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Trial of 2009 influenza A (H1N1) monovalent MF59-adjuvanted vaccine

Trial of 2009 influenza A (H1N1) monovalent MF59-adjuvanted vaccine
Trial of 2009 influenza A (H1N1) monovalent MF59-adjuvanted vaccine
BACKGROUND: The 2009 pandemic influenza A (H1N1) virus has emerged to cause the first pandemic of the 21st century. Development of effective vaccines is a public health priority.

METHODS: We conducted a single-center study, involving 176 adults, 18 to 50 years of age, to test the monovalent influenza A/California/2009 (H1N1) surface-antigen vaccine, in both MF59-adjuvanted and nonadjuvanted forms. Subjects were randomly assigned to receive two intramuscular injections of vaccine containing 7.5 microg of hemagglutinin on day 0 in each arm or one injection on day 0 and the other on day 7, 14, or 21; or two 3.75-microg doses of MF59-adjuvanted vaccine, or 7.5 or 15 microg of nonadjuvanted vaccine, administered 21 days apart. Antibody responses were measured by means of hemagglutination-inhibition assay and a microneutralization assay on days 0, 14, 21, and 42 after injection of the first dose.

RESULTS: The most frequent local and systemic reactions were pain at the injection site and muscle aches, noted in 70% and 42% of subjects, respectively; reactions were more common with the MF59-adjuvanted vaccine than with nonadjuvanted vaccine. Three subjects reported fever, with a temperature of 38 degrees C or higher, after either dose. Antibody titers, expressed as geometric means, were higher at day 21 among subjects who had received one dose of MF59-adjuvanted vaccine than among those who had received one dose of nonadjuvanted vaccine (P<0.001 by the microneutralization assay). By day 21, hemagglutination-inhibition and microneutralization antibody titers of 1:40 or more were seen in 77 to 96% and 92 to 100% of subjects receiving MF59-adjuvanted vaccine, respectively, and in 63 to 72% and 67 to 76% of those receiving nonadjuvanted vaccine, respectively. By day 42, after two doses of vaccine, hemagglutination-inhibition and microneutralization antibody titers of 1:40 or more were seen in 92 to 100% and 100% of recipients of MF59-adjuvanted vaccine, respectively, and in 74 to 79% and 78 to 83% of recipients of nonadjuvanted vaccine, respectively.

CONCLUSIONS: Monovalent 2009 influenza A (H1N1) MF59-adjuvanted vaccine generates antibody responses likely to be associated with protection after a single dose is administered. (ClinicalTrials.gov number, NCT00943358).
2424-2435
Clark, T.
712ec18e-613c-45df-a013-c8a22834e14f
Pareek, M.
19ebd2b3-9d91-4f35-8550-0c3ad6420cc4
Hoschler, K.
ee23d12e-ae8b-4376-87fd-9d1c4e850f45
Dillon, H.
2a1d8637-38ab-447b-8fcf-94a53dad3bee
Nicholson, K.G.
f5ee1433-1c07-4dc3-8a83-62d971f5ec3a
Groth, N.
de1333ff-2f48-4c7f-a4c4-909a6f33fcc7
Stephenson, I.
cffd5c3c-042f-4902-a2c3-b07b7b79a470
Clark, T.
712ec18e-613c-45df-a013-c8a22834e14f
Pareek, M.
19ebd2b3-9d91-4f35-8550-0c3ad6420cc4
Hoschler, K.
ee23d12e-ae8b-4376-87fd-9d1c4e850f45
Dillon, H.
2a1d8637-38ab-447b-8fcf-94a53dad3bee
Nicholson, K.G.
f5ee1433-1c07-4dc3-8a83-62d971f5ec3a
Groth, N.
de1333ff-2f48-4c7f-a4c4-909a6f33fcc7
Stephenson, I.
cffd5c3c-042f-4902-a2c3-b07b7b79a470

Clark, T., Pareek, M., Hoschler, K., Dillon, H., Nicholson, K.G., Groth, N. and Stephenson, I. (2009) Trial of 2009 influenza A (H1N1) monovalent MF59-adjuvanted vaccine. New England Journal of Medicine, 361 (25), 2424-2435. (doi:10.1056/NEJMoa0907650). (PMID:19745215)

Record type: Article

Abstract

BACKGROUND: The 2009 pandemic influenza A (H1N1) virus has emerged to cause the first pandemic of the 21st century. Development of effective vaccines is a public health priority.

METHODS: We conducted a single-center study, involving 176 adults, 18 to 50 years of age, to test the monovalent influenza A/California/2009 (H1N1) surface-antigen vaccine, in both MF59-adjuvanted and nonadjuvanted forms. Subjects were randomly assigned to receive two intramuscular injections of vaccine containing 7.5 microg of hemagglutinin on day 0 in each arm or one injection on day 0 and the other on day 7, 14, or 21; or two 3.75-microg doses of MF59-adjuvanted vaccine, or 7.5 or 15 microg of nonadjuvanted vaccine, administered 21 days apart. Antibody responses were measured by means of hemagglutination-inhibition assay and a microneutralization assay on days 0, 14, 21, and 42 after injection of the first dose.

RESULTS: The most frequent local and systemic reactions were pain at the injection site and muscle aches, noted in 70% and 42% of subjects, respectively; reactions were more common with the MF59-adjuvanted vaccine than with nonadjuvanted vaccine. Three subjects reported fever, with a temperature of 38 degrees C or higher, after either dose. Antibody titers, expressed as geometric means, were higher at day 21 among subjects who had received one dose of MF59-adjuvanted vaccine than among those who had received one dose of nonadjuvanted vaccine (P<0.001 by the microneutralization assay). By day 21, hemagglutination-inhibition and microneutralization antibody titers of 1:40 or more were seen in 77 to 96% and 92 to 100% of subjects receiving MF59-adjuvanted vaccine, respectively, and in 63 to 72% and 67 to 76% of those receiving nonadjuvanted vaccine, respectively. By day 42, after two doses of vaccine, hemagglutination-inhibition and microneutralization antibody titers of 1:40 or more were seen in 92 to 100% and 100% of recipients of MF59-adjuvanted vaccine, respectively, and in 74 to 79% and 78 to 83% of recipients of nonadjuvanted vaccine, respectively.

CONCLUSIONS: Monovalent 2009 influenza A (H1N1) MF59-adjuvanted vaccine generates antibody responses likely to be associated with protection after a single dose is administered. (ClinicalTrials.gov number, NCT00943358).

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More information

e-pub ahead of print date: 10 September 2009
Published date: 17 December 2009
Organisations: Faculty of Medicine

Identifiers

Local EPrints ID: 356770
URI: https://eprints.soton.ac.uk/id/eprint/356770
PURE UUID: 35228245-17b7-42d9-ba96-e3aad28c1ca2
ORCID for T. Clark: ORCID iD orcid.org/0000-0001-6026-5295

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Date deposited: 25 Sep 2013 15:53
Last modified: 06 Jun 2018 12:23

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Contributors

Author: T. Clark ORCID iD
Author: M. Pareek
Author: K. Hoschler
Author: H. Dillon
Author: K.G. Nicholson
Author: N. Groth
Author: I. Stephenson

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