Fluzone (influenza vaccine) / Sanofi - LARVOL DELTA

A Trial to Evaluate the Effect of CD388/MK1406 on the Immunogenicity of Fluzone HD Vaccine (CD388.SQ.1.08/MK-1406-007) (clinicaltrials.gov) - P1 | N=710 | Active, not recruiting | Sponsor: Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | N=100 ➔ 710

Enrollment change

Vaccine Responses in Patients With B Cell Malignancies (clinicaltrials.gov) - P4 | N=350 | Recruiting | Sponsor: National Heart, Lung, and Blood Institute (NHLBI) | N=500 ➔ 350

Enrollment change • Chronic Lymphocytic Leukemia • Hematological Malignancies • Lymphoma • Oncology • BCL2

PIVOT: Immunogenicity of Alternative Annual Influenza Vaccination Strategies in Older Adults in Hong Kong (clinicaltrials.gov) - P4 | N=1861 | Completed | Sponsor: The University of Hong Kong | Active, not recruiting ➔ Completed | Trial completion date: Dec 2026 ➔ Dec 2025

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

Ibrutinib as an Immune Modulating Agent for Patients With Asymptomatic, High-risk CLL/SLL Risk Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (clinicaltrials.gov) - P2 | N=42 | Completed | Sponsor: Jennifer Woyach | Active, not recruiting ➔ Completed | Trial completion date: Dec 2026 ➔ Jan 2026

Trial completion • Trial completion date • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • TP53

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

Adjuvants enhance protective antibodies against seasonal influenza viruses following a single vaccination of Fluzone. (PubMed, Virology) - "Lungs collected from mice vaccinated with Fluzone plus TRAC478 had low levels of lung infiltrating cells following a single vaccination. Overall, the use of adjuvant, particularly TRAC478, enhanced the elicitation of protective antibodies elicited by Fluzone following a single vaccination."

Journal • Infectious Disease • Influenza • Respiratory Diseases

Ibrutinib as an Immune Modulating Agent for Patients With Asymptomatic, High-risk CLL/SLL Risk Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (clinicaltrials.gov) - P2 | N=42 | Active, not recruiting | Sponsor: Jennifer Woyach | Trial completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • TP53

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

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

A Phase 0 Window of Opportunity Trial of Intratumoral Seasonal Influenza Immunization in Cutaneous Squamous Cell Carcinoma (CSCC) Patients Awaiting Curative Excision (clinicaltrials.gov) - P1 | N=25 | Recruiting | Sponsor: Dana-Farber Cancer Institute | Trial completion date: Aug 2025 ➔ Aug 2026 | Trial primary completion date: Aug 2025 ➔ Aug 2026

Trial completion date • Trial primary completion date • Genetic Disorders • Infectious Disease • Influenza • Non-melanoma Skin Cancer • Oncology • Respiratory Diseases • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Ibrutinib as an Immune Modulating Agent for Patients With Asymptomatic, High-risk CLL/SLL Risk Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (clinicaltrials.gov) - P2 | N=42 | Active, not recruiting | Sponsor: Jennifer Woyach | Trial primary completion date: Aug 2025 ➔ Dec 2025

Trial primary completion date • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • TP53

Pharmacovigilance-based 12-year post-marketing safety analysis of quadrivalent influenza vaccines in children: a VAERS surveillance study. (PubMed, Front Pediatr) - "We conducted a comprehensive 12-year pharmacovigilance analysis utilizing data from the Vaccine Adverse Event Reporting System (VAERS) for individuals under 18 years receiving six FDA-approved QIVs between 2013 and 2024, representing three distinct platforms: four egg-based inactivated vaccines (Afluria, Fluarix, FluLaval, Fluzone), one cell culture-based inactivated vaccine (Flucelvax), and one live-attenuated intranasal vaccine (FluMist). This pharmacovigilance analysis demonstrates generally favorable safety profiles for pediatric QIVs, with cell culture formulations showing superior safety characteristics. The extremely low absolute risk of Guillain-Barré syndrome supports continued routine pediatric influenza vaccination while highlighting the importance of platform-specific safety monitoring."

