None listed
Conditions
Brief summary
Asthma is a high impact, chronic inflammatory airway disease where modulation holds the promise of long term clinical benefits. Different types of cells have been involved in asthma such as eosinophils, neutrophils and a mixture of both eosinophils and neutrophils. The main purpose of this study is to see if treatment with conjugated pneumococcal vaccine (Prevenar 13) will help people with eosinophilic asthma. It is hypothesised that Prevenar 13 will attenuate eosinophilic airway inflammation and improve health status.
Interventions
Prevenar 13 (Active ingredients: 30.8 mg pneumococcal purified capsular polysaccharides and 32 mg CRM197 protein)
0.5ml to be administered by intramuscular injection
given in 2 doses at monthly intervals
Parallel group to receive Pneumovax 23 (Pneumococcal vaccine polyvalent). It contains a mixture of purified capsular polysaccharides from the 23 most prevalent or invasive pneumococcal types of Streptococcus pneumoniae.
Each 0.5 ml dose of vaccine contains 25 mcg of each polysaccharide type d
Prevenar 13 (Active ingredients: 30.8 mg pneumococcal purified capsular polysaccharides and 32 mg CRM197 protein) 0.5ml to be administered by intramuscular injection given in 2 doses at monthly intervals Parallel group to receive Pneumovax 23 (Pneumococcal vaccine polyvalent). It contains a mixture of purified capsular polysaccharides from the 23 most prevalent or invasive pneumococcal types of Streptococcus pneumoniae. Each 0.5 ml dose of vaccine contains 25 mcg of each polysaccharide type dissolved in isotonic saline solution containing 0.25% phenol as preservative. 0.5ml to be administered by intramuscular injection 1 dose given, followed by 1 dose of saline 4 weeks later
Sponsors
Hunter Medical Research Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Symptomatic stable asthma [ACQ(6) > 0.75], confirmed variable airflow obstruction, maintenance therapy
Exclusion criteria
Forced expiratory volume in 1 second (FEV1) < 40% predicted.. Received pneumococcal vaccination with Pneumovax in the past 12 months, or Prevenar ever. Current smoking (or having quit within 6 months of study entry). Cold or respiratory tract infection within 4 weeks of study entry. Pregnancy, breast feeding, possibility of becoming pregnant (unwilling to use contraception during the treatment phase). Inability to attend study visits. Participation in another investigative drug study within 4 weeks of study entry.
Outcome results
None listed