PCV and EHPC Study
Research type
Research Study
Full title
FULL TITLE: Pneumococcal Conjugate Vaccine (PCV-13) and Experimental Human Pneumococcal Carriage Study (EHPC) Study. KEY WORDS: mucosa, innate, cellular, humoral, Streptococcus pneumoniae, pneumococcus, carriage, colonisation, human, lung, antibody, vaccine, T-cells, genome sequencing, conjugate vaccine, protection.
IRAS ID
114074
Contact name
Stephen Gordon
Contact email
Eudract number
2012-005141-20
Research summary
The purpose of our study is to refine a research model for vaccine effect testing. In our previous studies, we demonstrated that nasal pneumococcal carriage could be reproducibly achieved in healthy adult volunteers without adverse events. The dose-response curve allowed prediction of a 30-60% endpoint enabling combined testing for benefit and harm for our future vaccine studies. Healthy non-smoking volunteers, who meet the study inclusion / exclusion criteria are recruited, then randomised to receive either protein-conjugated pneumococcal polysaccharide-13 (referred to as PCV) or Hepatitis A (Avaxim) vaccination. This vaccine has been chosen due to its safety profile, preparation (contains alum as does PCV - which may be immunogenic), lack of effect on nasal colonisation/immunity and health benefit for those involved in the study if the volunteer travels to endemic areas in the future. Natural carriage volunteers (screened by nasal wash) will continue in the study. We expect 10-15% to be natural pneumococcal carriers. 5-12 weeks after vaccination (to which both the volunteer and study team are blinded) the volunteers will be inoculated with 0.1ml of a well-characterised penicillin-sensitive pneumococcus (serotype 6B) to each nostril at 80,000 cfu/nostril. The volunteers will be observed for the development of pneumococcal carriage through urine, saliva, blood and nasal wash samples. Volunteers will be offered bronchoscopy and bronchoalveolar lavage (BAL) to determine lower airway mucosal responses potentially protective against pneumonia. This model will be used to understand the impact of PCV on pneumococcal carriage in healthy adult humans. Volunteer samples pre and post vaccination, and comparison of the immune response of colonised versus non-colonised subjects and the PCV vaccinated and alternate vaccinated subjects will provide new information on the innate, cellular and immune response to PCV vaccination and pneumococcal colonisation. In the future this model will be used in testing the effects of new candidate vaccines.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
12/NW/0873
Date of REC Opinion
15 Jan 2013
REC opinion
Further Information Favourable Opinion