iiCON-Supported Phase II Trial to Advance Novel Pneumococcal Vaccine, PnuBioVax
Key Insights
A new £3.2 million Medical Research Council-funded trial will advance the development of PnuBioVax, a novel vaccine against pneumococcal disease (search).
The phase II study will assess PnuBioVax's ability to prevent pneumococcal carriage in healthy adults via a controlled human infection model (CHIM) trial in Malawi.
PnuBioVax, developed by ImmBio (search), targets serotype 3 pneumococcus (search) (SPN3), a dominant strain with increasing antimicrobial resistance, especially in low- and middle-income countries.
The Infection Innovation Consortium (iiCON) is managing a new £3.2 million Medical Research Council-funded trial to advance the development of PnuBioVax, a novel vaccine against pneumococcal disease (search). This disease exhibits high rates of antibiotic resistance and remains a major global health concern.
Addressing Pneumococcal Disease with PnuBioVax
Pneumococcal disease (search) poses a substantial global economic burden and is the biggest preventable killer of children worldwide, particularly in low- and middle-income countries (LMICs). Despite the availability of effective vaccines against common serotypes in developed countries, serotype 3 pneumococcus (search) (SPN3) remains a significant challenge. Incidence of SPN3 has shown limited changes despite a decade of PCV13 immunization programs, making it the dominant strain in many regions. SPN3 is now the most common cause of severe pneumonia in children in Europe and is of increasing concern due to the high prevalence of antimicrobial resistance.
Novel Protein-Based Vaccine Approach
The proposed solution involves a protein-based pneumococcal vaccine designed to prevent SPN3 transmission. This vaccine would be administered to individuals at high risk of disease and those likely to transmit the infection, such as children and adults with immunocompromise, particularly those with HIV (search). Preventing carriage in these populations is expected to reduce the emergence of antimicrobial resistance in pneumococcal isolates.
Phase II Trial Details
iiCON is collaborating with ImmBio (search), the vaccine's developer, which has already completed successful phase I safety and immunogenicity studies. The phase II study will recruit young, healthy adults for a controlled human infection model (CHIM) trial in Malawi. Participants will be vaccinated and then inoculated in their nose to assess whether they establish bacterial carriage. This will be compared to the existing PCV13 vaccine and a placebo. CHIM trials for pneumococcal disease (search) have been well established at the Liverpool School of Tropical Medicine for many years, building on the existing £4.5 million MARVELS (Malawi Accelerated Research in Vaccines by Experimental and Laboratory Systems) program at the Malawi Liverpool Wellcome Programme in Malawi.
Expert Perspectives
Professor Stephen Gordon, director of experimental medicine at iiCON, stated, "iiCON is delighted to receive this funding from the MRC in order to tackle this urgent health priority/public health issue in Malawi... In the development of the vaccine we hope to cover multiple serotypes at low cost and effectively block community transmission."
Graham Clarke, ImmBio (search) chairman, added, "ImmBio is delighted to be working with iiCON on this project, combining ImmBio's innovative approach to vaccines with the iiCON's unique ability to progress it with novel clinical studies... [This] needs a clinical pathway acceptable to regulatory authorities, to successfully address major unmet healthcare needs."
Following the trial, the low-cost vaccine may offer potential for local manufacturing and distribution in Africa.