Pneumococcal conjugate vaccines (PCVs), including the 13-valent PCV (PCV13), have been highly effective in reducing pneumococcal disease burden, but additional serotypes not in PCV13 continue to proliferate, according to a new study.
The report in the journal Vaccine notes that the 20-valent PCV (PCV20) was developed to expand protection against pneumococcal disease beyond PCV13. A new industrysupported study led by Kaiser Permanente Vaccine Study Center researchers assessed consistency of immune responses across three lots of PCV20 and described the safety profile of PCV20 as part of the phase lll clinical development program.
Included in the phase lll, randomized, multicenter, double-blind study of pneumococcal vaccine-naive adults aged 18 to 49 years were 1, 710 participants. They were grouped in a 2:2:2:1 ratio to receive one of three lots of PCV20 or PCV13.
The study team determined Immunogenicity through serotype-specific opsonophagocytic activity (OPA) titers before and approximately 1 month (28-42 days) after vaccination. Evaluated were reported local reactions within 10 days, systemic events within 7 days, adverse events (AEs) within 30 days, and serious AEs (SAEs) and newly diagnosed chronic medical conditions (NDCMCs) within 6 months after vaccination.
“Equivalence in immune responses (OPA geometric mean titers) for all 20 vaccine serotypes was demonstrated across the 3 PCV20 lots,” the researchers report. “Robust responses, assessed by OPA geometric mean fold rises, percentage of participants achieving ≥4-fold rises, and percentage of participants with OPA titers ≥lower limit of quantitation, were observed after PCV20. Reported rates of local reactions, systemic events, and AEs were similar between the pooled PCV20 lots and PCV13; most events were mild or moderate. Reported rates of SAEs and NDCMCs were low and similar between the PCV20 and PCV13 groups.”
The study concluded that three different lots of PCV20 “demonstrated robust and consistent immunogenicity,” adding that the safety and tolerability of PCV20 were acceptable and similar to that of PCV13.
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