Typhim Vi (typhoid polysaccharide vaccine) / Sanofi - LARVOL DELTA

A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and Infants (clinicaltrials.gov) - P1 | N=551 | Completed | Sponsor: GlaxoSmithKline | Active, not recruiting ➔ Completed

Trial completion

A Study to Evaluate Safety, Reactogenicity, and Immune Response of GVGH iNTS-TCV Vaccine Against Invasive Nontyphoidal Salmonella and Typhoid Fever (clinicaltrials.gov) - P1/2 | N=155 | Completed | Sponsor: GlaxoSmithKline | Recruiting ➔ Completed

Trial completion • Infectious Disease

Common Variable Immunodeficiency Associated With A Novel TNFSF12 Variant In A Patient With Non-Hodgkin Lymphoma (ACAAI 2025) - "Four years after receiving rituximab, immunologic evaluation while on IgG replacement showed persistently low IgG (473 mg/dL)and IgA (10 mg/dL), absent class-switched memory B cells, and poor Typhim Vi polysaccharide vaccine response consistent with a diagnosis of CVID. We contribute to the existing literature by describing a novel TNFSF12 variant associated with a CVID phenotype. This case highlights the importance of genetic testing in patients with CVID to optimize treatment and facilitate genetic counseling."

Clinical • B Cell Non-Hodgkin Lymphoma • Hematological Malignancies • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Primary Immunodeficiency • Thrombocytopenia • TNFSF12

SMART: Smallpox Vaccine for Mpox Post-Exposure Prophylaxis: A Cluster RCT (clinicaltrials.gov) - P4 | N=3000 | Recruiting | Sponsor: McMaster University | N=1560 ➔ 3000 | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Jun 2025 ➔ Jun 2026

Enrollment change • Trial completion date • Trial primary completion date • Infectious Disease

Comparative immune response of Typbar TCV® (typhoid conjugate vaccine) in extremes of age: An Indian experience. (PubMed, Hum Vaccin Immunother) - "Results established that Typbar TCV® induced significantly higher antibody titer compared to Typhim Vi on days 28 and 90 (p < .001). Thus, Typbar TCV® was studied effectively from 6 months to above 85 years, which is the upper age limit. CTRI Registration number: CTRI/2016/01/006476, CTRI/2024/06/069638."

Clinical • Journal • Infectious Disease

FEIV: Inflammatory Challenge and Fear (clinicaltrials.gov) - P1 | N=288 | Recruiting | Sponsor: University of California, San Francisco | Not yet recruiting ➔ Recruiting | Initiation date: Nov 2024 ➔ Mar 2025

Enrollment open • Trial initiation date • CNS Disorders • Mood Disorders • Post-traumatic Stress Disorder

A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and Infants (clinicaltrials.gov) - P1 | N=552 | Active, not recruiting | Sponsor: GlaxoSmithKline | Recruiting ➔ Active, not recruiting | Phase classification: P1/2 ➔ P1

Enrollment closed • Phase classification

Safety and Immunogenicity of a Novel Conjugate Vaccine Against Salmonella Typhi and Salmonella Paratyphi A in Healthy Adults (clinicaltrials.gov) - P1 | N=97 | Completed | Sponsor: GlaxoSmithKline | Recruiting ➔ Completed

Trial completion • Infectious Disease

Interim safety data from a phase 1/2a, randomized, controlled, observer-blind trial to evaluate the safety, reactogenicity and immunogenicity of a trivalent vaccine against invasive nontyphoidal Salmonellosis (iNTS) and Typhoid Fever in healthy . (ASTMH 2024) - "In stage 1, 50 European adults were randomized in a 2:2:1 ratio to receive either iNTS-TCV vaccine and concomitant saline in different arms, or separate iNTS-GMMA and TCV vaccines in different arms, or placebo and saline in different arms intramuscularly, on Days 1, 57 and 169...Menveo, Boostrix and Typhim Vi are administered as controls for the 1 st , 2 nd and 3 rd doses respectively...In conclusion, based on available data, the anticipated benefit/risk profile of the iNTS-TCV vaccine continues to be positive, with no safety concerns precluding further clinical development. First immunogenicity results are expected later in 2024 and would be presented at the congress."

Clinical • P1/2 data • Fatigue • Infectious Disease • Musculoskeletal Pain • Pain

FEIV: Inflammatory Challenge and Fear (clinicaltrials.gov) - P1 | N=288 | Not yet recruiting | Sponsor: University of California, San Francisco

New P1 trial • CNS Disorders • Mood Disorders • Post-traumatic Stress Disorder

SMART: Smallpox Vaccine for Mpox Post-Exposure Prophylaxis: a Cluster RCT (clinicaltrials.gov) - P4 | N=1560 | Recruiting | Sponsor: McMaster University | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Dec 2024 ➔ Jun 2025

Enrollment open • Trial completion date • Trial primary completion date • Infectious Disease

A randomized, triple-blinded, placebo-controlled clinical trial evaluating immune responses of Typhim Vi and PPSV23 vaccines in healthy adults: The PREP study. (PubMed, Vaccine) - P1 | "The PPSV3 group showed a higher inflammatory profile, suggesting that PPSV23 induces a stronger immune response compared to Typhim Vi. The distinct immune responses induced by the two vaccines indicate the potential for utilizing vaccines as models for studying inflammation responses associated with different infectious pathogens."

