Long Term Persistence and Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51

Japanese Encephalitis Clinical Trial

Official title:

Long Term Persistence and Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00595270
• Other study ID #: IC51-305
• Status: Completed
• Phase: Phase 3
• First received: January 4, 2008
• Last updated: February 5, 2014
• Start date: October 2005
• Est. completion date: April 2009

Study information

• Verified date: February 2014
• Source: Valneva Austria GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-InstitutUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The study investigates the long term persistence the Japanese encephalitis vaccine IC51 and the need of a booster dose

Description:

This is an open label, non‐randomized multi‐center phase 3 follow‐up study. All volunteers having completed trial IC51‐304 (NCT00595790) will be enrolled into this trial at 2 sites

Recruitment information / eligibility

• Status: Completed
• Enrollment: 349
• Est. completion date: April 2009
• Est. primary completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• At least 18 years of age

• Written informed consent obtained prior to study entry

• Subjects correctly included in and having completed study IC51-304 according to the protocol.

Exclusion Criteria:

• Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period

• Immunodeficiency including post-organ-transplantation or immunosuppressive therapy

• Pregnancy, lactation or unreliable contraception in female subjects

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Encephalitis
• Encephalitis, Japanese
• Japanese Encephalitis

Intervention

Biological:
• IC51

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Valneva Austria GmbH

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long Term Immunogenicity of IC51 Vaccine 24 Months After the Primary Vaccination	Seroprotection rate (SPR) (anti-JEV neutralizing antibody titer = 1:10) 24 months (M24) after the primary vaccination - imputed; Persistence of immunogenicity (SPR) at M24 defined as: pos. (positive) (persistent): Subjects; with a non-missing, pos. seroconversion at D56 (Study IC51-304) and; without booster at M11 or M23 and; with non-missing, seroprotection (SP) pos. PRNT50 at M6 or M12 and; with non-missing, SP pos. PRNT50 at M24; neg. (negative) (non-persistent): Subjects with; missing or neg. seroconversion at D56 (Study IC51-304) or; booster at M11 or at M23, or; non-missing, SP neg. PRNT50 at M6 or M12 or; missing PRNT50 at both M6 and M12 or; missing or SP neg. PRNT50 (serum dilution giving 50% reduction in plaques in a Plaque Reduction Neutralization Test) at M24	- 24 months	No
Secondary	SPR 24 Months After the Primary Vaccination (Observed)	Persistence of immunogenicity (SPR) at M24 (observed) defined as : positive (persistent): Subjects; with a non-missing, positive seroconversion at D56 (Study IC51-304), and; who did not receive a booster dose at Visit 2 (M11) or Visit 4 (M23), and; with a non-missing, SP positive PRNT50 result at Visit 1 (M6) or Visit 3 (M12), and; with a non-missing, SP positive PRNT50 result at Visit 5 (M24); negative (non-persistent): Subjects; with missing or negative seroconversion at D56 (Study IC51-304), or; who did receive a booster dose at Visit 2 (M11) or at Visit 4 (M23), or; with a non-missing, SP negative PRNT50 result at Visit 1 (M6) or Visit 3 (M12), or; with a missing PRNT50 result at both Visit 1 (M6) and Visit 3 (M12), or; with a non-missing, SP negative PRNT50 result at Visit 5 (M24)	24 months	No
Secondary	Persistent and Actual SPR 6, 12 and 24 Months After Primary Vaccination		- 24 months	No
Secondary	Persistent and Actual GMT 6, 12 and 24 Months After Primary Vaccination		24 months	No
Secondary	SCR 1 Month After the Booster Doses		1 month	No
Secondary	GMT 1month After Booster Doses		1 month	No
Secondary	Safety Profile of IC51		study duration	Yes