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Investigators from Spain conducted a case-control study to assess the effectiveness of a 4-component protein-based meningococcal B vaccine (4CMenB). This vaccine includes antigens that are present in strains of serogroup B meningococci and some other serogroups. The 4CMenB vaccine has been available in Spain for children at high risk for invasive meningococcal disease since 2015 and is available for purchase for any child; meningococcal C (MenC) conjugate vaccine has been available for all children since 2000. For the study, cases were children <60 months old born and living in Spain with laboratory-confirmed invasive meningococcal disease between October 5, 2015 and October 6, 2019, identified by review of regional epidemiologic surveillance unit data. Agglutination or PCR was used to determine serogroup. Four controls were matched to each case, based on date of birth (±1 day), province of birth, and province of residence. Vaccine registries were reviewed to determine the 4CMenB immunization status of study participants; meningococcal C vaccination status also was determined. Participants were considered to be fully vaccinated with 4CMenB if they had received the primary series (2 doses for children <2 years old and 1 dose for those ≥2 years old) and a booster dose, partially vaccinated, or unvaccinated. A final category of receipt of ≥1 dose of 4CMenB was determined to include children who were either partially or fully immunized. Primary study outcomes were meningococcal disease caused by any serogroup and by serogroup B. Conditional logistic regression was used to calculate matched odds ratios (OR) and 95% confidence intervals for the outcomes in each vaccination status category after adjusting for sex and high-risk conditions; Group C vaccination status was included in all serogroup analyses. Vaccine effectiveness was calculated as (1-adjusted matched OR) x 100.
Data were analyzed on 306 case children with meningococcal disease, including 243 (79.4%) with serogroup B, 5 (1.6%) with sero-group C, and 1,224 matched controls. Among cases, 11.4% had received ≥1 dose of 4CMenB vaccine, and 5.2% were fully vaccinated. For controls, 24.3% had received ≥1 dose, and 14.2% were fully vaccinated. The effectiveness of complete vaccination with 4CMenB against any invasive meningococcal disease was 76% (95% CI, 57, 87) and 71% (95% CI, 45, 85) against serogroup B disease. Effectiveness of ≥1 dose of the vaccine against any serogroup and serogroup B disease were 68% (95% CI, 50, 79) and 64% (95% CI, 41, 78), respectively; effectiveness was 54% (95% CI, 18, 74) and 50% (95% CI, 3, 75), respectively, for partial immunization with 4CMenB.
The authors conclude the 4CMenB vaccination was effective in preventing invasive meningococcal disease caused by serogroup B specifically and all serogroups.
Dr Brady has disclosed no financial relationship relevant to this commentary. This commentary contains a discussion of an unapproved/investigative use of a commercial product/device.
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