Pneumococcal Infection Clinical Trial
Official title:
Immune Response to Pneumococcal Vaccination in HIV Infected Individuals
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.
Status | Completed |
Enrollment | 124 |
Est. completion date | March 2015 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 19 Years to 65 Years |
Eligibility |
Inclusion Criteria: - HIV negative: - never immunized with PPV23 - HIV positive: - need for PPV23 per standard of care Exclusion Criteria: - steroid use - other immunosuppressive agents; - pregnancy - incapable of completing consent form |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | The University of Toledo-Health Science Campus | Toledo | Ohio |
Lead Sponsor | Collaborator |
---|---|
University of Toledo Health Science Campus | National Institutes of Health (NIH) |
United States,
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. — View Citation
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. — View Citation
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. 1994 Jul;7(7):641-6. — View Citation
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 — View Citation
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. — View Citation
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. — View Citation
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;1 — View Citation
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. — View Citation
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. — View Citation
Müller S, Köhler H. B cell superantigens in HIV-1 infection. Int Rev Immunol. 1997;14(4):339-49. Review. — View Citation
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. — View Citation
Opravil M, Fierz W, Matter L, Blaser J, Lüthy R. Poor antibody response after tetanus and pneumococcal vaccination in immunocompromised, HIV-infected patients. Clin Exp Immunol. 1991 May;84(2):185-9. — View Citation
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. 1 — View Citation
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 pneu — View Citation
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. Review. — View Citation
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. — View Citation
* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Antibody activity and response by opsonophagocytic assay (OPT) and ELISA (ug/ml) | Day 0 and day 30 of vaccination | No | |
Secondary | Polysaccharide-specific B cell phenotype: percentage naive or memory B cell distribution flow cytometry | Day 0 and Day7 of vaccination | No | |
Secondary | Flow cytometry : percentage cells expressing tumor necrosis factor receptors on surface | Day 0 and Day7 of vaccination | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02463539 -
Residual Anti-pneumococcal Immunity After Pneumococcal Immunization in ANCA-associated Vasculitis
|
N/A | |
Completed |
NCT03095326 -
Pneumococcal Vaccination for Splenectomised Thalassemia Major Patients in Indonesia
|
Phase 4 | |
Completed |
NCT02260882 -
Revaccination With PNEUMOVAX™ 23 in Older Japanese Adults (V110-902)
|
Phase 4 | |
Completed |
NCT02572635 -
A Phase I Study to Evaluate the Safety and Immunogenicity of PnuBioVax
|
Phase 1 | |
Completed |
NCT01654263 -
A Phase IIb, Open-Label, Dose Ranging Study of 13-Valent Pneumococcal Conjugate Vaccine in Adults 55 Through 74 Years of Age Previously Vaccinated With 23-Valent Pneumococcal Polysaccharide Vaccine
|
Phase 2 | |
Completed |
NCT01531322 -
A Study Assessing 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Subjects
|
Phase 1 | |
Completed |
NCT00496093 -
Safety, Tolerability and Immunogenicity of Pneumovax 23 in Healthy Adults in India (V110-011)
|
Phase 3 | |
Completed |
NCT02062281 -
Study of Evaluating Safety and Immunogenicity of 23-Valent Pneumococcal Polysaccharide Vaccine With Influenza Vaccine in Children and Adults
|
Phase 4 | |
Completed |
NCT00133549 -
9-valent CRM 197 Pneumococcal
|
Phase 2 | |
Completed |
NCT03467984 -
A Study to Evaluate the Safety and Immunogenecity of LBVE(Multivalent Pneumococcal Conjugate Vaccine) in Healthy Infants
|
Phase 2 | |
Active, not recruiting |
NCT03489018 -
The Effect of Fractional Doses of Pneumococcal Conjugate Vaccines on Immunogenicity and Carriage in Kenyan Infants
|
Phase 4 | |
Recruiting |
NCT02463578 -
Immunogenicity of a Combined Anti-pneumococcal Vaccine Schedule in Patients With ANCA-associated Vasculitis
|
N/A | |
Completed |
NCT00535730 -
ZOSTAVAX™ Administered Concomitantly With PNEUMOVAX™ 23 (V211-012)(COMPLETED)
|
Phase 3 | |
Completed |
NCT02558751 -
Pneumonia Vaccine in Aging HIV Positive Individuals
|
Phase 0 | |
Completed |
NCT00560950 -
Revaccination With PNEUMOVAX(TM) 23 in Older Adults (V110-007)
|
Phase 3 | |
Completed |
NCT05425732 -
Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults (V116-003, STRIDE-3)
|
Phase 3 | |
Not yet recruiting |
NCT03549208 -
A Study to Evaluate the Safety and Immunogeneicity of Multivalent Pneumococcal Conjugate Vaccine in Healthy Adults
|
Phase 1 | |
Completed |
NCT03619252 -
Pneumococcal Vaccination of Multiple Myeloma Patients on Novel Agents
|
Phase 4 | |
Not yet recruiting |
NCT03341195 -
Mobile Phone SMS Messages and Automated Calls in Improving Vaccine Coverage Among Children in Pakistan
|
N/A | |
Recruiting |
NCT06177912 -
A Clinical Study of the V116 Vaccine for Children and Teenagers (V116-013)
|
Phase 3 |