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

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

"The regular vaccine contains 15 mcg HA protein per strain. But the flublok vaccine contains 45 mcg HA protein per strain. Can you explain why? All these questions are related to your tweet. I'll explain why based on your responses. 1/" (@SynthIge)

Clinical

Trimeric, APC-Targeted Subunit Vaccines Protect Mice against Seasonal and Pandemic Influenza. (PubMed, J Virol) - "To further evaluate the versatility of the format, we developed MHCII-targeted HA from influenza A/California/04/2009(H1N1) as a protein vaccine and benchmarked this against Pandemrix and Flublok...Here, we have developed a novel vaccine where influenza hemagglutinin is presented in the natural trimeric form and then steered toward antigen-presenting cells for increased immunogenicity. We demonstrate efficient induction of antibodies and T-cell responses, and demonstrate that the vaccine format can protect mice against influenza subtypes H1N1, H5N1, and H7N1."

Journal • Preclinical • Infectious Disease • Influenza • Respiratory Diseases • HLA-DRB1

Evaluation of Antibody Response to High-Dose Seasonal Influenza Vaccination in Patients With Myeloid Malignancy Receiving Chemotherapy and Healthy Volunteers (clinicaltrials.gov) - P4 | N=130 | Completed | Sponsor: Roswell Park Cancer Institute | Recruiting ➔ Completed | N=200 ➔ 130 | Trial completion date: Mar 2026 ➔ Jun 2022 | Trial primary completion date: Apr 2025 ➔ Jun 2022

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Infectious Disease • Influenza • Leukemia • Myelodysplastic Syndrome • Oncology • Respiratory Diseases

"why is it so hard to get flublok @SanofiUS" (@SSFyimby)

Influenza vaccine for 2022-2023. (PubMed, Med Lett Drugs Ther) - No abstract available

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

Sanofi higher dose flu vaccines preferentially recommended for adults 65+ in CDC Morbidity and Mortality Weekly Report (PRNewswire) - "The Centers for Disease Control and Prevention (CDC) has published the updated Advisory Committee on Immunization Practices (ACIP) guidance granting preferential recommendation for specific flu vaccines in people age 65+ in its Morbidity and Mortality Weekly Report (MMWR), a journal highlighting the latest in public health news and communicating recommendations derived from science-based research....Sanofi's Fluzone® High-Dose Quadrivalent (Influenza Vaccine) and Flublok® Quadrivalent (Influenza Vaccine) were among the flu vaccines preferentially recommended by the CDC ACIP for adults 65+."

Clinical guideline • Infectious Disease • Influenza

"@SanofiUS I need the flublok vaccine before Tuesday. Who has it in stock in Orange County California. PLEASE HELP" (@MartyMmjbk)

Clinical

Immunogenicity Trial of Egg- Versus Non-Egg-Based Influenza Vaccines Among HCP (clinicaltrials.gov) - P4 | N=864 | Completed | Sponsor: Centers for Disease Control and Prevention | Unknown status ➔ Completed

Preclinical • Trial completion • Infectious Disease • Respiratory Diseases