Flublok (influenza vaccine) / Sanofi, Ildong, Shionogi - LARVOL DELTA

A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age (clinicaltrials.gov) - P3 | N=1300 | Recruiting | Sponsor: Vaxcyte, Inc.

New P3 trial • Infectious Disease • Influenza • Pneumococcal Infections • Respiratory Diseases

Elicitation of Protective Immune Responses Against Influenza Virus Following Intranasal Delivery of Fluzone or Flublok Vaccines. (PubMed, Vaccines (Basel)) - "Almost all mice vaccinated with Flublok plus CDA died from H3N2 influenza virus challenged with ~2 logs higher viral lung titers than mice administered Flublok only or Flublok plus TRAC478. Overall; Fluzone and Flublok can effectively be used for intranasal vaccination."

Journal • Infectious Disease • Influenza • Respiratory Diseases

Comparative evaluation of 5 combination adjuvants on immunogenicity and efficacy of approved seasonal influenza vaccines. (PubMed, NPJ Vaccines) - "To address this, we have performed a side-by-side comparison of 5 novel combination adjuvants (Alhydroxyquim-II, T-VANT, TRAC-478, IVAX-1 and IVAX-3) by formulating each with two approved seasonal influenza vaccines, Flublok® and Fluzone HD®, and assessing immunogenicity and efficacy in female and male C57Bl/6 mice. Greater morbidity after challenge was also detected in males compared to females. Side-by-side comparisons of existing and novel adjuvants with the same antigen and model system will help inform rational adjuvant selection and guide vaccine development for influenza and other infectious diseases."

Journal • Infectious Disease • Influenza • Respiratory Diseases

Integrated analysis of humoral and memory B-cell responses reveals distinct immune landscapes shaped by influenza vaccine platforms. (PubMed, NPJ Vaccines) - "This study employed an integrated analysis of humoral and MBC responses elicited by three licensed influenza vaccines: inactivated Fluzone standard dose (FluZ), recombinant protein-based FluBlok (FluB), and live-attenuated intranasal FluMist (FluM). Notably, FluM-vaccinees showed greater inter-correlation among multiple MBC subsets, particularly for H3. These findings uncover distinct platform-specific immune landscape and demonstrate that FluB induces superior MBC responses, providing a framework for designing next-generation vaccines."

Journal • Infectious Disease • Influenza • Respiratory Diseases

Adjuvanted Recombinant Hemagglutinin Vaccine Provides Durable and Broad-Spectrum Immunogenicity in Mice. (PubMed, Vaccines (Basel)) - " In mouse immunization studies, the a-RIV vaccine elicited significantly stronger humoral and cellular immune responses than the licensed recombinant vaccine Flublok and the conventional inactivated influenza vaccine (IIV)... Our data demonstrate that the a-RIV elicits enhanced, durable, and broadly cross-reactive immune responses against multiple influenza subtypes. These findings support the potential of adjuvanted recombinant HA-based vaccine as a promising candidate for the development of next-generation influenza vaccine."

Journal • Preclinical • Infectious Disease • Influenza • Respiratory Diseases

Re-shaping the immune response to influenza vaccination in a host with immune memory from influenza. (PubMed, bioRxiv) - "In this manuscript, to mimic the typical human vaccine recipient using a mouse model, we evaluated the impact of previous influenza infection on the adaptive immune response elicited by the recombinant influenza vaccine Flublok, co-delivered with either AddaVax, an MF59 mimetic or a nanolipoparticle innate activator R-DOTAP...These results are consistent with the view the microenvironment of the vaccine draining lymph node, developed in the context of immune memory, rather than infection-induced CD4 T cell imprinting, plays the decisive role in the functional phenotype, magnitude, and fate of vaccine-elicited CD4 T cells. These results have important implications for both pre-clinical models of vaccination and future vaccine strategies."

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

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

Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices - United States, 2025-26 Influenza Season. (PubMed, MMWR Morb Mortal Wkly Rep) - "Updates for the 2025-26 season include 1) antigenic composition of 2025-26 U.S. seasonal influenza vaccines, 2) Food and Drug Administration (FDA) approval of FluMist (LAIV3) for self-administration or caregiver administration, 3) FDA approval of a change in age indication for Flublok (RIV3) from ≥18 years to ≥9 years, and 4) a new ACIP recommendation that children aged ≤18 years, pregnant women, and all adults receive seasonal influenza vaccines only in single-dose formulations that are free of thimerosal as a preservative. A comprehensive summary of recommendations, including those discussed in this report, as well as previous recommendations concerning topics not addressed in this report and that remain unchanged for the 2025-26 season, is available at Influenza; ACIP Recommendations for Vaccination. Additional background information also is available at Prevention and Control of Seasonal Influenza with Vaccines."

Clinical guideline • Journal • Infectious Disease • Influenza • Respiratory Diseases

Immunogenicity of Influenza Vaccinations (clinicaltrials.gov) - P4 | N=605 | Completed | Sponsor: Duke University | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Influenza • Respiratory Diseases

A phase I study of the safety, reactogenicity and immunogenicity of two quadrivalent seasonal influenza vaccines (Fluzone® or Flublok®) with or without one of two adjuvants (AF03 or Advax-CpG55.2) in healthy adults 18-45 years of age. (PubMed, Vaccine) - P1 | "In this highly immunologically-experienced cohort, neither AF03 nor Advax-CpG55.2 demonstrated notable benefit when added to the seasonal influenza vaccine. (ClinicalTrials.gov ID# NCT03945825)."

