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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-13373 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| HCI145280 | Other Identifier | Huntsman Cancer Institute/University of Utah |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (PCV20, PPSV23) | Experimental | Patients receive pneumococcal 20-valent conjugate vaccine IM on day 1. PnumoVax23 will be given as an intramuscular injection on Visit 2 (approximately Day 75) |
|
| Arm II (PCV20, PPPSV23) | Experimental | Patients who have received or are receiving venetoclax therapy, receive pneumococcal 20-valent conjugate vaccine IM at study visit 1 and pneumococcal polyvalent vaccine IM at study visit 2 in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pneumococcal 20-valent Conjugate Vaccine | Biological | Given IM |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who achieve the protocol defined change in antibody titers | Will examine the proportion of patients who achieve the protocol defined change in antibody titers from baseline in at least 10 of 19 S.pneumoniae serotypes shared between pneumococcal 20-valent conjugate vaccine (PCV20) and pneumococcal polyvalent vaccine (PPSV23) at Study Visit 2 and 3. The observed proportion and an exact 95% binomial confidence interval will be reported. A one sample exact binomial test will be performed at one-sided alpha = 0.05. The null hypothesis is that the proportion is 50% or lower. | At 30 and 90 days post-PCV20 vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who have a two-fold increase of immunoglobulin levels | Will examine the proportion of patients who have a two-fold increase of immunoglobulin levels from baseline at Study Visit 2 and 3 and do not develop pneumonia within five years post-PPSV23 vaccination. The observed proportion and an exact 95% binomial confidence interval will be reported. | Up to 5 years post- PPSV23 vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients that contract pneumonia | Kaplan-Meier methods will be used to analyze time-to-pneumonia from baseline until five years after study entry, stratified by therapeutic strategy. | Up to 5 years post PPSV23 vaccination |
| Proportion of venetoclax treated chronic lymphocytic leukemia (CLL) patients who achieve a two-fold increase in antibody titers |
Inclusion Criteria:
Exclusion Criteria:
Subjects who have experienced a severe allergic reaction to prior pneumococcal vaccination.
Subjects who have received a PCV13 or PCV20 pneumococcal vaccination in the last five years.
Active infection requiring systemic antibiotic therapy.
Current or prior use of immunosuppressive medication within 14 days of cycle one day one, EXCEPT for the following permitted steroids:
Concurrent illness or condition, which, in the opinion of the treating investigator, would negatively impact the subject's study participation.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Samuel | Contact | 801-587-4713 | david.samuel@hci.utah.edu |
| Name | Affiliation | Role |
|---|---|---|
| Daniel Ermann, MD | Huntsman Cancer Institute/ University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsman Cancer Institute/University of Utah | Recruiting | Salt Lake City | Utah | 84112 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Howlader N, Noone A, Krapcho M, et al. SEER Cancer Statistics Review, 1975-2016. Vol. 2020. Bethesda, MD: National Cancer Institute; 2019. | ||
| 13697946 | Background | FAIRLEY GH, SCOTT RB. Hypogammaglobulinaemia in chronic lymphatic leukaemia. Br Med J. 1961 Oct 7;2(5257):920-4. doi: 10.1136/bmj.2.5257.920. No abstract available. | |
| 16025268 |
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| Pneumococcal Polyvalent Vaccine | Biological | Given IM |
|
|
| Proportion of vaccinated patients who have a two-fold increase in at least 10 of 19 S. pneumonia serotypes shared between PCV20 and PPSV23 vaccines | Will examine the proportion of vaccinated patients who have a two-fold increase in at least 10 of 19 S. pneumonia serotypes shared between PCV20 and PPSV23 vaccines and do not develop pneumonia within five years post PPSV23 vaccination. The observed proportion and an exact 95% binomial confidence interval will be reported. | Up to 5 years post PPSV23 vaccination |
| Proportion of patients who have a two-fold increase in antibody titers to an individual serotype vaccination | Will examine the proportion of patients who have a two-fold increase in antibody titers to an individual serotype at Study Visit 2 and 3 post PPCV20 vaccination. The observed proportion and 95% exact binomial confidence intervals will be reported for each serotype. | At 30 and 90 days post-PCV20 vaccination |
