Contact information
Type
Scientific
Primary contact
Dr Paul Kelly
ORCID ID
Contact details
Institute of Cell and Molecular Science
Barts & The London School of Medicine
London
E1 2AD
United Kingdom
+44 (0)20 7882 2643
m.p.kelly@qmul.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
067948; Well07
Study information
Scientific title
Oral vaccination: effects on non-specific host defence in the intestine and the interaction with micronutrients
Acronym
OVN
Study hypothesis
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
University of Zambia School of Medicine Research Ethics Committee gave approval on the 3rd December 2007
Study design
Two phase study: initial observational study followed by randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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 names
Rotarix®, Vivotif®
Primary outcome measures
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 trial start date
01/01/2008
Overall trial end date
31/10/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Residence in ongoing cohort study area in Misisi township, Lusaka
2. Aged greater than 18 years, either sex
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
150
Participant 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
Recruitment start date
01/01/2008
Recruitment end date
31/10/2009
Locations
Countries of recruitment
Zambia
Trial participating centre
Institute of Cell and Molecular Science
London
E1 2AD
United Kingdom
Sponsor information
Organisation
Queen Mary University of London (UK)
Sponsor details
Research and Development Office
24 - 26 Walden Street
London
E1 2AN
United Kingdom
+44 (0)20 7882 7273
g.collins@qmul.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
The Wellcome Trust (UK) (grant ref: 067948)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary