Clinical trial NCT00530660: Safety and Immunogenicity Study of a Booster Vaccination With a Non-Adjuvanted H5N1 Influenza Vaccine (Follow Up to Study 810501)
Official title: An Open-label Phase II Study to Assess the Immunogenicity and Safety of a Booster Vaccination With a Heterologous Vero Cell-Derived Whole Virus H5N1 Influenza Vaccine in a Healthy Young Adult Population (Follow Up to Study 810501)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Keywords: Pandemic influenza
Lead sponsor: Resilience Government Services, Inc.
Sponsor class: INDUSTRY
First posted: 2007-09-17
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Maximum age (years): 46
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this Phase II follow-up study (to study 810501) is to assess the immunogenicity and safety of a booster vaccination with a non-adjuvanted H5N1 influenza vaccine administered 12 to 17 months after a two-dose regimen of different doses of an adjuvanted or non-adjuvanted H5N1 influenza vaccine in a healthy young adult population. A data safety monitoring board will review the safety data after the booster vaccination. The H5N1 influenza antibody persistence 180 days after the booster vaccination will also be assessed.


Eligibility criteria: Inclusion Criteria:

Subjects who participated in Study 810501 will be eligible for participation in the study if they:

* Completed the Day 42 visit in study 810501
* Have an understanding of the study, agree to its provisions, and give written informed consent prior to study entry
* Are clinically healthy, as determined by the Investigator's clinical judgment through collection of medical history and performance of a physical examination
* Agree to keep a daily record of symptoms for the duration of the study
* If female and capable of bearing children, have a negative urine pregnancy test result at study entry and agree to employ adequate birth control measures for the duration of the study

Exclusion Criteria:

* Have a history of vaccination with an H5N1 influenza virus since the second vaccination in study 810501
* Have had an allergic reaction to one of the components of the vaccine since the second vaccination in Study 810501
* Have been diagnosed with a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, rheumatic, autoimmune, hematological, renal or metabolic disorder since the second vaccination in Study 810501
* Are unable to lead an independent life as a result of either physical or mental handicap
* Suffer from any kind of immunodeficiency since the second vaccination in Study 810501
* Suffer from a disease or were undergoing a treatment within 30 days prior to the scheduled booster vaccination or are currently undergoing a form of treatment that can be expected to influence immune response. Such treatment includes, but is not limited to, systemic or high dose inhaled (\>800µg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs
* Have had severe allergic reactions or anaphylaxis since the second vaccination in Study 810501
* Have a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating
* Have undergone systemic corticoid therapy within 30 days prior to study entry
* Have a functional or surgical asplenia
* Have a known or suspected problem with alcohol or drug abuse
* Were administered an investigational drug within six weeks prior to study entry or are concurrently participating in a clinical study that includes the administration of an investigational product
* Are a member of the team conducting this study or are in a dependent relationship with the study investigator. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator If female, are pregnant or lactating

Primary outcomes:
measure: Number of subjects with antibody response to the vaccine strain (A/Indonesia/05/2005) associated with protection 21 days after the booster vaccination (HI antibody titer >= 1:40 or MN titer >= 1:20)
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: University Hospital, Department of Clinical Pharmacology, General Hospital Vienna
Study officials:
affiliation: Baxter Healthcare Corporation
name: Baxter BioScience Investigator
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ehrlich HJ, Muller M, Fritsch S, Zeitlinger M, Berezuk G, Low-Baselli A, van der Velden MV, Pollabauer EM, Maritsch F, Pavlova BG, Tambyah PA, Oh HM, Montomoli E, Kistner O, Noel Barrett P. A cell culture (Vero)-derived H5N1 whole-virus vaccine induces cross-reactive memory responses. J Infect Dis. 2009 Oct 1;200(7):1113-8. doi: 10.1086/605608.