ArticleOpen forum infectious diseases2014
Point-of-Use Mixing of Influenza H5N1 Vaccine and MF59 Adjuvant for Pandemic Vaccination Preparedness: Antibody Responses and Safety. A Phase 1 Clinical Trial.
Article in Open forum infectious diseases, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
11 citing papers in PubMed.
- Safety and immunogenicity of ascending doses of influenza A(H7N9) inactivated vaccine with or without MF59®.Vaccine · 2025Trial
- Future Goals and Long-term Vision of the Infectious Diseases Clinical Research Consortium/Vaccine and Treatment Evaluation Unit Network.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Article
- From Yesterday to Tomorrow: How Vaccine Platforms Have Shaped the Vaccine and Treatment Evaluation Units.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Article
- Emerging and Pandemic Pathogens: Lessons Learned From a Clinical Research Network.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Review
- AVIAN INFLUENZA VIRUS: THE NEXT PANDEMIC?Transactions of the American Clinical and Climatological Association · 2025Review
- The antibody landscapes following AS03 and MF59 adjuvanted H5N1 vaccination.NPJ vaccines · 2022Article
- Squalene Emulsion Manufacturing Process Scale-Up for Enhanced Global Pandemic Response.Pharmaceuticals (Basel, Switzerland) · 2020Article
- A New Adjuvant MTOM MediatesFrontiers in immunology · 2017Article
- An oil-in-water nanoemulsion enhances immunogenicity of H5N1 vaccine in mice.Nanomedicine : nanotechnology, biology, and medicine · 2016Article
- Extrapolating theoretical efficacy of inactivated influenza A/H5N1 virus vaccine from human immunogenicity studies.Vaccine · 2016Article
- Review
Corrections and comments
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Authors and funding
59 authors.
Funding
Abstract
backgroundAvian influenza A/H5N1 has threatened human health for nearly 2 decades. Avian influenza A vaccine without adjuvant is poorly immunogenic. A flexible rapid tactic for mass vaccination will be needed if a pandemic occurs.
methodsA multicenter, randomized, blinded phase 1 clinical trial evaluated safety and antibody responses after point-of-use mixing of influenza A/Indonesia/05/2005 (H5N1) vaccine with MF59 adjuvant. Field-site pharmacies mixed 3.75, 7.5, or 15 mcg of antigen with or without MF59 adjuvant just prior to intramuscular administration on days 0 and 21 of healthy adults aged 18-49 years.
resultsTwo hundred and seventy subjects were enrolled. After vaccination, titers of hemagglutination inhibition antibody ≥1:40 were achieved in 80% of subjects receiving 3.75 mcg + MF59 vs only 14% receiving 15 mcg without adjuvant (P < .0001). Peak hemagglutination inhibition antibody geometric mean titers for vaccine + MF59 were ∼65 regardless of antigen dose, and neutralizing titers were 2- to 3-fold higher. Vaccine + MF59 produced cross-reactive antibody responses against 4 heterologous H5N1 viruses. Excellent safety and tolerability were demonstrated.
conclusionsPoint-of-use mixing of H5N1 antigen and MF59 adjuvant achieved target antibody titers in a high percentage of subjects and was safe. The feasibility of the point-of-use mixing should be studied further.
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