US-based Genocea Biosciences has started the Phase IIa clinical trial of its universal vaccine candidate GEN-004 for treating Streptococcus pneumonia (pneumococcus).
The trial is designed to evaluate the effect of dosing with GEN-004 on the frequency, magnitude and duration of colonization by pneumococcus in the nasopharynx of healthy adults.
Around 90 healthy adult subjects from one site in the UK will be enrolled in the trial who will be then placed randomly for GEN-004 or placebo.
Genocea chief medical officer Seth Hetherington said: "Following the positive Phase 1 data results, which we announced in June, this Phase 2a human challenge study is an important step towards demonstrating proof of concept for GEN-004.
"The objective of this study is to demonstrate that GEN-004 can prevent or reduce colonization of the nasopharynx, the first and necessary precursor to establishment of infection."
Following completion of the third dose of GEN-004 or placebo, all subjects will be challenged with pneumococcus.
Genocea president and chief executive officer Chip Clark said: "Available pneumococcal vaccines protect by inducing B cell, or antibody, immune responses directed towards a minority of the more than 90 known serotypes of pneumococcus.
"Furthermore, serotypes not included in the available vaccines are increasingly responsible for causing pneumococcal disease."
The company intends to report interim results from the Phase IIa trial in the middle of 2015.
GEN-004 is a potential universal pneumococcal vaccine designed based on insights from the company’s ATLAS platform. The product contains three conserved pneumococcal protein antigens, SP0148, SP1912, and SP2108, shown by ATLAS to be associated with protective TH17 T cell responses against pneumococcus in humans.
Image: Streptococcus pneumoniae in spinal fluid. Photo: courtesy of BlueMonday.