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

February 4, 2014 updated by: Novartis

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
51

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Wilrijk
      • Antwerp, Wilrijk, Belgium, 2610
        • Centre for the Evaluation of Vaccination (CEV)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 42 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Anti-Vi ELISA Geometric Mean Concentration (GMC)
Time Frame: At 3 days after vaccination
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)
At 3 days after vaccination
Anti-Vi ELISA GMC
Time Frame: At 7 days after vaccination
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
At 7 days after vaccination
Anti-Vi ELISA GMC
Time Frame: At 28 days after vaccination
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
At 28 days after vaccination
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
At 3 days after vaccination as compared to baseline
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
At 7 days after vaccination as compared to baseline
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
At 28 days after vaccination as compared to baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Subjects Reporting Any (Local, Systemic and Other) Post Vaccination Reaction
Time Frame: During the 7-day period after vaccination
Solicited reactions collected during the 7-day period after vaccination are pain, erythema, induration, chills, malaise, myalgia, headache, arthralgia, fatigue and fever.
During the 7-day period after vaccination
Number of Subjects Reporting AE
Time Frame: During the 28-day period after vaccination
AE during 28 days after vaccination(including solicited reactions during 7 days after vaccination)
During the 28-day period after vaccination
Number of Subjects Reporting Serious Adverse Events (SAEs)
Time Frame: During the 28-day period after vaccination
During the 28-day period after vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pierre van Damme, MD, Universiteit Antwerpen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 19, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 22, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 24, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H01_04E1TP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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