The sponsor had developed a new vaccine to help develop a new and better way to protect the body against a bacterium, called Streptococcus pneumonia. This vaccine is designed to prevent disease caused by all strains of pneumococcus, which is unlike other currently available vaccines that do not protect against all strains. This vaccine has been tested for safety using healthy volunteers. The purpose of this study was to assess the effectiveness of the study drug in combination with Aluminium Hydroxide (a substance that is designed to stimulate the immune system) in providing protection against carriage of pneumococcal bacteria in the nose. This is tested by vaccinating healthy volunteers followed by an inoculation in the nostril with S. pneumonia serotype 6.
The primary challenges of this study were:
- Recruiting a large cohort of healthy volunteers into a study with tight inclusion/exclusion criteria and a long follow up of 13 months
- The participants had to have 3 vaccinations, inoculation with S. pneumonia serotype 6, 4 nasal washes and 3 sets of PBMCs
- There was very little flexibility in the 11 outpatient visits dates and times therefore the participants had to commit to these right from the beginning
Participants were recruited primarily from the local Universities through information received at fresher’s fairs or directly contacting the research unit after seeing adverts and posters. Once they had received the patient information sheet and were interested in the study, they would be invited to the unit for a PowerPoint presentation containing study information presented by a member of the study team. If they were interested they could review study dates for each available cohort before committing. This additional pre-screen information session was added to ensure participants knew exactly what their commitment would be to ensure they understood the full facts before committing to a screening appointment.
Over 150 participants were screened with the required number being randomised a month ahead of schedule.
Only one participant was lost to follow up, but there were sufficient numbers of participants to complete all the defined time points for vaccination, inoculation and sampling.
All of the participants who completed the defined timepoints have now completed the study.
The research unit coordinated the research study effectively with all outcomes met and no participants have been lost to follow up ensuring high quality patient safety and complete datasets. The participants on the trial enjoyed their research experience with many interested in taking part in future research studies.