A phase 1 study to evaluate the safety and immunogenicity of PnuBioVax

• Research type

  Research Study

• Full title

  A randomised, placebo controlled, parallel group, double-blind, dose escalation, single centre trial to evaluate the safety and immunogenicity of PnuBioVax administered on three occasions 28 days apart at dose levels of 50 µg, 200 µg, and 500 µg in healthy adult subjects.

• IRAS ID

  187480

• Contact name

  Girish K Sharma

• Contact email

  Girish.Sharma@simbec.com

• Sponsor organisation

  ImmunoBiology Limited

• Eudract number

  2015-002986-51

• Duration of Study in the UK

  0 years, 4 months, 1 days

• Research summary

  Streptococcus pneumoniae is a type of bacteria that can cause infections of the ears, sinuses or lungs. It can also cause more serious infections of the blood or brain. The elderly and young children are more vulnerable to these types of infections. The vaccines available at present are effective only on a certain number of strains of the bacteria. The PnuBioVax vaccine is being developed to work on a broader range of strains. This study will be looking at the safety and tolerability of the study drug for three different dosages: 50 µg, 200 µg, and 500 µg.
  The study will involve 8 visits in total; screening period to determine eligibility, 3 treatment periods comprising of an overnight stay at the clinic (days 1, 29 and 57) and 4 outpatient follow up visits (7 days after each dosing period and one on day 85). Volunteers will also be requested to complete a diary card from day 1 to day 85.
  36 Volunteers will take part in this study and will be randomly assigned to each sequential dose group.

  •Group 1: 9 people will be given up to 3 doses of 50 µg PnuBioVax (study drug) and 3 people will be given up to 3 doses of a placebo
  •Group 2: 9 people will be given up to 3 doses of 200 µg PnuBioVax (study drug) and 3 people will be given up to 3 doses of a placebo
  •Group 3: 9 people will be given up to 3 doses of 500 µg PnuBioVax (study drug) and 3 people will be given up to 3 doses of a placebo

  The population eligible to take part in the study are healthy male and female subjects between 18 and 40 years of age.

• REC name

  Wales REC 2

• REC reference

  15/WA/0283

• Date of REC Opinion

  26 Aug 2015

• REC opinion

  Further Information Favourable Opinion