Immunomodulatory effects of a proprietary Arabinogalactan extract

Completed

Conditions: Immune response to the 23-valent pneumococcal vaccine
Respiratory
Pneumonia vaccination

Registration Number: ISRCTN98817459

Lead Sponsor: onza, Inc (USA)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 50

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measurements of: <br>1. Plasma levels of pneumococcal IgG (subtypes 4, 6B, 9V, 14, 18C, 19F and 23F; enzyme-linked immunosorbent assay [ELISA])<br>2. Salivary IgA (ELISA)<br>3. Peripheral white blood cell counts (lymphocytes, neutrophils, etc.,)<br>4. Plasma complement (C3 and C4)<br>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)<br><br>All outcomes measured at baseline, day 30, day 51, and day 72.

Secondary Outcome Measures