Adverse events • Journal • P4 data • Infectious Disease • Influenza • Novel Coronavirus Disease • Pediatrics • Respiratory Diseases

Pooled Analysis of Methodologically Harmonized Pragmatic Randomized Trials of High-Dose vs. Standard-Dose Influenza Vaccine Against Severe Clinical Outcomes (clinicaltrials.gov) - P4 | N=466320 | Completed | Sponsor: Tor Biering-Sørensen | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Influenza • Respiratory Diseases

DANFLU-2: A Pragmatic Randomized Trial to Evaluate the Effectiveness of High-Dose Quadrivalent Influenza Vaccine vs. Standard-Dose Quadrivalent Influenza Vaccine in Older Adults (clinicaltrials.gov) - P4 | N=332438 | Completed | Sponsor: Tor Biering-Sørensen | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Influenza • Respiratory Diseases

Characterizing Late-season Influenza Vaccine Responses to Compare the 2023 and 2024 Vaccine Formulations (clinicaltrials.gov) - P4 | N=23 | Completed | Sponsor: La Jolla Institute for Immunology | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Influenza • Respiratory Diseases

Elevated NK and T cell-associated cytokines in plasma are associated with serological response to influenza vaccination. (PubMed, Front Immunol) - "A cohort of 100 people were sampled pre- (Day 0) and post-vaccination (Day 7) with the inactivated, quadrivalent Fluzone construct in the autumn of 2019 (UGA4)...In conclusion, plasma chemokines and cytokine levels prior to or in the first few days post-influenza vaccination may be predictive of serological responses to vaccination, with changes in IFN-γ, IL-17A, and IL-15 post-vaccination possibly indicative of the activation of cell-mediated immunity. These findings support the need for larger, high-resolution studies exploring the role of plasma proteomics in serological responses to influenza vaccination."

Journal • Infectious Disease • Influenza • Respiratory Diseases • CCL11 • CCL2 • CCL22 • IFNG • IL15 • IL17A

Vaccine Responses in Patients With B Cell Malignancies (clinicaltrials.gov) - P4 | N=500 | Recruiting | Sponsor: National Heart, Lung, and Blood Institute (NHLBI) | Trial completion date: Aug 2025 ➔ Aug 2026 | Trial primary completion date: Aug 2025 ➔ Aug 2026

Trial completion date • Trial primary completion date • Chronic Lymphocytic Leukemia • Hematological Malignancies • Lymphoma • Oncology • BCL2

Pooled Analysis of Methodologically Harmonized Pragmatic Randomized Trials of High-Dose vs. Standard-Dose Influenza Vaccine Against Severe Clinical Outcomes (clinicaltrials.gov) - P4 | N=466320 | Active, not recruiting | Sponsor: Tor Biering-Sørensen | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Influenza • Respiratory Diseases

Influenza strain-specific T cell responses longitudinally post-vaccination with FluZone. (PubMed, Vaccine) - "Dynamics of cytokine-producing T cells early post-influenza vaccination may reflect ongoing immune responses, but activated and degranulating T cells better represent longitudinal changes in serological responses. Differences between T cells specific to influenza A and B subtypes warrant further investigation to understand why they diverge and the relevance to vaccine design and evaluation."

Journal • Genetic Disorders • Infectious Disease • Influenza • Obesity • Respiratory Diseases • IFNG

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

Trial completion • Infectious Disease • Influenza • Respiratory Diseases

Ibrutinib as an Immune Modulating Agent for Patients With Asymptomatic, High-risk CLL/SLL Risk Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (clinicaltrials.gov) - P2 | N=42 | Active, not recruiting | Sponsor: Jennifer Woyach | Trial completion date: Aug 2025 ➔ Dec 2025 | Trial primary completion date: Jul 2019 ➔ Aug 2025

Trial completion date • Trial primary completion date • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • TP53

DANFLU-2: A Pragmatic Randomized Trial to Evaluate the Effectiveness of High-Dose Quadrivalent Influenza Vaccine vs. Standard-Dose Quadrivalent Influenza Vaccine in Older Adults (clinicaltrials.gov) - P4 | N=339700 | Active, not recruiting | Sponsor: Tor Biering-Sørensen | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Influenza • Respiratory Diseases

Pooled Analysis of Methodologically Harmonized Pragmatic Randomized Trials of High-Dose vs. Standard-Dose Influenza Vaccine Against Severe Clinical Outcomes (clinicaltrials.gov) - P4 | N=450000 | Not yet recruiting | Sponsor: Tor Biering-Sørensen | Initiation date: Aug 2024 ➔ May 2025

Trial initiation date • Infectious Disease • Influenza • Respiratory Diseases

Impact of age and prior COVID-19 on the response to influenza a components in the 2020-2021 Fluzone vaccine. (PubMed, Vaccine) - "While prior COVID-19 infection was not associated with notable differences in the humoral response in this cohort, older age consistently correlated with reduced responses across multiple readouts. These findings highlight the need for targeted approaches to improve influenza vaccine effectiveness in older adults, who remain at elevated risk for severe outcomes from both influenza virus and SARS-CoV-2 infections."

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

Ibrutinib as an Immune Modulating Agent for Patients With Asymptomatic, High-risk CLL/SLL Risk Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (clinicaltrials.gov) - P2 | N=42 | Active, not recruiting | Sponsor: Jennifer Woyach | Trial completion date: Dec 2024 ➔ Aug 2025

Trial completion date • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • TP53