Mucosal immunology and nutrition Nutritional, Metabolic, Endocrine Nutrition
Conditions
Interventions
Phase 1a: Rotarix® oral rotavirus vaccine - 1 dose
Phase 1b: Vivotif® oral typhoid vaccine - 1, 2, or 3 doses at intervals of 48 hours
Phase 2: the vaccine chosen and the number of doses will depend
Sponsors
Queen Mary University of London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Residence in ongoing cohort study area in Misisi township, Lusaka 2. Aged greater than 18 years, either sex
Exclusion criteria
Exclusion criteria: 1. Helminth infection 2. Pregnancy 3. Breastfeeding 4. Aged greater than 65 years 5. Diarrhoea within one month prior to recruitment 6. Medication with antibiotics or non-steroidal anti-inflammatory drugs (NSAIDs) within one month prior to recruitment 7. Any vaccination within 6 months prior to recruitment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expression of antimicrobial peptides and cytokines in micronutrient recipients compared to placebo. Enteroscopy will be carried out on day 0 (the day of immunisation), which will be after the participant has been receiving the micronutrient supplement or placebo for 2 months) and then again at one specific time point after that (undecided as of 25/02/2009). The purpose of enteroscopy is to obtain seven biopsies from the jejunum which will be processed for analysis of messenger ribonucleic acid (mRNA), antimicrobial peptides and cytokines by real time polymerase chain reaction (RT-PCR). | — |
Secondary
| Measure | Time frame |
|---|---|
| Response of peripheral blood mononuclear cells to vaccine antigens in vitro in micronutrient recipients compared to placebo. Blood will be collected on the same day as the the enteroscopy and peripheral blood mononuclear cells (PBMCs) prepared by Ficoll centrifugation. An assay of mRNA will be by RT-PCR. | — |
Countries
Zambia
Outcome results
None listed