NCT02515240

Brief Summary

The purpose of the study. To characterize the immune response to the pneumococcal vaccine in HIV positive individuals and to dissect the most appropriate timing and frequency of vaccination.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jul 2010

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2015

Completed
28 days until next milestone

First Posted

Study publicly available on registry

August 4, 2015

Completed
Last Updated

August 7, 2015

Status Verified

July 1, 2015

Enrollment Period

3.9 years

First QC Date

July 7, 2015

Last Update Submit

August 5, 2015

Conditions

Pneumococcal Infection

Outcome Measures

Primary Outcomes (1)

  • Antibody activity and response by opsonophagocytic assay (OPT) and ELISA (ug/ml)

    Day 0 and day 30 of vaccination

Secondary Outcomes (2)

  • Polysaccharide-specific B cell phenotype: percentage naive or memory B cell distribution flow cytometry

    Day 0 and Day7 of vaccination

  • Flow cytometry : percentage cells expressing tumor necrosis factor receptors on surface

    Day 0 and Day7 of vaccination

Study Arms (6)

healthy controls

ACTIVE COMPARATOR

healthy individuals, HIV negative, 19-50 yrs if age, immunized with one shot of PPV23 vaccine.

Biological: PPV23

newly diagnosed HIV >200

ACTIVE COMPARATOR

Newly diagnosed HIV positive patients with CD4 count \>200, immunized with one shot of PPV23 vaccine.

Biological: PPV23

newly diagnosed HIV <200

ACTIVE COMPARATOR

Newly diagnosed HIVpositive patients with CD4 count \<200, immediately immunized with one shot of PPV23 vaccine.

Biological: PPV23

newly diagnosed HIV <200 delayed

ACTIVE COMPARATOR

Newly diagnosed HIV positive patients with CD4 count \<200 delayed immunization with one shot of PPV23 vaccine, treated for 6-12 months with Highly Active Anti-Retroviral Therapy (HAART) first.

Biological: PPV23

HAART experienced HIV>200

ACTIVE COMPARATOR

HIV positive, on HAART treatment for 5 years, nadir CD4 count \<200, but at present CD4 count is \>200, immunized with one shot of PPV23 vaccine.

Biological: PPV23

HAART experienced HIV<200

ACTIVE COMPARATOR

HIVpositive, on HAART treatment for 5 years, nadir CD4 count \<200, and at present CD4 count is \<200, immunized with one shot of PPV23 vaccine.

Biological: PPV23

Interventions

PPV23BIOLOGICAL

23 valent pneumococcal polysaccharide vaccine in Healthy adults.

Also known as: 23 valent pneumococcal polysaccharide vaccine
HAART experienced HIV<200HAART experienced HIV>200healthy controlsnewly diagnosed HIV <200newly diagnosed HIV <200 delayednewly diagnosed HIV >200

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV negative:
  • never immunized with PPV23
  • HIV positive:
  • need for PPV23 per standard of care

You may not qualify if:

  • steroid use
  • other immunosuppressive agents;
  • pregnancy
  • incapable of completing consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Toledo-Health Science Campus

Toledo, Ohio, 43614, United States

Location

Related Publications (17)

  • Ballet JJ, Sulcebe G, Couderc LJ, Danon F, Rabian C, Lathrop M, Clauvel JP, Seligmann M. Impaired anti-pneumococcal antibody response in patients with AIDS-related persistent generalized lymphadenopathy. Clin Exp Immunol. 1987 Jun;68(3):479-87.

    PMID: 3652522RESULT

  • Janoff EN, Douglas JM Jr, Gabriel M, Blaser MJ, Davidson AJ, Cohn DL, Judson FN. Class-specific antibody response to pneumococcal capsular polysaccharides in men infected with human immunodeficiency virus type 1. J Infect Dis. 1988 Nov;158(5):983-90. doi: 10.1093/infdis/158.5.983.

    PMID: 3183430RESULT

  • Klein RS, Selwyn PA, Maude D, Pollard C, Freeman K, Schiffman G. Response to pneumococcal vaccine among asymptomatic heterosexual partners of persons with AIDS and intravenous drug users infected with human immunodeficiency virus. J Infect Dis. 1989 Nov;160(5):826-31. doi: 10.1093/infdis/160.5.826.

    PMID: 2572650RESULT

  • Kroon FP, van Dissel JT, Ravensbergen E, Nibbering PH, van Furth R. Enhanced antibody response to pneumococcal polysaccharide vaccine after prior immunization with conjugate pneumococcal vaccine in HIV-infected adults. Vaccine. 2000 Nov 22;19(7-8):886-94. doi: 10.1016/s0264-410x(00)00232-2.

