Assessment of Salmonella Typhim Vi(TM) vaccine (Sanofi Pasteur MSD) for the investigation of selective antibody deficiency to polysaccharide. - Assessment of Salmonella Typhim Vi Vaccine

• Conditions: Suspected primary antibody deficiency states will be investigated

• Registration Number: EUCTR2010-018596-24-GB
• Lead Sponsor: Oxford Radcliffe Hospital NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-22
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1 Participant (or legal guardian in the case of paediatrics) is willing and able to give informed consent for participation in the study. 2 Male or Female, aged 6 years of age or greater. 3 Presenting patient with suspected antibody deficiency, including although not exclusive to recurrent bacterial infections of the upper and lower respiratory tracts or recurrent otitis media. Other parameters – evidence for bacterial infection: increased CRP, raised WBC or bacterial confirmation. 4 Inclusion of participants should be decided by an immunologist. 5 Healthy volunteers must be in good health.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Inability or unwillingness to provide informed consent for the study or blood draws. 2. Known previous vaccination with Prevenar vaccine if performed before tests with Pneumovax were carried out. 3. All exclusion criteria as set out on the use of the vaccine including, but not exclusively: history of severe reaction to a vaccine containing similar components. 4. If the recipient is pregnant determined by asking the patient 5. If the recipient is a nursing mother 6. If the recipient has a severe infection or co-morbidity requiring hospitalisation at the time of immunisation. 7. In the case of Pneumovax investigation any individual must be excluded if the recipient has received IVIG or intramuscular and sub-cutaneous immunoglobulin treatment in the last 12 months. 8. Known prior Typhim Vi immunisation 9. Known immuno-compromised, due to immunosuppressive medication or other well-defined immunodeficiency such as HIV. 10. Chromosomal abnormalities and recognised associated clinical symptoms 11. They have had typhoid previously or are a known chronic carrier.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: The secondary question that will be answered is whether a response to the Typhim Vi vaccine correlates with the response to the currently used vaccine, Pneumovax a pneumococcal polysaccharide vaccination is the currently used polysaccharide vaccine;Primary end point(s): Comparison of the proportion of patients responding to pure polysacharide vaccination either by pneumocovax or by Salmonella typhim Vi where a positive response is defined as 3 fold or greater increase in specific antibody titre.;Main Objective: The study results will allow an informed assessment of the usefulness of the Typhim Vi vaccine against Salmonella typhoid to assess the lack of antibodies to pure bacterial polysaccharide antigens in patients who are antibody deficient. The current vaccine ( pneumovax, Sanofi Pasteur) is likely to be withdrawn from use in the near future, so it is important that a potential replacement polysaccharide vaccine has been examined should this ocurr.