Vaxneuvance (15-valent pneumococcal conjugate vaccine) / Merck (MSD), Ligand - LARVOL DELTA

Protocol for a phase IV, Experimental Human Pneumococcal Challenge (EHPC) model to investigate Streptococcus pneumoniae serotype 3 (SPN3) colonisation following PCV15, a double-blind randomised controlled trial in healthy participants aged 18-50 years in the UK (RATIONALE-15). (PubMed, BMJ Open) - P4 | "The study is approved by the NHS Research and Ethics Committee (Reference: 24/SC/0388) and by the Medicines and Healthcare Products Regulatory Agency (Reference: CTA 21584/0485/001-0001). NCT06731374 - ISRCTN91656864."

Clinical protocol • Journal • P4 data • Infectious Disease • Pneumococcal Infections • Pneumonia • Respiratory Diseases

Cost-Effectiveness Analysis of Pediatric and Adult Pneumococcal Conjugate Vaccine Strategies in Canada (ISPOR-EU 2025) - "OBJECTIVES: In Canada, PCV15 (Vaxneuvance) and PCV20 (Prevnar 20) are approved for use in adult and pediatric populations... Funding PCV20 for both pediatric and adult public immunization programs could result in greater health and economic gains than funding PCV15 in pediatric and PCV21 in adult programs. Additionally, using one vaccine for all ages could enhance equity, simplify vaccine procurement, and improve logistical inefficiencies related to training, supply, and storage."

Clinical • Cost effectiveness • HEOR • Infectious Disease • Otorhinolaryngology • Pediatrics • Pneumococcal Infections • Pneumonia • Respiratory Diseases

Health Economic Analysis of Risk- and Age-Based Pneumococcal Vaccination With PCV21 vs. PCV20 in France (ISPOR-EU 2025) - "Vaccination of at-risk adults and those aged 65 years and more with PCV21 is expected to be cost-effective compared to vaccination with PCV20 in France."

HEOR • Omic analysis • Pneumococcal vaccines • CNS Disorders • Infectious Disease • Pediatrics • Pneumococcal Infections • Pneumonia • Respiratory Diseases

Level of ICER of Health Economic Assessment in France in 2024 (ISPOR-EU 2025) - "Dominant treatments were Vaxneuvance for pneumococcus meningitis and nivolumab in early NSCLC. These levels of ICER are high compared to those accepted abroad, notably the UK... These levels of ICER are high compared to those accepted abroad, notably the UK. This is partly explained by CEESP's methodological requirements on one side and the fact that the cost-effectiveness analysis is conducted on the treatment price before negotiations with the French Pricing Committee. The CEESP's recommendations for exploring and controlling uncertainty leads to the selection of conservative assumptions to prevent any risk of underestimating ICER."

HEOR • CNS Disorders • Infectious Disease • Lung Cancer • Non Small Cell Lung Cancer • Pneumococcal Infections • Solid Tumor

A Phase 3, Randomized Trial Investigating the Safety, Tolerability, and Immunogenicity of V116, an Adult-Specific Pneumococcal Conjugate Vaccine, in Pneumococcal Vaccine-Naïve Adults 18-64 Years of Age at Increased Risk of Pneumococcal Disease, STRIDE-8. (PubMed, Clin Infect Dis) - P3 | "V116 elicits robust immune responses and is well tolerated in adults 18-64 years of age with conditions associated with an increased risk of PD."

Clinical • Journal • P3 data • Diabetes • Infectious Disease • Metabolic Disorders • Pneumococcal Infections • Pulmonary Disease • Respiratory Diseases

What About Vaccine-Experienced Younger Adults? Cost-Effectiveness of PCV21 Use in Vaccine-Experienced US Adults Aged 19-64 Years with Underlying Medical Conditions. (PubMed, Am J Prev Med) - "The use of PCV21 in US adults aged 19-64 years with underlying medical conditions can be cost-effective, or cost-saving in most cases, across a wide range of scenarios."

HEOR • Journal • Infectious Disease • Pneumococcal Infections

V114 and Acute Otitis Media (clinicaltrialsregister.eu) - P3 | N=7119 | Sponsor: Merck Sharp & Dohme LLC

New P3 trial • Dermatology • Infectious Disease • Otorhinolaryngology

Indirect comparison of the immunogenicity of 15-valent and 20-valent pneumococcal conjugate vaccines in children using a 2 + 1 schedule. (PubMed, Expert Rev Vaccines) - "RRDs for serotypes 22F and 33F were non-inferior at both PPS and PTD. In a 2 + 1 schedule, PCV15 demonstrates immunogenicity comparable or superior to PCV20 across PCV13 serotypes, especially for serotype 3."

