Condition category
Nutritional, Metabolic, Endocrine
Date applied
24/02/2009
Date assigned
25/02/2009
Last edited
25/02/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.qmul.ac.uk

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

Publication citations

Additional files

Editorial Notes