Safety, Tolerability and Efficacy Study of Pneumococcal Vaccine
Research type
Research Study
Full title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of GEN-004, a Pneumococcal Protein Subunit Vaccine, on Colonization Following Intranasal Challenge with S. pneumoniae
IRAS ID
156622
Contact name
Neil French
Contact email
Sponsor organisation
Genocea Biosciences, Inc.
Eudract number
2014-000944-13
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
Clinical Trials.gov Identifier (NCT number):, NCT02116998; ,
Research summary
We are interested in developing new and better ways to protect the body against a bug, or bacterium, called Streptococcus pneumoniae (also known as pneumococcus). In most people pneumococcus can occasionally be found harmlessly inhabiting the nose where it does not cause any problem (pneumococcal carriage).
Pneumococcus is the leading cause of both respiratory tract and invasive infections among young children worldwide. Mortality caused by invasive disease is substantial worldwide while respiratory tract infection, and otitis media in particular, is the most common reason for the use of antibiotic therapy in young children in the developed world.
The vaccine being tested, GEN-004, is designed to provide protection against pneumococcus and to prevent infections caused by all strains of pneumococcus, which is unlike other currently available vaccines that do not protect against all strains.
Therefore, the purpose of this 15 month study is to assess the safety, tolerability and effectiveness of GEN-004 in combination with Aluminium Hydroxide (a substance that is designed to stimulate the immune system) following inoculation in the nostril with Streptococcus pneumoniae Serotype 6.
Healthy non-smoking volunteers, who meet the study inclusion/exclusion criteria are recruited, then randomised to receive either GEN-004 vaccine with aluminium hydroxide adjuvant OR placebo (salt water).
Subjects will then receive study drug or placebo for 3 doses 28 days apart. 1 week after the last dose all subjects will be inoculated with live bacteria (S. Pneumoniae). This model will be used to help understand the safety and efficacy of the vaccine following colonisation. It will also help understand better immune response to the vaccine.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
14/NW/0355
Date of REC Opinion
30 Jul 2014
REC opinion
Further Information Favourable Opinion