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Safety and Immunogenicity Following Meningococcal and Pneumococcal Immunization Among Adult People Living With HIV

NCT04875819 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2021-05-06

No results posted yet for this study

Summary

MENPI is an investigator-initiated single-centre randomized controlled trial which aims to assess the efficacy and safety of meningococcal and pneumococcal vaccination in adults living with HIV receiving antiretroviral treatment.

Participants are randomized 1:1 to either a two-dose Menveo® and Bexsero® regimen or a Prevenar13®/Pneumovax23® prime-boost regimen at day 0 and day 60 and cross over on day 90. All participants will follow an identical follow up program including plasma collection, pharyngeal swab, and adverse event registration.

Immunogenicity will be determined on venous blood sampled at 30 days post-vaccination and yearly for five years.

Conditions

  • Hiv
  • Meningococcal Infections
  • Pneumococcal Infections

Interventions

DRUG

Neisseria meningitidis oligosaccharide conjugate vaccine and recombinant protein-based vaccine

One dose (0.5 ml) of conjugate vaccine against meningococcal serogroups ACWY (Menveo®) and one dose of a recombinant protein-based vaccine against meningococcal serogroup B (Bexsero®) at day 0 followed by another dose (0.5 ml) of each vaccine at day 60.

DRUG

13 valent pneumococcal conjugate vaccine and 23 valent pneumococcal polysaccharide vaccine

One dose (0.5 ml) of pneumococcal conjugate vaccine (Prevenar13®) at day 0 and one dose (0.5 ml) of pneumococcal polysaccharide vaccine (Pneumovax23®) at day 60.

Sponsors & Collaborators

  • Thomas Benfield

    lead OTHER

Principal Investigators

  • Michaela Tinggaard, M.D. · Department of Infectious Diseases, Hvidovre Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-28
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04875819 on ClinicalTrials.gov