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

  • STATUS
    Recruiting
  • End date
    Dec 10, 2026
  • participants needed
    55
  • sponsor
    Thomas Benfield
Updated on 12 May 2021

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.

Details
Condition Pneumococcal infection, Pneumococcal Disease, HIV, HIV, HIV (Pediatric), HIV positive, HIV infection, HIV Infections, Meningococcal infection, AIDS Vaccines, HIV (Pediatric), Pneumococcal Disease, HIV Infections, meningococcal infections, human immunodeficiency virus, hiv disease, HIV Vaccine, hiv vaccines, streptococcus pneumoniae infections, pneumococcal infections, meningococcal disease
Treatment Neisseria meningitidis oligosaccharide conjugate vaccine and recombinant protein-based vaccine, 13 valent pneumococcal conjugate vaccine and 23 valent pneumococcal polysaccharide vaccine
Clinical Study IdentifierNCT04875819
SponsorThomas Benfield
Last Modified on12 May 2021

Eligibility

Yes No Not Sure

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 C
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.)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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