Safety and Immunogenicity of a Subvirion Monovalent Unadjuvanted Inactivated Influenza A(H3N2) Variant Vaccine in Healthy Persons ≥18 Years Old

Wendy A Keitel; Lisa A Jackson; Srilatha Edupuganti; Patricia L Winokur; Mark J Mulligan; Natalie J Thornburg; Shital M Patel; Nadine G Rouphael; Lilin Lai; Sandhya Bangaru; Monica M McNeal; Abbie R Bellamy; Heather R Hill; VTEU H3N2v Vaccine Study Work Group

doi:10.1093/infdis/jiv056

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Safety and Immunogenicity of a Subvirion Monovalent Unadjuvanted Inactivated Influenza A(H3N2) Variant Vaccine in Healthy Persons ≥18 Years Old

Journal article

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Peer reviewed

Safety and Immunogenicity of a Subvirion Monovalent Unadjuvanted Inactivated Influenza A(H3N2) Variant Vaccine in Healthy Persons ≥18 Years Old

Wendy A Keitel, Lisa A Jackson, Srilatha Edupuganti, Patricia L Winokur, Mark J Mulligan, Natalie J Thornburg, Shital M Patel, Nadine G Rouphael, Lilin Lai, Sandhya Bangaru, …

The Journal of infectious diseases, Vol.212(4), pp.552-561

08/15/2015

DOI: 10.1093/infdis/jiv056

PMCID: PMC4539893

PMID: 25649171

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Abstract

Variant influenza A(H3N2) viruses (H3N2v) have transmitted recently from pigs to humans in the United States. Vaccines strategies are needed. Healthy adults received 2 doses of subvirion H3N2v vaccine (15 µg of hemagglutinin/dose) 21 days apart in this open-label trial. Serum hemagglutination inhibition (HAI) and neutralizing (Neut) antibody (Ab) titers were measured before and 8 and 21 days after each dose. Memory B-cell (MBC) responses were assessed. Vaccine was well tolerated. A total of 40% of subjects had an HAI Ab titer of ≥40 before vaccination. Eight-seven percent (95% confidence interval [CI], 79%-93%) and 73% (95% CI, 63%-81%) of subjects 18-64 years old (98 subjects) and ≥65 years old (90 subjects), respectively, had an HAI titer of ≥40 21 days after dose 1 (P = .01); 51% (95% CI, 41%-61%) and 52% (95% CI, 41%-62%) of younger and older subjects, respectively, developed ≥4-fold rises in titer (P = not significant). Neut Ab response patterns were similar. Geometric mean titers were higher in younger subjects. Dose 2 provided no significant enhancement in responses. Cross-reactive MBCs were detected before vaccination and expanded after vaccination. Preexisting H3N2v-specific MBCs positively correlated with early increases in vaccine-induced Ab. In most healthy adults, one 15-µg dose of vaccine elicited levels of HAI Abs associated with protection. Studies in children and elderly individuals are indicated to define the immunization needs of these groups. NCT01746082.

Immunoglobulin G - blood

Humans

Middle Aged

Male

Influenza A Virus, H3N2 Subtype - immunology

Antibodies, Viral - blood

Young Adult

B-Lymphocytes - immunology

Influenza Vaccines - immunology

Adolescent

Adult

Female

Aged

Influenza, Human - prevention & control

Details

Title: Subtitle: Safety and Immunogenicity of a Subvirion Monovalent Unadjuvanted Inactivated Influenza A(H3N2) Variant Vaccine in Healthy Persons ≥18 Years Old
Creators: Wendy A Keitel - Department of Molecular Virology & Microbiology Department of Medicine, Baylor College of Medicine, Houston, Texas
Lisa A Jackson - Group Health Research Institute, Seattle, Washington
Srilatha Edupuganti - The Hope Clinic of the Emory Vaccine Center Department of Medicine, Division of Infectious Diseases, Emory University School of Medicine, Atlanta, Georgia
Patricia L Winokur - Department of Internal Medicine, University of Iowa Iowa City VA Health System, Iowa City
Mark J Mulligan - The Hope Clinic of the Emory Vaccine Center Department of Medicine, Division of Infectious Diseases, Emory University School of Medicine, Atlanta, Georgia
Natalie J Thornburg - Vanderbilt Vaccine Center Department of Pathology, Microbiology and Immunology Department of Pediatrics, Vanderbilt University, Nashville, Tennessee
Shital M Patel - Department of Molecular Virology & Microbiology Department of Medicine, Baylor College of Medicine, Houston, Texas
Nadine G Rouphael - The Hope Clinic of the Emory Vaccine Center Department of Medicine, Division of Infectious Diseases, Emory University School of Medicine, Atlanta, Georgia
Lilin Lai - The Hope Clinic of the Emory Vaccine Center Department of Medicine, Division of Infectious Diseases, Emory University School of Medicine, Atlanta, Georgia
Sandhya Bangaru - Vanderbilt Vaccine Center Department of Pathology, Microbiology and Immunology Department of Pediatrics, Vanderbilt University, Nashville, Tennessee
Monica M McNeal - Cincinnati Children's Hospital Medical Center, University of Cincinnati, Ohio
Abbie R Bellamy - EMMES Corporation, Rockville, Maryland
Heather R Hill - EMMES Corporation, Rockville, Maryland
VTEU H3N2v Vaccine Study Work Group
Resource Type: Journal article
Publication Details: The Journal of infectious diseases, Vol.212(4), pp.552-561
DOI: 10.1093/infdis/jiv056
PMID: 25649171
PMCID: PMC4539893
ISSN: 0022-1899
eISSN: 1537-6613
Grant note: HHSN272200800005C / PHS HHS HHSN272200800005C / NIAID NIH HHS UL1 TR000454 / NCATS NIH HHS HHSN272200800007C / NIAID NIH HHS HHSN272200800006C / PHS HHS HHSN272200800013C / NIAID NIH HHS HHSN272200800002C / NIAID NIH HHS T32 AI074492 / NIAID NIH HHS HHSN272200800002C / PHS HHS HHSN272200800004C / NIAID NIH HHS HHSN272200800007C / PHS HHS U54 TR001356 / NCATS NIH HHS HHSN272200800008C / PHS HHS HHSN272200800006C / NIAID NIH HHS HHSN272200800008C / NIAID NIH HHS HHSN272200800013C / PHS HHS HHSN272200800004C / PHS HHS UL1TR000454 / NCATS NIH HHS
Language: English
Date published: 08/15/2015
Academic Unit: Infectious Diseases; Medicine Administration; Internal Medicine
Record Identifier: 9984094532802771

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