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Ebola: CDC in talks with Nigeria over Human trial as suspected cases rise

Medic-ALL (01:09:2014)

There are strong indications that officials from the Centers for Disease Control and Prevention (CDC) in USA are in talks with health officials in Nigeria about the prospects for conducting a phase 1 safety study of the Ebola vaccine among healthy adults in the country amid mounting anxiety about the spread of the deadly virus in West Africa, according to the National Institutes of Health (NIH).

The pace of human safety testing for experimental Ebola vaccines has been expedited in response to the ongoing virus outbreak in West Africa which has impacted negatively on businesses in the three affected countries of Liberia, Sierra Leone and Guinea, with neighbouring countries closing their borders and banning flights from affected countries to other parts of Africa.

NIH explained that “the early-stage trial will begin initial human testing of a vaccine co-developed by NIAID [National Institute of Allergy and Infectious Diseases] and GlaxoSmithKline (GSK) and will evaluate the experimental vaccine’s safety and ability to generate an immune system response in healthy adults. Testing will take place at the NIH Clinical Center in Bethesda, Maryland, USA.”

The experimental vaccine is expected to first be given to three healthy human volunteers to see if they suffer any adverse effects. If deemed safe, it will then be given to another small group of volunteers, aged 18 to 50, to see if it produces a strong immune response to the virus. All will be monitored closely for side effects.

It is understood that the vaccine will be administered to volunteers by an injection in the deltoid muscle of their arm, first in a lower dose, then later in a higher dose after the safety of the vaccine has been determined.

Anthony Fauci, NIAID director, explained that there is an urgent need for a protective Ebola vaccine, as it is important to establish that a vaccine is safe and spurs the immune system to react in a way necessary to protect against infection.
“We know the best way to prevent the spread of Ebola infection is through public health measures, including good infection control practices, isolation, contact tracing, quarantine, and provision of personal protective equipment. However, a vaccine will ultimately be an important tool in the prevention effort. The launch of phase 1 Ebola vaccine studies is the first step in a long process.”

Preclinical studies that are usually carried out on such drugs were waived by the FDA (Food and Drug Administration) during the expedited review and care is being taken to go slowly, particularly as it pertains to the dosing .

Meanwhile, the number of suspected cases in Nigeria has continued to rise after one of the initial contacts of the Liberian-American-Sawyerr, a Nigerian Diplomat working with ECOWAS, Olu-Ibukun Koye who was said to have escaped from quarantine and traveled to Rivers State in the Southern Part of the country. Where he was attended to by a now late medical doctor, Dr Enemuo, who died a few days afterwards and whose corpse tested positive to the deadly virus. The late doctor's wife and other possible contacts in the Southern State have now being placed under quarantine.

Ref: BusinessDay

Medic-ALL.Inc 2014

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