iiCON-Supported Phase II Trial Aims to Combat Pneumococcal Disease with Novel Vaccine
Key Insights
A new £3.2 million Medical Research Council-funded trial, managed by iiCON (search), will advance the development of a novel vaccine against pneumococcal disease (search), addressing antibiotic resistance (search) and global health concerns.
The phase II study will assess ImmBio (search)'s PnuBioVax, a protein-based vaccine, in a controlled human infection model (CHIM) trial in Malawi, comparing its efficacy against PCV13 and a placebo in preventing SPN3 carriage.
The trial seeks to prevent transmission of serotype 3 pneumococcus (SPN3), which has become a dominant strain with high antimicrobial resistance, particularly impacting children and immunocompromised individuals in low- and middle-income countries.
A new Phase II trial, supported by the Infection Innovation Consortium (iiCON (search)), is set to evaluate a novel vaccine against pneumococcal disease (search). The £3.2 million trial, funded by the Medical Research Council, aims to address the rising concerns of antibiotic resistance (search) and the global burden of pneumococcal infections.
Pneumococcal disease (search) remains a significant global health challenge, particularly in low- and middle-income countries (LMICs), where it is a leading preventable cause of child mortality. Despite the availability of effective vaccines like PCV13, certain serotypes, such as serotype 3 pneumococcus (SPN3), have shown limited reduction in incidence and have become dominant strains in many regions.
Addressing SPN3 Dominance
SPN3 is now a common cause of severe pneumonia (search) in children in Europe and is increasingly concerning due to its high prevalence of antimicrobial resistance. In Malawi, SPN3 is the most common pneumococcal strain carried in the community since the introduction of PCV13. Preventing its transmission is therefore a critical priority.
The trial will assess ImmBio (search)'s PnuBioVax, a protein-based pneumococcal vaccine designed to prevent SPN3 transmission. The vaccine will be administered to individuals at high risk of disease and those likely to transmit the infection, such as children and immunocompromised adults, particularly those with HIV (search). Preventing carriage in these populations is expected to reduce the emergence of antimicrobial resistance in pneumococcal isolates.
Trial Design and Methodology
The Phase II study will recruit healthy young 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 carriage of the bacteria. The results will be compared to those of the existing PCV13 vaccine and a placebo. The CHIM trials for pneumococcal disease (search) are well-established at the Liverpool School of Tropical Medicine. This trial will build on the current £4.5 million MARVELS (Malawi Accelerated Research in Vaccines by Experimental and Laboratory Systems) programme at the Malawi Liverpool Wellcome Programme in Malawi.
Professor Stephen Gordon, Director of Experimental Medicine at iiCON (search), 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."
Potential for Local Manufacturing and Distribution
Following the trial, the low-cost vaccine may be manufactured and distributed in Africa, potentially boosting the local economy and ensuring access to communities in need. Graham Clarke, ImmBio (search) Chairman, added, "ImmBio is delighted to be working with iiCON (search) on this project, combining ImmBio’s innovative approach to vaccines with iiCON’s unique ability to progress it with novel clinical studies."