Dr Nana Akosua Ansah, the Head of the Clinical Science Department of the Navrongo Health Research Centre (NHRC), who disclosed this in an interview with the Ghana News Agency (GNA) in Navrongo, said it would be conducted on adults from the ages of 18 to 50 years.
She said the trial would be the first time the vaccine would be introduced to human beings in Ghana.
“It is the first in human study, studies have been done in animals, and it has been found to be safe.
This is the first time that it is going to be introduced into human beings,” she noted.
She said the enrolment process for the trial was voluntary, and that interested members of the public could participate in the process intended to last for about seven months for each participant.
Dr Ansah said the study was in two parts: Eight months for Part ‘A’ which involves vaccination and safety assessments and nine months for Part ‘B’ which involves selecting the optimal dose for vaccination and further evaluation of safety and tolerability.
She explained that “because it is a safety study, we are not recruiting a lot of people.
The total is 108 and considering that it is between two sites, we will recruit at most 54 per side.
“We are doing at least one participant a day and at most two so that we can keep a good eye on them and make sure that all the procedures are followed successfully.”
“We always stick to good clinical practices, so we are confident that we will get volunteers to help us fight against Lassa fever.”
Dr Ansah said the NHRC had highly skilled staff and Specialists to screen the participants and take care of any participant who may suffer from any reaction.
She indicated that the template that was used by the NHRC for the Ebola vaccine trial which worked successfully and was safe would be the same template to be used for the Lassa fever virus vaccine trial.
“So, we are confident that this will be as safe as the Ebola vaccine was,” The Head of Clinical Science said.
She said the Lassa fever virus was endemic in West Africa, and the Navrongo and Kintampo Health Research Centres were the choice of study for the vaccine trial, as Ghana had so far not detected any case of the disease.
“Phase one must be done in a naive population. In recent times, we know that there was an outbreak in Nigeria, it has been seen in Cote d’Ivoire, Togo and in Burkina Faso. So, it looks like the numbers are increasing.”
Dr Ansah said the Lassa fever virus was a haemorrhagic fever just like Ebola, but not as deadly as Ebola, and insisted that even though it may not be as deadly, it was still a cause for concern, “So it is important that we get the vaccine out as soon as possible.”
She said the Food and Drugs Authority (FDA) of Ghana had inspected the sites of the NHRC and KHRC for the trial study to ensure the centres were ready and well-equipped to commence the trial.