A new vaccine against pneumococcal lung infections can safely be used in humans and is able to trigger an effective immune reaction, according to the company ImmunoBiology.
Marking the first time for the vaccine PnuBioVax to be tested in humans, the company presented the results of the phase 1 clinical trial at the 10th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD) in Glasgow, U.K.
“The results of this study have demonstrated the safety of PnuBioVax in adults, and we are now looking at developing the vaccine further, focusing on the at-risk populations for pneumococcal disease of the young and the elderly” said ImmunoBiology‘s Development Director Dr. Chris Bailey, in a press release.
The study enrolled 36 healthy adult male and female volunteers. Participants were divided into four groups; three groups received three different doses of the vaccine (50, 200, and 500 µg) and the last group received a placebo. All were administered three times, 28 days apart.
Neither the clinician nor the participants knew who recieved what.
- The vaccine is safe and well tolerated. No serious adverse effects were seen, and no clinically significant changes in vital signs, electrocardiography (ECG) and blood chemistries were observed.
- The vaccine is able to trigger and immune response. An increase in the total antibody response was seen in people who were given the higher doses of 200 and 500 µg of the vaccine. This increase was statistically significant when compared to the placebo group.
- The vaccine may offer protection against different strains of pneumococcal bacteria. The vaccine was able to trigger the production of different antibodies against specific relevant antigens.
- The best dose to use is 200 µg. There was a relationship with the dose of the vaccine and the immune response, and there were no clear advantages of using the higher dose of 500 µg.
According to Graham Clarke, CEO of ImmunoBiology, the company is now looking for partners to progress PnuBioVax through late stage clinical development, manufacturing and marketing.
Pneumococcal lung infections are caused by a bacteria called Streptococcus pneumoniae. The bacteria can live in the nose and throat of many people without causing disease. However, it can sometimes spread to other areas of the body causing serious illness such as lung infections, acute sinusitis, middle ear infections, meningitis, sepsis, and infections of the heart. People with weak immune systems, including infants and the elderly, are particularly at risk and could benefit from the vaccine.