Nasal subunit vaccine

MUCOVACC: Mucosal Vaccines Against HIV: combined mucosal - systemic immunisation

The MUCOVACC consortium, funded by the Bill & Melinda Gates Foundation, will include nasal prime in the upcoming MUCOVACC2 trial based in York and St George's. See the cervico-vaginal vaccines page for more details.

MUVAPRED: Mucosal Vaccines Against Poverty Related Diseases

Mucosal immunology and mucosal vaccines are a key research interest in the Institute. Prof David Lewis was lead participant for the Institute's role as a clinical site for the evaluation and testing of novel vaccine strategies to deliver antigens via mucosal surfaces in the 5th Framework programme "MUCIMM".

Following the successful completion of 'MUCIMM' the Institute has again been selected as the sole clinical test site for Phase 1 vaccine trials of TB and HIV mucosal vaccines in the €15 million "MUVAPRED" integrated programme from 2004 - 2009. A total of €1.1 million is earmarked to the Institute to conduct up to 5 clinical trials . Prof David Lewis is sub-project coordinator for human studies, GMP and clinical trials within the MUVAPRED integrated programme. For further information contact Prof David Lewis or see the MUVAPRED website.

Press Release to mark International  AIDS Day, Dec 1st 2006:

On 26th September 2006, at the St George's Vaccine Institute, London, the first dose was given in a Phase 1 trial of a novel nasal vaccine against HIV. The trial is the first in a series of trials of novel mucosal vaccines against HIV funded by a European Union Commission grant to the "MUVAPRED" consortium. The vaccine uses a small part of the HIV virus 'envelope' (the outer protective shell of the virus) that has been carefully modified to enhance the protection it affords against HIV infection. Delivery via the nose is not only more convenient in that it avoids the use of needles, but also exploits the remarkable ability of nasal immunisation using appropriate "mucosal adjuvants" to provoke protective immune responses in the genital tract. While the genital tract is the key point of entry for HIV infection world-wide, conventional injected vaccines disappointingly do not provoke localised immune protection on the genital surface. This study uses a molecule called "LTK63" developed by Novartis Vaccines as a mucosal adjuvant to boost the immune response to the HIV components of the vaccine, and to direct the response to the genital tract. In total 30 subjects will be recruited to this study, which will for the first time determine the safety and immunogenicity of the vaccine in humans, and will compare responses to the HIV components with and without the LTK63 mucosal adjuvant. Fourteen subjects have already received two to three nasal doses of the vaccine, in a protocol that will see them receive three doses by the nasal route, followed by two doses injected intramuscularly. Pre-clinical studies have shown that this protocol results in antibodies against HIV appearing in genital tract secretions. The study is open to both men and women who will have responses to the vaccine measured in blood taken at various times after immunisation, to detect antibody and cellular immune responses against HIV. In addition, and unique to this study, women will have responses against HIV measured in samples obtained from the cervix and vagina using novel techniques developed at the St George's Vaccine Institute.

The study completed recruitment in 2007, and data management is underway.

Click here for the ClinicalTrials.gov entry

Publications

• Transient Facial Nerve Paralysis (Bell's Palsy) Following Intranasal Delivery of a Genetically Detoxified Mutant of Escherichia coli Heat Labile Toxin. DJM Lewis , Z Huo , S Barnett , I Kromann , R Giemza , E Galiza , M Woodrow , B Thierry-Carstensen , P Andersen , D Novicki , G Del Giudice , R Rappuoli. PLoS ONE 2009; 4(9): e6999. doi:10.1371/journal.pone.0006999.