Nutrition effects on oral vaccination
| ISRCTN | ISRCTN68751738 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68751738 |
| Secondary identifying numbers | 067948; Well07 |
- Submission date
- 24/02/2009
- Registration date
- 25/02/2009
- Last edited
- 25/02/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Paul Kelly
Scientific
Scientific
Institute of Cell and Molecular Science
Barts & The London School of Medicine
London
E1 2AD
United Kingdom
| Phone | +44 (0)20 7882 2643 |
|---|---|
| m.p.kelly@qmul.ac.uk |
Study information
| Study design | Two phase study: initial observational study followed by randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Oral vaccination: effects on non-specific host defence in the intestine and the interaction with micronutrients |
| Study acronym | OVN |
| Study objectives | That live, attenuated oral vaccines up-regulate innate immune responses in the intestine, which would be expected to give non-specific protection against other diarrhoea pathogens, and that micronutrients can enhance the innate immune response to oral vaccines. |
| Ethics approval(s) | University of Zambia School of Medicine Research Ethics Committee gave approval on the 3rd December 2007 |
| Health condition(s) or problem(s) studied | Mucosal immunology and nutrition |
| Intervention | 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 on results of phase 2b which are not yet fully analysed. The dose of the micronutrient supplement used (the randomised element) will be 2 tablets of Immunace® (which includes 23 micronutrients) daily, or placebo, for 2 months. Immunace is made by Vitabiotics Plc. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Rotarix®, Vivotif® |
| Primary outcome measure | 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 outcome measures | 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. |
| Overall study start date | 01/01/2008 |
| Completion date | 31/10/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 150 |
| Key inclusion criteria | 1. Residence in ongoing cohort study area in Misisi township, Lusaka 2. Aged greater than 18 years, either sex |
| Key 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 |
| Date of first enrolment | 01/01/2008 |
| Date of final enrolment | 31/10/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
- Zambia
Study participating centre
Institute of Cell and Molecular Science
London
E1 2AD
United Kingdom
E1 2AD
United Kingdom
Sponsor information
Queen Mary University of London (UK)
University/education
University/education
Research and Development Office
24 - 26 Walden Street
London
E1 2AN
England
United Kingdom
| Phone | +44 (0)20 7882 7273 |
|---|---|
| g.collins@qmul.ac.uk | |
| Website | http://www.qmul.ac.uk |
"ROR" |
https://ror.org/026zzn846 |
Funders
Funder type
Charity
The Wellcome Trust (UK) (grant ref: 067948)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
