A phase I evaluation of inactivated influenza A/H5N1 vaccine administered by the intradermal or the intramuscular route

作者：Patel Shital M^*; Atmar Robert L; El Sahly Hana M; Cate Thomas R; Keitel Wendy A

来源：Vaccine, 2010, 28(17): 3025-3029.

DOI：10.1016/j.vaccine.2009.10.152

• Intradermal vaccination
• Pandemic influenza
• H5N1 vaccine

In a phase I clinical trial, one hundred healthy young adults were randomized to receive two doses 28 days apart of an inactivated, subvirion vaccine containing 15 or 45 mu g of influenza A/H5N1 hemagglutinin (HA) by the intramuscular (IM) route, or 3 or 9 mu g of H5 HA by the intradermal(ID) route. Seventy-seven subjects received a third dose. All regimens were safe and well tolerated. Antibody responses after two or three doses were low (<= 20% or <= 38%, respectively) and similar in groups given 3 or 9 mu g ID or 15 mu g IM, and were significantly lower than those given 45 mu g IM. Higher dosages of H5 HA and/or inclusion of adjuvant will be required to enhance immunogenicity by the ID route.

• 出版日期2010-4-9