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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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.
• Препарат 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.

Первичные конечные точки

• Change in immunogenic response from baseline, Menveo [Срок оценки: Day 30 and year 1, 2, 3, 4, and 5 post-vaccination]
• Change in immunogenic response from baseline, Bexsero [Срок оценки: Day 30 and year 1, 2, 3, 4, and 5 post-vaccination]
• Change in immunogenic response from baseline, Prevenar13/Pneumovax23 [Срок оценки: Day 30 and year 1, 2, 3, 4, and 5 post-vaccination]

Вторичные конечные точки (5)

• Number of participants with immediate adverse events [Срок оценки: 30 minutes post-vaccination]
• Number of participants with short term adverse events [Срок оценки: Day 5 post vaccination]
• Number of participants with long term adverse events [Срок оценки: Day 90 post-vaccination]
• Streptococcus pneumoniae carriage rates [Срок оценки: Baseline and day 30 post-vaccination]
• Neisseria meningitidis carriage rates [Срок оценки: Baseline and day 30 post-vaccination]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Дания · 1 центр

• Hvidovre Hospital — Hvidovre

Публикации

• 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

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