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Adverse Events Following Vaccination With Bivalent rLP2086 (Trumenba®): An Observational, Longitudinal Study During a
Background:
In February 2015, two unlinked culture-confirmed cases of Neisseria meningitidis serogroup B (MenB) disease occurred at a local college in Rhode Island ("college X") within 3 days. This represented a 489-fold increase in the incidence of MenB disease, and an outbreak was declared. For the first time, bivalent rLP2086 (Trumenba) was selected as a mandatory intervention response. A mass vaccination clinic was coordinated, which provided a unique opportunity to collect safety data in a real-world population of college-age participants. Though the Advisory Committee on Immunization Practices recommends MenB vaccination for college-age individuals (16-23 year olds), there is limited quantifiable safety data available for this population.
Methods:
The Dillman total design survey method was used. Adverse events of bivalent rLP2086 were solicited and quantified retrospectively 2-4 months following each dose of vaccine. Safety data from six clinical trials were used as comparison tools.
Results:
The most commonly reported adverse event following vaccination was injection site pain. Reported rates of injection site pain, fatigue, myalgia, fever, and chills were similar than those reported in clinical trials. Reported rates of headache were lower than in clinical trials.
Conclusions:
This study is the first to examine adverse events of bivalent rLP2086 in a real-world setting where more than 90% of a college-age population was vaccinated.
Insights
This study assessed the safety of the bivalent Neisseria meningitidis serogroup B (MenB) vaccine (rLP2086) in a real-world college setting. Adverse event rates were comparable to clinical trials, with headache rates being lower.
Area of Science:
- Vaccinology
- Epidemiology
- Public Health
Background:
- An outbreak of Neisseria meningitidis serogroup B (MenB) disease occurred at a college, prompting a mandatory vaccination response.
- Bivalent rLP2086 (Trumenba) was used for the first time in a mass vaccination campaign.
- Limited safety data exists for MenB vaccination in college-age individuals.
Purpose of the Study:
- To evaluate the safety and quantify adverse events of bivalent rLP2086 in a real-world college population.
- To compare real-world safety data with existing clinical trial data.
Main Methods:
- The Dillman total design survey method was employed for data collection.
- Adverse events were solicited retrospectively 2-4 months post-vaccination.
- Safety data from six clinical trials served as a comparison.
Main Results:
- Injection site pain was the most frequent adverse event.
- Reported rates of injection site pain, fatigue, myalgia, fever, and chills were similar to clinical trial findings.
- Headache rates were lower than those observed in clinical trials.
Conclusions:
- This study provides the first real-world safety data for bivalent rLP2086 in a highly vaccinated college-age population.
- The vaccine demonstrated a safety profile consistent with clinical trial results.
- The findings support the recommendation for MenB vaccination in college students.
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