Brief Title
Extension Study of H01_04TP to Evaluate the Booster Response Induced by Vi-CRM197 in Adults
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)
Brief Summary
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 Phase
Phase 2
Study Type
Interventional
Primary Outcome
Anti-Vi ELISA Geometric Mean Concentration (GMC)
Secondary Outcome
Number of Subjects Reporting Any (Local, Systemic and Other) Post Vaccination Reaction
Condition
Typhoid Fever
Intervention
NVGH Vi-CRM197
Study Arms / Comparison Groups
NVGH Vi-CRM/NVGH Vi-CRM
Description: 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
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
51
Start Date
October 2011
Completion Date
December 2011
Primary Completion Date
December 2011
Eligibility 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)
Gender
All
Ages
18 Years - 42 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Pierre Van Damme, MD, ,
Location Countries
Belgium
Location Countries
Belgium
Administrative Informations
NCT ID
NCT01438996
Organization ID
H01_04E1TP
Responsible Party
Sponsor
Study Sponsor
Novartis
Study Sponsor
Pierre Van Damme, MD, Principal Investigator, Universiteit Antwerpen
Verification Date
February 2014