Vaxelis (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus, haemophilus b conjugate and hepatitis B vaccine) / Merck (MSD), Sanofi - LARVOL DELTA

Cmss1 limits FMDV infection by enhancing antigen presentation and CD8+ T cell responses. (PubMed, J Virol) - "We identified VP419-30 as an immunodominant CD8+ T cell epitope of FMDV and established an in vitro system to evaluate the antigen-presenting capacities. Based on these findings, we validate Cmss1 as a novel host factor in antigen processing and presentation during FMDV infection. Since DCs play critical roles in mediating immune responses, our findings comprehensively characterize the immune features of dendritic cells for the first time and present a new mechanism through which the host defends against FMDV infection, suggesting Cmss1 as a novel potential target for antiviral therapies."

Journal • Infectious Disease • CD8 • IFNAR2

Infant protection from invasive Haemophilus influenzae type b disease using the PRP-OMPC conjugate vaccine: An update. (PubMed, Hum Vaccin Immunother) - "Additional studies that are recently published address previously open questions regarding Vaxelis, including immunogenicity after the first infant dose, co-administration with meningococcal B vaccine, and interchangeability with other hexavalent vaccines. This brief review summarizes recently published Vaxelis data, with potential implications for ongoing control of invasive Hib disease in Europe."

Journal • Review • Infectious Disease • Influenza • Meningococcal Infections • Pediatrics • Respiratory Diseases • Tetanus

Study of Mixed Vaccination Schedules With a 21-valent Pneumococcal Conjugate Vaccine and a 20-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age (clinicaltrials.gov) - P3 | N=580 | Recruiting | Sponsor: Sanofi | Trial completion date: May 2027 ➔ Aug 2027 | Trial primary completion date: May 2027 ➔ Aug 2027

Trial completion date • Trial primary completion date • Infectious Disease • Pneumococcal Infections

PRELIMINARY ANALYSIS OF PRE-BOOSTER IMMUNE RESPONSE TO HEXAVALENT VACCINES FOLLOWING THREE-DOSE PRIME VACCINATION IN PRETERM INFANTS (ESPID 2025) - "Methods UK-based infants receiving a three-dose Infanrix hexa (Hex-I) or Vaxelis (Hex-V) hexavalent vaccine schedule at 2-3-4 months were recruited at 12-months and not given Hib/MenC. Sample analysis is ongoing; more samples expected by May 2025. Conclusions/Learning Points These preliminary data suggest that infants born preterm have lower anti-PRP antibodies at 18-months than term infants and could be at increased risk of Hib infection prior to booster vaccination."

Prematurity • Hepatitis B • Infectious Disease • Influenza • Pertussis

Study of Mixed Vaccination Schedules With a 21-valent Pneumococcal Conjugate Vaccine and a 20-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age (clinicaltrials.gov) - P3 | N=580 | Recruiting | Sponsor: Sanofi | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Pneumococcal Infections

Study of the Safety of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age (clinicaltrials.gov) - P3 | N=2320 | Recruiting | Sponsor: Sanofi | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Pneumococcal Infections

MADI-02: Maternal Determinants of Infant Immunity to Pertussis (clinicaltrials.gov) - P4 | N=200 | Recruiting | Sponsor: Centre Hospitalier Universitaire Saint Pierre | Trial primary completion date: Dec 2024 ➔ Aug 2025

Trial primary completion date • Infectious Disease • Pertussis • Respiratory Diseases

Study of the Safety of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age (clinicaltrials.gov) - P3 | N=2320 | Not yet recruiting | Sponsor: Sanofi

New P3 trial • Infectious Disease • Pneumococcal Infections

Study of Mixed Vaccination Schedules With a 21-valent Pneumococcal Conjugate Vaccine and a 20-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age (clinicaltrials.gov) - P3 | N=580 | Not yet recruiting | Sponsor: Sanofi

New P3 trial • Infectious Disease • Pneumococcal Infections

Preferences of nurses in the United Kingdom for attributes of pediatric hexavalent vaccines: a discrete-choice experiment. (PubMed, Expert Rev Pharmacoecon Outcomes Res) - "Nurses generally preferred vaccines that have been available for longer than 3 years versus less than 1 year. Nurses did not have clear preferences either way on plastic blister in packaging or for how long vaccines can be stored at room temperature before needing to be discarded.In this survey, nurses' preferences were mainly influenced by device type, preferring ready-to-use vaccines available as pre-filled syringes to vaccines that need to be mixed before use."

Journal • Cough • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Influenza • Pediatrics • Pertussis • Respiratory Diseases • Tetanus

CORAL: Co-administration Study of an Investigational Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers (clinicaltrials.gov) - P3 | N=2226 | Active, not recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Recruiting ➔ Active, not recruiting

Enrollment closed • Pediatrics • Respiratory Diseases • Respiratory Syncytial Virus Infections

Study of a 4-Dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age (clinicaltrials.gov) - P3 | N=1630 | Recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Pneumococcal Infections

Study of a 4-Dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age (clinicaltrials.gov) - P3 | N=1630 | Not yet recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company

New P3 trial • Infectious Disease • Pneumococcal Infections

Safety and Immunogenicity of an Investigational Pentavalent Meningococcal ABCYW Vaccine Against Meningococcal Disease in Children, Toddlers, and Infants (clinicaltrials.gov) - P1/2 | N=750 | Recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Meningococcal Infections • Pediatrics

Safety and Immunogenicity of an Investigational Pentavalent Meningococcal ABCYW Vaccine Against Meningococcal Disease in Children, Toddlers, and Infants (clinicaltrials.gov) - P1/2 | N=750 | Not yet recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company

New P1/2 trial • Infectious Disease • Meningococcal Infections • Pediatrics

CORAL: Co-administration Study of an Investigational Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers (clinicaltrials.gov) - P3 | N=2226 | Recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Trial completion date: Mar 2026 ➔ Sep 2025

Trial completion date • Pediatrics • Respiratory Diseases • Respiratory Syncytial Virus Infections

Haemophilus influenzae Type b Vaccine Immunogenicity in American Indian/Alaska Native Infants. (PubMed, Pediatrics) - "Postdose 1 immunogenicity of Vaxelis was noninferior to PedvaxHIB. Our findings support the use of Vaxelis in AI/AN children, a population with elevated risk of Hib disease."

