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NCT Number: NCT04875819

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

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.

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Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Communicable Diseases Genital Diseases Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Meningococcal Infections Neisseriaceae Infections Pneumococcal Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Streptococcal Infections Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hvidovre Hospital

Hvidovre, 2650, Denmark

Location status: Recruiting

Location contact

Michaela Tinggaard

CONTACT

[email protected]

+4522326800

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Neisseria meningitidis oligosaccharide conjugate vaccine and recombinant protein-based vaccine

Drug

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®

13 valent pneumococcal conjugate vaccine and 23 valent pneumococcal polysaccharide vaccine

Drug

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®

Primary outcomes

  1. 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.

  2. 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.

  3. 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)

Secondary outcomes

  1. Number of participants with immediate adverse events

    Time frame: 30 minutes post-vaccination

  2. Number of participants with short term adverse events

    Time frame: Day 5 post vaccination

  3. Number of participants with long term adverse events

    Time frame: Day 90 post-vaccination

  4. 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

  5. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Michaela Tinggaard, M.D.

CONTACT

[email protected]

22326800

Sponsors and collaborators

Lead sponsor

Thomas Benfield

Other

Registry information

Official study title

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

Acronym: MENPI

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
May 6, 2021
Registry last updated
May 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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