Early Trial Shows Pneumonia Vaccine Safety, Immune Response

Pneumococcus colony (NIST.gov)

23 June 2014. An early-stage clinical trial testing a vaccine by Genocea Biosciences Inc. to prevent pneumonia and related bacterial diseases shows the vaccine caused no serious side effects and induced more immune system cells to prevent these infections. The Cambridge, Massachusetts biotechnology company says it plans to present the findings at a medical conference later this year.

Genocea Biosciences develops vaccines and therapies that harness the power of T cells, white blood cells that directly or indirectly attack specific invading pathogens. The company’s technology platform, called Atlas, is based on research by immunologist Darren Higgins at University of California in Berkeley and Harvard Medical School. The technology starts with high-throughput screening to identify a small number of key targets, then developing antigens corresponding to those targets to stimulate the appropriate T cells for preventing or treating the infection.

The clinical trial is an early-stage study of Genocea’s experimental vaccine code-named GEN-004 to prevent infections caused by Streptococcus pneumoniae, or pneumococcus bacteria. Pneumococcus bacteria are responsible for pneumonia, when the infection inhabits the lungs, and infections of the ears and sinus, as well as life-threatening meningitis and sepsis infections.

GEN-004 acts by preventing pneumococcus bacteria from colonizing the nose and throat region, where the bacteria like to congregate. The company says its Atlas technology identified three key targets associated with a type of T cell, called TH17, that protects against pneumococcus bacteria. GEN-004 was designed to stimulate a response from TH17 cells that prevents invading pneumococcus bacteria from colonizing in the nose and throat.

The clinical trial tested GEN-004 at three dosage levels and with aluminum hydroxide boosters against a placebo among 90 healthy volunteers. The trial looked primarily at the safety and tolerability of GEN-004, but also tracked TH17 levels among the participants over a one-year period. The company says GEN-004 created measurable increases in TH17 levels among participants taking the highest doses (100 micrograms) with the booster, and reported no serious adverse results with the vaccine.

Based on the findings, Genocea is planning an intermediate-stage trial of GEN-004 testing the combination of vaccine and booster against a placebo.

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