Nutrition effects on oral vaccination
| ISRCTN | ISRCTN68751738 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68751738 |
| Protocol serial number | 067948; Well07 |
| Sponsor | Queen Mary University of London (UK) |
| Funder | The Wellcome Trust (UK) (grant ref: 067948) |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
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
| Primary study design | Interventional |
|---|---|
| Study design | Two phase study: initial observational study followed by randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Rotarix®, Vivotif® |
| Primary outcome measure(s) |
Expression of antimicrobial peptides and cytokines in micronutrient recipients compared to placebo. |
| Key secondary outcome measure(s) |
Response of peripheral blood mononuclear cells to vaccine antigens in vitro in micronutrient recipients compared to placebo. |
| Completion date | 31/10/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
- Zambia
Study participating centre
E1 2AD
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
