GSK3277511A / GSK - LARVOL DELTA

Ex-vivo RNA expression analysis of vaccine candidate genes in COPD sputum samples. (PubMed, Respir Res) - P=N/A | "The NTHi-Mcat vaccine candidate genes were expressed in sputum samples, and each gene had a specific level of expression. No statistically significant differences in gene expression were detectable between stable and exacerbation samples. However, the history of COPD exacerbations was slightly associated with the expression of pd, pilA and uspA2. Trial registration NCT01360398 ( https://www."

Journal • Preclinical • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Inflammation • Influenza • Pulmonary Disease • Respiratory Diseases

"Next up preventable medicine for Exac.COPD. The need for a vaccine for Non-typeable H. influenzae. NTHi-Mcat vaccine did not reduce sputum bacterial load. Sadly vaccine efficacy found to be zero. Likely due to our poor definitions of Exac.COPD (@ProfHurst!) #BTSWinter2022" (@DrMattPav)

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

A detailed analysis of possible efficacy signals of NTHi-Mcat vaccine against severe COPD exacerbations in a previously reported randomised phase 2b trial. (PubMed, Vaccine) - P2 | "Results suggest potential efficacy with the NTHi-Mcat vaccine against severe exacerbations in certain patients with COPD, in particular those who have frequent exacerbations and use inhaled corticosteroids. This potential signal requires confirmation in an appropriately designed prospective clinical trial."

Journal • P2b data • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Pneumococcal Infections • Pulmonary Disease • Respiratory Diseases

Safety and immunogenicity of three doses of non-typeable Haemophilus influenzae-Moraxella catarrhalis (NTHi-Mcat) vaccine when administered according to two different schedules: a phase 2, randomised, observer-blind study. (PubMed, Respir Res) - P2 | "No safety concerns were identified when the investigational NTHi-Mcat vaccine was administered via a 0-2-6 months or 0-2-12 months schedule to older adults with a smoking history. Persistent immune responses were observed after the third vaccine dose. Trial registration https://clinicaltrials.gov/ ; NCT03443427, registered February 23, 2018."

Journal • P2 data • Cardiovascular • Chronic Obstructive Pulmonary Disease • Dermatology • Gastroenterology • Gastrointestinal Disorder • Gout • Immunology • Infectious Disease • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Lung Cancer • Myocardial Infarction • Oncology • Psoriasis • Pulmonary Disease • Respiratory Diseases • Rheumatology • Solid Tumor • Ulcerative Colitis

Non-typeable Haemophilus influenzae-Moraxella catarrhalis vaccine for the prevention of exacerbations in chronic obstructive pulmonary disease: a multicentre, randomised, placebo-controlled, observer-blinded, proof-of-concept, phase 2b trial. (PubMed, Lancet Respir Med) - P2 | "NTHi-Mcat vaccine administered to patients with COPD did not show efficacy in reducing the yearly rate of moderate or severe exacerbations. No safety concerns were identified."

Clinical • Journal • P2b data • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases

Long-term immunogenicity and safety of a non-typeable Haemophilus influenzae-Moraxella catarrhalis vaccine: 4-year follow-up of a phase 1 multicentre trial. (PubMed, Vaccine X) - P1 | "Immune responses against NTHi antigens persisted for 4 years after two-dose vaccination with the investigational NTHi-Mcat vaccine. There was no persistent response against the Mcat antigen. No safety concerns were identified during the long-term follow-up."

Clinical • Journal • P1 data • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Lung Cancer • Neuralgia • Oncology • Pain • Pulmonary Disease • Respiratory Diseases • Solid Tumor

[VIRTUAL] Late Breaking Abstract - First-time assessment of efficacy of candidate vaccine to prevent acute exacerbations of chronic obstructive pulmonary disease (AECOPD): multicentre, randomised, controlled, observer-blind phase 2b trial (ERS 2021) - P2 | "NTHi-Mcat vaccine administered to patients with COPD was immunogenic but did not reduce the yearly rate of moderate/severe exacerbations. No safety concerns were identified. There were fewer reports of COPD leading to hospitalisation in the vaccine group."

