Safety, Tolerability, Immunogenicity of the Novel Pneumococcal Conjugate Vaccine V114 in Patients at Risk for Pneumococcal Disease

The following article is a part of conference coverage from the IDWeek 2021, being held virtually from September 29 to October 3, 2021. The team at Infectious Disease Advisor will be reporting on the latest news and research conducted by leading experts in the field. Check back for more from the IDWeek 2021.

A novel 15-valent pneumococcal conjugate vaccine (V114) was found to be safe, tolerable, and effective against 15 vaccine serotypes in adult patients when administered alone or sequentially with the 23-valent pneumococcal polysaccharide vaccine (PPSV23), according to research presented at IDWeek, held virtually from September 29 to October 3, 2021. In addition, V114 contains 2 more serotypes of epidemiologic significance than the standard 13-valent pneumococcal conjugate vaccine (PCV13).

Investigators analyzed the safety, tolerability, and immunogenicity of V114 among patients enrolled in the PNEU-DAY Phase 3 study (NCT03547167). Patients aged 18 to 49 years with or without pneumococcal disease (PD) risk factors were randomly assigned to receive either V114 or PCV13 followed by PPSV23 after 6 months. To assess the safety and tolerability of V114 and PCV13, the investigators divided patients into 3 subgroups according to the number of baseline PD risk factors (0, 1, or >2). Baseline PD risk factors included chronic liver, lung, and heart disease; diabetes, tobacco use, and alcohol consumption.

The investigators also assessed vaccine tolerability by collecting data on patient-reported adverse events that occurred following each vaccination. In addition, they determined vaccine immunogenicity by analyzing patients’ serotype-specific opsonophagocytic activity (OPA) at day 30 after each vaccination.

Among a total of 1135 patients who received either V114 (n=1135) or PCV13 (n=380), 25.2% had no baseline PD risk factors, 54.7% had 1 risk factor, and 20.1% had 2 or more risk factors. Incidence and type of adverse event after vaccination with either V114, PCV13, or PPSV23 were comparable among the 3 subgroups, with injection-site pain, myalgia, and fatigue as the most commonly reported adverse events.

Both V114 and PCV13 were found to be immunogenic for all 13 shared serotypes among patients in all 3 subgroups based on OPA geometric mean titers measured at baseline and day 30 following vaccination for the 13 shared serotypes. In addition, “V114 induced a robust immune response to the 2 unique [serotypes] (22F and 33F) in all [3] subgroups,” the investigators concluded.

Reference

Hammit L, Quinn D, Janczewska E, et al. Phase 3 trial to evaluate the safety, tolerability, and immunogenicity of V114 followed by 23-valent pneumococcal polysaccharide vaccine 6 months later in at-risk adults aged 18-49 years (PNEU-DAY): a subgroup analysis by baseline risk factors. Presented at: IDWeek; September 29 to October 3, 2021. Poster 1050.

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