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

Primary Purpose

Hiv, Meningococcal Infections, Pneumococcal Infections

Status
Recruiting
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Neisseria meningitidis oligosaccharide conjugate vaccine and recombinant protein-based vaccine
13 valent pneumococcal conjugate vaccine and 23 valent pneumococcal polysaccharide vaccine
Sponsored by
Thomas Benfield
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hiv

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • Hvidovre HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Menveo + Bexsero

Prevenar13 + Pneumovax23

Arm Description

Outcomes

Primary Outcome Measures

Change in immunogenic response from baseline, Menveo
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.
Change in immunogenic response from baseline, Bexsero
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.
Change in immunogenic response from baseline, Prevenar13/Pneumovax23
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)

Secondary Outcome Measures

Number of participants with immediate adverse events
Number of participants with short term adverse events
Number of participants with long term adverse events
Streptococcus pneumoniae carriage rates
Proportion of study subject with a culture or PCR positive pharyngeal swab sample
Neisseria meningitidis carriage rates
Proportion of study subject with a culture or PCR positive pharyngeal swab sample

Full Information

First Posted
April 12, 2021
Last Updated
May 5, 2021
Sponsor
Thomas Benfield
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1. Study Identification

Unique Protocol Identification Number
NCT04875819
Brief Title
Safety and Immunogenicity Following Meningococcal and Pneumococcal Immunization Among Adult People Living With HIV
Acronym
MENPI
Official Title
Safety and Immunogenicity Following Meningococcal and Pneumococcal Immunization Among Adult People Living With HIV: A Single Center, Non-blinded, Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Recruiting
Study Start Date
April 28, 2021 (Actual)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Thomas Benfield

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hiv, Meningococcal Infections, Pneumococcal Infections

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Menveo + Bexsero
Arm Type
Experimental
Arm Title
Prevenar13 + Pneumovax23
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Neisseria meningitidis oligosaccharide conjugate vaccine and recombinant protein-based vaccine
Other Intervention Name(s)
Menveo® and Bexsero®
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
13 valent pneumococcal conjugate vaccine and 23 valent pneumococcal polysaccharide vaccine
Other Intervention Name(s)
Prevenar13® and Pneumovax23®
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in immunogenic response from baseline, Menveo
Description
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.
Time Frame
Day 30 and year 1, 2, 3, 4, and 5 post-vaccination
Title
Change in immunogenic response from baseline, Bexsero
Description
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.
Time Frame
Day 30 and year 1, 2, 3, 4, and 5 post-vaccination
Title
Change in immunogenic response from baseline, Prevenar13/Pneumovax23
Description
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)
Time Frame
Day 30 and year 1, 2, 3, 4, and 5 post-vaccination
Secondary Outcome Measure Information:
Title
Number of participants with immediate adverse events
Time Frame
30 minutes post-vaccination
Title
Number of participants with short term adverse events
Time Frame
Day 5 post vaccination
Title
Number of participants with long term adverse events
Time Frame
Day 90 post-vaccination
Title
Streptococcus pneumoniae carriage rates
Description
Proportion of study subject with a culture or PCR positive pharyngeal swab sample
Time Frame
Baseline and day 30 post-vaccination
Title
Neisseria meningitidis carriage rates
Description
Proportion of study subject with a culture or PCR positive pharyngeal swab sample
Time Frame
Baseline and day 30 post-vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michaela Tinggaard, M.D.
Phone
22326800
Email
michaela.tinggaard@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michaela Tinggaard, M.D.
Organizational Affiliation
Department of Infectious Diseases, Hvidovre Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hvidovre Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michaela Tinggaard
Phone
+4522326800
Email
michaela.tinggaard@regionh.dk

12. IPD Sharing Statement

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

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