    PMID: 11115712RESULT

  • Loeliger AE, Rijkers GT, Aerts P, Been-Tiktak A, Hoepelman AI, van Dijk H, Borleffs JC. Deficient antipneumococcal polysaccharide responses in HIV-seropositive patients. FEMS Immunol Med Microbiol. 1995 Sep;12(1):33-41. doi: 10.1111/j.1574-695X.1995.tb00171.x.

    PMID: 8580899RESULT

  • Ochs HD, Junker AK, Collier AC, Virant FS, Handsfield HH, Wedgwood RJ. Abnormal antibody responses in patients with persistent generalized lymphadenopathy. J Clin Immunol. 1988 Jan;8(1):57-63. doi: 10.1007/BF00915157.

    PMID: 2966810RESULT

  • Opravil M, Fierz W, Matter L, Blaser J, Luthy R. Poor antibody response after tetanus and pneumococcal vaccination in immunocompromised, HIV-infected patients. Clin Exp Immunol. 1991 May;84(2):185-9. doi: 10.1111/j.1365-2249.1991.tb08146.x.

    PMID: 2025948RESULT

  • Ragni MV, Ruben FL, Winkelstein A, Spero JA, Bontempo FA, Lewis JH. Antibody responses to immunization of patients with hemophilia with and without evidence of human immunodeficiency virus (human T-lymphotropic virus type III) infection. J Lab Clin Med. 1987 May;109(5):545-9.

    PMID: 3572201RESULT

  • Rodriguez-Barradas MC, Musher DM, Lahart C, Lacke C, Groover J, Watson D, Baughn R, Cate T, Crofoot G. Antibody to capsular polysaccharides of Streptococcus pneumoniae after vaccination of human immunodeficiency virus-infected subjects with 23-valent pneumococcal vaccine. J Infect Dis. 1992 Mar;165(3):553-6. doi: 10.1093/infdis/165.3.553.

    PMID: 1347058RESULT

  • Unsworth DJ, Rowen D, Carne C, Sonnex C, Baglin T, Brown DL. Defective IgG2 response to Pneumovax in HIV seropositive patients. Genitourin Med. 1993 Oct;69(5):373-6. doi: 10.1136/sti.69.5.373.

    PMID: 8244356RESULT

  • Berberian L, Goodglick L, Kipps TJ, Braun J. Immunoglobulin VH3 gene products: natural ligands for HIV gp120. Science. 1993 Sep 17;261(5128):1588-91. doi: 10.1126/science.7690497.

    PMID: 7690497RESULT

  • Berberian L, Shukla J, Jefferis R, Braun J. Effects of HIV infection on VH3 (D12 idiotope) B cells in vivo. J Acquir Immune Defic Syndr (1988). 1994 Jul;7(7):641-6.

    PMID: 8207642RESULT

  • Karray S, Zouali M. Identification of the B cell superantigen-binding site of HIV-1 gp120. Proc Natl Acad Sci U S A. 1997 Feb 18;94(4):1356-60. doi: 10.1073/pnas.94.4.1356.

    PMID: 9037057RESULT

  • Townsley-Fuchs J, Neshat MS, Margolin DH, Braun J, Goodglick L. HIV-1 gp120: a novel viral B cell superantigen. Int Rev Immunol. 1997;14(4):325-38. doi: 10.3109/08830189709116523.

    PMID: 9186784RESULT

  • Muller S, Kohler H. B cell superantigens in HIV-1 infection. Int Rev Immunol. 1997;14(4):339-49. doi: 10.3109/08830189709116524.

    PMID: 9186785RESULT

  • Chang Q, Abadi J, Alpert P, Pirofski L. A pneumococcal capsular polysaccharide vaccine induces a repertoire shift with increased VH3 expression in peripheral B cells from human immunodeficiency virus (HIV)-uninfected but not HIV-infected persons. J Infect Dis. 2000 Apr;181(4):1313-21. doi: 10.1086/315405. Epub 2000 Apr 13.

    PMID: 10762563RESULT

  • Iyer AS, Khaskhely NM, Leggat DJ, Ohtola JA, Saul-McBeth JL, Khuder SA, Westerink MA. Inflammatory Markers and Immune Response to Pneumococcal Vaccination in HIV-Positive and -Negative Adults. PLoS One. 2016 Mar 1;11(3):e0150261. doi: 10.1371/journal.pone.0150261. eCollection 2016.

    PMID: 26930208DERIVED

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

23-valent pneumococcal capsular polysaccharide vaccine

Condition Hierarchy (Ancestors)

Streptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Julie MA Westerink, MD

    University of Toledo-HSC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2015

First Posted

August 4, 2015

Study Start

July 1, 2010

Primary Completion

June 1, 2014

Study Completion

March 1, 2015

Last Updated

August 7, 2015

Record last verified: 2015-07

Locations

US(1)