Immune response to the 23-valent pneumococcal vaccine Respiratory Pneumonia vaccination
Conditions
Interventions
This is a randomised double-blind placebo controlled parallel group study with 45 healthy adults who had not previously had the pneumonia vaccine. The study was conducted at a single site Medicus Rese
Lonza, Inc., Allendale, NJ). The placebo was maltodextrin (Maltin M100). The test product and the placebo were administered by mixing the powders into a beverage of the subject's choice for a maximum
Sponsors
Lonza, Inc (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 65 years, either sex 2. Had a Body Mass Index (BMI) greater than 18 kg/m^2 and less than 30 kg/m^2 at screening 3. Agreed to all study visits and visit procedures 4. Agreed to use appropriate forms of birth control if females of child bearing potential 5. Agreed not to initiate/change any exercise or diet programs during the study
Exclusion criteria
Exclusion criteria: 1. Previously had the pneumococcal vaccine 2. Had allergies to the test product 3. Had any major systemic, inflammatory or chronic disease 4. Had any active infection or infection in the past month requiring antibiotics or anti-viral medication 5. Used immunosuppressive drugs in the prior 5 years 6. Known alcohol or drug abuse 7. Were pregnant or lactating 8. Had any medical condition which in the opinion of the investigator might interfere with the subject's ability in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measurements of: 1. Plasma levels of pneumococcal IgG (subtypes 4, 6B, 9V, 14, 18C, 19F and 23F; enzyme-linked immunosorbent assay [ELISA]) 2. Salivary IgA (ELISA) 3. Peripheral white blood cell counts (lymphocytes, neutrophils, etc.,) 4. Plasma complement (C3 and C4) 5. Cytokine levels (epithelial neutrophil-activating peptide [ENA]-78, eotaxin, granulocyte monocyte colony stimulating factor [GM-CSF], interferon-gamma [IFNg], interleukin [IL]-10, IL-12P40, IL-1RA, IL-2, IL-4, IL-5, IL-6, IL-8, monocyte chemotactic protein [MCP]-1, MCP-3, platelet-derived growth factor [PDGF]-BB, tumour necrosis factor [TNF]-alpha A and leptin) All outcomes measured at baseline, day 30, day 51, and day 72. | — |
Secondary
| Measure | Time frame |
|---|---|
| Oxidative stress via F2 isoprostance in urine. All outcomes measured at baseline, day 30, day 51, and day 72. | — |
Countries
United States of America
Outcome results
None listed