Inactivated Influenza A/H9N2 Vaccine With and Without MF59 Adjuvant in Ambulatory Adults

NCT00133471 | Completed Phase 1

• 1 other identifier: 04-019
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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. Study participants will include up to 96 healthy adults, ages 18-34. The 4 dosages of the experimental H9N2 vaccine to be tested in this study are the following: 3.75, 7.5, 15, and 30-mcg (with and without MF59 adjuvant). Participants will be vaccinated on Days 0 and 28. Participants will record any vaccine side effects in a diary for 7 days following each vaccination. Participants will return to the clinic on days 2 and 7 after vaccination. Blood samples will be collected 7 days following each vaccination. Serum and nasal wash specimens will be collected before each vaccination and 4 weeks after injections (0, 4, and 8 weeks). Participants will be involved in study related procedures for up to 8 months.

Conditions

Influenza

Keywords

Influenza, vaccine, A/H9N2, MF59, adjuvant

Outcome Measures

Primary Outcomes (1)

• The frequency and severity of solicited local and systemic adverse events in each vaccine dosage level group.

  Duration of study.

Secondary Outcomes (4)

• 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.

• Rates of significant increases in titer between pre- and post-immunization serum samples 28 days after each vaccination.

  Days 28 and 56.

• The geometric mean titer (GMT) of serum HAI antibody against the influenza A/H9N2 virus.

  One month after the second vaccination.

• The proportion of subjects with a 4-fold or greater increase in percent HA-specific antibody in nasal wash specimens for each vaccine group.

  Nasal wash samples collected on Days 0, 28, and 56.

Study Arms (8)

Group 1A: 3.75 mcg A/H9N2 no adjuvant

EXPERIMENTAL

12 subjects to receive 3.75 mcg A/H9N2 with no adjuvant.

Biological: Influenza A/H9N2 vaccine

Group 2B: 7.5 mcg A/H9N2 plus MF59 adjuvant

EXPERIMENTAL

12 subjects to receive 7.5 mcg A/H9N2 plus MF59 adjuvant.

Biological: Influenza A/H9N2 vaccine; Drug: MF59 adjuvant

Group 3A: 15 mcg A/H9N2 no adjuvant

EXPERIMENTAL

12 subjects to receive 15 mcg A/H9N2 with no adjuvant.

Biological: Influenza A/H9N2 vaccine

Group 3B: 15 mcg A/H9N2 plus MF59 adjuvant

EXPERIMENTAL

12 subjects to receive 15 mcg A/H9N2 plus MF59 adjuvant.

Biological: Influenza A/H9N2 vaccine; Drug: MF59 adjuvant

Group 4B: 30 mcg A/H9N2 plus MF59 adjuvant

EXPERIMENTAL

12 subjects to receive 30 mcg A/H9N2 plus MF59 adjuvant.

Biological: Influenza A/H9N2 vaccine; Drug: MF59 adjuvant

Group 4A: 30 mcg A/H9N2 no adjuvant

EXPERIMENTAL

12 subjects to receive 30 mcg A/H9N2 with no adjuvant.

Biological: Influenza A/H9N2 vaccine

Group 2A: 7.5 mcg A/H9N2 no adjuvant

EXPERIMENTAL

12 subjects to receive 7.5 mcg A/H9N2 with no adjuvant.

Biological: Influenza A/H9N2 vaccine

Group 1B: 3.75 mcg A/H9N2 plus MF59 adjuvant

EXPERIMENTAL

12 subjects to receive 3.75 mcg A/H9N2 plus MF59 adjuvant.

Biological: Influenza A/H9N2 vaccine; Drug: MF59 adjuvant

Interventions

Influenza A/H9N2 vaccine BIOLOGICAL

A single lot of monovalent inactivated SA influenza A/H9N2 vaccine. All injections will be administered in a 0.5-mL volume into the deltoid muscle. Dosage levels are: 3.75-, 7.5-, 15-, and 30-mcg of HA of the vaccine strain with and without MF59 adjuvant.

Group 1A: 3.75 mcg A/H9N2 no adjuvant; Group 1B: 3.75 mcg A/H9N2 plus MF59 adjuvant; Group 2A: 7.5 mcg A/H9N2 no adjuvant; Group 2B: 7.5 mcg A/H9N2 plus MF59 adjuvant; Group 3A: 15 mcg A/H9N2 no adjuvant; Group 3B: 15 mcg A/H9N2 plus MF59 adjuvant; Group 4A: 30 mcg A/H9N2 no adjuvant; Group 4B: 30 mcg A/H9N2 plus MF59 adjuvant

MF59 adjuvant DRUG

MF59 adjuvant is an oil-in-water emulsion.

Group 1B: 3.75 mcg A/H9N2 plus MF59 adjuvant; Group 2B: 7.5 mcg A/H9N2 plus MF59 adjuvant; Group 3B: 15 mcg A/H9N2 plus MF59 adjuvant; Group 4B: 30 mcg A/H9N2 plus MF59 adjuvant

Eligibility Criteria

• Age: 18 Years - 34 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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. doi: 10.1086/508174. Epub 2006 Sep 25.

  PMID: 17029131 RESULT

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 19, 2005
• First Posted: August 23, 2005
• Study Start: March 1, 2005
• Primary Completion: December 1, 2005
• Study Completion: December 1, 2005
• Last Updated: August 27, 2010

Record last verified: 2009-01

Locations

US (1)