Pneumonia Vaccine in Aging HIV Positive Individuals

NCT02558751 | Completed Early Phase 1

• 1 other identifier: R01AG045973
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators hypothesized that vaccination with either the 23-valent pneumococcal polysaccharide vaccine (PPV23) alone or the 13-valent pneumococcal conjugate vaccine (PCV 13) followed by PPV23 results in similar antibody levels/functional activity and induce a similar pneumococcal polysaccharide (PPS)-specific B cell response in HIV-positive individuals \>50 years of age and HIV-negative persons\>50 years of age. The investigators immunized the study group HIV+ persons\>50 and controls (HIV negative \>50 years) with PCV13 followed by PPV23 and HIV+\>50 with PPV23 alone. The investigators examined immune responses to PPS23F and PPS14 on a quantitative and qualitative level using ELISA and opsonophagocytic assays (OPA). To test the hypothesis that the levels of antigen specific B cells identified with PPS were comparable between the PPV23 and PCV13 vaccine recipients. Pre- and post-immunization peripheral blood samples were obtained. Extensive B cell phenotype analysis using fluorescent antibodies was used to characterize PPS-labeled B cells. Specific phenotypes were correlated with antibody levels and OPA and compared to historic populations immunized with PPV.

Conditions

Pneumococcal Infection

Keywords

pneumococcal conjugate vaccine; aging HIV

Outcome Measures

Primary Outcomes (4)

• Antibody response measured by ELISA (ug/ml)

  Change in ug/ml from day 0 to day 30

• Opsonophagocytic antibody activity measured by opsonophagocytic assay (OPA titer)

  Change in OPA titer from day 0 to day 30

• Antibody response measured by ELISA (ug/ml)

  Change in ug/ml from day 0 to day 90

• Opsonophagocytic antibody activity measured by opsonophagocytic assay (OPA titer)

  Change in OPA titer from day 0 to day 90

Secondary Outcomes (17)

• B cell phenotype of PPS-specific B cells expressing CD27+IgM+: flowcytometry (%)

  Change from day 0 to day 7 in %

• Serum C-reactive protein (ng/ml)

  day 0

• Flow cytometry : percentage cells expressing BAFF-R on surface (%)

  Change from day 0 to day 7

• Flow cytometry : percentage cells expressing BAFF-R on surface (%)

  Change from day 56 to day 63

• B cell phenotype of PPS-specific B cells expressing CD27IgM: flowcytometry (%)

  Change from day 56 to day 63 (%)

Study Arms (3)

HIV positive PPV23

ACTIVE COMPARATOR

HIV-positive individuals 50-65 years of age immunized with one dose of the 23-valent pneumococcal polysaccharide vaccine, PPV23

Biological: 23-valent pneumococcal polysaccharide vaccine

HIV positive PCV13/PPV23

ACTIVE COMPARATOR

HIV-positive individual 50-65 years of age, Intervention: one dose of 13-valent pneumococcal conjugate vaccine,PCV13, followed 8 weeks later with one dose of 23-valent pneumococcal polysaccharide vaccine, PPV23

Biological: 23-valent pneumococcal polysaccharide vaccine; Biological: 13-valent pneumococcal conjugate vaccine

HIV negative PCV13/PPV23

ACTIVE COMPARATOR

HIV-negative individual 50-65 years of age, Intervention: one dose of 13-valent pneumococcal conjugate vaccine,PCV13, followed 8 weeks later with one dose of 23-valent pneumococcal polysaccharide vaccine, PPV23

Biological: 23-valent pneumococcal polysaccharide vaccine; Biological: 13-valent pneumococcal conjugate vaccine

Interventions

23-valent pneumococcal polysaccharide vaccine BIOLOGICAL

One standard adult dose of the 23-valent pneumococcal polysaccharide vaccine

Also known as: PPV23 or Pneumovax

HIV negative PCV13/PPV23; HIV positive PCV13/PPV23; HIV positive PPV23

13-valent pneumococcal conjugate vaccine BIOLOGICAL

One dose of the 13-valent pneumococcal conjugate vaccine, PCV13, followed 8 weeks later by one dose of the 23-valent pneumococcal polysaccharide vaccine, PPV23.

Also known as: PCV13 or Prevnar 13

HIV negative PCV13/PPV23; HIV positive PCV13/PPV23

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV negative:
• never immunized with PCV13
• HIV positive:
• need for pneumococcal vaccination per standard of care

You may not qualify if:

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

Sponsors & Collaborators

• University of Toledo Health Science Campus: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

The University of Toledo-Health Science Campus

Toledo, Ohio, 43614, United States

Location

Related Publications (5)

• 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: 3652522 RESULT

• 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: 3183430 RESULT

• 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: 2572650 RESULT

• 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: 11115712 RESULT

• 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: 1347058 RESULT

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

23-valent pneumococcal capsular polysaccharide vaccine; Pneumococcal Vaccines; 13-valent pneumococcal vaccine

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Maria AJ Westerink, M.D.

  University of Toledo

  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: September 16, 2015
• First Posted: September 24, 2015
• Study Start: July 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: September 24, 2015

Record last verified: 2015-09

Locations

US (1)