06 January 2012

Human trials initiated for new HIV vaccine

HYMS is part of a team which is evaluating whether an injectable vaccine for HIV is safe for use in human volunteers.

The team is made up of members of HYMS; St George's University, London; Imperial College; Medical Research Council Clinical Trial Unit and Infectious Disease Research Institute.

The vaccine contains trimeric HIV envelope protein (gp140) which can target the virus' most virulent strain Clade C that has caused the greatest number of HIV infections around the globe, infecting half of the 34 million people with HIV.

The trial, which is funded by the Wellcome Trust and goes by the name MUCOVAC2, is evaluating a vaccine that contains the HIV trimeric gp140 protein CN54, representative of Clade C strains of the virus.

This clade of HIV is the most prevalent type of virus in Sub-Saharan Africa and responsible for the greatest number of infections globally. The trimeric protein represents the major target for antibodies on the viral surface.

The vaccine candidate will be formulated with an adjuvant - GLA - developed to enhance immune responsiveness following intramuscular injection. GLA formulations have been previously tested clinically with promising results.

The scientists have enrolled 36 healthy, HIV-negative women aged 18-45 years at St George's University of London and the HYMS Experimental Medicine Unit at York Hospital.

The trial will evaluate vaccine's safety and determine the quality and magnitude of induced immune responses. The research is expected to take less than a year to complete with results available early 2013.

Women will be randomly assigned to receive the vaccine by intramuscular injection, intranasal immunization through the application of liquid drops to the nose, or a combination of intramuscular injection followed by intravaginal immunization through the application of a gel-based formulation. This will enable researchers to compare the safety and levels of induced antibodies in the blood and vaginal secretions generated by the different vaccine approaches.

Leading the study for St George’s is Dr Catherine Cosgrove, with Professor Charles Lacey, HYMS' Consultant Physician and Professor of Genitourinary Medicine, leading the study at York.

"Globally, women comprise half of the 34 million people living with HIV. In Sub-Saharan Africa, women represent nearly 60 percent of adults with the virus. Our collaboration marks an important juncture for the field as we begin to assess which routes of immunization may provide the best responses to protect women,” remarked Professor Robin Shattock, who is Chair in Mucosal Infection and Immunity at Imperial College, and who leads the consortium which developed the MUCOVAC2 trial.

Additional information about MUCOVAC2 and other UK vaccine studies is available at http://www.helpmakehistory.mrc.ac.uk