iiCON Backs Phase II Trial Of Next-Gen Pneumococcal Vaccine, PnuBioVax

The Infection Innovation Consortium (iiCON) is leading a £3.2 million Medical Research Council-funded trial to advance the development of a new vaccine for pneumococcal disease. This disease, known for its high antibiotic resistance, is a major health threat worldwide. Pneumococcal disease places a significant economic and health burden globally, particularly in low- and middle-income countries (LMICs). It remains the leading preventable cause of death in children, despite existing vaccines targeting common invasive strains in developed nations.

One strain, Serotype 3 pneumococcus (SPN3), poses a unique challenge. Immunization programs using PCV13 have shown limited impact on SPN3 incidence over the past decade, making it the dominant strain in many regions. In Europe, SPN3 is now the leading cause of severe pneumonia in children and is concerning due to its high levels of antimicrobial resistance. In Malawi, SPN3 has become the most prevalent pneumococcal strain in communities since the introduction of PCV13, highlighting the urgent need for solutions to prevent its spread and associated diseases. This trial aims to address these critical gaps by advancing a vaccine targeting this persistent and resistant strain.

To tackle the challenges posed by Serotype 3 pneumococcus (SPN3), a protein-based pneumococcal vaccine is being developed to prevent its transmission. This vaccine will target people at risk of the disease and those likely to spread the infection, such as children and immunocompromised adults, especially those living with HIV. These groups are also frequently exposed to antibiotics, so reducing SPN3 carriage among them can help curb antimicrobial resistance.

iiCON is collaborating with ImmBio, a small vaccine company behind PnuBioVax. ImmBio has already completed successful Phase I safety and immunogenicity studies for the vaccine. The next step is a Phase II trial, which will take place in Malawi, using a controlled human infection model (CHIM). The trial will recruit healthy young adults who will be vaccinated and later exposed to the bacteria via their nose to see if they establish bacterial carriage. Results will be compared to those from the existing PCV13 vaccine and a placebo.

CHIM trials for pneumococcal disease have been a core focus at the Liverpool School of Tropical Medicine, and this trial builds on the £4.5 million MARVELS program (Malawi Accelerated Research in Vaccines by Experimental and Laboratory Systems) at the Malawi Liverpool Wellcome Programme. MARVELS is advancing CHIM studies for pneumococcus, salmonella, and TB, with pneumococcal research as its flagship project. If successful, this affordable vaccine could be manufactured and distributed within Africa, offering a promising solution to reduce the impact of pneumococcal disease and antimicrobial resistance.

Professor Stephen Gordon, Director of Experimental Medicine at iiCON, mentioned, “iiCON is delighted to receive this funding from the MRC in order to tackle this urgent health priority/public health issue in Malawi. Not only will it save lives, it will help to upskill and boost the local economy as we very much hope that the vaccine will eventually be manufactured and distributed locally. This way, we can ensure the communities that really need this vaccine will be receiving it.  In the development of the vaccine we hope to cover multiple serotypes at low cost and effectively block community transmission.”

Graham Clarke, ImmBio Chairman, said in a statement,“ImmBio is delighted to be working with iiCON on this project, combining ImmBio’s innovative approach to vaccines with iiCON’s unique ability to progress it with novel clinical studies.  Multi-protein based vaccines have the potential to address pathogen diversity but like all new vaccines, needs a clinical pathway acceptable to regulatory authorities, to successfully address major unmet healthcare needs.”