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Recruiting NCT04875819

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

Phase IV Interventional Hiv Meningococcal Infections Pneumococcal Infections

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Neisseria meningitidis oligosaccharide conjugate vaccine and recombinant protein-based vaccine, 13 valent pneumococcal conjugate vaccine and 23 valent pneumococcal polysaccharide vaccine.
Who it may be relevant to
Registry conditions: Hiv, Meningococcal Infections, Pneumococcal Infections. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Primary outcome measures

  • Change in immunogenic response from baseline, Menveo [Time frame: 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]
  • Change in immunogenic response from baseline, Prevenar13/Pneumovax23 [Time frame: Day 30 and year 1, 2, 3, 4, and 5 post-vaccination]
Secondary outcome measures (5)
  • Number of participants with immediate adverse events [Time frame: 30 minutes post-vaccination]
  • Number of participants with short term adverse events [Time frame: Day 5 post vaccination]
  • Number of participants with long term adverse events [Time frame: Day 90 post-vaccination]
  • Streptococcus pneumoniae carriage rates [Time frame: Baseline and day 30 post-vaccination]
  • Neisseria meningitidis carriage rates [Time frame: Baseline and day 30 post-vaccination]

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.)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Prevention

Study locations

Denmark · 1 center
  • Hvidovre Hospital — Hvidovre

Publications

  • Miller L, Arakaki L, Ramautar A, Bodach S, Braunstein SL, Kennedy J, Steiner-Sichel L, Ngai S, Shepard C, Weiss D. Elevated risk for invasive meningococcal disease among persons with HIV. Ann Intern Med. 2014 Jan 7;160(1):30-7. doi: 10.7326/0003-4819-160-1-201401070-00731. PMID 24166695
  • Simmons RD, Kirwan P, Beebeejaun K, Riordan A, Borrow R, Ramsay ME, Delpech V, Lattimore S, Ladhani S. Risk of invasive meningococcal disease in children and adults with HIV in England: a population-based cohort study. BMC Med. 2015 Dec 9;13:297. doi: 10.1186/s12916-015-0538-6. PMID 26654248
  • Harboe ZB, Larsen MV, Ladelund S, Kronborg G, Konradsen HB, Gerstoft J, Larsen CS, Pedersen C, Pedersen G, Obel N, Benfield T. Incidence and risk factors for invasive pneumococcal disease in HIV-infected and non-HIV-infected individuals before and after the introduction of combination antiretroviral therapy: persistent high risk among HIV-infected injecting drug users. Clin Infect Dis. 2014 Oct 15 PMID 25038114
  • MacNeil JR, Rubin LG, Patton M, Ortega-Sanchez IR, Martin SW. Recommendations for Use of Meningococcal Conjugate Vaccines in HIV-Infected Persons - Advisory Committee on Immunization Practices, 2016. MMWR Morb Mortal Wkly Rep. 2016 Nov 4;65(43):1189-1194. doi: 10.15585/mmwr.mm6543a3. PMID 27811836
  • Lujan-Zilbermann J, Warshaw MG, Williams PL, Spector SA, Decker MD, Abzug MJ, Heckman B, Manzella A, Kabat B, Jean-Philippe P, Nachman S, Siberry GK; International Maternal Pediatric Adolescent AIDS Clinical Trials Group P1065 Protocol Team. Immunogenicity and safety of 1 vs 2 doses of quadrivalent meningococcal conjugate vaccine in youth infected with human immunodeficiency virus. J Pediatr. 2012 PMID 22622049
  • Frota ACC, Ferreira B, Harrison LH, Pereira GS, Pereira-Manfro W, Machado ES, de Oliveira RH, Abreu TF, Milagres LG, Hofer CB. Safety and immune response after two-dose meningococcal C conjugate immunization in HIV-infected children and adolescents in Rio de Janeiro, Brazil. Vaccine. 2017 Dec 15;35(50):7042-7048. doi: 10.1016/j.vaccine.2017.10.043. Epub 2017 Oct 31. PMID 29100708
  • Pedersen RH, Lohse N, Ostergaard L, Sogaard OS. The effectiveness of pneumococcal polysaccharide vaccination in HIV-infected adults: a systematic review. HIV Med. 2011 Jul;12(6):323-33. doi: 10.1111/j.1468-1293.2010.00892.x. Epub 2010 Nov 8. PMID 21059168
  • Lee KY, Tsai MS, Kuo KC, Tsai JC, Sun HY, Cheng AC, Chang SY, Lee CH, Hung CC. Pneumococcal vaccination among HIV-infected adult patients in the era of combination antiretroviral therapy. Hum Vaccin Immunother. 2014;10(12):3700-10. doi: 10.4161/hv.32247. PMID 25483681

Identifiers

NCT: NCT04875819 · H-19001166 · 2020-000863-22

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