FLUAD (trivalent inactivated influenza vaccine) / CSL Behring - LARVOL DELTA

mFLUSIVA - an mRNA-based influenza vaccine. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases

Fluad vs. Fluzone High-Dose Vaccine Effectiveness Among Adults ?65 Years (clinicaltrials.gov) - P=N/A | N=1500000 | Recruiting | Sponsor: Kaiser Permanente | N=960000 ➔ 1500000 | Trial completion date: May 2026 ➔ May 2028 | Trial primary completion date: May 2025 ➔ May 2027

Enrollment change • Trial completion date • Trial primary completion date • Cardiovascular • Infectious Disease • Influenza • Pneumonia • Respiratory Diseases

Seasonal influenza mRNA vaccine induces stronger innate and comparable or better adaptive responses than licensed inactivated vaccines. (PubMed, NPJ Vaccines) - "Both the mRNA vaccine and Fluad generated higher frequencies of HA-specific memory B and T cell responses compared to Vaxigrip, with the mRNA vaccine inducing a particularly stronger response in the draining lymph nodes, potentially increasing antibody diversity and affinity. Altogether, these findings support the advancement of influenza mRNA vaccines as promising clinical candidates."

Journal • Infectious Disease • Influenza • Respiratory Diseases

B Cell and Antibody Response to Seasonal Influenza Vaccines in Younger and Older Adults (clinicaltrials.gov) - P4 | N=50 | Active, not recruiting | Sponsor: University of Alabama at Birmingham | Recruiting ➔ Active, not recruiting | Trial completion date: May 2026 ➔ May 2027

Enrollment closed • Trial completion date • Infectious Disease • Influenza • Respiratory Diseases

FluVax3: A Deep Longitudinal Analysis of Next Generation Influenza Vaccines in Older Adults (clinicaltrials.gov) - P4 | N=75 | Active, not recruiting | Sponsor: The Jackson Laboratory | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Influenza • Respiratory Diseases

Assessment of hemagglutinin-inhibition activity following influenza vaccination during the 2022-2023, 2023-2024, and 2024-2025 seasons. (PubMed, PLoS One) - "In this three-season (2022-2023-2024-2025) study, 1,328 participants aged 9-89 years received one of six vaccine types (Fluzone standard dose (SD) or high dose (HD), Fluad, Flucelvax, Flublok, Flumist). Participants vaccinated with Flumist had low or no measurable serum HAI activity. Overall, the elicitation of vaccine induced immune responses is strongly influenced by vaccine formulation, age and immune history of the participant."

Journal • Infectious Disease • Influenza • Respiratory Diseases

Immunogenicity and safety of higher-dose cell-based adjuvanted quadrivalent influenza vaccines: Combined results of randomised, controlled dose-finding and dose-confirmation studies. (PubMed, Vaccine) - P2, P3 | "Investigational formulations contained 15, 30, or 45 μg HA per strain, and 1×, 2×, and 3× the dose of MF59 adjuvant included in Fluad®...aQIVc [45,2×] demonstrated the highest immune response of all formulations tested, with no safety concerns, and was selected for further investigation in a Phase 3 study (NCT06015282). Clinical trial registry: NCT04782323 (https://clinicaltrials.gov/study/NCT04782323; registered date 2021-03-01), NCT05501561 (https://clinicaltrials.gov/study/NCT05501561; registered date 2022-08-11)."

Clinical • Journal • Infectious Disease • Influenza • Respiratory Diseases

mRNA-CRID-001: A Study of Modified mRNA Vaccines in Healthy Adults (clinicaltrials.gov) - P1 | N=308 | Completed | Sponsor: ModernaTX, Inc. | Active, not recruiting ➔ Completed

Trial completion • Cytomegalovirus Infection • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases

WU 345: Immune Responses to Adjuvanted and Non-adjuvanted Seasonal Influenza Vaccines in the Lymphoid Tissues. (clinicaltrials.gov) - P1 | N=2 | Terminated | Sponsor: Washington University School of Medicine

New P1 trial • Infectious Disease • Influenza • Respiratory Diseases

An mRNA influenza vaccine induces immunity comparable to an adjuvanted vaccine in a randomized trial. (PubMed, NPJ Vaccines) - P1 | "mRNA-1010 and FLUAD generated strong HA-specific CD4+ T-cell responses; a trend toward higher CD8+ T-cell responses was observed in mRNA-1010 recipients compared with FLUAD recipients for two of the four strains. These findings support the potential of the mRNA platform for seasonal influenza vaccination."

Journal • Infectious Disease • Influenza • Respiratory Diseases • CD4 • CD8

A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Adults (clinicaltrials.gov) - P2 | N=172 | Completed | Sponsor: ModernaTX, Inc. | Recruiting ➔ Completed | N=325 ➔ 172

Enrollment change • Trial completion • Infectious Disease • Influenza • Respiratory Diseases

Comparative analysis of cellular immune responses to four seasonal inactivated influenza vaccines in younger and older adults. (PubMed, J Immunol) - "Participants were categorized by age, 28-60 and 65-85 yr, and were vaccinated with 1 of 4 influenza vaccines (Fluzone Standard-Dose [FSD], Flucelvax [FCEL], Fluzone High-Dose [FHD], or Fluad [FAD]) during the 2023-2024 influenza season. These findings highlight the critical role of antigen dose and quality in inducing HA-specific cellular immunity and coordinating B and T cell activation. Synergistically engaging ASCs, cTfh, MBCs, and CD4+ T cells to enhance immunological memory and establish long-term vaccine-induced immunity should be considered in future influenza vaccine design."

