Adjuvanted inactivated influenza Vaccine Quadrivalent for Older People

Advanced age is associated with an increase in morbidity and mortality from influenza. Immunization is the best option to protect individuals against influenza and its complications. Older people are less likely than their younger counterparts to mount an appropriate immune response to influenza vaccines. The adjuvanted inactivated influenza vaccine quadrivalent (aIIV4) is designed to elicit a more robust immune response in older people compared with traditional inactivated influenza vaccines. The aIIV4 is indicated for active immunization against influenza caused by influenza virus subtypes A and types B contained in the vaccine and is licensed by the Food and Drug Administration for use in persons 65 years of age and older. The aIIV4 should be administered by intramuscular injection. Like other influenza vaccines, aIIV4 carries a warning regarding the occurrence of Guillain-Barré syndrome. The most common adverse reactions associated with aIIV4 are injection site pain, fatigue, headache, arthralgia, and myalgia.

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LB14. Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine Administered by Intramuscular Route in Subjects Aged 65 Years and Older

Open Forum Infectious Diseases ◽

10.1093/ofid/ofy229.2188 ◽

2018 ◽

Vol 5 (suppl_1) ◽

pp. S764-S764 ◽

Cited By ~ 1

Author(s):

Lee-Jah Chang ◽

Ya Meng ◽

Helene Janosczyk ◽

Victoria Landolfi ◽

H Keipp Talbot ◽

...

Keyword(s):

United States ◽

Immune Response ◽

Influenza Vaccine ◽

Standard Dose ◽

The United States ◽

Influenza Vaccines ◽

High Dose ◽

Post Vaccination ◽

B Lineage ◽

Research Grant

Abstract Background Older adults (≥65 years of age) remain at increased risk of influenza because they do not respond to standard dose influenza vaccines as well as younger adults. A high dose, inactivated trivalent influenza vaccine, IIV3-HD, containing four times the antigen content (60 µg hemagglutinin per influenza strain) of standard-dose influenza vaccines has been available in the United States since 2010. Two distinct B influenza lineages (Victoria and Yamagata) have co-circulated for over a decade, making it difficult to predict which will predominate the next season. IIV4-HD has been developed to address the frequent influenza B strain mismatches by incorporating a strain from each B lineage. This pivotal Phase III study evaluated the safety and immunogenicity of IIV4-HD as compared with two IIV3-HD vaccines. Method A randomized, modified double-blind, multicenter study (NCT03282240) was conducted in 2670 healthy subjects in the United States, who were randomly assigned to receive IIV4-HD, a licensed IIV3-HD, or an IIV3-HD with the alternate B influenza strain. Using the hemagglutinin inhibition (HAI) assay at baseline and 28 days after vaccination, post-vaccination geometric mean titers and seroconversion rates were measured. Safety data were collected through 6 months post-vaccination. Result IIV4-HD was noninferior to the licensed IIV3-HD and the investigational IIV3-HD (containing the alternate B strain) for all four influenza strains as assessed by HAI GMTs and seroconversion rates. Moreover, IIV4-HD induced a superior immune response (HAI GMTs and seroconversion rates) compared with the immune response induced by the IIV3-HD that does not contain the corresponding B strain. Reactogenicity profiles were comparable across all study groups. Most unsolicited adverse events were of Grade 1 or Grade 2 intensity. One serious adverse event considered related by the Investigator was reported in the IIV4-HD group. Conclusion Vaccination of adults 65 years of age and older with IIV4-HD was found to be noninferior to two IIV3-HD vaccines with a similar safety profile. The addition of a second B lineage strain does not adversely affect the safety or immunogenicity profile of IIV4-HD compared with IIV3-HD. Disclosures L. J. Chang, Sanofi Pasteur: Employee, Salary. Y. Meng, Sanofi Pasteur: Employee, Salary. H. Janosczyk, Sanofi Pasteur: Employee, Salary. V. Landolfi, Sanofi Pasteur: Employee, Salary. H. K. Talbot, Sanofi Pasteur: Investigator, Research grant. Gilead: Investigator, Research grant. MedImmune: Investigator, Research grant. Vaxinnate: Safety Board, none. Seqirus: Safety Board, none.

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Adverse reactions to BNT162b2 mRNA COVID-19 vaccine in medical staffs with a history of allergy.

10.1101/2021.09.13.21263473 ◽

2021 ◽

Author(s):

Sumito Inoue ◽

Akira Igarashi ◽

Keita Morikane ◽

Osamu Hachiya ◽

Masafumi Watanabe ◽

...

