Immunogenicity following pneumococcal and meningococcal vaccination among people living with HIV MedDRA version: 20.0 Level: LLT Classification code 10020180 Term: HIV positive System Organ Class: 100000004848
Conditions
Interventions
Trade Name: Prevenar-13
Pharmaceutical Form:
INN or Proposed INN: 2.2 µg of each of polysaccharide for serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F and 4.4 µg of polysaccharide for seroty
group B NadA protein
group B fHbp fusion protein and 25 µg OMV group B strain NZ98/254
Other descriptive name: MENINGOCOCCAL GROUP B VACCINE
Concentration unit: ml millilitre(s)
Concentration type: equal
Concentration nu
Sponsors
Thomas Benfield
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age > 18 years • Seropositive for HIV-1 • Recipient of ART • Plasma HIV-RNA =65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: • Pregnancy or breastfeeding • History of meningococcal or pneumococcal vaccination • Allergies towards any of the vaccine components • Temperature > 38 ?C • Sign of bacterial infection • Previous known or suspected disease caused by N. meningitidis • Active AIDS associated illness • Active malignancy • End-stage renal or kidney disease • Bleeding disorder • Recipient of any blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation within the last month • Use of immunosuppressive agents (corticosteroids, cancer chemotherapeutic agents etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the quantitative antibody response following a two-dose meningococcal vaccine against serogroups A, B, C, W and Y and following a PCV-PPV prime-boost among PLWH after 60 and 180 days and after one, two and five years;Secondary Objective: -to evaluate the safety of a two-dose MenACWY+B vaccine among adult PLWH -to evaluate the safety of a PCV-PPV prime-boost among adult PLWH -to determine nasopharyngeal and oral carriage prevalence of N. meningitidis and S. pneumoniae at baseline (day 0), day 60 and day 180 ;Primary end point(s): Proportion of study subjects with an immunogenic response following a two-dose regimen of MenACWY+B or PCV-PPV prime-boost;Timepoint(s) of evaluation of this end point: Day 60 and 180 + year 1, 2 and 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Immediate (within 30 minutes), short term (within 5 days) and long term (within 180 days) adverse events - Proportion of study subjects with nasopharyngeal and/or oral carriage of N. meningitidis and S. pneumoniae ;Timepoint(s) of evaluation of this end point: Day 0, 60 and 180 | — |
Countries
Denmark
Contacts
Public ContactDepartment of Infectious Diseases
Hvidovre Hospital
Outcome results
None listed