Journal • Infectious Disease • Influenza • Respiratory Diseases • CD4

Influenza vaccines for 2025-2026. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Hepatitis B • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

B Cell and Antibody Response to Seasonal Influenza Vaccines in Younger and Older Adults (clinicaltrials.gov) - P4 | N=50 | Recruiting | Sponsor: University of Alabama at Birmingham | Trial completion date: May 2025 ➔ May 2026 | Trial primary completion date: May 2025 ➔ May 2026

Trial completion date • Trial primary completion date • Infectious Disease • Influenza • Respiratory Diseases

Which Enhanced Influenza Vaccine Has the Greatest Immunogenicity in Long-Term Care Residents: The Adjuvanted or the High-Dose Formulation? (PubMed, J Am Med Dir Assoc) - P4 | "Overall the antihemagglutinin and antineuraminidase titers demonstrate similarities between the vaccines and support them both being in the enhanced flu vaccine category preferentially recommended by the Centers for Disease Control and Prevention for people >65 years of age."

Journal • Infectious Disease • Influenza • Respiratory Diseases

Shared clinical and immunologic features of mRNA vaccines: preliminary results from a comparative clinical study. (PubMed, Front Immunol) - P1 | "This ongoing, open-label, phase 1 trial randomized healthy adults (18-75 years) to receive a single dose of mRNA-1273.222 (bivalent COVID-19), mRNA-1345 (RSV), mRNA-1010 (influenza), and FLUAD (active influenza comparator) or 2 or 3 doses of mRNA-1647 (CMV). This suggests that the observed reactogenicity of mRNA vaccines may be related to shared features of the mRNA platform (LNP platform). ClinicalTrials.gov, identifier NCT05397223."

Clinical • Journal • Infectious Disease • Inflammation • Influenza • Novel Coronavirus Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections • CCL4 • CCL8 • CD4 • CD8 • CXCL9 • IFNG • IL1R1 • IL2RA • IL6

Emulsion adjuvant-induced uric acid release modulates optimal immunogenicity by targeting dendritic cells and B cells. (PubMed, NPJ Vaccines) - "Squalene-based emulsion (SE) adjuvants like MF59 and AS03 are used in protein subunit vaccines against influenza virus (e.g., Fluad, Pandemrix, Arepanrix) and SARS-CoV-2 (e.g., Covifenz, SKYCovione)...In an influenza vaccine model, UA contributed to protection against influenza viral infection. These results demonstrate the importance of DAMPs, specifically the versatile role of UA in the immunogenicity of SE adjuvants, by regulating DCs and B cells."

Journal • Infectious Disease • Inflammation • Influenza • Novel Coronavirus Disease • Respiratory Diseases

A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Adults (clinicaltrials.gov) - P2 | N=325 | Recruiting | Sponsor: ModernaTX, Inc. | Active, not recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Influenza • Respiratory Diseases

Adjuvanted Inactivated Vaccine Versus Inactivated Influenza Vaccine in Hutterite Children (clinicaltrials.gov) - P4 | N=3425 | Completed | Sponsor: McMaster University | Unknown status ➔ Completed | N=2500 ➔ 3425

Enrollment change • Trial completion • Infectious Disease • Influenza • Respiratory Diseases

A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Adults (clinicaltrials.gov) - P2 | N=325 | Active, not recruiting | Sponsor: ModernaTX, Inc. | N=98 ➔ 325

Enrollment change • Infectious Disease • Influenza • Respiratory Diseases

Comparison of immunogenicity of adjuvanted and high dose influenza vaccination in long-term care facility residents. (PubMed, medRxiv) - P4 | "The current study compares adjuvanted trivalent inactivated flu vaccine (aTIV, FLUAD) versus high-dose flu vaccine (HD-IIV3, FLUZONE HD) to determine if they met non-inferiority standards for older long-term care facility (LTCF) residents...The recombinant influenza vaccine (RIV, Flublok) was assessed similarly in year two for a small number of participants who were carried over from year 1 (n=32)...For the primary outcome, aTIV is non-inferior to HD-IIV3 for HAI titer of H1N1 and H3N2 but failed to meet non-inferiority criteria for Influenza B and seroconversion for all assessed strains. For the secondary outcome, aTIV was non-inferior to HD-IIV3 for both titer and seroconversion of anti-neuraminidase for both H1N1 and H3N2."

Journal • Infectious Disease • Influenza • Respiratory Diseases

A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Adults (clinicaltrials.gov) - P2 | N=98 | Active, not recruiting | Sponsor: ModernaTX, Inc. | Trial completion date: Aug 2024 ➔ Oct 2025 | Trial primary completion date: Aug 2024 ➔ Oct 2025

Trial completion date • Trial primary completion date • Infectious Disease • Influenza • Respiratory Diseases

Systemic dysregulation and molecular insights into poor influenza vaccine response in the aging population. (PubMed, Sci Adv) - "We investigated longitudinally (up to five time points) a cohort of 234 vaccinated >65-year-old vaccinees with adjuvanted vaccine FluAd across two independent seasons...We propose a subset of long-chain fatty acids as modulators of persistent inflammation in poor responders. Our findings provide a potential link between low-grade chronic inflammation and poor vaccination response and open avenues for possible pharmacological interventions to enhance vaccine responses."

Journal • Infectious Disease • Inflammation • Influenza • Respiratory Diseases • IL15

Influenza vaccine for 2024-2025. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Hepatitis B • Infectious Disease • Influenza • Respiratory Diseases • Respiratory Syncytial Virus Infections

Systems Investigation of Vaccine Responses in Aging and Frailty (clinicaltrials.gov) - P2 | N=96 | Recruiting | Sponsor: Yale University

Trial completion date • Trial primary completion date • Infectious Disease • Influenza • Respiratory Diseases • IL6