A study in the February 8 issue of JAMA reports that routine infant immunizations with a vaccine for serogroup B Neisseria meningitidis, a bacterium that causes serious diseases like sepsis and meningitis, proved effective against meningococcal strains and displayed minimal interference with the response to the routine vaccinations.

The study’s background says that although some serogroup B Neisseria meningitidis (MenB) vaccines demonstrated efficacy in clinical trials and also controlled a clonal MenB outbreak in New Zealand, their usefulness proved limited, due to the fact that these vaccines only target a highly specific strain, particularly in young children.

Nicoletta Gossger, M.D., of the University of Oxford in the UK and her team, set out to examine the immune and reactive response of a wide-spectrum multicomponent serogroup B meningococcal vaccine (4CMenB) in a large group of infants that were categorized into two groups, one who received the vaccine in addition to routine vaccination, and the other one separately.

They examined 1,885 European infants at the age of 2 months from August 2008 to July 2010 in a multi-center randomized controlled study. The infants were randomized to receive:

  • (Group 1) – 4CMenB at 2, 4, and 6 months with routine vaccines (7-valent pneumococcal and combined diphtheria, tetanus, acellular pertussis, inactivated polio, hepatitis B, Haemophilus influenzae type b vaccines), or
  • (Group 2) – 4CMenB at 2, 4, and 6 months and routine vaccines at 3, 5, and 7 months, or
  • (Group 3) – 4CMenB with routine vaccines at 2, 3, and 4 months, or
  • (Group 4) – routine vaccines alone at 2, 3, and 4 months

The primary outcome was measured as the percentage of participants with human complement serum bactericidal activity (hSBA) titer (concentration) of 1:5 or greater against 3 MenB strains specific for vaccine antigens (NZ98/254, 44/76-SL, and 5/99).

The findings showed that after 4CMenB immunization, 99% or more participants in Group 1 and 2 had hSBA titers of >1:5 for 44/76-SL and 5/99 strains. For the NZ98/254 strain 79% in Group 1 had titers of >1:5, together with 81.7% in Group 4 and 86.1% of those vaccinated at 2, 4, and 6 months without routine vaccines.

The vaccine achieved the predefined criteria of sufficient immunity response for all three strains. The participants’ responses to routine vaccines with 4CMenB proved to be non-inferior, meaning that the new treatment is equivalent to standard treatment with regard to routine vaccines alone for all antigens, with the exception for responses to pertactin, a pertussis antigen, and the pneumococcal vaccine serotype 6B.

The researchers conclude:

“Fever was seen following 26 percent to 41 percent of 4CMenB doses when administered alone, compared with 23 percent to 36 percent after routine vaccines given alone and 51 percent to 61 percent after 4CMenB and routine vaccines administered together. In conclusion, 4CMenB was immunogenic, generally well tolerated, and showed minimal interference with routine vaccines in the first year of life.

The flexibility in schedule allows it to be incorporated into a range of country-specific immunization schedules and for primary immunization to be completed in early infancy. If licensed, the decisions regarding vaccine introduction will require detailed assessment of potential vaccine coverage at a regional level and monitoring after implementation to determine the accuracy of such predictions.

Nevertheless, this vaccine could potentially provide improved protection for infants against meningococcal disease beyond the protection provided by currently licensed vaccines.”

Amanda C. Cohn, M.D., and Nancy E. Messonnier, M.D., of the Centers for Disease Control and Prevention, Atlanta, write in a linked editorial that:

“The potential of 4CMenB vaccine to reduce serogroup B meningococcal disease is substantial, but it cannot be compared with the success of conjugate vaccine programs. 4CMenB vaccine may not reduce nasopharyngeal [pertaining to the cavity of the nose and the nasal parts of the pharynx] carriage or produce herd immunity, as the serogroup C conjugate vaccine did in the United Kingdom. Booster doses may be required to sustain protection but may not confer the same degree of immunologic memory as conjugate vaccines.

Countries will have to weigh the benefits of serogroup B vaccination against the costs of adding vaccines to the infant schedule. However, the anticipated licensure of this vaccine in Europe and other countries means that for the first time vaccines to prevent all 5 of the serogroups that cause most meningococcal disease worldwide will be available.”

Written by Petra Rattue