Journal • Infectious Disease • Influenza • Respiratory Diseases

Use of Haemophilus influenzae Type b-Containing Vaccines Among American Indian and Alaska Native Infants: Updated Recommendations of the Advisory Committee on Immunization Practices - United States, 2024. (PubMed, MMWR Morb Mortal Wkly Rep) - "Hib vaccination with a monovalent Hib conjugate vaccine consisting of Hib capsular polysaccharide (polyribosylribitol phosphate [PRP]) conjugated to outer membrane protein complex of Neisseria meningitidis serogroup B, PRP-OMP (PedvaxHIB, Merck and Co., Inc.) has historically been preferred for AI/AN infants, who are at increased risk for invasive Hib disease, because it provides substantial protection after the first dose. On June 26, 2024, CDC's Advisory Committee on Immunization Practices (ACIP) recommended that a hexavalent, combined diphtheria and tetanus toxoids and acellular pertussis (DTaP), inactivated poliovirus (IPV), Hib conjugate, and hepatitis B (HepB) vaccine, DTaP-IPV-Hib-HepB (Vaxelis, MSP Vaccine Company) should be included with monovalent PRP-OMP in the preferential recommendation for AI/AN infants because of the PRP-OMP Hib component...For the booster dose of Hib vaccine, no vaccine formulation is preferred for AI/AN children; any Hib vaccine..."

Journal • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Influenza • Meningococcal Infections • Pertussis • Respiratory Diseases • Tetanus

MADI-02: Maternal Determinants of Infant Immunity to Pertussis (clinicaltrials.gov) - P4 | N=200 | Recruiting | Sponsor: Centre Hospitalier Universitaire Saint Pierre | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Pertussis • Respiratory Diseases

CORAL: Co-administration Study of an Investigational Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers (clinicaltrials.gov) - P3 | N=2226 | Not yet recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company

New P3 trial • Pediatrics • Respiratory Diseases • Respiratory Syncytial Virus Infections

CORAL: Co-administration Study of an Investigational Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers (clinicaltrials.gov) - P3 | N=2226 | Recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Not yet recruiting ➔ Recruiting

Enrollment open • Pediatrics • Respiratory Diseases • Respiratory Syncytial Virus Infections

February 2024 ACIP Meeting Update: Meningococcal, RSV, COVID-19, and Other Vaccines. (PubMed, Pediatrics) - "The ACIP met February 28 to 29, 2024, to discuss coronavirus disease (COVID-19) vaccines, chikungunya vaccines, DT vaccine, influenza vaccines, polio vaccines, RSV vaccines, meningococcal vaccines, pneumococcal vaccines and Vaxelis (DTaP, Inactivated Poliovirus, Haemophilus influenzae b Conjugate & Hepatitis B Vaccine). This update summarizes the proceedings of these meetings, with an emphasis on topics that are most relevant to the pediatric population. Major updates for pediatric clinicians include information about changes on influenza vaccine composition, meningococcal vaccination considerations, updated guidance for children with a contraindication to pertussis-containing vaccines, and recommendations of the world's first chikungunya vaccine for certain populations."

Journal • Chikungunya • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Influenza • Meningococcal Infections • Novel Coronavirus Disease • Pediatrics • Pertussis • Pneumococcal Infections • Respiratory Diseases • Respiratory Syncytial Virus Infections

Preferences of healthcare providers in Switzerland for attributes of pediatric hexavalent vaccines: a discrete-choice experiment. (PubMed, Curr Med Res Opin) - "According to CRAI, the most important attribute was Hib seroprotection, followed by years on the market, device type, and packaging size. Hib seroprotection at 11-12 months was the most important hexavalent vaccine attribute to HCPs in this study."

Journal • Infectious Disease • Influenza • Pediatrics • Respiratory Diseases

A phase 4, open-label study to evaluate the safety and immunogenicity of DTaP5-HBV-IPV-Hib in children previously vaccinated with DTaP2-HBV-IPV-Hib or DTaP5-HBV-IPV-Hib (V419-016). (PubMed, Hum Vaccin Immunother) - "The purpose of this study was to describe the safety, tolerability, and immunogenicity of a booster dose of Vaxelis® in participants who previously received a primary infant series of either DTaP2-HBV-IPV-Hib (Hexyon®) or Vaxelis®. The booster was well tolerated in both groups. These data support the use of Vaxelis® as a booster in mixed HV regimens."

Journal • P4 data • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Influenza • Pediatrics • Pertussis • Respiratory Diseases • Tetanus

Characterization and Engineering of Two Highly Paralogous Sesquiterpene Synthases Reveal a Regioselective Reprotonation Switch. (PubMed, Angew Chem Int Ed Engl) - "The cryoelectron microscopy-derived AhCS complex structure provided the structural basis for identifying different key active site residues that may govern their functional disparity. The structure-guided mutagenesis of these residues resulted in successful functional interconversion between AhCS and AhIS, thus targeting the three active site residues [L311-S419-C458]/[M311-V419-A458] that may act as a C3/C6 reprotonation switch for GA. These findings could facilitate the rational design or directed evolution of STPSs with structurally diverse skeletons."

Journal