Meningitis Combination Vaccine

Protocol Description

Meningitis is caused by the bacteria Neisseria meningitidis. Meningitis can attack the brain and spinal cord and cause swelling in those areas as well as a serious infection of the bloodstream, called septicemia. Approximately 10% to 15% of people infected with meningococcal disease will die, sometimes as quickly as 24 hours after symptoms appear. For those who survive, about 1 in 5 may experience a variety of long-term disabilities including hearing loss, brain damage and nervous system problems, kidney damage, loss of limbs, and skin scarring. There have been five common groups of the bacteria that cause meningococcal disease: A, C, W, Y, and B. In the United States, three of these bacterial groups—B, C, and Y—cause most of the meningococcal disease cases.

There are currently two different types of vaccines for meningitis — one for groups A, C, W, and Y and another for group B. You or your loved ones may have been vaccinated for meningitis ACWY when you were younger, as it’s recommended for 11 to 12 year olds (plus a booster shot at age 16). Since a meningitis B vaccine was not available until 2014, most teenagers have not yet received it yet. As a result, millions of teenagers and young adults are not vaccinated against meningitis B. That is why we are conducting a clinical trial looking at a combination vaccine, MenABCWY, to be administered as a booster in healthy adolescents and young adults, 15 through 21 years of age, who previously received one dose of the MenACWY vaccine to fully protect them also against meningitis B. We will assess the immunogenicity and safety of the MenABCWY vaccine when administered as a booster in healthy adolescents and young adults, previously primed with a MenACWY vaccine.

Benefits

There may or may not be a direct medical benefit to you/your adolescent/young adult if you/they take part in this study. This study may help us learn more about meningococcal disease and the effects of the MenABCWY vaccine and how well it works. By taking part, you/ your adolescent/young adult may help make new or improve existing vaccine(s) to protect people against diseases caused by the meningitis germ.

Eligibility Criteria

WHO can participate? Adolescent/young adult between the ages of 15 and 21 years of age.

WHAT happens? Adolescent/young adult enrolled in the clinical trial will receive a total of 3 vaccinations.

Each adolescent/young adult will have a 50/50 chance, like a coin toss, of receiving either:

• 2 doses of the Men ABCWY vaccine (a combination of the two meningococcal vaccines Menveo and Bexsero) and 1 dose of placebo (no study product)
OR
• 1 dose of MenACWY vaccine (Menveo) and 2 doses of MenB vaccine (Bexsero).

Requirements

• 4 in-person study visits
• 5 follow-up phone calls
• 3 vaccinations (at visits 1, 3, and 4)
• 3 blood draws (at visits 1,2 and 4)
• Total duration: 12 months from first vaccination

Status: Open to Enrollment

Source(s) of Support

GlaxoSmithKline Biologicals SA

Additional Information

To learn more and see if your adolescent/young adult is eligible to participate in this study, please complete the survey. Compensation to participate is provided. Participation in this trial is completely voluntary.

Primary Investigator

Alejandro Hoberman, MD

Contact Information

For additional information or to enroll, please contact 412-692-7382 or email us.