Pneumococcal Pneumonia Vaccine Series (PCV20 and PPSV23) in Patients With Chronic Lymphocytic Leukemia Associated Immunodeficiency, PROTECT CLL Trial

Summary

This phase II trial tests whether the pneumococcal pneumonia vaccine series (PCV20 and PPSV23) works to mount an effective immune response in patients with chronic lymphocytic leukemia. PCV20 and PPSV23 are both vaccines that protect against bacteria that cause pneumococcal disease. Giving these vaccinations as series may make a stronger immune response and prevent against pneumococcal infections in patients with chronic lymphocytic leukemia. This is a single-center trial, conducted at Huntsman Cancer Institute.

Timeline

Start

2022-01-31

Primary completion

2027-03

Completion

2028-06

Publications

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• Background Svensson T, Kattstrom M, Hammarlund Y, Roth D, Andersson PO, Svensson M, Nilsson I, Rombo L, Cherif H, Kimby E. Pneumococcal conjugate vaccine triggers a better immune response than pneumococcal polysaccharide vaccine in patients with chronic lymphocytic leukemia A randomized study by the Swedish CLL group. Vaccine. 2018 Jun 14;36(25):3701-3707. doi: 10.1016/j.vaccine.2018.05.012. Epub 2018 May 7.
• Background Cordonnier C, Labopin M, Chesnel V, Ribaud P, Camara Rde L, Martino R, Ullmann AJ, Parkkali T, Locasciulli A, Yakouben K, Pauksens K, Bonnet E, Einsele H, Niederwieser D, Apperley J, Ljungman P. Immune response to the 23-valent polysaccharide pneumococcal vaccine after the 7-valent conjugate vaccine in allogeneic stem cell transplant recipients: results from the EBMT IDWP01 trial. Vaccine. 2010 Mar 24;28(15):2730-4. doi: 10.1016/j.vaccine.2010.01.025. Epub 2010 Jan 29.
• Background Chan CY, Molrine DC, George S, Tarbell NJ, Mauch P, Diller L, Shamberger RC, Phillips NR, Goorin A, Ambrosino DM. Pneumococcal conjugate vaccine primes for antibody responses to polysaccharide pneumococcal vaccine after treatment of Hodgkin's disease. J Infect Dis. 1996 Jan;173(1):256-8. doi: 10.1093/infdis/173.1.256.
• Background Vernacchio L, Neufeld EJ, MacDonald K, Kurth S, Murakami S, Hohne C, King M, Molrine D. Combined schedule of 7-valent pneumococcal conjugate vaccine followed by 23-valent pneumococcal vaccine in children and young adults with sickle cell disease. J Pediatr. 1998 Aug;133(2):275-8. doi: 10.1016/s0022-3476(98)70235-5.
• Background Cannon K, Elder C, Young M, Scott DA, Scully IL, Baugher G, Peng Y, Jansen KU, Gruber WC, Watson W. A trial to evaluate the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine in populations of adults >/=65 years of age with different prior pneumococcal vaccination. Vaccine. 2021 Dec 17;39(51):7494-7502. doi: 10.1016/j.vaccine.2021.10.032. Epub 2021 Nov 25.
• Background Fischer K, Al-Sawaf O, Bahlo J, Fink AM, Tandon M, Dixon M, Robrecht S, Warburton S, Humphrey K, Samoylova O, Liberati AM, Pinilla-Ibarz J, Opat S, Sivcheva L, Le Du K, Fogliatto LM, Niemann CU, Weinkove R, Robinson S, Kipps TJ, Boettcher S, Tausch E, Humerickhouse R, Eichhorst B, Wendtner CM, Langerak AW, Kreuzer KA, Ritgen M, Goede V, Stilgenbauer S, Mobasher M, Hallek M. Venetoclax and Obinutuzumab in Patients with CLL and Coexisting Conditions. N Engl J Med. 2019 Jun 6;380(23):2225-2236. doi: 10.1056/NEJMoa1815281. Epub 2019 Jun 4.
• Background de Weerdt I, Hofland T, de Boer R, Dobber JA, Dubois J, van Nieuwenhuize D, Mobasher M, de Boer F, Hoogendoorn M, Velders GA, van der Klift M, Remmerswaal EBM, Bemelman FJ, Niemann CU, Kersting S, Levin MD, Eldering E, Tonino SH, Kater AP. Distinct immune composition in lymph node and peripheral blood of CLL patients is reshaped during venetoclax treatment. Blood Adv. 2019 Sep 10;3(17):2642-2652. doi: 10.1182/bloodadvances.2019000360.
• Background Hallek M, Cheson BD, Catovsky D, Caligaris-Cappio F, Dighiero G, Dohner H, Hillmen P, Keating M, Montserrat E, Chiorazzi N, Stilgenbauer S, Rai KR, Byrd JC, Eichhorst B, O'Brien S, Robak T, Seymour JF, Kipps TJ. iwCLL guidelines for diagnosis, indications for treatment, response assessment, and supportive management of CLL. Blood. 2018 Jun 21;131(25):2745-2760. doi: 10.1182/blood-2017-09-806398. Epub 2018 Mar 14.

Drugs

Indications