NCT03789539

Reactogenicity, Safety and Immunogenicity of an Universal Influenza Vaccine Uniflu

Reactogenicity, Safety and Immunogenicity of an Recombinant Universal Influenza Vaccine Uniflu in Healthy Volunteers From 18 to 60 Years Old

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: VA Pharma Limited Liability Company · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This is a single-site, randomized, double-blind, placebo-controlled study of Uniflu in fifty four (54) volunteers 18-60 years of age with a dose escalation. All subjects will receive an intramuscular (IM) injection twice,with a 21 days interval between treatments.

Detailed description

This is a single-site, randomized, double-blind, placebo-controlled study of Uniflu in fifty four (54) volunteers 18-60 years of age. All subjects will receive an intramuscular (IM) injection twice,with a 21 days interval between treatments. Subjects will undergo screening procedures within 6 days prior to first vaccination which will include medical history, vital signs, physical examination and safety blood and urine lab tests. On the first treatment visit, eligible subjects will undergo pre-dose physical examination,vital signs, ECG, a blood sample will be drawn for circulating IgE. They receive an IM injection of either vaccine or placebo, according to the above treatment assignment, into the deltoid muscle. The subjects will remain under medical supervision for 72 hrs, after that time they will be released from the Clinical research center. The second treatment will take place 21 days after the first vaccination. Procedures will be the same as on the first treatment visit. Follow-up visits take place at 4th, 5th, 6th, 14th, 35th days. A Study Termination visit will take place at 42nd day of research. Adverse events (AEs) and changes in concomitant medications will be recorded, vital signs will be measured and the subjects will undergo physical examination and ECG. Blood and urine samples will be collected for safety.

Conditions

• Safety Issues

Interventions

Type	Name	Description
BIOLOGICAL	LD Universal Influenza Vaccine Uniflu	low dose Universal Influenza Vaccine Uniflu
BIOLOGICAL	HD Universal Influenza Vaccine Uniflu	High dose Universal Influenza Vaccine Uniflu
BIOLOGICAL	Placebo	Placebo saline

Timeline

• Start date: 2018-06-02
• Primary completion: 2018-12-02
• Completion: 2018-12-31
• First posted: 2018-12-28
• Last updated: 2018-12-28

Locations

1 site across 1 country: Russia