October 4, 2022

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Merck 15-valent Pneumonia Vaccine: Infant Key Phase 3 Study Successful

Merck 15-valent Pneumonia Vaccine:Vaxneuvance (V114) Infant Key Phase 3 Study Successful

Merck 15-valent Pneumonia Vaccine:Vaxneuvance (V114) Infant Key Phase 3 Study Successful: the serotype-specific immune response is not inferior to Preliminary 13!

Vaxneuvance is formed by combining pneumococcal polysaccharides from 15 serotypes with CRM197 carrier protein, including 22F and 33F serotypes.

Pneumonia vaccine (picture from: firstcry.com)

Merck & Co recently announced the top-line results of the key Phase 3 PNEU-PED (V114-029) study. The study is evaluating the immunogenicity, safety and tolerability of Vaxneuvance (15-valent pneumococcal conjugate vaccine, V114) in healthy infants (n=1720) aged 42-90 days. In this study, infants were vaccinated with Vaxneuvance or the marketed 13-valent pneumococcal conjugate vaccine (PCV13, namely: Prevnar 13[ Preliminary 13]).

In this study, the primary endpoint showed: (1) After receiving any vaccine dose, the safety of Vaxneuvance is usually comparable to that of PCV13. (2) 30 days after the third dose (PD3), according to the serotype-specific response rate (the proportion of individuals reaching an acceptable immunoglobulin G[IgG] threshold of 0.35mcg/mL) and the serotype-specific IgG geometry Average concentration (GMC), Vaxneuvance is not inferior to PCV13 in all 13 common serotypes and 12 serotypes out of 13 common serotypes. Specifically, for the 12 shared serotypes, the lower limit of the bilateral 95% confidence interval (CI) of the serotype-specific IgG-GMC ratio was greater than 0.5; the lower limit of serotype 6A was 0.48, which barely missed the non-inferiority criterion. (3) 30 days (PD4) after the fourth dose (toddlers) vaccination, based on serotype-specific IgG GMC, Vaxneuvance is not inferior to PCV13 in all 13 common serotypes.

The secondary endpoint showed that the immune response of Vaxneuvance was statistically superior to PCV13 for shared serotype 3 and unique serotypes 22F and 33F compared with PCV13 according to pre-specified criteria. In addition, when used simultaneously with Vaxneuvance or PCV13, the immune response to antigens contained in several commonly used pediatric vaccines showed non-inferiority.

PNEU-LINK (V114-031) is a phase 3 study evaluating the safety and tolerability of Vaxneuvance in healthy infants. In this study, Vaxneuvance was generally well tolerated, and its safety was comparable to that of PCV13 in healthy infants aged 42-90 days (n=2409). The full results of the PNEU-PED and PNEU-LINK research will be announced at the upcoming scientific conference.

Dr. Roy Baynes, Senior Vice President and Head of Global Clinical Development, Merck Research Laboratories, said: “In essence, pneumococcal disease is constantly evolving. Disease strains associated with invasiveness bring a huge burden of disease to children. Innovations to help protect vulnerable groups around the world. At Merck, our goal is to design pneumococcal vaccines that target the strains that cause the largest proportion of the disease, while maintaining a strong immune response to these serotypes. With serotypes 22F and 33F With the addition of, Vaxneuvance has the potential to play an important role in preventing invasive pneumococcal disease in children.”

Merck 15-valent Pneumonia Vaccine: Infant Key Phase 3 Study Successful

Pneumococcal pneumonia (Image source: bigstockphoto.com)

Pneumococcal disease is an infection caused by Streptococcus pneumoniae. The different strains of this bacteria are called serotypes. Invasive pneumococcal disease (IPD) occurs when Streptococcus pneumoniae invades parts of the body where bacteria are not normally present.

Vaxneuvance (V114) is a 15-valent pneumococcal conjugate vaccine, which is composed of pneumococcal polysaccharides from 15 serotypes combined with CRM197 carrier protein, including 22F and 33F serotypes. Vaxneuvance was developed to prevent pneumococcal disease in adults and children. Previously, the US FDA has granted Vaxneuvance Breakthrough Drug Designation (BTD) for use in pediatric populations from 6 weeks to 18 years old and adults aged 18 years and older to prevent invasive pneumococcal disease (IPD) caused by vaccine serotypes.

In July 2021, Vaxneuvance was approved by the U.S. FDA for use in adults aged 18 and above to prevent the 15 types of Streptococcus pneumoniae serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F) caused by invasive pneumococcal disease (IPD). Vaxneuvance was approved through a priority review process. Currently, this vaccine is also being reviewed by the European Medicines Agency (EMA). In the adult population, data from 7 randomized double-blind studies showed that for 13 common serotypes, Vaxneuvance induced an immune response not lower than the currently available 13-valent pneumococcal conjugate vaccine (PCV13, namely: Prevnar 13 13]). In addition, for the common serotype 3 and the two serotypes 22F and 33F unique to Vaxneuvance, Vaxneuvance induces an immune response better than PCV13.

Merck plans to submit a supplementary application for Vaxneuvance for children to the US FDA before the end of this year. There are 100 different types of pneumococcal bacteria, and their effects on children are different from adults. Children under 2 years of age are particularly susceptible to pneumococcal infection, and the incidence of IPD is still the highest in the first year after birth. Certain pneumococcal serotypes continue to put children at risk, including serotypes 22F, 33F, and 3, which account for more than a quarter of all IPD cases in children under 5 years of age.

Vaxneuvance’s Phase 3 clinical development project consists of 16 clinical trials, and is studying Vaxneuvance in different populations with increased risk of pneumococcal disease (including healthy elderly people, healthy children, immune-compromised people, people with certain chronic diseases). Population) safety, tolerability and immunogenicity, 10 clinical trials are studying the application of Vaxneuvance in children and infants.

(source:internet, reference only)

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