BACKGROUND: During development of an A/H1N1 pandemic influenza vaccine, this study was performed to identify the antigen and adjuvant content which would provide optimal antibody response and persistence in adults and the elderly. Dose-sparing strategies, such as inclusion of adjuvants, are critical in ensuring the widest possible population coverage in the event of an influenza pandemic, despite a limited global capacity for vaccine manufacture. METHODS:Healthy subjects aged 18-64 years (n = 1240) and ≥65 years (n = 1352) were vaccinated with 1 of 8 investigational vaccine formulations varying in antigen quantity (3.75 µg to 30 µg of hemagglutinin) and MF59(®) adjuvant (none, half dose, or full dose). All subjects received 2 vaccine doses administered 3 weeks apart. Antibody response was assessed by hemagglutination inhibition assay 1 and 3 weeks after administration of first and second doses. Antibody persistence was assessed after 6 and 12 mo. Vaccine safety was monitored over 12 mo. RESULTS: All 8 investigational A/H1N1 vaccine formulations were well tolerated, and rapidly induced high antibody titers which met all of the Center for Biologics Evaluation and Research (CBER) and Committee for Medicinal Products for Human Use (CHMP) licensure criteria 3 weeks after one dose. The highest antibody titers were observed in participants vaccinated with higher quantities of antigen and adjuvant. CONCLUSION: A single vaccine dose containing 3.75 µg of A/California/7/2009 (H1N1) antigen with MF59 adjuvant was identified as optimal for young to middle-aged (18-64 years) and older (≥65 years) adult populations.
RCT Entities:
BACKGROUND: During development of an A/H1N1 pandemic influenza vaccine, this study was performed to identify the antigen and adjuvant content which would provide optimal antibody response and persistence in adults and the elderly. Dose-sparing strategies, such as inclusion of adjuvants, are critical in ensuring the widest possible population coverage in the event of an influenza pandemic, despite a limited global capacity for vaccine manufacture. METHODS: Healthy subjects aged 18-64 years (n = 1240) and ≥65 years (n = 1352) were vaccinated with 1 of 8 investigational vaccine formulations varying in antigen quantity (3.75 µg to 30 µg of hemagglutinin) and MF59(®) adjuvant (none, half dose, or full dose). All subjects received 2 vaccine doses administered 3 weeks apart. Antibody response was assessed by hemagglutination inhibition assay 1 and 3 weeks after administration of first and second doses. Antibody persistence was assessed after 6 and 12 mo. Vaccine safety was monitored over 12 mo. RESULTS: All 8 investigational A/H1N1 vaccine formulations were well tolerated, and rapidly induced high antibody titers which met all of the Center for Biologics Evaluation and Research (CBER) and Committee for Medicinal Products for Human Use (CHMP) licensure criteria 3 weeks after one dose. The highest antibody titers were observed in participants vaccinated with higher quantities of antigen and adjuvant. CONCLUSION: A single vaccine dose containing 3.75 µg of A/California/7/2009 (H1N1) antigen with MF59 adjuvant was identified as optimal for young to middle-aged (18-64 years) and older (≥65 years) adult populations.
Authors: Murdo Ferguson; George Risi; Matthew Davis; Eric Sheldon; Mira Baron; Ping Li; Miguel Madariaga; Louis Fries; Olivier Godeaux; David Vaughn Journal: J Infect Dis Date: 2012-03-01 Impact factor: 5.226
Authors: Christoph Hatz; Frank von Sonnenburg; Daniela Casula; Maria Lattanzi; Geert Leroux-Roels Journal: Vaccine Date: 2012-03-22 Impact factor: 3.641
Authors: Timo Vesikari; Markus Knuf; Peter Wutzler; Aino Karvonen; Dorothee Kieninger-Baum; Heinz-Josef Schmitt; Frank Baehner; Astrid Borkowski; Theodore F Tsai; Ralf Clemens Journal: N Engl J Med Date: 2011-10-13 Impact factor: 91.245
Authors: Neil M Ferguson; Derek A T Cummings; Christophe Fraser; James C Cajka; Philip C Cooley; Donald S Burke Journal: Nature Date: 2006-04-26 Impact factor: 49.962
Authors: Patricia Winokur; Hana M El Sahly; Mark J Mulligan; Sharon E Frey; Richard Rupp; Evan J Anderson; Kathryn M Edwards; David I Bernstein; Kenneth Schmader; Lisa A Jackson; Wilbur H Chen; Heather Hill; Abigail Bellamy Journal: Vaccine Date: 2021-01-21 Impact factor: 3.641
Authors: Nicos Karasavvas; Chitraporn Karnasuta; Hathairat Savadsuk; Sirinan Madnote; Dutsadee Inthawong; Somsak Chantakulkij; Surawach Rittiroongrad; Sorachai Nitayaphan; Punnee Pitisuttithum; Prasert Thongcharoen; Vinai Siriyanon; Charla A Andrews; Susan W Barnett; James Tartaglia; Faruk Sinangil; Donald P Francis; Merlin L Robb; Nelson L Michael; Viseth Ngauy; Mark S de Souza; Robert M Paris; Jean-Louis Excler; Jerome H Kim; Robert J O'Connell Journal: AIDS Res Hum Retroviruses Date: 2015-09-09 Impact factor: 2.205
Authors: Fatima Laher; Zoe Moodie; Kristen W Cohen; Nicole Grunenberg; Linda-Gail Bekker; Mary Allen; Nicole Frahm; Nicole L Yates; Lynn Morris; Mookho Malahleha; Kathryn Mngadi; Brodie Daniels; Craig Innes; Kevin Saunders; Shannon Grant; Chenchen Yu; Peter B Gilbert; Sanjay Phogat; Carlos A DiazGranados; Marguerite Koutsoukos; Olivier Van Der Meeren; Carter Bentley; Nonhlanhla N Mkhize; Michael N Pensiero; Vijay L Mehra; James G Kublin; Lawrence Corey; David C Montefiori; Glenda E Gray; M Juliana McElrath; Georgia D Tomaras Journal: PLoS Med Date: 2020-02-24 Impact factor: 11.069