Effect of Obesity on Immune Response to Pneumovax 23
Completed
Conditions studied: Obesity
In brief
Pneumococcal infections are a leading cause of adult and childhood hospitalization and death. It has been shown that obese individuals are at higher risk for this bacterial infection. As a result, investigators will vaccinate obese individuals to see if they are offered the same level of protection from the vaccine as normal-weight individuals. The vaccine used for this particular bacterial infection is called Pneumovax 23. The purpose of this study is to compare how body mass index affects protection that the vaccine provides against these bacteria. Primary Hypothesis: Levels of protection from the vaccine are no different in pre- and post- vaccination in healthy BMI individuals and obese individuals.
Key facts
- Study ID
- NCT02471014
- Run by
- University of Florida
- People needed
- 50
- Starts
- 2016-12-01
- Expected to finish
- 2019-05-16
- Last updated by the study team
- 2020-12-01
Who can join
Age: 18 and older, up to 35. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Control group
- aged 18-35
- BMIs between 22-25kg/m2, Obese group
- Aged 18 - 35
- BMIs greater than 30kg/m2, and
- waist to hip ratio of at least 0.9 in males and at least 0.85 in females
You may not qualify if…
- Pregnancy: Pregnant, Planning to become pregnant, or Breastfeeding
- Diabetes mellitus (A1C> 6.5%): Diagnosed with diabetes
- Abnormal CMP and CBC values as determined by the Principal Investigator.
- Inability to fast for 8 hours prior to the initial blood draw
- Immunization: Immunized with Pneumovax 23, or Immunized with Prevnar
- Medications:Currently taking any of the following medications or within the 4 weeks of study:
- i. Immunosuppressive drugs or chemotherapeutic agents such as azathioprine, mycophenolate mofetil, TNF inhibitors, cyclosporine, methotrexate, leflunomide, cyclophosphamide, sulfasalazine, antimalarial drugs, chlorambucil, nitrogen mustard
- ii. Steroids such as prednisone, cortisone, hydrocortisone
- iii. Antidiabetic drugs such as metformin, insulin, glipizide, meglitinide, sulfonylurea, glimepiride, repaglinide, nateglinide
- History of clinical illness (exclusion during clinic)
- Pneumonia or Previously had Pneumonia
- Low blood pressure or Experienced dizzy spells
- Significant cardiovascular disease:Recently hospitalizations deemed significant at the discretion of the Principal Investigator, or History of heart attack, or History of stroke
- Spleen, Splenectomy, or Damage to spleen
- Lung Disease or History of lung disease
- Kidney disease, Blood in urine, or Protein in urine
- Liver disease, Previous or current liver diseases such as hepatitis A, B, or C, liver cirrhosis, or autoimmune hepatitis, or Elevated AST/ALT lab test
- Leukopenias
- Hemoglobinopathies, History of sickle cell disease, or thalassemia
- HIV/AIDS, or a history of HIV infection
- Recreational IV drug use, or Intravenous drug injection predisposes users to infections, such as human immunodeficiency virus, that may alter the immune system and therefore affect the immunoglobulin response to Pneumovax23.
- History of IV-drug use, or IV drug use is a risk factor for HIV infection, which may change the immune response to Pneumovax 23.
- History of idiopathic thrombocytopenic purpura
- History of chronic inflammatory diseases such as rheumatoid arthritis or chronic granulomatous disease
- Autoimmune disease
Where it is running
- Uf Ctsi Crc — Gainesville, Florida, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.