This study aims to evaluate the immunogenicity, safety and tolerability of co-administration of vaccinations for meningitis B (Bexsero®) and meningitis ACWY (Menveo®) in adults and children aged 10-45 years living with HIV. All participants will be vaccinated with both Menveo® and Bexsero® on days 0 and 30. Immunogenicity will be determined on venous blood sampled at days 0 and 60. Adverse effects will be recorded to evaluate safety.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
55
Bexsero® 0.5ml IM vaccine administered into non-dominant arm of participant
Menveo® 0.5ml IM vaccine administered into dominant arm of participant
St Georges University Hospital
London, United Kingdom
RECRUITINGChange in hSBA geometric mean titres to relevant strains of meningococcal B following two doses of the 4CmenB vaccine (Bexsero®) in people living with HIV
The human complement serum bactericidal assay (hSBA) mean titres against relevant strains of meningococcal B at baseline and one month after completion of vaccination.
Time frame: Day 0 (baseline) and Day 60
The proportion of participants who achieve at least a four fold increase in hSBA titres.
Blood will be taken one month after the second vaccine and serum tested for hSBA titres. The proportion of participants who achieve at least a four fold increase in hSBA titres will be calculated.
Time frame: Day 60
The proportion of participants who achieve a 'protective' hSBA titre of >1:4 after two doses of Bexsero
Blood will be taken one month after the second vaccine and serum tested for hSBA titres. The proportion of participants who are deemed to have protective titres \>1:4 will be calculated.
Time frame: Day 60
The incidence of solicited and unsolicited adverse and serious adverse events after two doses of MenACWY (Menveo®) and 4CMenB (Bexsero®) vaccines when co-administered in people living with HIV
We will assess the following: 1. The incidence of subjects with solicited local and systemic AEs up to 7 days (including the day of vaccination) after Visits 1 and 2. 2. The incidence of subjects with any other (unsolicited) AEs, including any SAEs, AEs leading to withdrawal and medically attended AEs up to 7 days (including the day of vaccination) after Visits 1 and 2. 3. The incidence of subjects with SAEs and AEs leading to withdrawal throughout the study period.
Time frame: Day 7 after vaccines 1 and 2
The geometric mean titres to Meningococcal ACWY antigens after two doses of the MenACWY (Menveo®) vaccine in people with HIV at one month after the second vaccination
We will measure rSBA GMTs for MenACWY antigens at baseline and Visit3.
Time frame: Day 60
The proportion of subjects with at least a four fold change in rSBA from baseline to 30 days after the second vaccine
The proportion of subjects with at least 4 fold increase in rSBA against relevant MenACWY serogroups from baseline to Visit3.
Time frame: Day 0 and Day 60
The proportion of subjects with "protective" rSBA titres >1:8 against relevant MenACWY serogroups after two doses of Menveo
The proportion of subjects with "protective" rSBA titres \>1:8 against relevant MenACWY serogroups at Visit3.
Time frame: Day 60
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.