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| Towards an inhaled vaccine against pneumonia - trial of inhaled low-dose interleukin-12 as an immune potentiator to enhance natural responses against pneumococci colonising the nasopharynx |
| Source of record | UK Trials |
| ISRCTN | ISRCTN82733574 |
| Date ISRCTN assigned | 04/03/2008 |
| Local reference number(s) | BAL0801 |
| Public title | Towards an inhaled vaccine against pneumonia - trial of inhaled low-dose interleukin-12 as an immune potentiator to enhance natural responses against pneumococci colonising the nasopharynx |
| Scientific title | Interleukin-12 as an adjuvant for mucosal vaccination against pneumococcal disease |
| Acronym | Mucosal IL-12 Pneumovac |
| Disease/condition/study domain | Pneumococcal carriage, otitis media, pneumonia and invasive pneumococcal disease |
| 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? |
| Design/methodology | 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 |
| Research ethics review | 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 |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Aged over 18, either sex 2. Healthy volunteers 3. Normal lung function 4. Non-smokers |
| Participants - exclusion criteria | 1. Asthma 2. Any pre-existing chronic illness 3. Current ill-health 4. Pregnancy 5. Recent ex-smokers |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Anticipated start date | 01/10/2008 |
| Anticipated end date | 30/09/2011 |
| Status of trial | Ongoing |
| Target number of participants | 100 |
| Interventions | 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 |
| Primary outcome measure(s) | 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 measure(s) | 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 |
| Sources of funding | 1. The Wellcome Trust (UK) - funding applied for but pending 2. National Institute of Health Research (NIHR) Biomedical Research Centre Royal Liverpool University Hospital (UK) - partial funding obtained |
| Sponsor name | Liverpool School of Tropical Medicine (UK) |
| Sponsor details | Liverpool School of Tropical Medicine Pembroke Place Liverpool United Kingdom L3 5QA |
| Sponsor telephone | +44 (0)151 705 3212 |
| Sponsor fax | +44 (0)151 705 3370 |
| Sponsor email | s.roberts@liverpool.ac.uk |
| Sponsor website | http://www.liv.ac.uk/lstm/ |
| Contact name | Dr Stephen Gordon |
| Contact details | Liverpool School of Tropical Medicine Pembroke Place Liverpool United Kingdom L3 5QA |
| Contact telephone | +44 (0)151 705 3169 |
| Contact fax | +44 (0)151 705 3370 |
| Contact email | sbgordon@liverpool.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN82733574 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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