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

NCT01438996 | Completed Phase 2 Results

• 1 other identifier: H01_04E1TP
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Typhoid Fever

Keywords

Typhoid fever; Glycoconjugate vaccine; Vi polysaccharide; Immunogenicity

Outcome Measures

Primary Outcomes (6)

• Anti-Vi ELISA Geometric Mean Concentration (GMC)

  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

  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

  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

  At 3 days after vaccination as compared to baseline

• Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titers

  At 7 days after vaccination as compared to baseline

• Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titers

  At 28 days after vaccination as compared to baseline

Secondary Outcomes (3)

• Number of Subjects Reporting Any (Local, Systemic and Other) Post Vaccination Reaction

  During the 7-day period after vaccination

• Number of Subjects Reporting AE

  During the 28-day period after vaccination

• Number of Subjects Reporting Serious Adverse Events (SAEs)

  During the 28-day period after vaccination

Study Arms (3)

NVGH Vi-CRM/NVGH Vi-CRM

EXPERIMENTAL

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-PS/NVGH Vi-CRM

EXPERIMENTAL

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

NVGH Vi-CRM

EXPERIMENTAL

One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults

Biological: NVGH Vi-CRM197

Interventions

NVGH Vi-CRM197 BIOLOGICAL

Vi-CRM197 glycoconjugated vaccine

NVGH Vi-CRM; NVGH Vi-CRM/NVGH Vi-CRM; Vi-PS/NVGH Vi-CRM

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All Subjects:
• Males and females of age ≥18 to ≤42 years.
• Individuals, who, after the nature of the study have 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 and clinical judgment of the investigator.
• 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:
• Individuals who previously participated in the H01\_04TP study and were vaccinated with either NVGH Vi-CRM197 (5μg) or with the licensed Vi-PS.
• Individuals who have received no Vi vaccination subsequent to the one received in the H01\_04TP study.
• All subjects:
• 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, 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.

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Centre for the Evaluation of Vaccination (CEV)

Antwerp, Wilrijk, 2610, Belgium

Location

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
• Organization: Novartis Vaccines Institute for Global Health

audino.podda@novartis.com

+39 0577 243496

Study Officials

• Pierre Van Damme, MD

  Universiteit Antwerpen

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2011
• First Posted: September 22, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 24, 2014
• Results First Posted: March 24, 2014

Record last verified: 2014-02

Locations

BE (1)