A phase II study of an investigational tetravalent influenza vaccine formulation combining MF59<sup>®</sup>

Herbinger, Karl‐Heinz; Sonnenburg, Frank von; Nothdurft, Hans Dieter; Perona, Pamela; Borkowski, Astrid; Fragapane, Elena; Nicolay, Uwe; Clemens, Ralf

doi:10.4161/hv.26495

Cited by 7 publications

(2 citation statements)

References 26 publications

(30 reference statements)

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“…As expected, aQIV excelled in the production of antibodies to both B lineages, that was not observed after aTIV use [ 9 ]. Similar results were obtained in other studies where aQIV was used [ 13 , 14 ].…”

Section: Introductionsupporting

confidence: 90%

Immunogenicity and Safety of the Quadrivalent Adjuvant Subunit Influenza Vaccine in Seropositive and Seronegative Healthy People and Patients with Common Variable Immunodeficiency

et al. 2020

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Background. Influenza prophylaxis with the use of quadrivalent vaccines (QIV) is increasingly being introduced into healthcare practice. Methods. In total, 32 healthy adults and 6 patients with common variable immunodeficiency (CVID) received adjuvant QIV during 2018–2019 influenza season. Depending on initial antibody titers, healthy volunteers were divided into seronegative (≤1:20) and seropositive (≥1:40). To evaluate immunogenicity hemagglutination inhibition assay was used. Results. All participants completed the study without developing serious post-vaccination reactions. Analysis of antibody titer 3 weeks after immunization in healthy participants showed that seroprotection, seroconversion levels, GMR and GMT for strains A/H1N1, A/H3N2 and B/Colorado, B/Phuket among initially seronegative and seropositive participants meet the criterion of CHMP effectiveness. CVID patients showed increase in post-vaccination antibody titer without reaching conditionally protective antibody levels. Conclusion. Adjuvant QIV promotes formation of specific immunity to vaccine strains, regardless of antibodies’ presence or absence before. In CVID patients search of new regimens should be continued.

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Section: Introductionsupporting

confidence: 90%

Immunogenicity and Safety of the Quadrivalent Adjuvant Subunit Influenza Vaccine in Seropositive and Seronegative Healthy People and Patients with Common Variable Immunodeficiency

et al. 2020

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“…However, many of these antigens induce relatively low levels of functional neutralizing antibody when tested clinically 12 13 14 , which prompted testing of additional pandemic vaccine formulations containing adjuvants 15 . The most commonly used adjuvants in clinical stage H5N1 vaccines are alum (Alhydrogel, Adju-Phos ® ) and oil-in-water emulsions containing squalene 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 . Emulsion-adjuvanted H5N1 vaccines have been thoroughly tested clinically, and have been shown to improve vaccine potency, and to provide critical dose sparing functions.…”

mentioning

confidence: 99%

A Formulated TLR7/8 Agonist is a Flexible, Highly Potent and Effective Adjuvant for Pandemic Influenza Vaccines

Hoeven

Fox

Granger

et al. 2017

Sci Rep

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Since 1997, highly pathogenic avian influenza viruses of the H5N1 subtype have been transmitted from avian hosts to humans. The severity of H5N1 infection in humans, as well as the sporadic nature of H5N1 outbreaks, both geographically and temporally, make generation of an effective vaccine a global public health priority. An effective H5N1 vaccine must ultimately provide protection against viruses from diverse clades. Toll-like receptor (TLR) agonist adjuvant formulations have a demonstrated ability to broaden H5N1 vaccine responses in pre-clinical models. However, many of these agonist molecules have proven difficult to develop clinically. Here, we describe comprehensive adjuvant formulation development of the imidazoquinoline TLR-7/8 agonist 3M-052, in combination with H5N1 hemagglutinin (HA) based antigens. We find that 3M-052 in multiple formulations protects both mice and ferrets from lethal H5N1 homologous virus challenge. Furthermore, we conclusively demonstrate the ability of 3M-052 adjuvant formulations to broaden responses to H5N1 HA based antigens, and show that this broadening is functional using a heterologous lethal virus challenge in ferrets. Given the extensive clinical use of imidazoquinoline TLR agonists for other indications, these studies identify multiple adjuvant formulations which may be rapidly advanced into clinical trials in an H5N1 vaccine.

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Prevention of Emerging Infections in Children

Puthanakit

Anugulruengkitt

Jantarabenjakul

2022

Pediatric Clinics of North America

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A phase II study of an investigational tetravalent influenza vaccine formulation combining MF59^®

Cited by 7 publications

References 26 publications

Immunogenicity and Safety of the Quadrivalent Adjuvant Subunit Influenza Vaccine in Seropositive and Seronegative Healthy People and Patients with Common Variable Immunodeficiency

Immunogenicity and Safety of the Quadrivalent Adjuvant Subunit Influenza Vaccine in Seropositive and Seronegative Healthy People and Patients with Common Variable Immunodeficiency

A Formulated TLR7/8 Agonist is a Flexible, Highly Potent and Effective Adjuvant for Pandemic Influenza Vaccines

Prevention of Emerging Infections in Children

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A phase II study of an investigational tetravalent influenza vaccine formulation combining MF59®

Cited by 7 publications

References 26 publications

Immunogenicity and Safety of the Quadrivalent Adjuvant Subunit Influenza Vaccine in Seropositive and Seronegative Healthy People and Patients with Common Variable Immunodeficiency

Immunogenicity and Safety of the Quadrivalent Adjuvant Subunit Influenza Vaccine in Seropositive and Seronegative Healthy People and Patients with Common Variable Immunodeficiency

A Formulated TLR7/8 Agonist is a Flexible, Highly Potent and Effective Adjuvant for Pandemic Influenza Vaccines

Prevention of Emerging Infections in Children

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Product

Resources

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A phase II study of an investigational tetravalent influenza vaccine formulation combining MF59^®