Inactivated Influenza A/H9N2 Vaccine With and Without MF59 Adjuvant in Ambulatory Adults
Status:
Completed
Trial end date:
2005-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)