drugset / Trial / NCT02515240
Immune Response to Pneumococcal Vaccination in HIV Infected Individuals
Phase 0
Completed
124 enrolled
University of Toledo Health Science Campus
National Institutes of Health (NIH) · collab
Non-randomizedParallel-groupOpen-labelPrevention
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.
Timeline
- Start
- 2010-07
- Primary completion
- 2014-06
- Completion
- 2015-03
Publications
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results Muller S, Kohler H. B cell superantigens in HIV-1 infection. Int Rev Immunol. 1997;14(4):339-49. doi: 10.3109/08830189709116524.
- Results 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Pneumovax 23 | Vaccine | — | — |