NCT01376479

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Inviragen Inc. · Industry
• Sex: All
• Age: 21 Years – 45 Years
• Healthy volunteers: Accepted

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 description

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.

Conditions

• Hand, Foot and Mouth Disease

Interventions

Type	Name	Description
BIOLOGICAL	INV21 Low Dose	Inactivated EV71 vaccine containing whole viral particles of EV71 formulated with aluminum hydroxide.
BIOLOGICAL	INV21 High Dose	Inactivated EV71 vaccine consisting of whole viral particles of EV71 formulated with aluminum hydroxide.
BIOLOGICAL	Placebo	Phosphate Buffered Saline (PBS)

Timeline

• Start date: 2011-08-01
• Primary completion: 2011-11-01
• Completion: 2012-04-01
• First posted: 2011-06-20
• Last updated: 2015-05-06

Locations

1 site across 1 country: Singapore