Extension Study of H01_04TP to Evaluate the Booster Response Induced by Vi-CRM197 in Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01438996
First received: September 19, 2011
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

The purpose of this study is to evaluate the immunogenicity and the kinetics of the anti-Vi antibody response following secondary vaccination with the Novartis Vaccines Institute for Global Health (NVGH) Vi-CRM197 vaccine in healthy adults previously vaccinated with either the NVGH Vi-CRM197 or Vi-polysaccharide (Typherix) in the H01_04TP study (NCT01193907) and the immunogenicity and the kinetics of the anti-Vi antibody response following primary vaccination with the NVGH Vi-CRM197 vaccine in naïve healthy adults.


Condition Intervention Phase
Typhoid Fever
Biological: NVGH Vi-CRM197
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase 2, Open-label, Single-center, Extension Study to Evaluate the Booster Response Induced by Vi-CRM197 After Priming With Either Vi-CRM197 or Typherix Administered in Adult Subjects in H01_04TP Study (NCT01193907)

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Anti-Vi ELISA Geometric Mean Concentration (GMC) [ Time Frame: At 3 days after vaccination ] [ Designated as safety issue: No ]
    To evaluate the immunogenicity and the kinetics of the immune response induced by one dose of NVGH Vi-CRM197 at study day 3 after vaccination as as measured by enzyme-linked immunosorbent assay (ELISA)

  • Anti-Vi ELISA GMC [ Time Frame: At 7 days after vaccination ] [ Designated as safety issue: No ]
    To evaluate the immunogenicity and the kinetics of the immune response induced by one dose of NVGH Vi-CRM197 at study day 7 after vaccination as as measured by ELISA

  • Anti-Vi ELISA GMC [ Time Frame: At 28 days after vaccination ] [ Designated as safety issue: No ]
    To evaluate the immunogenicity and the kinetics of the immune response induced by one dose of NVGH Vi-CRM197 at study day 28 after vaccination as as measured by ELISA

  • Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titers [ Time Frame: At 3 days after vaccination as compared to baseline ] [ Designated as safety issue: No ]
  • Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titers [ Time Frame: At 7 days after vaccination as compared to baseline ] [ Designated as safety issue: No ]
  • Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titers [ Time Frame: At 28 days after vaccination as compared to baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Subjects Reporting Any (Local, Systemic and Other) Post Vaccination Reaction [ 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, fatigue and fever.

  • Number of Subjects Reporting AE [ Time Frame: During the 28-day period after vaccination ] [ Designated as safety issue: Yes ]
    AE during 28 days after vaccination(including solicited reactions during 7 days after vaccination)

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

Enrollment: 51
Study Start Date: October 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NVGH Vi-CRM/NVGH Vi-CRM
One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study
Biological: NVGH Vi-CRM197
Vi-CRM197 glycoconjugated vaccine
Experimental: Vi-PS/NVGH Vi-CRM
One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study
Biological: NVGH Vi-CRM197
Vi-CRM197 glycoconjugated vaccine
Experimental: NVGH Vi-CRM
One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
Biological: NVGH Vi-CRM197
Vi-CRM197 glycoconjugated vaccine

  Eligibility

Ages Eligible for Study:   18 Years to 42 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria

All Subjects:

  1. Males and females of age ≥18 to ≤42 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. 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.

    H01_04TP subjects only:

  5. Individuals who previously participated in the H01_04TP study and were vaccinated with either NVGH Vi-CRM197 (5μg) or with the licensed Vi-PS.
  6. Individuals who have received no Vi vaccination subsequent to the one received in the H01_04TP study.

Inclusion criteria

All subjects:

  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, 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 received any 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
  12. Individuals who have received blood, blood products and/or plasma derivatives including parenteral immunoglobulin preparations in the past 12 weeks.
  13. Individuals who are part of study personnel or close family members to the personnel conducting this study.
  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 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.
  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.
  21. Any condition which, in the opinion of the investigator may interfere with the evaluation of the study objectives.

    Naïve subjects only:

  22. Individuals who have previously received any vaccine against typhoid fever (either oral live attenuated or injectable vaccines)
  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: NCT01438996

Locations
Belgium
Centre for the Evaluation of Vaccination (CEV)
Antwerp, Wilrijk, Belgium, 2610
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Pierre Van Damme, MD Universiteit Antwerpen
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01438996     History of Changes
Other Study ID Numbers: H01_04E1TP
Study First Received: September 19, 2011
Results First Received: December 16, 2013
Last Updated: February 4, 2014
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:
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 August 28, 2014