Clinical Trial: Safety and Immunogenicity Study of an Inactivated Vaccine Against Hand, Foot and Mouth Disease Caused by Enterovirus 71

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase I, Double Blind, Randomized, Placebo-controlled, Dose Escalation Study to Assess the Safety and Immunogenicity of a Prophylactic Vaccine Against Enterovirus Infection in Healthy Adults

Brief Summary: The purpose of this study is to evaluate the safety and immune response of an inactivated vaccine to prevent hand, foot and mouth disease (HFMD) caused by Enterovirus 71 (EV71).

Detailed Summary: Hand, foot and mouth disease (HFMD) caused by Enterovirus 71 (EV71) can be severely debilitating for some children with a risk of paralysis and death. The most susceptible age group is the 1 to 5 year olds, and the disease is spread via the oral-fecal route. Currently, there is no antiviral therapy nor there is a vaccine available to prevent HFMD. In this study, an inactivated vaccine (INV21) based on the EV71 antigen will be evaluated in terms of safety and immune response that is generated after two doses of the vaccine are given to healthy adults. Safety assessments include the frequency and severity of systemic adverse events as well as local reactions. Immune response will be assessed by measurement of EV71 neutralizing antibody levels at specified time points throughout the study.
Sponsor: Inviragen Inc.

Current Primary Outcome: Frequency of systemic adverse events and local reactions in healthy adults following two doses of INV21 given 28 days apart [ Time Frame: 56 days ]

Frequency and severity of systemic adverse events up to 56 days post first dose. Frequency and severity of local reactions up to 14 days post each dose.


Original Primary Outcome: Same as current

Current Secondary Outcome: Immunogenicity of INV21 vaccine in healthy adults following two doses given 28 days apart [ Time Frame: 8 months ]

Geometric mean titers based on neutralizing antibody titers. Measurement of fold-increase over baseline of neutralizing titers against EV71. Durability of immune response at 2 months and 6 months after the last dose.


Original Secondary Outcome: Same as current

Information By: Takeda

Dates:
Date Received: June 16, 2011
Date Started: August 2011
Date Completion:
Last Updated: May 5, 2015
Last Verified: May 2015