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New vaccine protected adolescents against meningococcal B
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A two-dose regimen of a multicomponent meningococcal serogroup B vaccine was well tolerated and provided protective immunity in healthy adolescents, according to new findings published in The Lancet.
Miguel L. O’Ryan, MD, of the University of Chile, and colleagues assessed the immunogenicity and tolerability of a four-component vaccine (4CMenB, Novartis) among adolescents aged 11 to 17 years across 12 sites in Santiago and Valparaíso, Chile.
During the observer-blind, placebo-controlled study, 1,631 participants were randomly assigned to one, two or three doses of the candidate vaccine or placebo at 1-, 2- or 6-month intervals.
Serum bactericidal activity (hSBA) was assessed against strains for individual vaccine antigens. Local and systemic reactions were examined 7 days after each vaccination.
Data support the use of the candidate vaccine in a two-dose regimen, according to the results, because 99% to 100% of those who received two or three doses had hSBA titers of at least 4 against test strains, indicating protection vs. 92% to 97% with one dose (P< .0145) and 29% to 50% among those assigned placebo.
Compared with 73% to 76% of those who received one dose of the vaccine that had sustained titers of at least by 6 months, 91% to 100% of those who received two or three doses had sustained titers of at least 4 at 6 months. No serious adverse events were reported.
“The vaccine should be introduced into countries with significant disease impact caused by meningococcus B in the near future,” O’Ryan told Infectious Disease News. “We hope to expect a significant reduction of cases, deaths and sequelae over time in the countries that include the vaccine in their national programs.”
In an accompanying editorial, David S. Stephens, MD, of Emory University School of Medicine in Atlanta, wrote: “The 4CMenB vaccine could be a key to the future prevention of serogroup B meningococcal disease and is the result of over a decade of concentrated effort. The investments in this vaccine have been substantial and might not be repeated, but important questions remain. … The effects of the vaccine on overall meningococcal carriage and on prevention of disease due to other meningococcal serogroups remain important unknown variables. Also, since immunological memory is not a reliable predictor of protection against meningococci, long-term persistence of hSBA concentrations (greater than 6 months) after the two-dose series of 4CMenB vaccines needs to be defined.”
For more information:
- Santolaya ME. Lancet. 2012;doi:10.1016/S0140-6736(11)61713-3.
- Stephens DS. Lancet. 2012;doi:10.1016/S0140-6736(11)61934-X.
Disclosure: This research was funded by Novartis Vaccines and Diagnostics.
The authors make yet another attempt to develop a vaccine against meningococcus group B. This is the major cause of this disease in infants younger than 1 year of age in the United States. It also is an unaddressed cause of disease in all age groups. Previous attempts to produce a group B vaccine have yielded disappointing results. In that, within this group, there are several strains and vaccines that have been successful against some strains (ie, in Cuba and New Zealand), that have not been protective against others. The true test of this vaccine will be its efficacy in clinical trial in areas affected by diverse strains of group B meningococcus.
- Philip A. Brunell, MD
Infectious Disease News Editorial Board member
Disclosure: Dr. Brunell reports no relevant financial disclosures.
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