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Point-of-Use Mixing of Influenza H5N1 Vaccine and MF59 Adjuvant for Pandemic Vaccination Preparedness: Antibody Responses and Safety. A Phase 1 Clinical Trial.

Abstract：

BACKGROUND:Avian influenza A/H5N1 has threatened human health for nearly 2 decades. Avian influenza A vaccine without adjuvant is poorly immunogenic. A flexible rapid tactic for mass vaccination will be needed if a pandemic occurs. METHODS:A multicenter, randomized, blinded phase 1 clinical trial evaluated safety and antibody responses after point-of-use mixing of influenza A/Indonesia/05/2005 (H5N1) vaccine with MF59 adjuvant. Field-site pharmacies mixed 3.75, 7.5, or 15 mcg of antigen with or without MF59 adjuvant just prior to intramuscular administration on days 0 and 21 of healthy adults aged 18-49 years. RESULTS:Two hundred and seventy subjects were enrolled. After vaccination, titers of hemagglutination inhibition antibody ≥1:40 were achieved in 80% of subjects receiving 3.75 mcg + MF59 vs only 14% receiving 15 mcg without adjuvant (P < .0001). Peak hemagglutination inhibition antibody geometric mean titers for vaccine + MF59 were ∼65 regardless of antigen dose, and neutralizing titers were 2- to 3-fold higher. Vaccine + MF59 produced cross-reactive antibody responses against 4 heterologous H5N1 viruses. Excellent safety and tolerability were demonstrated. CONCLUSIONS:Point-of-use mixing of H5N1 antigen and MF59 adjuvant achieved target antibody titers in a high percentage of subjects and was safe. The feasibility of the point-of-use mixing should be studied further.

journal_name

Open Forum Infect Dis

journal_title

Open forum infectious diseases

authors

Mulligan MJ,Bernstein DI,Frey S,Winokur P,Rouphael N,Dickey M,Edupuganti S,Spearman P,Anderson E,Graham I,Noah DL,Mangal B,Kim S,Hill H,Whitaker J,Emery W,Beck A,Stephens K,Hartwell B,Ogilvie M,Rimann N,Osinski

doi

10.1093/ofid/ofu102

subject

Has Abstract

pub_date

2014-11-18 00:00:00

pages

ofu102

issue

3

issn

2328-8957

pii

ofu102

journal_volume

1

pub_type

杂志文章

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