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

Novartis

Status and phase: Completed; Phase 2

Conditions: Typhoid Fever

Treatments: Biological: NVGH Vi-CRM197 12.5 mcg; Biological: NVGH Vi-CRM197 1.25 mcg; Biological: NVGH Vi-CRM197 5.0 mcg; Biological: Vi-polysaccharide vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01193907

H01_04TP

2010-021874-12 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 88 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Males and females of age ≥18 to ≤40 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. Individuals with negative urine screening tests for drug addition (Opiate, Cocaine, Amph/Metamphetamine, Cannabinoides )
5. 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.

Exclusion criteria

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, might interfere with the results of the study or 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 have previously received any vaccines against typhoid fever (either oral live attenuated or injectable vaccines).
12. 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.
13. Individuals who have received blood, blood products and/or plasma derivatives including parenteral immunoglobulin preparations in the past 12 weeks.
14. Individuals who are part of study personnel or close family members to the personnel conducting this study.
15. Individuals with body temperature > 38.0 degrees Celsius within 3 days of intended study immunization.
16. BMI > 35 kg/m2.
17. Individuals with history of substance or alcohol abuse within the past 2 years.
18. 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.
19. Females with history of stillbirth, neonatal loss, or previous infant with anomaly.
20. Individuals who have a previously ascertained or suspected disease caused by S. Typhi.
21. Individuals who have had household contact with/and or intimate exposure to an individual with laboratory confirmed S. Typhi.
22. Any condition which, in the opinion of the investigator may interfere with the evaluation of the study objectives.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

88 participants in 4 patient groups

NVGH Vi-CRM197 conjugate vaccine 12.5 mcg

Experimental group

Description:

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

Treatment:

Biological: NVGH Vi-CRM197 12.5 mcg

NVGH Vi-CRM197 conjugate vaccine 5 mcg

Experimental group

Description:

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

Treatment:

Biological: NVGH Vi-CRM197 5.0 mcg

NVGH Vi-CRM197 conjugate vaccine 1.25 mcg

Experimental group

Description:

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

Treatment:

Biological: NVGH Vi-CRM197 1.25 mcg

Typherix

Active Comparator group

Description:

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

Treatment:

Biological: Vi-polysaccharide vaccine