Keyword(s):

Severe Acute Respiratory Syndrome ◽

Injection Site ◽

Adverse Reactions ◽

University Hospital ◽

Injection Site Pain ◽

High Efficacy ◽

Online Questionnaire ◽

Duration Of Symptoms ◽

History Of ◽

Site Pain

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID-19) vaccination is progressing globally. Several adverse reactions have been reported with vaccination against COVID-19. It is unknown whether adverse reactions to COVID-19 vaccination are severe in individuals with allergies. We administered the COVID-19 vaccine to the medical staff at Yamagata University Hospital from March to August 2021. Subsequently, we conducted an online questionnaire-based survey to investigate the presence of allergy and adverse reactions after vaccination and examined the association between allergy and adverse reactions after immunization. Responses were collected from 1586 subjects after the first vaccination and 1306 subjects after the second administration of the BNT162b2 mRNA COVID-19 vaccine. Adverse reactions included injection site pain, injection site swelling, fever, fatigue or malaise, headache, chills, nausea, muscle pain outside the injection site, and arthralgia. The frequency and severity of most adverse reactions were higher after the second vaccination compared to the first. The frequency of some adverse reactions and their severity were higher, and the duration of symptoms was longer in subjects with allergies than in subjects without allergies. Although several participants visited the emergency room for treatment after the first and second vaccinations, nobody was diagnosed with anaphylaxis. Given the serious consequence of COVID-19 and the reported high efficacy of this vaccine against this disease, we conclude that vaccination of allergic individuals is generally recommended.

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ISCOM-like Nanoparticles Formulated with Quillaja brasiliensis Saponins Are Promising Adjuvants for Seasonal Influenza Vaccines

Vaccines ◽

10.3390/vaccines9111350 ◽

2021 ◽

Vol 9 (11) ◽

pp. 1350

Author(s):

Mariana Rivera-Patron ◽

María Moreno ◽

Mariana Baz ◽

Paulo M. Roehe ◽

Samuel P. Cibulski ◽

...

Keyword(s):

Immune Response ◽

Immune Responses ◽

Influenza Vaccine ◽

Public Health Intervention ◽

Humoral Response ◽

Influenza Vaccines ◽

Respiratory Illnesses ◽

Cellular Immune Responses ◽

Saponin Fraction ◽

Cellular Immune

Vaccination is the most effective public health intervention to prevent influenza infections, which are responsible for an important burden of respiratory illnesses and deaths each year. Currently, licensed influenza vaccines are mostly split inactivated, although in order to achieve higher efficacy rates, some influenza vaccines contain adjuvants. Although split-inactivated vaccines induce mostly humoral responses, tailoring mucosal and cellular immune responses is crucial for preventing influenza infections. Quillaja brasiliensis saponin-based adjuvants, including ISCOM-like nanoparticles formulated with the QB-90 saponin fraction (IQB90), have been studied in preclinical models for more than a decade and have been demonstrated to induce strong humoral and cellular immune responses towards several viral antigens. Herein, we demonstrate that a split-inactivated IQB90 adjuvanted influenza vaccine triggered a protective immune response, stronger than that induced by a commercial unadjuvanted vaccine, when applied either by the subcutaneous or the intranasal route. Moreover, we reveal that this novel adjuvant confers up to a ten-fold dose-sparing effect, which could be crucial for pandemic preparedness. Last but not least, we assessed the role of caspase-1/11 in the generation of the immune response triggered by the IQB90 adjuvanted influenza vaccine in a mouse model and found that the cellular-mediated immune response triggered by the IQB90-Flu relies, at least in part, on a mechanism involving the casp-1/11 pathway but not the humoral response elicited by this formulation.

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Immunogenicity Measures of Influenza Vaccines: A Study of 1164 Registered Clinical Trials

Vaccines ◽

10.3390/vaccines8020325 ◽

2020 ◽

Vol 8 (2) ◽

pp. 325 ◽

Cited By ~ 1

Author(s):

Alexander Domnich ◽

Ilaria Manini ◽

Donatella Panatto ◽

Giovanna Elisa Calabrò ◽

Emanuele Montomoli

Keyword(s):

Immune Response ◽

Influenza Vaccine ◽

Humoral Immune Response ◽

Adaptive Immune Response ◽

Point Of View ◽

Influenza Vaccines ◽

Study Phase ◽

Cell Mediated Immunity ◽

Humoral Immune ◽

Immunological Assays

Influenza carries an enormous burden each year. Annual influenza vaccination is the best means of reducing this burden. To be clinically effective, influenza vaccines must be immunogenic, and several immunological assays to test their immunogenicity have been developed. This study aimed to describe the patterns of use of the various immunological assays available to measure the influenza vaccine-induced adaptive immune response and to determine its correlates of protection. A total of 76.5% of the studies included in our analysis measured only the humoral immune response. Among these, the hemagglutination-inhibition assay was by far the most widely used. Other, less common, humoral immune response assays were: virus neutralization (21.7%), enzyme-linked immunosorbent (10.1%), single radial hemolysis (4.6%), and assays able to quantify anti-neuraminidase antibodies (1.7%). By contrast, cell-mediated immunity was quantified in only 23.5% of studies. Several variables were significantly associated with the use of single assays. Specifically, some influenza vaccine types (e.g., adjuvanted, live attenuated and cell culture-derived or recombinant), study phase and study sponsorship pattern were usually found to be statistically significant predictors. We discuss the principal findings and make some suggestions from the point of view of the various stakeholders.

