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

May 5, 2021 updated by: Thomas Benfield

Safety and Immunogenicity Following Meningococcal and Pneumococcal Immunization Among Adult People Living With HIV: A Single Center, Non-blinded, Randomized Clinical Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

55

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy or breastfeeding
  • History of meningococcal or pneumococcal vaccination
  • Allergies towards any of the vaccine components
  • Temperature > 38 ᵒC
  • Sign of bacterial infection
  • Previous known or suspected disease caused by N. meningitidis
  • Active AIDS associated illness
  • Active malignancy
  • End-stage renal or liver 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Menveo + Bexsero
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.
Other Names:
  • Menveo® and Bexsero®
Experimental: Prevenar13 + Pneumovax23
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.
Other Names:
  • Prevenar13® and Pneumovax23®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in immunogenic response from baseline, Menveo
Time Frame: Day 30 and year 1, 2, 3, 4, and 5 post-vaccination
A ≥4-fold rise in rabbit complement source (rSBA) for the four serogroups A, C, Y, and W-135. Seroprotection is defined as an rSBA titre ≥1:8 and patients will be classified as previously immune if baseline rSBA is ≥1:8.
Day 30 and year 1, 2, 3, 4, and 5 post-vaccination
Change in immunogenic response from baseline, Bexsero
Time Frame: Day 30 and year 1, 2, 3, 4, and 5 post-vaccination
A ≥4-fold rise in antibody titers against a panel of four meningococcal serogroup B reference strains between pre-vaccination and post-vaccination timepoints, or a post-vaccination antibody titre ratio of ≥1:4 for individuals who were seronegative before vaccination.
Day 30 and year 1, 2, 3, 4, and 5 post-vaccination
Change in immunogenic response from baseline, Prevenar13/Pneumovax23
Time Frame: Day 30 and year 1, 2, 3, 4, and 5 post-vaccination
A ≥2-fold rise in serum anti-capsular IgG GMC for 12 shared pneumococcal polysaccharides (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F)
Day 30 and year 1, 2, 3, 4, and 5 post-vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with immediate adverse events
Time Frame: 30 minutes post-vaccination
30 minutes post-vaccination
Number of participants with short term adverse events
Time Frame: Day 5 post vaccination
Day 5 post vaccination
Number of participants with long term adverse events
Time Frame: Day 90 post-vaccination
Day 90 post-vaccination
Streptococcus pneumoniae carriage rates
Time Frame: Baseline and day 30 post-vaccination
Proportion of study subject with a culture or PCR positive pharyngeal swab sample
Baseline and day 30 post-vaccination
Neisseria meningitidis carriage rates
Time Frame: Baseline and day 30 post-vaccination
Proportion of study subject with a culture or PCR positive pharyngeal swab sample
Baseline and day 30 post-vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thomas Benfield

Investigators

  • Principal Investigator: Michaela Tinggaard, M.D., Department of Infectious Diseases, Hvidovre Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2021

Primary Completion (Anticipated)

December 1, 2026

Study Completion (Anticipated)

December 1, 2026

Study Registration Dates

First Submitted

April 12, 2021

First Submitted That Met QC Criteria

May 5, 2021

First Posted (Actual)

May 6, 2021

Study Record Updates

Last Update Posted (Actual)

May 6, 2021

Last Update Submitted That Met QC Criteria

May 5, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-19001166
  • 2020-000863-22 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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