respiratory syncytial virus (RSV) vaccine (GSK3389245A) / GSK - LARVOL DELTA

Safety and immunogenicity of a ChAd155-vectored respiratory syncytial virus vaccine in infants 6-7 months of age: a phase 1/2 randomized trial. (PubMed, J Infect Dis) - P1/2 | "ChAd155-RSV administered to 6-7-month-olds had a reactogenicity/safety profile like other childhood vaccines, showed no evidence of VAERD, and induced a humoral immune response."

Journal • P1/2 data • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Safety and immunogenicity of a ChAd155-vectored RSV vaccine (ChAd155-RSV) in healthy RSV-seropositive children 12-23 months of age. (PubMed, J Infect Dis) - P1/2 | "Three ChAd155-RSV dosages were found to be well tolerated. A dose-dependent immune response was observed post-dose 1 with no observed booster effect post-dose 2. Further investigation of ChAd155-RSV in RSV-seronegative children is warranted."

Journal • Respiratory Diseases • Respiratory Syncytial Virus Infections

ChAd155-RSV vaccine is immunogenic and efficacious against bovine RSV infection-induced disease in young calves. (PubMed, Nat Commun) - "Immunized calves present no clinical signs of enhanced respiratory disease. Collectively, this supports the development of ChAd155-RSV as an RSV vaccine candidate for infants."

Journal • Infectious Disease • Pediatrics • Respiratory Diseases • Respiratory Syncytial Virus Infections

Respiratory Syncytial Virus (RSV) Investigational Vaccine in Infants Aged 6 and 7 Months Likely to be Unexposed to RSV (clinicaltrials.gov) - P1/2 | N=201 | Completed | Sponsor: GlaxoSmithKline | Phase classification: P1 ➔ P1/2

Phase classification • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Repeated-Dose Toxicity, Biodistribution, and Shedding Assessments With a ChAd155 Respiratory Syncytial Virus Vaccine Candidate Evaluated in Rabbits and Rats. (PubMed, Int J Toxicol) - "The shedding results demonstrated that ChAd155-RSV was generally not detectable in any secretions or excreta samples. In conclusion, the ChAd155-RSV vaccine was well-tolerated locally and systemically."

Journal • Preclinical • Infectious Disease • Pediatrics • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Study to Evaluate Safety, Reactogenicity and Immunogenicity of GSK Biologicals' RSV Investigational Vaccine Based on Viral Proteins Encoded by Chimpanzee-derived Adenovector (ChAd155-RSV) (GSK3389245A) in RSV-seropositive Infants (clinicaltrials.gov) - P1/2; N=107; Completed; Sponsor: GlaxoSmithKline; N=82 ➔ 107

Clinical • Enrollment change • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections • CD4 • IL2 • TNFA

Respiratory Syncytial Virus (RSV) Investigational Vaccine in Infants Aged 6 and 7 Months Likely to be Unexposed to RSV (clinicaltrials.gov) - P1; N=201; Completed; Sponsor: GlaxoSmithKline; Active, not recruiting ➔ Completed

Clinical • Trial completion • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

[VIRTUAL] CHAD155-VECTORED RESPIRATORY SYNCYTIAL VIRUS (RSV) INVESTIGATIONAL VACCINE (CHAD155-RSV) IS IMMUNOGENIC WHEN ADMINISTERED AT DIFFERENT DOSE LEVELS IN INFANTS AGED 6–7 MONTHS (ESPID 2021) - "In RSV seronaïve infants, ChAd155-RSV vaccine induced a significant binding and neutralizing RSV antibody responses which were greater at the higher dose level and increased after the second dose."

Meningococcal Infections • Pneumococcal Infections • Respiratory Diseases • Respiratory Syncytial Virus Infections

[VIRTUAL] REACTOGENICITY AND SAFETY OF CHAD155-VECTORED RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE (CHAD155-RSV) ADMINISTERED AT DIFFERENT DOSE LEVELS IN INFANTS AGED 6–7 MONTHS (ESPID 2021) - "Overall, no safety concern was detected with any ChAd155-RSV dose level/schedule."

Clinical • Dermatology • Meningococcal Infections • Pain • Pneumococcal Infections • Respiratory Diseases • Respiratory Syncytial Virus Infections

RSV Investigational Vaccine in RSV-seropositive Infants Aged 12 to 23 Months (clinicaltrials.gov) - P1/2; N=82; Completed; Sponsor: GlaxoSmithKline; Phase classification: P2 ➔ P1/2

Clinical • IO biomarker • Phase classification • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections • CD40LG • IFNG • IL2 • TNFA

RSV Investigational Vaccine in RSV-seropositive Infants Aged 12 to 23 Months (clinicaltrials.gov) - P2; N=82; Completed; Sponsor: GlaxoSmithKline; Active, not recruiting ➔ Completed

Clinical • IO biomarker • Trial completion • Infectious Disease • Respiratory Diseases • CD40LG • IFNG • IL2 • TNFA

Respiratory Syncytial Virus (RSV) Investigational Vaccine in Infants Aged 6 and 7 Months Likely to be Unexposed to RSV (clinicaltrials.gov) - P1; N=201; Active, not recruiting; Sponsor: GlaxoSmithKline; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

Respiratory Syncytial Virus (RSV) Investigational Vaccine in Infants Aged 6 and 7 Months Likely to be Unexposed to RSV (clinicaltrials.gov) - P1; N=250; Recruiting; Sponsor: GlaxoSmithKline; Trial primary completion date: May 2020 ➔ Feb 2020

Clinical • Trial primary completion date

Respiratory Syncytial Virus (RSV) Investigational Vaccine in Infants Aged 6 and 7 Months Likely to be Unexposed to RSV (clinicaltrials.gov) - P1; N=250; Recruiting; Sponsor: GlaxoSmithKline; N=150 ➔ 250

Clinical • Enrollment change