Serogroup B Meningitis Vaccine Protective in College Outbreak

Janis C. Kelly

April 27, 2015

A 2013-2014 outbreak of invasive meningococcal disease caused by Neisseria meningitides serogroup B among students at Princeton University in New Jersey provided an unexpected opportunity to field-test the 4CMenB vaccine, which was later approved as Bexsero (Novartis) by the US Food and Drug Administration (FDA).

A research team led by Lucy A. McNamara, PhD, from the Centers for Disease Control and Prevention (CDC) Epidemic Intelligence Service Program, Atlanta, Georgia, reported results of this use of 4CMenB in 5000 university students in an article published online April 27 and in the May issue of Pediatrics.

In 2013 to 2014, serogroup B meningococcal (MenB) infection was reported in seven undergraduates (between March and November 2013) and in one visiting high school student. All eight patients developed headache and fever, seven developed a rash, and seven had meningitis. None of these eight cases were fatal, but three patients had long-term sequelae (hearing loss, neurocognitive deficits, or chronic headaches). The same strain of N meningitidis caused all eight cases.

The New Jersey Department of Health called in the CDC after the sixth case to help investigate the outbreak and to determine the target population for potential vaccination.

At the time there were no licensed MenB vaccines in the United States, but two vaccines — rLP2086 (later approved as Trumenba, Wyeth) and 4CMenB — were under prelicensure review at the FDA.

After tests by Novartis showing that 4CMenB would be expected to protect against the outbreak strain, the CDC submitted to the FDA an application for expanded-access investigational new drug use of the then-investigational vaccine. 4CMenB was chosen for the New Jersey outbreak in part because it had already been licensed in Europe and Australia. (The purpose of an investigational new drug is to provide access to a vaccine or treatment in urgent situations with few or no other options, rather than to establish safety or efficacy.)

The FDA authorized use of 4CMenB in November 2013, and the vaccination program developed by the university and CDC kicked into high gear. The authors described this program in detail and recommended it as "a model for how to approach similar outbreaks in the future." The program included the following:

  • providing information about meningitis and about the vaccine to students and parents via emails, posters, text messages, a video, and meetings that included university and CDC staff;

  • setting up an efficient vaccination clinic with short wait times;

  • identifying the target population for vaccination (which included 5241 undergraduate students; 541 graduate students living in undergraduate and graduate student dormitories; 11 graduate students, faculty, or staff members with medical conditions that increased the risk for meningococcal disease; and 6 spouses and caregivers living with students in dormitories;

  • notifying potential vaccine recipients about the vaccine clinic through email, posters, and text messages;

  • monitoring vaccination coverage through real-time entry into recipients' electronic health records or by paper copies of informed consent forms for nonstudents; and

  • collecting adverse event reports passively by telephone and clinic visits and actively by survey at the time of the second vaccine dose and 30 days after the second vaccine dose.

The authors report that by May 14, 2014, 89.1% coverage with the two-dose vaccination series had been achieved. Through February 1, 2015, there had been no additional cases of MenB disease in those who had received at least one dose of vaccine.

The ninth MenB case, which was fatal, occurred 4 months after the beginning of the university outbreak and involved an unvaccinated student at another university "who had close contact with [vaccinated Princeton] undergraduates at an off-campus social event 8 days before disease onset." The patient had a petechial rash but no evidence of meningitis.

The authors write that although the vaccine did provide primary protection to the target student population, "the occurrence of this case demonstrates that the vaccination campaign had not eliminated carriage from the [Princeton] population by this time and that transmission of the outbreak strain was ongoing. This finding is consistent with a recent study demonstrating that 4CMenB has at most a modest impact on prevalence of meningococcal carriage in vaccinated people."

The FDA approved Bexsero in January 2015. The FDA approved Trumenba in October 2014. Both vaccines were approved and licensed for use in individuals aged 10 through 25 years. Previously approved vaccines protect against serogroups A, C, W, and Y.

Bexsero was also used as an investigational new drug in a smaller outbreak of MenB disease that occurred at the University of California, Santa Barbara, during the same period as the outbreak in New Jersey.

The authors have disclosed no relevant financial relationships.

Pediatrics. 2015;798-804.

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