None listed
Conditions
Brief summary
The BOOST MenB Study is a randomised controlled trial investigating the best timing of the Meningococcal B (Bexsero®) vaccine in adolescents. Currently, two doses are given approximately 2-3 months apart, around age 15-16. This study aims to determine if spacing the doses several years apart would provide longer-lasting protection. It will also explore whether Bexsero® offers cross-protection against gonorrhoea.
Interventions
The intervention is the extended-interval 4CMenB (Bexsero®) vaccination schedule, defined in the protocol as:
Group B – Intervention group:
Dose 1: 4CMenB at 11–13 years of age
Dose 2: 4CMenB at 14–16 years of age
Interval: 24–36 months between doses
This schedule represents a long-interval dosing strategy designed to test whether giving the two doses several years apart improves antibody persistence.
The 4CMenB (Bexsero®) is supplied as a 0.5 mL dose in a pre-filled syringe and administered by
The intervention is the extended-interval 4CMenB (Bexsero®) vaccination schedule, defined in the protocol as: Group B – Intervention group: Dose 1: 4CMenB at 11–13 years of age Dose 2: 4CMenB at 14–16 years of age Interval: 24–36 months between doses This schedule represents a long-interval dosing strategy designed to test whether giving the two doses several years apart improves antibody persistence. The 4CMenB (Bexsero®) is supplied as a 0.5 mL dose in a pre-filled syringe and administered by intramuscular injection. Vaccines are administered according to the Australian Immunisation Handbook procedures.
Sponsors
University of Adelaide
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
11 Years to 13 Years
Healthy volunteers
Yes
Inclusion criteria
• Children aged 11-13 years (not yet 14) at randomisation. • The participant and parent (and/or legal guardian) are capable of understanding the written informed consent, providing signed and witnessed written informed consent and assent, and understanding and complying with protocol requirements. • Participant is willing to receive two doses of 4CMenB vaccine and up to four blood samples throughout the study duration.
Exclusion criteria
• Received a prior 4CMenB vaccine in the previous 10 years • Previously received two or more 4CMenB containing vaccines at least 8 weeks apart • Immunodeficiency condition or immunosuppressive therapy. • Prior history of invasive meningococcal disease. • Participation in any other study receiving an investigational drug/vaccine • Known pregnancy • Any contraindication to receiving 4CMenB vaccine. • Any other condition that may interfere with the immune system
Outcome results
None listed