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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN82733574

Enrollment

100

Registered

2008-03-04

Start date

2008-10-01

Completion date

Unknown

Last updated

2017-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumococcal carriage, otitis media, pneumonia and invasive pneumococcal disease Respiratory Pneumococcal disease

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. Al

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026