Journal • Infectious Disease • Pneumococcal Infections

Safety, tolerability, and immunogenicity of an adult-specific pneumococcal conjugate vaccine, V116, in people living with HIV (STRIDE-7): a two-part, parallel-group, randomised, active comparator-controlled, international, phase 3 trial. (PubMed, Lancet HIV) - P3 | "V116 was well tolerated and immunogenic for all 21 serotypes, supporting the use of this vaccine in adults living with HIV. Adults at high risk of pneumococcal disease due to underlying comorbid conditions, such as HIV, might benefit from receiving V116. The serotypes in V116, including the eight unique serotypes, are expected to provide broader protection against pneumococcal disease than currently licensed vaccines."

Journal • P3 data • Human Immunodeficiency Virus • Infectious Disease • Pneumococcal Infections • CD4

Biochemical and Immunological Insights into Capsular Polysaccharide of Streptococcus pneumoniae Serotype 38 (American Type 71)An Emerging Nonvaccine Serotype. (PubMed, ACS Omega) - "Despite the availability of high-valency pneumococcal polysaccharide vaccine of PPSV23 (PNEUMOVAX 23) and conjugate vaccines such as VAXNEUVANCE and PREVNAR 20, nonvaccine serotypes continue to contribute to higher mortality rates...Serotype 38 polysaccharide exhibited immunological cross-reactivity with serotype 5 and serotype 1 polyclonal sera, likely due to a shared epitope region containing a keto sugar component (Sugp) in their repeating units, along with net charge properties similar to serotype 1. These findings revealed novel characteristics of the serotype 38 polysaccharide, including its amino acid composition and net charge, which may contribute to the development of new therapeutics and effective vaccines."

Journal • Infectious Disease • Pneumococcal Infections • Pneumonia

The impact of pneumococcal vaccination and nasopharyngeal colonization on the performance of a serotype-specific urine antigen detection (SSUAD) assay. (PubMed, Vaccine) - P3 | "To estimate the serotype-specific CAP burden of pneumococcal disease following the introduction of a new 15-valent pneumococcal conjugate vaccine (PCV), V114, a 15-plex serotype-specific urine antigen detection (SSUAD) assay was developed as a tool for surveillance of Streptococcuspneumoniae serotypes...In general, SSUAD positivity appeared unrelated to NP/OP carriage. Our findings suggest SSUAD can support pneumococcal disease surveillance and vaccine effectiveness research, excluding individuals with recent pneumococcal vaccination to avoid false-positives."

Journal • Infectious Disease • Pneumococcal Infections • Pneumonia • Respiratory Diseases

Cost-effectiveness analysis of routine pediatric vaccination of 15-valent pneumococcal conjugate vaccine in South Korea. (PubMed, Hum Vaccin Immunother) - "PCV15 was projected to provide a total savings of ₩36,213,756 [$27,751] with a gain of 2 QALYs versus PCV13. Under the model assumptions, switching from PCV13 to PCV15 is a cost-saving option for South Korea's routine pediatric pneumococcal vaccination program."

HEOR • Journal • CNS Disorders • Infectious Disease • Otorhinolaryngology • Pediatrics • Pneumococcal Infections • Pneumonia

Predicting the Epidemiological Effects in the United Kingdom of Moving from PCV13 to PCV15 in the Routine Pediatric 1 + 1 Vaccination Schedule. (PubMed, Vaccines (Basel)) - "Switching from PCV13 to PCV15 for routine pediatric vaccinations under the 1 + 1 dosing schedule in the UK led to a lower IPD incidence in both the pediatric and overall populations."

