Safety and Immunogenicity of a Subvirion Monovalent Unadjuvanted Inactivated Influenza A(H3N2) Variant Vaccine in Healthy Persons ≥18 Years Old
| Autor: | Keitel, Wendy A., Jackson, Lisa A., Edupuganti, Srilatha, Winokur, Patricia L., Mulligan, Mark J., Thornburg, Natalie J., Patel, Shital M., Rouphael, Nadine G., Lai, Lilin, Bangaru, Sandhya, McNeal, Monica M., Bellamy, Abbie R., Hill, Heather R., Bond, Nanette, Bosworth, Kathy, Brown, Janet, Banay, Jess, Cheesman, Coni, Lanford, Tracey, Munoz, Flor, Wells, Janet, Carste, Barb, Dunstan, Maya, Mathis, Angel, Parikh, Mihir, Phillips, C. Hallie, Spingola, Alyssa, Starkovich, Pat, Suyehira, Janice, Beck, Allison, Mask, Karen, Bower, Mary, Osinski, Eileen, Rimann, Nayoka, Turner, Pamela, Wang, DongLi, Stapleton, Jack, Won, Regina, Wagner, Nancy, Dull, Geraldine, Gerot, Necole, Reidy, Mary, Zhao, Dan, Segar, Ellen, Slaughter, James C., McDonough, Megan, He, Fenhua, Salata, Robert, Meissner, Cody, Sheffield, Jeanne, Spigarelli, Michael, Greenberg, Stephen, Agrawal, Anoop, Dublin, Sascha, Arterburn, David, Rimland, David, Ribner, Bruce, Meier, Jeff, Buchanan, Wendy, Chang, Soju, Lambert, Linda, Murray, Suzanne, Riddle, Valerie, Spiro, David |
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| Jazyk: | angličtina |
| Rok vydání: | 2015 |
| Předmět: |
Adult
Male medicine.medical_specialty Hemagglutination Inhibition Tests Adolescent Antibodies Viral Major Articles and Brief Reports Young Adult Internal medicine Influenza Human Immunology and Allergy Medicine Humans Aged B-Lymphocytes Hemagglutination assay biology business.industry Immunogenicity Influenza A Virus H3N2 Subtype Middle Aged Confidence interval Vaccination Titer Infectious Diseases Immunization Influenza Vaccines Immunoglobulin G Immunology biology.protein Female Antibody business |
| Popis: | Background Variant influenza A(H3N2) viruses (H3N2v) have transmitted recently from pigs to humans in the United States. Vaccines strategies are needed. Methods 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. Results 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. Conclusions 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. Clinical trials registration NCT01746082. |
| Databáze: | OpenAIRE |
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