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To Evaluate the Safety and Ability of the Medicine to Induce Antibodies Against the Respiratory Syncytial Virus in Healthy Adults

2015-03-26 05:53:22 | BioPortfolio

Summary

The purpose of this study is to evaluate the safety and immunogenicity of two doses of the investigational RSV F subunit vaccine administered intramuscularly (IM). In this current Phase 1, first-in-human study, the three different antigen amounts that have been selected will be evaluated in a stepwise manner in three different cohorts (cohort 1: low dosage of RSV F subunit vaccine, cohort 2: middle dosage of RSV F subunit vaccine, and cohort 3: high dosage of RSV F subunit vaccine). In addition, the effect of an adjuvant, either aluminum hydroxide or MF59, and antibody kinetics post-vaccination at different time points will be evaluated as compared to unadjuvanted RSV F subunit vaccine at the same dosage levels

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Conditions

Respiratory Syncytial Virus (RSV)

Intervention

RSV F subunit vaccine-Low dosage; no adjuvant, RSV F subunit vaccine-Medium dosage; no adjuvant, RSV F subunit vaccine-High dosage; no adjuvant, RSV F subunit vaccine-Low dosage; with aluminum hydroxide, RSV F subunit vaccine-Medium dosage; with aluminum

Location

Center for Vaccinology (CEVAC)
Ghent
East Flanders
Belgium

Status

Recruiting

Source

Novartis

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-03-26T05:53:22-0400

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