A Multicenter, Open-Label Study to Assess the Immunogenicity and Safety of a Booster Vaccination With a Recombinant H5N1 Influenza HA Vaccine in Healthy Young Adults Primed With a Two-Vaccination of a Recombinant H5N1 Influenza HA Vaccine

The study is designed to assess the immunogenicity and safety of one booster vaccination with 45 μg of a recombinant H5N1 influenza (A/Indonesia/05/2005) HA vaccine in healthy young adults, previously primed with a two-vaccination of 3 different doses of a recombinant H5N1 influenza (A/Vietnam/1203/2004) HA vaccine in a priming study (JPIP501-01a, NCT00980447).

开始日期2010-10-01

申办/合作机构

UMN Pharma, Inc.

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100 项与 Recombinant seasonal influenza HA vaccine(UMN Pharma, Inc) 相关的转化医学

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100 项与 Recombinant seasonal influenza HA vaccine(UMN Pharma, Inc) 相关的专利（医药）

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项与 Recombinant seasonal influenza HA vaccine(UMN Pharma, Inc) 相关的文献（医药）

2023-05-01·Reviews in Medical Virology2区 · 医学

Systematic review of the efficacy, effectiveness and safety of recombinant haemagglutinin seasonal influenza vaccines for the prevention of laboratory‐confirmed influenza in individuals ≥18 years of age

2区 · 医学

Review

作者: Pebody, Richard ; Hawkshaw, Sarah ; Comber, Laura ; Nohynek, Hanna ; Carnahan, Annasara ; Teljeur, Conor ; Krause, Tyra ; O’Neill, Michelle ; Robertson, Anna Hayman ; Jordan, Karen ; Wichmann, Ole ; Penttinen, Pasi ; Pavlopoulou, Ioanna ; Johansen, Kari ; Marshall, Liam ; Ryan, Máirín ; Nicolay, Nathalie ; Soler‐Soneira, Marta ; Jonge, Jorgen de ; Harrington, Patricia ; O Murchu, Eamon ; Pérez, Jaime Jesús

AbstractThe most effective means of preventing seasonal influenza is through vaccination. In this systematic review, we investigated the efficacy, effectiveness and safety of recombinant haemagglutinin (HA) seasonal influenza vaccines to prevent laboratory‐confirmed influenza. A systematic literature search was conducted in electronic databases and grey literature sources up to 7 February 2020. Randomised controlled trials and non‐randomised studies of interventions were eligible for inclusion. The search returned 28,846 records, of which 10 studies on recombinant HA influenza vaccine met our inclusion criteria. One study found that the quadrivalent recombinant HA influenza vaccine had higher relative vaccine efficacy (rVE) in preventing laboratory‐confirmed influenza during the 2014–15 season compared with traditional quadrivalent vaccination in adults aged ≥50 years (rVE = 30%, 95% CI 10%–47%, moderate‐certainty evidence). In a subgroup analysis, higher rVE was reported for influenza A (rVE = 36%, 95% CI 14% to 53%), but not for B (non‐significant). Another study reported higher efficacy for the trivalent recombinant HA vaccine compared with placebo (VE = 45%, 95% CI 19–63, 1 RCT, low‐certainty evidence) in adults aged 18–55 years. With the exception of a higher rate of chills (RR = 1.33, 95% CI 1.03–1.72), the safety profile of recombinant HA vaccines was comparable to that of traditional influenza vaccines. The evidence base for the efficacy and effectiveness of recombinant HA influenza vaccines is limited at present, although one study found that the quadrivalent recombinant HA influenza vaccine had higher rVE compared with traditional quadrivalent vaccination in adults aged ≥50 years.

2018-09-02·Human Vaccines & Immunotherapeutics3区 · 医学

T cell epitope engineering: an avian H7N9 influenza vaccine strategy for pandemic preparedness and response

3区 · 医学

Review

作者: Jang, Hyesun ; Schiffer, Celia ; M. Ross, Ted ; Martin, William D. ; De Groot, Anne S. ; M. Biron, Bethany ; Moise, Leonard ; Kurt Yilmaz, Nese ; Boyle, Christine M.

The delayed availability of vaccine during the 2009 H1N1 influenza pandemic created a sense of urgency to better prepare for the next influenza pandemic. Advancements in manufacturing technology, speed and capacity have been achieved but vaccine effectiveness remains a significant challenge. Here, we describe a novel vaccine design strategy called immune engineering in the context of H7N9 influenza vaccine development. The approach combines immunoinformatic and structure modeling methods to promote protective antibody responses against H7N9 hemagglutinin (HA) by engineering whole antigens to carry seasonal influenza HA memory CD4⁺ T cell epitopes - without perturbing native antigen structure - by galvanizing HA-specific memory helper T cells that support sustained antibody development against the native target HA. The premise for this vaccine concept rests on (i) the significance of CD4⁺ T cell memory to influenza immunity, (ii) the essential role CD4⁺ T cells play in development of neutralizing antibodies, (iii) linked specificity of HA-derived CD4⁺ T cell epitopes to antibody responses, (iv) the structural plasticity of HA and (v) an illustration of improved antibody response to a prototype engineered recombinant H7-HA vaccine. Immune engineering can be applied to development of vaccines against pandemic concerns, including avian influenza, as well as other difficult targets.

2016-08-02·Expert Review of Vaccines2区 · 医学

Recombinant hemagglutinin influenza vaccine provides broader spectrum protection

2区 · 医学

Review

作者: Izikson, Ruvim ; Dunkle, Lisa M.

INTRODUCTIONInfluenza causes annual epidemics worldwide that pose a significant public health burden and current predominant vaccines, while the most effective means of combatting the disease, provide sub-optimal protection. New more broadly effective vaccines are an important public health need.AREAS COVEREDInfluenza hemagglutinin (HA) is the principal viral surface protein that induces protective immunity to influenza infection. A recombinant seasonal influenza hemagglutinin (rHA) vaccine, recently introduced in the U.S., has demonstrated promising efficacy and safety in a number of clinical trials in adults. The immunodominant globular head of the HA protein induces antibodies that are narrowly specific to individual antigenically varied strains of influenza virus, resulting in poor affinity for antigenically drifted strains and the need for repeated annual vaccination. Broader spectrum protection may be achieved with immunity directed at more conserved viral antigens. We reviewed the data from clinical trials of the rHA vaccine conducted during seasonal epidemics characterized by antigenic mismatch between vaccine and circulating strains of influenza. Expert commentary: These data suggest that the rHA proteins produced in Lepidopteran cells offer broader-spectrum protection and result in clinical benefit.

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