Clinical • Journal • Infectious Disease • Inflammation • Pneumococcal Infections • CCL4 • IL10

Polysaccharide Antibody Response Study (clinicaltrials.gov) - P4 | N=200 | Completed | Sponsor: Universitaire Ziekenhuizen KU Leuven | Unknown status ➔ Completed

Trial completion

A TLR4 ligand-based adjuvant for promoting the immunogenicity of typhoid subunit vaccines. (PubMed, Front Immunol) - "None of the typhoid Vi Polysaccharide (ViPS) subunit vaccines incorporate adjuvants, and the immunogenicity of ViPS vaccines (e.g. Typbar TCV® and Typhim Vi®) is in part due to associated TLR4 ligands such as endotoxin present in these vaccines. Nevertheless, when adjuvanted with Turbo, poorly immunogenic ViPS induced a robust IgG response in young and adult mice, and this was observed even under antigen-limiting conditions. These data suggest that incorporation of Turbo as an adjuvant will make typhoid vaccines more immunogenic regardless of their intrinsic immunogenicity or conjugation status and maximize the efficacy across all ages."

Journal • Infectious Disease • Tetanus • TLR4

Monophosphoryl Lipid A-based Adjuvant to Promote the Immunogenicity of Multivalent Meningococcal Polysaccharide Conjugate Vaccines. (PubMed, Immunohorizons) - "Many Gram-negative bacterial polysaccharide vaccines, including the tetravalent meningococcal conjugate vaccines (MCV4) and typhoid Vi polysaccharide vaccines, do not incorporate adjuvants...Consistent with this hypothesis, two Food and Drug Administration-approved MCV4 vaccines, MENVEO and MenQuadfi, lack TLR4 ligands...Turbo upregulated the expression of the costimulatory molecules CD40 and CD86 on B cells, and Turbo-driven adjuvanticity is lost in mice deficient in CD40 and CD86. These data suggest that Turbo induces the required costimulatory molecules for its adjuvant activity and that incorporation of Turbo could make bacterial polysaccharide vaccines more immunogenic, minimize booster requirements, and be cost-effective, particularly for those individuals in low- and middle-income and disease-endemic countries."

IO biomarker • Journal • Infectious Disease • Meningococcal Infections • CD40 • CD86 • TLR4

Undetectable IgE as a Sentinel Biomarker for Humoral Immunodeficiency (clinicaltrials.gov) - P1 | N=37 | Completed | Sponsor: University of Virginia | Active, not recruiting ➔ Completed

Biomarker • Trial completion

SLVP033: Effects of Aging on Primary and Secondary Vaccine Responses in a 15-Year Longitudinal Cohort (clinicaltrials.gov) - P1 | N=54 | Completed | Sponsor: Stanford University | Active, not recruiting ➔ Completed

Trial completion • Hepatology • Infectious Disease • Inflammation • Influenza • Respiratory Diseases

Effects of Oral Iron Supplementation on Vaccine Response in Iron Deficient Kenyan Women (clinicaltrials.gov) - P=N/A | N=180 | Recruiting | Sponsor: Prof Simon Karanja | Trial primary completion date: Mar 2024 ➔ Jun 2024

Trial primary completion date • Anemia • Hematological Disorders

Autogenic splenic implantation versus splenectomy in patients undergoing distal pancreatectomy for benign or low-grade malignant lesions of the distal pancreas: study protocol for a multicentre, open-label, randomized controlled trial (RESTORE). (PubMed, Trials) - "This study will investigate the splenic immune function of patients who undergo ASI during minimally invasive distal pancreatectomy with splenectomy. The splenic immune function will be measured using the surrogate outcome of specific antibody titre after vaccination with a Salmonella typhi vaccine. The results will reveal details about splenic function after ASI and guide further treatment options for patients when a splenectomy cannot be avoided. It might eventually lead to a new standard of care making sometimes more demanding and time-consuming spleen-preserving procedures redundant."

Journal • Infectious Disease • Pancreatic Cancer

DIVA_II: Effects of Oral Iron Supplementation Before vs at Time of Vaccination on Immune Response in Iron Deficient Kenyan Women (clinicaltrials.gov) - P=N/A | N=180 | Recruiting | Sponsor: Swiss Federal Institute of Technology

New trial • Anemia • Hematological Disorders • IFNG

Assessment of humoral immune function in chronic obstructive pulmonary disease (COPD) patients (ERS 2023) - "Typhim Vi vaccine is a polysaccharide vaccine, and its response can be used to measure humoral immune function... Inadequate antibody response has been observed in some COPD patients (5/11 sample size), specifically those with more exacerbations, lower quality of life, and advanced age. Anti-typhi IgG response may be a biomarker for COPD phenotyping. Further investigation in a larger patient cohort is underway.; General respiratory patient care; Cell and molecular biology; Physiology; Public health"

Clinical • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Oncology • Pulmonary Disease • Respiratory Diseases

A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and Infants (clinicaltrials.gov) - P1/2 | N=550 | Recruiting | Sponsor: GlaxoSmithKline | Trial completion date: Jul 2024 ➔ Apr 2025 | Trial primary completion date: Jul 2024 ➔ Apr 2025

Trial completion date • Trial primary completion date

SMART: Smallpox Vaccine for Mpox Post-Exposure Prophylaxis: A Cluster RCT (clinicaltrials.gov) - P4 | N=1560 | Not yet recruiting | Sponsor: McMaster University | Initiation date: Apr 2023 ➔ Jul 2023

Trial initiation date • Infectious Disease

Safety and Immunogenicity of a Novel Conjugate Vaccine Against Salmonella Typhi and Salmonella Paratyphi A in Healthy Adults (clinicaltrials.gov) - P1 | N=96 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease

SLVP033: Effects of Aging on Primary and Secondary Vaccine Responses in a 15-Year Longitudinal Cohort (clinicaltrials.gov) - P1 | N=54 | Active, not recruiting | Sponsor: Stanford University | Trial completion date: Dec 2022 ➔ Dec 2023 | Trial primary completion date: Dec 2022 ➔ Dec 2023

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