Clinical • Journal • P1 data • Infectious Disease • Influenza • Respiratory Diseases

Immunogenicity of Influenza Vaccinations (clinicaltrials.gov) - P4 | N=605 | Active, not recruiting | Sponsor: Duke University | Recruiting ➔ Active, not recruiting | Trial primary completion date: May 2025 ➔ Dec 2024

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

Safety of quadrivalent recombinant influenza vaccine in pregnant persons and their infants. (PubMed, AJOG Glob Rep) - P=N/A | "Compared with receipt of a SD-IIV4 during pregnancy, this large study did not identify any pregnancy, birth, or neonatal/infant safety concerns following receipt of a RIV4 during pregnancy and demonstrates that the safety of RIV4 in pregnancy was similar to SD-IIV4. This study provides additional evidence regarding the safety of influenza vaccination in pregnant persons and further supports ACIP and ACOG recommendations that all pregnant persons receive an inactivated or recombinant influenza vaccine."

Journal • Gynecology • Infectious Disease • Influenza • Obstetrics • Respiratory Diseases • Small for Gestational Age

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

Randomized Immunogenicity Trial Comparing 2019-2020 Recombinant and Egg-Based Influenza Vaccines among Frequently Vaccinated Healthcare Personnel in Israel. (PubMed, Int J Infect Dis) - "RIV4 had improved immunogenicity for influenza vaccine strains among both infrequent and frequent vaccinees compared to standard-dose IIV4."

Journal • Infectious Disease • Influenza • Respiratory Diseases

Immunogenicity of Influenza Vaccinations (clinicaltrials.gov) - P4 | N=600 | Recruiting | Sponsor: Duke University | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Influenza • Respiratory Diseases

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

Immunogenicity of Influenza Vaccinations (clinicaltrials.gov) - P4 | N=600 | Not yet recruiting | Sponsor: Duke University

New P4 trial • Infectious Disease • Influenza • Respiratory Diseases

Preliminary findings from the Dynamics of the Immune Responses to Repeat Influenza Vaccination Exposures (DRIVE I) Study: a Randomized Controlled Trial. (PubMed, Clin Infect Dis) - "In the first two years, during which influenza did not circulate, repeat vaccinees and first-time vaccinees had similar post-vaccination geometric mean titers to all four vaccine strains, indicative of similar levels of clinical protection."

Journal • Infectious Disease • Influenza • Respiratory Diseases

Flublok Quadrivalent Vaccine Adjuvanted with R-DOTAP Elicits a Robust and Multifunctional CD4 T Cell Response That Is of Greater Magnitude and Functional Diversity Than Conventional Adjuvant Systems. (PubMed, Vaccines (Basel)) - "The elicited CD4+ T cells specific for HA-derived epitopes produce IL-2, IFN-γ, IL-4/5, and granzyme B and have multifunctional potential. Hence, R-DOTAP, which has been verified safe by human studies, can offer exciting opportunities as an immune stimulant for next-generation prophylactic recombinant protein-based vaccines."

Journal • Infectious Disease • Influenza • Respiratory Diseases • CD4 • GZMB • IFNG • IL2 • IL4

Whole Blood Reactivity to Viral and Bacterial Pathogens after Non-Emergent Cardiac Surgery during the Acute and Convalescence Periods Demonstrates a Distinctive Profile of Cytokines Production Compared to the Preoperative Baseline in Cohort of 108 Patients, Suggesting Immunological Reprogramming during the 28 Days Traditionally Recognized as the Post-Surgical Recovery Period. (PubMed, Biomedicines) - "For 108 patients undergoing elective heart surgery, whole blood was stimulated with lipopolysaccharide (LPS), Influenza A virus subtype N2 (H3N2), or the Flublok™ vaccine to represent common pathogenic challenges...While some non-specific markers of inflammation (white cell count, IL-6, and IL-8) returned to presurgical levels at t, CRP and platelet counts remained elevated. We showed that surgical stimulus reprograms leukocyte response to LPS with only partial restoration of non-specific markers of inflammation."

Journal • Surgery • Cardiovascular • Infectious Disease • Inflammation • Influenza • Respiratory Diseases • CRP • CSF1 • CXCL8 • IFNG • IL10 • IL6 • TNFA

Influenza vaccine for 2023-2024. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Hepatitis B • Infectious Disease • Influenza • Respiratory Diseases

"Your regular flu shot has 15 mcg HA per strain. But Flublok has 45 mcg HA per strain. You call that science. Sick fraudsters." (@SynthIge)

Evaluation of Antibody Response to High-Dose Seasonal Influenza Vaccination in Patients With Myeloid Malignancy Receiving Chemotherapy and Healthy Volunteers (clinicaltrials.gov) - P1 | N=130 | Completed | Sponsor: Roswell Park Cancer Institute | Phase classification: P4 ➔ P1

Phase classification • Acute Myelogenous Leukemia • Hematological Malignancies • Infectious Disease • Influenza • Leukemia • Myelodysplastic Syndrome • Oncology • Respiratory Diseases

"I never miss an opportunity to shill Flublok" (@TheEthanIverson)

"Can you explain why a regular flu shot has only 15 mcg of HA protein per strain but the Flublok vaccine was approved with 45 mcg of HA protein per strain? 2/" (@SynthIge)

Clinical