| Proportion of patients who maintain adequate immune response | Will examine the proportion of patients who maintain adequate immune response, defined as two-fold increase in antibody titers from baseline in 10/19 of S. pneumoniae serotypes, from PPSV23 vaccination to time of last follow-up at 5 years. Kaplan-Meier methods will be used to analyze time-to-pneumonia from baseline until five years after PPSV23 vaccination. | Up to 5 years post PPSV23 vaccination |
Will examine the proportion of Venetoclax treated CLL patients who achieve a two-fold increase in antibody titers from baseline in at least 10 of 19 S. pneumonia serotypes shared between PCV20 and PPSV23 vaccines at Study Visit 2 and 3. |
| At 30 and 90 days post PCV20 vaccination |
| Background |
| Ravandi F, O'Brien S. Immune defects in patients with chronic lymphocytic leukemia. Cancer Immunol Immunother. 2006 Feb;55(2):197-209. doi: 10.1007/s00262-005-0015-8. Epub 2005 Jul 16. |
| 8175032 | Background | Molica S, Levato D, Levato L. Infections in chronic lymphocytic leukemia. Analysis of incidence as a function of length of follow-up. Haematologica. 1993 Nov-Dec;78(6):374-7. |
| 20620978 | Background | Morrison VA. Infectious complications of chronic lymphocytic leukaemia: pathogenesis, spectrum of infection, preventive approaches. Best Pract Res Clin Haematol. 2010 Mar;23(1):145-53. doi: 10.1016/j.beha.2009.12.004. |
| 24421306 | Background | Rubin LG, Levin MJ, Ljungman P, Davies EG, Avery R, Tomblyn M, Bousvaros A, Dhanireddy S, Sung L, Keyserling H, Kang I; Infectious Diseases Society of America. 2013 IDSA clinical practice guideline for vaccination of the immunocompromised host. Clin Infect Dis. 2014 Feb;58(3):309-18. doi: 10.1093/cid/cit816. |
| 11472353 | Background | Sinisalo M, Aittoniemi J, Oivanen P, Kayhty H, Olander RM, Vilpo J. Response to vaccination against different types of antigens in patients with chronic lymphocytic leukaemia. Br J Haematol. 2001 Jul;114(1):107-10. doi: 10.1046/j.1365-2141.2001.02882.x. |
| 1644158 | Background | Itala M, Helenius H, Nikoskelainen J, Remes K. Infections and serum IgG levels in patients with chronic lymphocytic leukemia. Eur J Haematol. 1992 May;48(5):266-70. doi: 10.1111/j.1600-0609.1992.tb01805.x. |
| 11166890 | Background | Hartkamp A, Mulder AH, Rijkers GT, van Velzen-Blad H, Biesma DH. Antibody responses to pneumococcal and haemophilus vaccinations in patients with B-cell chronic lymphocytic leukaemia. Vaccine. 2001 Feb 8;19(13-14):1671-7. doi: 10.1016/s0264-410x(00)00409-6. |
| 18053620 | Background | Sinisalo M, Vilpo J, Itala M, Vakevainen M, Taurio J, Aittoniemi J. Antibody response to 7-valent conjugated pneumococcal vaccine in patients with chronic lymphocytic leukaemia. Vaccine. 2007 Dec 21;26(1):82-7. doi: 10.1016/j.vaccine.2007.10.053. Epub 2007 Nov 12. |
| 25506837 | Background | Pasiarski M, Rolinski J, Grywalska E, Stelmach-Goldys A, Korona-Glowniak I, Gozdz S, Hus I, Malm A. Antibody and plasmablast response to 13-valent pneumococcal conjugate vaccine in chronic lymphocytic leukemia patients--preliminary report. PLoS One. 2014 Dec 15;9(12):e114966. doi: 10.1371/journal.pone.0114966. eCollection 2014. |
| 23688527 | Background | Jackson LA, Gurtman A, Rice K, Pauksens K, Greenberg RN, Jones TR, Scott DA, Emini EA, Gruber WC, Schmoele-Thoma B. Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine in adults 70 years of age and older previously vaccinated with 23-valent pneumococcal polysaccharide vaccine. Vaccine. 2013 Aug 2;31(35):3585-93. doi: 10.1016/j.vaccine.2013.05.010. Epub 2013 May 18. |
| 29748028 | 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. |
| 20117269 | 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. |
| 8537671 | 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. |
| 9709721 | 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. |
| 34839993 | 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. |
| 31166681 | 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. |
| 31506282 | 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. |
| 29540348 | 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. |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D022242 | Pneumococcal Vaccines |
| C414006 | 23-valent pneumococcal capsular polysaccharide vaccine |
| ID | Term |
|---|---|
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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