Journal Article

Immunogenicity, Safety, and Cross-Reactivity of an Inactivated, Adjuvanted, Prototype Pandemic Influenza (H5N1) Vaccine: A Phase II, Double-Blind, Randomized Trial

Jiang Wu, Han-Hua Fang, Jiang-Ting Chen, Ji-Chen Zhou, Zi-Jian Feng, Chang-Gui Li, Yuan-Zheng Qiu, Yan Liu, Min Lu, Li-Ying Liu, Shan-Shan Dong, Qiang Gao, Xiao-Mei Zhang, Nan Wang, Wei-Dong Yin and Xiao-Ping Dong

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 48, issue 8, pages 1087-1095
Published in print April 2009 | ISSN: 1058-4838
Published online April 2009 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/597401
Immunogenicity, Safety, and Cross-Reactivity of an Inactivated, Adjuvanted, Prototype Pandemic Influenza (H5N1) Vaccine: A Phase II, Double-Blind, Randomized Trial

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Background. Avian influenza A virus H5N1 has the potential to cause a pandemic. Adjuvants and whole-virion vaccines are regarded as antigen sparing for pandemic vaccines.

Methods. A double-blind, randomized trial was performed from 28 August to 22 December 2007 in 402 adults; 301 adults were randomly assigned to receive 2 doses of an inactivated, aluminum-adjuvanted, whole-virion H5N1 vaccine containing 5, 10, or 15 μg of hemagglutinin per dose 28 days apart, and 101 of them received 2 doses of 10 μg of vaccine 14 days apart. The vaccine was manufactured from the recombinant A/Vietman/1194/2004 (NIBRG14) strain. Blood samples were collected for hemagglutination inhibition and microneutralization assays.

Results. All formulations were well tolerated, with no serious adverse events. Most local and systemic reactions were mild or moderate. Immune responses were induced after 1 dose in all vaccination groups. The highest immune response was seen after 2 doses of 15 μg of vaccine, with 90% and 100% seroconversion rates and 90% and 100% of participants having a titer of ⩾1:40 for hemagglutination inhibition and microneutralization assays, respectively. Both the 10- and 15-μg doses met or exceeded European Union licensure criteria. Generally, higher immune responses were elicited in participants vaccinated 28 days apart than those vaccinated 14 days apart. Cross-reaction assays showed that after 2 doses of 10 μg of vaccine, 98% and 87% of participants had a microneutralization titer of ⩾1:40 against heterologous Indonesia and Anhui strains, respectively.

Conclusions. The inactivated, aluminum-adjuvanted, whole-virion H5N1 vaccine not only showed good immunogenicity and safety but also elicited significant cross-reactivity against heterologous H5N1 strains in clade 2.

Trial registration. ClinicalTrials.gov identifier: NCT00535665.

Journal Article.  4115 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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