Clinical • Late-breaking abstract • P2b data • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases

Study to Assess the Immunogenicity and Safety of GSK's Investigational Vaccine (GSK3277511A) When Given to Healthy Smokers and Ex-smokers After Administration of Shingrix Vaccine (clinicaltrials.gov) - P2; N=542; Completed; Sponsor: GlaxoSmithKline; Active, not recruiting ➔ Completed

Clinical • Trial completion • Respiratory Diseases • CD4 • IFNG • IL17A • IL2 • TNFA

Study to Assess the Immunogenicity and Safety of GSK's Investigational Vaccine (GSK3277511A) When Given to Healthy Smokers and Ex-smokers After Administration of Shingrix Vaccine (clinicaltrials.gov) - P2; N=540; Not yet recruiting; Sponsor: GlaxoSmithKline

Clinical • New P2 trial • Respiratory Diseases • CD4 • IFNG • IL17A • IL2

Study to Assess the Immunogenicity and Safety of GSK's Investigational Vaccine (GSK3277511A) When Given to Healthy Smokers and Ex-smokers After Administration of Shingrix Vaccine (clinicaltrials.gov) - P2; N=540; Recruiting; Sponsor: GlaxoSmithKline; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Respiratory Diseases • CD4 • IFNG • IL17A • IL2

Study to Assess the Immunogenicity and Safety of GSK's Investigational Vaccine (GSK3277511A) When Given to Healthy Smokers and Ex-smokers After Administration of Shingrix Vaccine (clinicaltrials.gov) - P2; N=543; Active, not recruiting; Sponsor: GlaxoSmithKline; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Respiratory Diseases • CD4 • IFNG • IL17A • IL2

A Study to Test if a Third Dose of the Vaccine is Safe in Current and Former Smokers Aged 40 to 80 Years Old and to Gather Information on the Immune Response Following the Third Dose of the Vaccine (clinicaltrials.gov) - P2; N=200; Completed; Sponsor: GlaxoSmithKline; Active, not recruiting ➔ Completed

Clinical • Trial completion • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases • TNFA

Safety and immunogenicity of non-typeable Haemophilus influenzae-Moraxella catarrhalis vaccine. (PubMed, Vaccine) - P1 | "Responses against the Mcat antigen were similar across groups, with waning immunogenicity after 30 days post-dose 2. The investigational NTHi-Mcat vaccine had an acceptable safety and reactogenicity profile and good immunogenicity in older adults with a smoking history."

Clinical • Journal • Chronic Obstructive Pulmonary Disease • Infectious Disease

A Study to Test if a Third Dose of the Vaccine is Safe in Current and Former Smokers Aged 40 to 80 Years Old and to Gather Information on the Immune Response Following the Third Dose of the Vaccine (clinicaltrials.gov) - P2; N=200; Active, not recruiting; Sponsor: GlaxoSmithKline; Trial completion date: Jun 2020 ➔ Oct 2020

Clinical • Trial completion date • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

A Long Term Follow-up Study up to 4 Years After Study Vaccination to Assess Immunogenicity and Safety of the Investigational Vaccine in Adults (clinicaltrials.gov) - P1; N=81; Completed; Sponsor: GlaxoSmithKline; Active, not recruiting ➔ Completed

Clinical • Trial completion • Respiratory Diseases

A Study to Test if the Vaccine is Working Well in Chronic Obstructive Pulmonary Disease (COPD) Patients Aged 40 to 80 Years Old to Reduce Episodes of Worsening Symptoms and to Gather Further Information on Safety and Immune Response. (clinicaltrials.gov) - P2; N=606; Completed; Sponsor: GlaxoSmithKline; Active, not recruiting ➔ Completed

Clinical • Trial completion

A Study to Test if a Third Dose of the Vaccine is Safe in Current and Former Smokers Aged 40 to 80 Years Old and to Gather Information on the Immune Response Following the Third Dose of the Vaccine (clinicaltrials.gov) - P2; N=200; Active, not recruiting; Sponsor: GlaxoSmithKline; Trial primary completion date: May 2020 ➔ Dec 2019

Clinical • Trial primary completion date

Study to assess the immunogenicity and safety of GSK's investigational vaccine (GSK3277511A) when given to healthy smokers and ex-smokers after Shingrix vaccination (clinicaltrialsregister.eu) - P2; N=540; Ongoing; Sponsor: GlaxoSmithKline Biologicals

Clinical • IO Biomarker • New P2 trial

A Study to Test if the Vaccine is Working Well in Chronic Obstructive Pulmonary Disease (COPD) Patients Aged 40 to 80 Years Old to Reduce Episodes of Worsening Symptoms and to Gather Further Information on Safety and Immune Response. (clinicaltrials.gov) - P2; N=610; Active, not recruiting; Sponsor: GlaxoSmithKline; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed