Audino Podda, MD
• Organization: Novartis Vaccines Institute for Global Health

audino.podda@novartis.com

+39 0577 243496

Study Officials

• Pierre VanDamme, Dr.

  Center for the Evaluation of Vaccination (CEV)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2010
• First Posted: May 14, 2010
• Study Start: May 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: November 1, 2010
• Last Updated: January 17, 2014
• Results First Posted: June 13, 2012

Record last verified: 2013-12

Locations

BE (1)