Inactivated Influenza A/H9N2 Vaccine With and Without MF59 Adjuvant in Ambulatory Adults - Full Text View

Sponsored by:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00133471

Purpose

Influenza virus vaccines have been developed to prevent infection with influenza virus. The purpose of this study is to compare the body's reactions and immune responses after receiving different strengths of a H9N2 influenza virus vaccine with and without an adjuvant given into the arm muscle.

Condition	Intervention	Phase
Influenza	Biological: Influenza A/H9N2 vaccine Drug: MF59 adjuvant	Phase I Phase II

MedlinePlus related topics: Flu

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	Evaluation of the Reactogenicity and Immunogenicity of Four Dosage Levels of Intramuscular Monovalent Inactivated Influenza A/H9N2 Vaccine With and Without MF59 Adjuvant in Ambulatory Adults

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment:	96
Study Start Date:	March 2005
Estimated Study Completion Date:	December 2005

Detailed Description:

The primary goal of this study is to assess the safety of four different dosages of purified monovalent surface antigen (SA) influenza A/H9N2 virus vaccine with or without MF59 adjuvant and administered intramuscularly to ambulatory adults. The hypothesis is that all dosage levels of adjuvanted and nonadjuvanted vaccine will be well tolerated. The primary objective of this project is to evaluate the safety of four dosage levels of monovalent surface antigen (SA) influenza A/H9N2 virus vaccine (range 3.75-30mcg/dose) given with or without MF59 adjuvant. The primary endpoint is the frequency and severity of solicited local and systemic adverse events in each vaccine dosage level group. The secondary objective of this project is the following to determine the immunogenicity of four dosage levels of monovalent surface antigen (SA) influenza A/H9N2 virus vaccine (range 3.75-30mcg/dose) given with or without MF59 adjuvant. The secondary endpoints include the following: the proportions of subjects in each vaccine dosage group that achieve a serum HAI titer of at least 1:32 one month after the second vaccination; the geometric mean titer (GMT) of serum HAI antibody against the influenza A/H9N2 virus one month after the second vaccination; and the rates of significant increases in titer between pre- and post-immunization serum samples (defined as seroconversion-i.e., increase in titer from <1:4 pre-immunization to at least 1:8 after vaccination, or 4-fold or greater increase in titer between pre- and post-immunization samples) 28 days after each vaccination (days 28 and 56); and the proportion of subjects with a 4-fold or greater increase in percent HA-specific antibody in nasal wash specimens for each vaccine group. The study will be a double-blind evaluation of four dosage levels of study vaccine. The four dosage levels to be tested are 3.75-, 7.5-, 15-, and 30-mcg of HA of the vaccine strain with and without MF59 adjuvant. Because all dosage levels are lower than the total hemagglutinin content of the FLUAD® vaccine used in Europe, subjects will be enrolled into all dosage and adjuvant groups concurrently using a randomized, double-blind study design. Ninety-six persons 18-34 years of age will be enrolled. A single lot of monovalent inactivated SA influenza A/H9N2 vaccine will be used throughout the trial. All injections will be administered in a 0.5-mL volume into the deltoid muscle.

Eligibility

Ages Eligible for Study:	18 Years to 34 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Ambulatory, healthy males and non-pregnant female adults 18-34 years of age
Able to give informed consent and available for all study visits
Able to understand and comply with planned study procedures
Women capable of bearing children must utilize an acceptable means of birth control (abstinence, oral contraceptives ("the pill"), intrauterine devices (IUDs), contraceptive implants under the skin, or contraceptive injections, or condoms with foam)
On no concomitant medications except contraceptive medications
Normal screening laboratory values

Exclusion Criteria:

Known allergy to eggs or other components of vaccine
Prior receipt of an influenza A/H9N2 vaccine
Abnormal screening laboratory values (laboratory values must be within normal limits)
Pregnancy, desire to become pregnant in the next 3 months, or lactation
Immunosuppression as a result of underlying illness or treatment
Use of oral or parenteral steroids, high-dose inhaled steroids (>800 mcg per day of beclomethasone dipropionate or equivalent), other immunosuppressive or cytotoxic drugs
Active neoplastic disease or history of any hematologic malignancy
Acute or chronic condition that (in the opinion of the investigator) would render vaccination unsafe or would interfere with the evaluation of responses (including but not limited to the following: known chronic liver disease, significant renal disease, unstable or progressive neurologic disorder, diabetes mellitus, transplant recipient)
Use of experimental vaccines or medications within the month prior to study entry, or expected use of experimental or licensed vaccines or blood/blood products during the 1 month period after each inoculation with study vaccine
Receipt of immunoglobulin or other blood product within 3 months prior to enrollment
Receipt of other licensed vaccines within the preceding 2 weeks (inactivated vaccines) or 4 weeks (live vaccines)
History of a severe reaction following vaccination with a contemporary influenza vaccine
Subject is enrolled in another clinical trial
Study personnel (those persons identified on study personnel logs)
Any condition that in the opinion of the investigator would interfere with the interpretation or evaluation of the vaccine

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00133471

Locations

United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

More Information

Publications of Results:

Atmar RL, Keitel WA, Patel SM, Katz JM, She D, El Sahly H, Pompey J, Cate TR, Couch RB. Safety and immunogenicity of nonadjuvanted and MF59-adjuvanted influenza A/H9N2 vaccine preparations. Clin Infect Dis. 2006 Nov 1;43(9):1135-42. Epub 2006 Sep 25.

Study ID Numbers:	04-019
Study First Received:	August 19, 2005
Last Updated:	January 24, 2008
ClinicalTrials.gov Identifier:	NCT00133471
Health Authority:	Unspecified

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Influenza, vaccine, A/H9N2, surface antigen, MF59, adjuvant

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

N-(2-aminoethyl)-5-isoquinolinesulfonamide
Influenza, Human
Orthomyxoviridae Infections

Additional relevant MeSH terms:

RNA Virus Infections

ClinicalTrials.gov processed this record on January 14, 2009