AzTrials
AzTrials

Chronic Lymphocytic LeukemiaPhase 2NCT05183854

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

A Phase 2 study testing Pneumococcal 20-valent Conjugate Vaccine and Pneumococcal Polyvalent Vaccine in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by University of Utah at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pneumococcal 20-valent Conjugate Vaccine and Pneumococcal Polyvalent Vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
1 siteUnited States
Study dates
31 Jan 2022to Jun 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • NAIVE COHORT: Subjects must have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) (collectively referred to as CLL throughout) according to the 2018 International Workshop on CLL.
  • NAIVE COHORT: Male or female subject aged >= 18 years.
  • NAIVE COHORT: Subjects must not have received prior therapy for CLL.
  • VENETOCLAX-TREATMENT COHORT: Subjects must have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) (collectively referred to as CLL throughout) according to the 2018 International Workshop on CLL.
  • VENETOCLAX-TREATMENT COHORT: Subjects must have received venetoclax (any dose) for at least 12 months with the last dose =< 12 months prior to registration.

Who cannot join

  • 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.
  • If they have received PPSV23 in ≥ 1 year and no other pneumococcal vaccine they may be included.
  • 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:
  • Intranasal, inhaled, topical steroids, eye drops or local steroid injection (e.g., intra-articular injection);
Show all 9Show fewer
  • Systemic corticosteroids at physiologic doses =< 10 mg/day of prednisone or equivalent;
  • Steroids as premedication for hypersensitivity reactions (e.g., computed tomography [CT] scan premedication).
  • Concurrent illness or condition, which, in the opinion of the treating investigator, would negatively impact the subject's study participation.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

David Samuel contact

801-587-4713

david.samuel@hci.utah.edu

United States1 site, 1 recruiting

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112

    Catherine Cromar, 801-213-5652, catherine.cromar@hci.utah.edu

    Lindsey Gilstrap, 801-213-5652, lindsey.gilstrap@hci.utah.edu

    Recruiting

Other trials in United States

About this study

Official title: Phase II Study of the Efficacy of the Pneumococcal Pneumonia Vaccine Series in Patients With Chronic Lymphocytic Leukemia Associated Immunodeficiency (PROTECT CLL)

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.

Being tested
Pneumococcal 20-valent Conjugate Vaccine, Pneumococcal Polyvalent Vaccine
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pneumococcal 20-valent Conjugate VaccineBiological

    Also called PCV 20, PCV 20 Vaccine, Prevnar 20

    Given IM

  • Pneumococcal Polyvalent VaccineBiological

    Also called PCV 23, Pneumococcal 23-valent Polysaccharide Vaccine, Pneumococcal Polysaccharide Vaccine, Pneumococcal Vaccine Polyvalent

    Given IM

Study groups in NCT05183854
Study groupRoleWhat they receive
Arm I (PCV20, PPSV23)ExperimentalPatients receive pneumococcal 20-valent conjugate vaccine IM on day 1. PnumoVax23 will be given as an intramuscular injection on Visit 2 (approximately Day 75)
Receives: Biological: Pneumococcal 20-valent Conjugate Vaccine; Biological: Pneumococcal Polyvalent Vaccine
Arm II (PCV20, PPPSV23)ExperimentalPatients 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.
Receives: Biological: Pneumococcal 20-valent Conjugate Vaccine; Biological: Pneumococcal Polyvalent Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At 30 and 90 days post-PCV20 vaccination

Secondary outcomes (4)

  1. 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.

    Measured: Up to 5 years post- PPSV23 vaccination

  2. 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.

    Measured: Up to 5 years post PPSV23 vaccination

  3. 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.

    Measured: At 30 and 90 days post-PCV20 vaccination

  4. 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.

    Measured: Up to 5 years post PPSV23 vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2022
  2. Study start31 Jan 2022
  3. Primary completionMar 2027 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
61 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05183854
Sponsor's protocol ID
HCI145280
Other IDs
NCI-2021-13373, HCI145280
Status last verified
Apr 2026
First submitted
21 Dec 2021
Last updated
9 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Howlader N, Noone A, Krapcho M, et al. SEER Cancer Statistics Review, 1975-2016. Vol. 2020. Bethesda, MD: National Cancer Institute; 2019.

  • 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.

    PubMed 13697946

  • 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.

    PubMed 16025268

  • 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.

    PubMed 8175032

  • 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.

    PubMed 20620978

  • 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.

    PubMed 24421306

  • 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.

    PubMed 11472353

  • 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.

    PubMed 1644158

  • 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.

    PubMed 11166890

  • 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.

    PubMed 18053620

  • 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.

    PubMed 25506837

  • 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.

    PubMed 23688527

  • 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.

    PubMed 29748028

  • 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.

    PubMed 20117269

  • 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.

    PubMed 8537671

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pneumococcal 20-valent Conjugate Vaccine and Pneumococcal Polyvalent Vaccine in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by University of Utah at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact David Samuel (801-587-4713, david.samuel@hci.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients who achieve the protocol defined change in antibody titers (time frame: At 30 and 90 days post-PCV20 vaccination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05183854, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.

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