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Multiantibody Strategies for HIV

Clinical and Developmental Immunology ◽

10.1155/2013/632893 ◽

2013 ◽

Vol 2013 ◽

pp. 1-11 ◽

Cited By ~ 5

Author(s):

Andrew Hiatt ◽

Larry Zeitlin ◽

Kevin J. Whaley

Keyword(s):

Immune Response ◽

Monoclonal Antibodies ◽

Immune System ◽

Immune Evasion ◽

Neutralizing Antibodies ◽

Active Immunization ◽

Robust Immune Response ◽

Viral Immune Evasion ◽

Vaccination Strategies ◽

Appropriate Responsiveness

Vaccination strategies depend entirely on the appropriate responsiveness of our immune system against particular antigens. For this active immunization to be truly effective, neutralizing antibodies (nAbs) need to efficiently counter the infectivity or propagation of the pathogen. Some viruses, including HIV, are able to take advantage of this immune response in order to evade nAbs. This review focuses on viral immune evasion strategies that result directly from a robust immune response to infection or vaccination. A rationale for multi-Ab therapy to circumvent this phenomenon is discussed. Progress in the formulation, production, and regulatory approval of monoclonal antibodies (mAbs) is presented.

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Squalene-Based Influenza Vaccine Adjuvants and Their Impact on the Hemagglutinin-Specific B Cell Response

Pathogens ◽

10.3390/pathogens10030355 ◽

2021 ◽

Vol 10 (3) ◽

pp. 355

Author(s):

Phuong Nguyen-Contant ◽

Mark Y. Sangster ◽

David J. Topham

Keyword(s):

Immune Response ◽

Influenza Vaccine ◽

B Cell ◽

Rational Design ◽

Influenza Vaccines ◽

Vaccine Adjuvants ◽

Design And Optimization ◽

Cell Responses ◽

Influenza Hemagglutinin ◽

B Cell Responses

Influenza infections continue to cause significant annual morbidity and mortality despite ongoing influenza vaccine research. Adjuvants are administered in conjunction with influenza vaccines to enhance the immune response and strengthen protection against disease. Squalene-based emulsion adjuvants including MF59, AS03, and AF03, are registered for administration with influenza vaccines and are widely used in many countries. Squalene-based emulsion adjuvants induce a strong innate immune response, enhancing antigen presentation both quantitively and qualitatively to generate strong B cell responses and antibody production. They also diversify the reactivity profiles and strengthen the affinities of antibodies against the influenza hemagglutinin, increasing protection across virus clades. In this review, we consider the mechanisms of the enhancement of innate and adaptive immune responses by squalene-based emulsionSE adjuvants and the resulting increase in magnitude and breadth of hemagglutinin-specific B cell responses. We relate observed effects of SE adjuvants and current mechanistic understandings to events in responding lymph nodes. These insights will guide the rational design and optimization of influenza vaccines to provide broad and effective protection.

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Qualitative Assessment of Early Adverse Effects of Pfizer–BioNTech and Sinopharm COVID-19 Vaccines by Telephone Interviews

Vaccines ◽

10.3390/vaccines9090950 ◽

2021 ◽

Vol 9 (9) ◽

pp. 950

Author(s):

Sami Abu-Halaweh ◽

Rami Alqassieh ◽

Aiman Suleiman ◽

Mohammed Qussay Al-Sabbagh ◽

Maram AbuHalaweh ◽

...

Keyword(s):

Side Effects ◽

Adverse Effects ◽

Injection Site ◽

Adverse Reactions ◽

Qualitative Assessment ◽

Injection Site Pain ◽

Telephone Interviews ◽

Observational Cohort ◽

New Generation ◽

Site Pain

Vaccines are considered the best approach for countering the COVID-19 pandemic. In this study, we compared early side effects associated with vaccination with the Sinopharm and Pfizer–BioNTech COVID-19 vaccines. Participants of this observational cohort were interviewed based on semi-structured telephone interviews, with enquiries about side effects that developed after vaccination with each dose of these vaccines. Overall, 1004 participants were enrolled, of which 51.1% received Sinopharm vaccine and 48.9% received the Pfizer–BioNTech vaccine. After the first dose, 46.3% of participants had an adverse reaction, with injection site pain most commonly being reported (33.2%). Participants who received the Pfizer–BioNTech vaccine had significantly higher frequencies of all types of adverse reactions (p < 0.01), with no significant differences in the duration of adverse reactions between the two vaccines. Regarding the second dose, 48.6% of participants had adverse reactions, with injection site pain being most commonly reported (29%). Those who received the Pfizer vaccine reported higher frequencies of all adverse reactions (p < 0.01). However, a longer duration of adverse reactions was seen among Sinopharm vaccine recipients as compared to Pfizer–BioNTech vaccine recipients (p = 0.01). In conclusion, early adverse effects are reported following all types of vaccines but these are more likely to be encountered following the administration of new-generation vaccines. These side effects are mostly mild and treatable.

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