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15-valent pneumonia vaccine! Two phase 3 studies of Merck’s V114 pediatric clinical project were successful: the main immunogenicity and safety endpoints were reached!
Merck 15-valent pneumonia vaccine reached immunogenicity and safety endpoints. Merck & Co recently announced that the 15-valent pneumococcal conjugate vaccine V114 (15-valent) has reached the main immunogenicity and safety endpoints in two phase 3 trials of the phase 3 pediatric clinical program.
These data support the potential application of V114 in healthy infants, including: (1) infants who may have previously been vaccinated with the currently available 13-valent pneumococcal conjugate vaccine (PCV13) (PNEU-DIRECTION trial); (2) not yet vaccinated Pneumococcal vaccine (vaccine-naive) or infants who have previously received a complete or partial immunization regimen of low-priced pediatric pneumococcal conjugate vaccine (PCV) (PNEU-PLAN trial).
Pneumonia vaccine (picture from: firstcry.com)
The PNEU-DIRECTION (V114-027) interchangeability study is a phase 3, multi-center, randomized, double-blind study, carried out in healthy infants (n=900) aged 42-90 days, and is currently evaluating V114 and PCV13 in Interchangeability in terms of safety, tolerability and immunogenicity. In the study, these infants were randomly assigned to one of 5 vaccination groups and received: PCV13 complete 4-dose regimen, one of 3 PCV13 mixed 4-dose regimens + subsequent vaccination with V114, V114 complete 4-dose regimen. The results showed that infants vaccinated with PCV13 4-dose series and infants vaccinated with V114 after receiving the PCV13 mixed dose regimen have comparable immune responses against 13 serotypes or pneumococcal strains covered by the two vaccines. .
The catch-up study in PNEU-PLAN (V114-024) is a phase 3, multi-center, randomized, double-blind, positive-controlled, descriptive study in healthy infants, children and adolescents between 7 months and 17 years old (n=606) The safety, tolerability and immunogenicity of the V114 catch-up vaccination regimen are being evaluated. These subjects either have not been vaccinated against pneumococcal vaccine, or have previously been vaccinated with partial or complete vaccination regimens for pediatric PCV that have been marketed. In the study, subjects received 3 doses (7-11 months), 2 doses (12-23 months), and 1 dose (2-17 years) of V114 according to their age at the time of randomization. The results showed that when V114 was used as a supplementation regimen for healthy children aged 7 months to 17 years, the immune response against 13 shared serotypes was comparable to that of PCV13. For the two serotypes 22F and 33F contained in V144 but not in PCV13, the immunogenicity of the V114 group was higher than that of the PCV13 group.
In each study, V114 was generally well tolerated, and its safety was comparable to PCV13. The complete results of the PNEU-DIRECTION study and the PNEU-PLAN study will be announced at future scientific conferences.
Dr. Roy Baynes, Chief Medical Officer, Global Head of Clinical Development and Senior Vice President of Merck Research Laboratories, said: “Although pneumococcal conjugate vaccination has a positive impact on the number of pediatric cases, pneumococcal disease still causes people under 5 years of age worldwide. Serious illness and death of children. Merck’s goal is to expand coverage to new serotypes not covered by currently available pediatric pneumococcal conjugate vaccines, while maintaining a strong immune response to the existing vaccine serotypes to help maintain what has been achieved so far Progress. The results of these studies support the possibility of V114 to confer immunogenicity on PCV13 serotypes in infants who have previously received one or more doses of PCV13, and to confer immunogens on 15 serotypes of V114 in a supplemental environment The possibility of sex.”
Pneumococcal pneumonia (Image source: bigstockphoto.com)
Globally, the incidence of pneumococcal disease is on the rise, partly driven by pathogenic serotypes that are not covered by currently available pneumococcal conjugate vaccines. 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 invasive pneumococcal disease remains the highest in the first year after birth. Certain pneumococcal serotypes continue to put children at risk, including serotypes 22F and 33F, which account for 16% of all invasive pneumococcal disease cases in children under 5 years of age.
V114 is a 15-valent vaccine under development. It is composed of pneumococcal polysaccharides from 15 serotypes combined with CRM197 carrier protein, including 22F and 33F serotypes. These two serotypes are usually associated with invasive pneumococcal bacteria worldwide. The disease is related, but not included in the pneumococcal conjugate vaccine currently approved for use in adults.
V114 is in phase III clinical development for the prevention of pneumococcal disease in adults and children. In January 2019, the U.S. FDA has granted V114 Breakthrough Drug Designation (BTD) for the prevention of invasive pneumococcal disease (IPD) caused by the vaccine serotype in infants and adolescents from 6 weeks to 18 years old.
The Phase III clinical development project of V114 consists of 16 clinical trials, which studied the safety of V1114 in different groups of people (including healthy elderly people, healthy children, people with impaired immune function, and people with certain chronic diseases). Tolerability and immunogenicity.
Currently, V114 is being reviewed by the US FDA and European Medicines Agency (EMA): it is used in adults aged 18 and above to prevent invasive pneumococcal disease. In the United States, the FDA will make a review decision before July 18, 2021.
Based on the data of the pediatric clinical project, Merck plans to submit a supplementary biological product license application (sBLA) to the US FDA before the end of the year to apply V114 to the pediatric population.
(source:internet, reference only)