Materia Medica Malaysiana

Potential oral cholera vaccine developed by USM

PENANG: A Universiti Sains Malaysia (USM) team has developed strains of self-terminating mutant bacteria with the potential to be used as oral cholera vaccine.
However, the team cannot proceed with pre-clinical trials in humans because there are no laboratories here that have clinical good manufacturing practice (CGMP) status.
“To initiate studies in human subjects, we need to produce the vaccine in a laboratory that has CGMP status,” USM Kubang Kerian School of Health Sciences dean Prof Zainul Fadziruddin Zainuddin told a press conference at the main campus here yesterday.
“It would be good if we can have such a laboratory in this country, but it would cost about RM12mil to set up one,” he added.
According to Prof Zainul, USM could collaborate with Cuba to produce the strains for pre-clinical trials as it had a CGMP laboratory.
“But we will have to convince regulators there that the mutant strains produced will not be a threat to public health and the environment,” he said.
Assoc Prof Dr M. Ravichandran of the School of Medical Sciences first created the “programmed to die” strains in 2001 using genetic engineering technology. He created the strains together with his wife Dr P. Lalitha, a fellow researcher in the school.
“The mutant strains of VCUSM1 and VCUSM2 fulfilled the WHO (World Health Organisation) recommendation for the development of vaccine for 0139-type Vibrio cholerae,” said Dr Ravichandran, an Indian national.
He said the mutant strains could survive up to two hours in rabbits and up to two days in tap water, river water and sewage.
“We have in the market oral vaccines for the 01 strain that causes cholera, but none for the 0139 strain,” he said.
The existing vaccine for the 01 strain, he noted, did not provide 100% protection against cholera.
“The strains that we have created at USM provide 100% protection as shown in studies using rabbits as subjects,” he said, adding that rabbits given the vaccine were protected against cholera for up to a year.
Dr Ravichandran said USM was now looking into developing a vaccine formulation that provided protection against both the 01 and 0139 strains.
Biomedical and Health Research Platform head Prof Norazmi Mohd Nor said collaboration with foreign institutions and universities should be on an equal footing rather than just a matter of sending materials and products for others to develop.