Details

Autor(en) / Beteiligte

• Couch, Robert B
• Patel, Shital M
• Wade-Bowers, Chianti L
• Niño, Diane
• Miyaji, Eliane Namie

Titel

A randomized clinical trial of an inactivated avian influenza A (H7N7) vaccine

Ist Teil von

• PloS one, 2012-12, Vol.7 (12), p.e49704

Ort / Verlag

United States: Public Library of Science

Erscheinungsjahr

2012

Link zum Volltext

Quelle

MEDLINE

Beschreibungen/Notizen

• Concern for a pandemic caused by a newly emerged avian influenza A virus has led to clinical trials with candidate vaccines as preparation for such an event. Most trials have involved vaccines for influenza A (H5N1), A (H7N7) or A (H9N2). To evaluate dosage-related safety and immunogenicity of an inactivated influenza A (H7N7) vaccine in humans. One hundred twenty-five healthy young adults were randomized to receive two doses intramuscularly of placebo or 7.5, 15, 45 or 90 µg of HA of an inactivated subunit influenza A (H7N7) vaccine (25 per group), four weeks apart. Reactogenicity was evaluated closely for one week and for any adverse effect for six months after each dose. Serum hemagglutination-inhibiting and neutralizing antibody responses were determined four weeks after each dose and at six months. Reactogenicity evaluations indicated the vaccinations were well tolerated. Only one subject developed a ≥4-fold serum hemagglutination-inhibition (HAI) antibody response and a final titer of ≥1:40 four weeks after dose two and only five subjects developed a neutralizing antibody rise and a final titer of ≥1:40 in tests performed at a central laboratory. Four of the five were given the 45 or 90 µg HA dosage. A more sensitive HAI assay at the study site revealed a dose-response with increasing HA dosage but only 36% in the 90 µg HA group developed a ≥4-fold rise in antibody in this test and only one of these achieved a titer of ≥1:32. This inactivated subunit influenza A (H7N7) vaccine was safe but poorly immunogenic in humans. ClinicalTrials.gov NCT00546585.