Condition category
Respiratory
Date applied
16/01/2008
Date assigned
04/03/2008
Last edited
21/07/2014
Prospective/Retrospective
Prospectively 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 Stephen Gordon

ORCID ID

Contact details

Liverpool School of Tropical Medicine
Pembroke Place
Liverpool
L3 5QA
United Kingdom
+44 (0)151 705 3169
Stephen.Gordon@lstmed.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

BAL0801

Study information

Scientific title

Interleukin-12 as an adjuvant for mucosal vaccination against pneumococcal disease

Acronym

Mucosal IL-12 Pneumovac

Study hypothesis

1. Is IL-12 a safe and potentially effective adjuvant for human mucosal vaccination?
2. Will the adjuvant effect of IL-12 on mucosal defence against pneumococcus seen in animal models also be observed in studies with human experimental pneumococcal carriage?

Please note that as of 24/06/2008 more details on the pending sources of funding have been added to this record (i.e., duration of funding and date of result for Wellcome Trust funding). They can be seen below in the sources of funding section.

Ethics approval

Ethics approval pending as of 16/01/2008:
1. The Central Office for Research Ethics Committees (National Research Ethics Service, NHS, UK)
2. Liverpool School of Tropical Medicine Research Ethics Committee

Study design

SA1: Observational study lung effects subcut IL-12
SA2: Bayesian dual endpoint phase 1 dosing trial
SA3: Open label RCT of inhaled IL-12 vs placebo and experimental pneumococcal carriage

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Pneumococcal carriage, otitis media, pneumonia and invasive pneumococcal disease

Intervention

Specific aim 1 (SA1):
100 ng/kg subcutaneous IL-12 all participants (no control arm). IL-12 has been extensively phase 1 and 2 tested by this route and this is selected as a minimally toxic dose. All participants have bronchoscopy before and after to determine the pulmonary effect of subcutaneous IL-12 by paired comparison. The pulmonary measurements are the novel bit so SA1 is just an observational study of low-dose IL-12.

Specific aim 2 (SA2):
Starts at inhaled 0.25 ng/kg and proceeds in doubling measures to 2.5 ng/kg inhaled IL-12. The dual endpoints of toxicity (grade 1 symptoms only in 50% subjects) and efficacy (defined as equalling the pulmonary effect of 100 ng/kg IL-12 subcut from SA1) will be combined using a Bayesian dual endpoint trial design to obtain an optimal dose.

Specific aim 3 (SA3 - the intervention study):
Open label randomised controlled trial (RCT) comparing a single dose of inhaled IL-12 (dose defined in SA2) versus placebo. Endpoint is the effect on experimentally induced pneumococcal carriage.

Joint sponsor with Liverpool School of Tropical Medicine is:
Royal Liverpool University Hospital (UK)
Dr Ros Kelly
Acting R&D Manager
Royal Liverpool University Hospital and Broad Green Hospitals NHS Trust
Prescot Street
Liverpool L7 8XP
United Kingdom
Email: Rosalind.Kelly@rlbuht.nhs.uk

Intervention type

Drug

Phase

Not Applicable

Drug names

Interleukin-12 (IL-12)

Primary outcome measures

Specific Aim 1: Pulmonary markers of adjuvant activity following subcutaneous IL-12 (determination of efficacy endpoint for Specific Aim 2)
Specific Aim 2: Optimal mucosal dose of IL-12 (using dual endpoint [efficacy and toxicity] phase 1 design)
Specific Aim 3: Mucosal humoral and cellular responses to experimental pneumococcal carriage

Secondary outcome measures

1. Duration of pneumococcal carriage following IL-12 challenge
2. Effect of IL-12 and experimental pneumococcal carriage on susceptibility to repeat pneumococcal carriage challenge

Overall trial start date

01/10/2008

Overall trial end date

30/09/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged over 18, either sex
2. Healthy volunteers
3. Normal lung function
4. Non-smokers

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Asthma
2. Any pre-existing chronic illness
3. Current ill-health
4. Pregnancy
5. Recent ex-smokers

Recruitment start date

01/10/2008

Recruitment end date

30/09/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Liverpool School of Tropical Medicine
Liverpool
L3 5QA
United Kingdom

Sponsor information

Organisation

Liverpool School of Tropical Medicine (UK)

Sponsor details

Liverpool School of Tropical Medicine
Pembroke Place
Liverpool
L3 5QA
United Kingdom
+44 (0)151 705 3212
s.roberts@liverpool.ac.uk

Sponsor type

Hospital/treatment centre

Website

http://www.liv.ac.uk/lstm/

Funders

Funder type

Charity

Funder name

Wellcome Trust (UK) - funding applied for but pending, result due in mid July 2008

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Institute of Health Research (NIHR) Biomedical Research Centre Royal Liverpool University Hospital (UK) - partial funding obtained for staff costs for 3 years

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