UK-based biopharmaceutical company ImmunoBiology (ImmBio) has reported positive results from its first-in-human study of PnuBioVax vaccine against bacterial pathogen Streptococcus pneumoniae (NCT02572635).
PnuBioVax is a vaccine based on ImmBioVax technology that treats pneumococcal disease.
ImmBio’s new trial is a randomised, double blind study designed to determine the safety and immunogenicity of PnuBioVax when administered in three dosages as 50µg, 200µg and 500µg compared to placebo.
The study enrolled 36 healthy males and females aged between 18 to 40 and were treated with PnuBioVax intramuscularly on three occasions with an interval of 28 days.
ImmBio CEO Graham Clarke said: "Demonstrating that PnuBioVax is safe and immunogenic through this phase I clinical study is a fundamental step in our mission to create a universal vaccine against pneumococcal disease.
"This provides the real prospect of a strain-independent, pneumococcal disease prophylactic vaccine.
"We are now looking for partners to progress PnuBioVax through late stage clinical development, manufacturing and marketing."
Blood samples of the volunteers were tested to measure antibody responses to PnuBioVax assessed by enzyme-linked immunosorbent assay (ELISA).
The activity of specific antibodies against antigens was also assessed using an opsonophagocytic assay, which indicates an antibody’s ability to kill the pathogen and therefore protect against disease.
PnuBioVax was found to be safe and well tolerated by the volunteers, and was able in triggering antibody responses against key S. pneumoniae antigens broadly conserved across strains.
Image: Streptococcus pneumonia present in spinal fluid. Photo: courtesy of Dr. M.S. Mitchell via Wikipedia.