Journal • Review • Infectious Disease • Pediatrics • Pneumococcal Infections

A Study on the Immune Response and Safety of the Second Dose of an Investigational Chickenpox Vaccine When Given to Healthy Children 3 Months After a First Dose at 12 to 15 Months of Age (clinicaltrials.gov) - P3 | N=600 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Varicella Zoster

A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine and a Marketed Measles, Mumps and Rubella Vaccine When Administered as Intramuscular Injection to Healthy Children 12 to 15 Months of Age (clinicaltrials.gov) - P3 | N=900 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Measles • Mumps • Rubella • Varicella Zoster

Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age (clinicaltrials.gov) - P3 | N=1080 | Recruiting | Sponsor: Sanofi | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Pneumococcal Infections

Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age (clinicaltrials.gov) - P3 | N=1080 | Not yet recruiting | Sponsor: Sanofi

New P3 trial • Infectious Disease • Pneumococcal Infections

V114 and Acute Otitis Media (V114-032/PNEU-ERA) (clinicaltrials.gov) - P3 | N=7000 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Jun 2025 ➔ Jan 2026 | Trial primary completion date: Jun 2025 ➔ Jan 2026

Trial completion date • Trial primary completion date • Otorhinolaryngology

Economic evaluation of PCV21 in vaccine-naïve adults aged 19-64 years with underlying medical conditions in the United States. (PubMed, J Med Econ) - "The analysis indicated that the V116 strategy prevented a substantial number of cases and deaths compared to the PCV20 or PCV15 + PPSV23 strategies among vaccine-naive AR/HR adults aged 19-49 and 50-64 years...Deterministic and probabilistic sensitivity analyses confirmed the robustness of these findings, with over 95% of simulations yielding cost-saving results and all estimated ICERs remaining below $10,000/QALY gained. The findings suggest that the use of PCV21 (Capvaxive™) in adults aged 19-64 years with underlying medical conditions in the US can prevent a significant number of pneumococcal disease cases and deaths while demonstrating favorable economic outcomes across various scenarios."

HEOR • Journal • CNS Disorders • Infectious Disease • Pneumococcal Infections • Pneumonia • Respiratory Diseases

A dynamic transmission model for assessing the impact of pneumococcal vaccination in the United States. (PubMed, PLoS One) - "The calibrated model was then used to project the epidemiological impact of PCV15, a 15-valent pneumococcal vaccine, compared with the status quo vaccination with PCV13 and demonstrated the value of added serotypes in PCV15. Projections revealed that PCV15 would reduce IPD incidence by 6.04% (range: 6.01% to 6.06%) over 10 years when compared to PCV13."

Journal • Infectious Disease • Pediatrics • Pneumococcal Infections • Pneumonia

PCV13-Serotype Breakthrough Pneumococcal Disease in Infants Receiving High-Valency Conjugate Vaccines: Population-Level Modeling in France. (PubMed, Infect Dis Ther) - "Implementation of PCV15 in a 2 + 1 regimen could reduce bIPD incidence due to all PCV13 serotypes in infants, whereas PCV20 in a 2 + 1 regimen may lead to substantial increases in bIPD cases from PCV13 serotypes in infants. PCV20 in a 3 + 1 regimen could potentially lead to a resurgence of bIPD from PCV7 serotypes in infants."

Journal • Infectious Disease • Pneumococcal Infections

RATIONALE-15: Carriage to Assess Protection of New Pneumococcal Vaccines - PCV15 (clinicaltrials.gov) - P4 | N=106 | Recruiting | Sponsor: University of Oxford | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Pneumococcal Infections • Pneumonia

A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine and a Marketed Measles, Mumps and Rubella Vaccine When Administered as Intramuscular Injection to Healthy Children 12 to 15 Months of Age (clinicaltrials.gov) - P3 | N=900 | Not yet recruiting | Sponsor: GlaxoSmithKline

New P3 trial • Infectious Disease • Measles • Mumps • Rubella • Varicella Zoster

Safety, Tolerability, and Immunogenicity of the Pneumococcal Vaccines PPSV23 or PCV15 Co-Administered with a Booster Dose of mRNA-1273 SARS-CoV-2 Vaccine in Healthy Adults ≥50 Years of Age. (PubMed, Vaccines (Basel)) - P3 | "Co-administration of mRNA-1273 with PPSV23 or PCV15 in healthy adults ≥50 years of age was immunogenic and well tolerated."

Journal • Infectious Disease • Novel Coronavirus Disease • Pneumococcal Infections • Pneumonia • Respiratory Diseases

A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine When Given to Healthy Children 12 to 15 Months of Age (clinicaltrials.gov) - P3 | N=1840 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Varicella Zoster