Safety and immune respons following meningococcal and pneumococcal vaccination among adult people living with HIV.

Phase 1

• Conditions: Immunogenicity following pneumococcal and meningococcal vaccination among people living with HIV; MedDRA version: 20.0Level: LLTClassification code 10020180Term: HIV positiveSystem Organ Class: 100000004848; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2020-000863-22-DK
• Lead Sponsor: Thomas Benfield

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-28
• Last Update Posted: 14 June 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

•Age > 18 years
•Seropositive for HIV-1
•Recipient of ART
•Plasma HIV-RNA < 500 copies/ml
•Patients written consent obtained

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

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.)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified