Monday, 7 December 2015

Ebola vaccine trial:

“B’da people are not guinea pigs”
  - Researcher tells gov’t 
Ebola is very scary, and so what we need on this issue is a properly convened press conference, where Cameroonian biomedical researchers in the areas of immunology, molecular biochemistry and microbiology or other relevant fields from many institutions in the country (for transparency; and not just simple clinicians from the ministry or scientists from few places) are duly invited to be present, ask questions and help educate the population appropriately. We shouldn't be in a hurry to start testing, without appropriate sensitization and education. People usually believe their brothers and sisters more.
                A vaccine trial in itself is not a bad thing. In fact, it is an essential step in getting the final product to populations at risk (Cameroon was at risk, just as the USA was also at risk and could still be at risk tomorrow) and so trials need to be encouraged, whenever they are properly and transparently and publicly done.
                But what is frightening and needs to be further checked in this Cameroon Daily Journal newspaper report is the mention of an experimental "non-replicative" challenge infection later on in humans.
                To quote the journal: "The minister of public health, Andre Mama Fouda announced on October 30 that in carrying out the clinical tests, volunteers will be injected with a dose of the Ebola virus after getting a dose of the vaccine. There are no guarantees that the vaccine will prevent them from getting infected by the killer virus but the minister pointed out that the experimental vaccine does not contain any virus capable of reproducing itself in the human body and so cannot lead to infection."

                Usually an experimental challenge infection for a disease like Ebola would be verified in animals like guinea pigs and monkeys, not humans. For human efficacy studies, a challenge infection has to be verified in a natural setting, where the disease is present and transmission is on-going, e.g. as was in Liberia. If the transmission in West Africa is over, then we can only say it was a missed opportunity and wait for next time, with a portfolio of many candidate vaccines that have gone passed phase I and cleared to proceed to phase II. It is true that the world needs to be prepared for the next outbreak, which will surely come someday, but I do sincerely think that any risk versus benefits analysis of a challenge infection in humans should involve a much larger local scientists’ base. That a challenge virus that is not replicative would be given to study subjects later on, first of all does not sound like good science.
                In fact, the purpose of the vaccine is to prevent viral replication if the virus ever attacks the vaccinated, which means that any challenge virus that would be given to study subjects after the trial vaccination must be replicative, to enable an investigation of this replication process. It is therefore, likely that somebody along this information chain, from the producer of the vaccine to this reader is either telling a lie about the "non-replication" issue or is not providing enough details.
                In vaccinology, such experimental challenge infections are ethically applicable only in situations where the infection is either fully self-limiting or can be fully treated within a relatively short period of time with good drugs. But, this is currently not clear or applicable with the Ebola virus. Therefore, a properly convened and constituted press conference or working session is absolutely needed, before such an experimental challenge infection can ever be brought in. I think it is the people's right to know the details and accept the trial in their city or not, because if one of the volunteers become sick of ebola disease tomorrow it could easily become a problem of everyone in the city. Finally, I would like other biomedical scientists in the field of vaccinology to comment on this write-up or kindly provide more clarification.
NB: Disclaimer: Please note, the views in this write-up are personal and do not represent the views of any organization I work for or associate with.
                Thank you for reading.
NB: Disclaimer: Please note, the views in this write-up are personal and do not represent the views of any organization I work for or associate with.
                Thank you for reading.

Fidelis Cho-Ngwa, Ph.D.(Associate Professor, Biochemistry/Molecular Biotechnology);




No comments:

Post a Comment