Study of Single Dose GHB16L2 Trivalent Influenza Vaccine in Healthy Adults

AVIR Green Hills Biotechnology

Status and phase

Completed

Phase 2

Phase 1

Conditions

Influenza, Human

Treatments

Biological: Placebo

Biological: GHB16L2

Study type

Interventional

Funder types

Industry

Identifiers

NCT01369862

GHB-CS08

Details and patient eligibility

About

The purpose of this phase I/II trial is to evaluate safety and tolerability of a single dose of GHB16L2 administered by liquid nasal spray for vaccination against seasonal influenza virus infection. It is also performed to assess immunogenicity and pharmacokinetics (shedding).

Full description

GHB16L2 intends to provide a novel vaccination for influenza virus infection. 80 healthy volunteers will be included at a ratio of 1:1 for GHB16L2 or placebo. GHB16L2 will be administered once on day 1. Follow-up visits will be performed on days 2, 8 and 29.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy male and female volunteers, 18-60 years
Seronegative for one or two of the applied vaccine strains
Low antibody titres for H1N1v
Written informed consent to participate in this study
For female volunteers of childbearing potential, provision of a history and current use of reliable contraceptive practices

Exclusion criteria

Acute febrile illness (>37.3°C)
Signs of acute or chronic upper or lower tract respiratory illnesses
History of severe atopy
Seasonal influenza vaccination in 2008/2009 and/or later seasons and/or pandemic influenza vaccination at any time
Fever ≥38.0°C in the time period between the pre-screening visit and day 1
Known increased tendency of nose bleeding
Volunteers with clinically relevant abnormal paranasal anatomy
Volunteers with clinically relevant abnormal laboratory values
In female volunteers of childbearing potential, a positive urine pregnancy test
Simultaneous treatment with immunosuppressive drugs incl. Corticosteroids (≥2 weeks) within 4 weeks prior to study medication application
Clinically relevant history of renal, hepatic, GI, cardiovascular, haematological, skin, endocrine, neurological or immunological diseases
History of leukaemia or cancer
HIV or Hepatitis B or C seropositivity
Volunteers who underwent rhino or sinus surgery, or surgery of another traumatic injury of the nose within 30 days prior to application of study medication
Volunteers who have received antiviral drugs, treatment with immunoglobulins or blood transfusions, or an investigational drug within 4 weeks prior to study medication application
Volunteers who have received anti-inflammatory drugs 2 days prior to study medication application
Volunteers who are not likely to cope with the requirements of the study or with a significant physical or mental condition that may interfere with the completion of the study