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Pentavalent meningitis vaccine continues to show promise in phase 3 trial

Pentavalent meningitis vaccine continues to show promise in phase 3 trial

 



Disclosure: Hydara and Stevens do not report related financial disclosures. See this study for relevant financial disclosures of all other authors.


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Important points:

  • A pentavalent vaccine against meningitis continues to show promise in phase 3 trials in the meningitis zone of Africa.
  • Researchers found no safety concerns with the vaccine.

pentavalent vaccine against Meningococcus It was shown to be safe and effective in a phase III trial in children and adolescents from the meningitis zone of Africa, researchers reported. of New England Journal of Medicine.

Previously phase 2 trial Proven A single dose of vaccine NmCV-5 elicited an immune response similar to that of two doses of MenACWY-D, one of three doses Commercially available quadrivalent meningococcal conjugate vaccine.



New strain of antibiotic-resistant meningococcus emerges in US Credit: CDC/Sarah Bailey Kachin
vaccine against Meningococcus It was effective in a phase 3 trial in the meningitis zone of Africa. Image: CDC/Sarah Bailey Kachin.

In the new trial, the investigational vaccine elicited an immune response against four serotypes contained in the MenACWY-D vaccine, in addition to serotype X, which has been increasingly reported in African meningitis zones.

“The highest incidence of meningitis and mortality from meningitis occurs in the African meningitis belt, which stretches from Gambia and Senegal in the west to Ethiopia in the east, and is primarily caused by meningitis. prevalent in meningococcus, It occurs against the background of a high rate of endemic diseases. ” Dr. Fadima C. Hydala, Drs and colleagues at the Vaccine Development Center in Mali wrote:

Six meningococcal serogroups (A, B, C, W, X, and Y) can cause invasive disease, but serogroup A spreads throughout the meningococcal belt, according to the researchers. It was said to have been “virtually eliminated” after a mass vaccination campaign.

WHO has licensed and prequalified four quadrivalent meningococcal ACWY vaccines, but their use in meningococcal zones is “limited by supply and cost constraints,” the researchers wrote. there is

Haidara et al. investigated the efficacy of NmCV-5 in 1,800 participants aged 2 to 29 years in Mali and Gambia who received either an vaccine or MenACWY-D as a control group. In the vaccine groups, the proportion of participants who experienced a reaction to a serotype ranged from 70.5% (95% CI, 67.8%–73.2%) in serogroup A to 98.5% (95% CI, 97.6%99.2%) in serogroup W. %) range. Additionally, 97.2% (95% CI, 96%98.1%) responded to X.

Regarding safety, the incidence of systemic adverse events was similar in both groups, 11.1% in the NmCV-5 group and 9.2% in the MenACWY-D group, and all events were ‘mild or moderate in severity’. It caused “analgesia” and “has no obvious safety concerns,” the authors wrote.

“On the basis of these trial data, NmCV-5 may emerge as a tool to support the control of meningococcal disease, particularly throughout the meningococcal zone of sub-Saharan Africa, and thus, the epidemic. and other goals of the Global Roadmap for the program to eliminate meningitis by 2030,” they wrote.

in the accompanying editorial Dr. David S. Stevens, Emory University’s dean of medicine and associate director of research at the Woodruff Center for Health Sciences said another trial of the vaccine in infants is underway.

“Although challenges remain, these efforts bring us one step closer to curbing the burden of meningococcal disease and meningitis globally,” Stevens said.

References:

Hydara FC and others N English J Medicine. 2023; doi:10.1056/NEJ Moa2214924.

Stevens DS and others N English J Medicine 2023; doi:10.1056/NEJ Moa2301698.

Dr. Tapia et al. N English J Medicine 2021; doi:10.1056/NEJ Moa2013615.

Sources

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2/ https://www.healio.com/news/pediatrics/20230525/pentavalent-meningitis-vaccine-continues-to-show-promise-in-phase-3-trial

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