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Kandidat Vaksin Ebola  memiliki profil keamanan yang dapat diterima

Hasil pertama dari uji coba kandidat vaksin  Ebola menyarankan vaksin memiliki profil keamanan yang dapat diterima pada dosis yang diuji , dan mampu menghasilkan respon imun . Percobaan yang lebih besar di Afrika Barat diperlukan untuk mengetahui apakah respon imun yang cukup besar untuk melindungi terhadap infeksi Ebola dan penyakit , ....read more

Ebola candidate
vaccine has acceptable safety profile

Date:

January 29, 2015

Source:

University of Oxford

Summary:

The first results from
a trial of a candidate Ebola vaccine suggest the vaccine has an acceptable
safety profile at the doses tested, and is able to generate an immune response.
Larger trials in West Africa are needed to tell whether immune responses are
large enough to protect against Ebola infection and disease, scientists say

...................

the first results from a
trial of a candidate Ebola vaccine at Oxford University suggest the vaccine has
an acceptable safety profile at the doses tested, and is able to generate an
immune response.

The vaccine was well tolerated. Its safety profile is pretty much as we had
hoped,' said Professor Adrian Hill of the Jenner Institute at Oxford
University, who led the trial.

The researchers say these results suggest the vaccine is suitable for
further testing in West Africa during the current outbreak, with the aim of
determining whether the vaccine offers protection against Ebola.

The candidate Ebola vaccine is being co-developed by the US National
Institutes of Health (NIH) and GSK against the Zaire strain of Ebola, which is
the one circulating in West Africa. The first doses for use in large scale
trials in West Africa have been delivered to Liberia by GSK.

The vaccine uses a single Ebola virus gene in a chimpanzee adenovirus to
generate an immune response. As it does not contain infectious Ebola virus
material, it cannot cause a person who is vaccinated to become infected with
Ebola.

The Oxford University trial is one of several safety trials of the GSK/NIH
vaccine candidate -- in the USA, UK, Mali and Switzerland -- that have been
fast-tracked in response to the Ebola outbreak in West Africa.

The UK trial is funded by the Wellcome Trust, Medical Research Council
(MRC) and Department for International Development (DFID). The NIH is providing
the NIH/GSK Ebola vaccine for the Oxford University study.

The initial findings are published in the New England Journal of
Medicine (NEJM).

Trial results

60 healthy volunteers were vaccinated at the University of Oxford's Jenner
Institute between 17 September and 18 November.

The NEJM paper reports safety data and immune responses
for the volunteers for 28 days after immunisation. Follow-up of the vaccinees
will continue beyond these initial data until six months after the volunteers
received the experimental vaccine.

The volunteers received one of three different vaccine doses. 20 volunteers
received a low dose vaccine (1 x 10^10 viral particles (vp)); 20 volunteers a
middle dose (2.5 x 10^10 vp); and 20 volunteers a high dose (5 x 10^10 vp).

The experimental vaccine was well tolerated at all three doses. The
majority of adverse events reported by the volunteers were mild in severity.
Two people experienced a moderate fever within 24 hours of receiving the
vaccine, but this passed within a day.

'People typically experienced mild symptoms that lasted for one or maybe
two days, such as pain or reddening at the injection site, and occasionally
people felt feverish,' said Professor Hill. 'It's very similar to what has been
seen in previous studies with this general type of vaccine.'

The primary goal of the trial was to assess safety. However, the scientists
also assessed immune responses to Ebola seen in the volunteers before and after
vaccination.

Importantly, the vaccine generated immune responses against Ebola in the
volunteers.

Levels of antibodies increased over a period of 28 days after vaccination,
and there was no significant difference in the levels seen at different doses.
Levels of T cells -- cellular immunity is the other arm of the body's immune
system -- peaked at 14 days.

The levels of antibody response are similar to those seen with a similar
vaccine dose in a US study of a related GSK/NIH Ebola vaccine formulation
published on Wed 26 Nov. They were lower than seen in the US study which tested
a significantly higher vaccine dose, but the US study used a formulation not
available for control of the ongoing outbreak in West Africa.

The antibody response is lower than antibody levels which were found in
macaque monkeys protected by the same vaccine against Ebola. The T cell
response, specifically the CD8+ T cell response, was also several fold lower
than that observed in protected macaques. However, what level of immune
response is needed to protect humans is currently not known. The efficacy of
the Ebola vaccine can only be tested in much larger studies in the field during
the current outbreak.

'The results are very encouraging in terms of the safety profile of the
vaccine. That is the main outcome from this trial,' says Professor Hill. 'We
have seen an immune response in the great majority of people receiving the vaccine.
It is possible to be optimistic about the immune responses we've seen; it's
also hard to be really confident the levels would be protective. Larger trials
in West Africa will be able to tell us more. We are also currently assessing
another option, involving a booster dose, for improving immune response
levels.'

Other trials and next steps

Similar initial results from a US trial in 20 people of a related Ebola
vaccine formulation were published on Wed 26 Nov. That 'bivalent' GSK/NIH
candidate vaccine included a gene for the Zaire species of Ebola, and also a
gene for the related Sudan virus.

It is the single, 'monovalent' GSK/NIH candidate vaccine tested at Oxford
and other sites which is being taken forward for wider trials in the current
Ebola epidemic.

Results from trials of the monovalent vaccine in Mali and Switzerland are
expected shortly.

The safety and immunogenicity data from the Oxford trial supports the move
into much larger scale studies in West Africa, testing vaccine effectiveness to
prevent Ebola virus disease.

The Oxford University scientists have also begun testing the safety of a
candidate booster vaccine against Ebola, to find out whether it could further
increase the immune responses.

30 of the original volunteers have been invited back and received a second
candidate Ebola vaccine of a different type made by Bavarian Nordic, a company
based in Denmark. Ongoing trials in Oxford are still seeking to assess further
this two-dose regime. Anyone interested in volunteering should contact vaccinetrials@ndm.ox.ac.uk.

Professor Hill said: 'The speed at which all this is happening is
remarkable. We'd especially like to thank all the volunteers. They continue to
take time out of their busy lives to give blood samples at regular intervals so
we can understand more about their immune responses having received the
vaccine. It's also thanks to the hard work of many scientists, funders, pharma
firms, regulators and agencies, all coming together, that we can make such
rapid progress.'

He added: 'Whether we have a vaccine that is safe, effective and works, we
won't know for a while yet. But we owe it to the people who have been affected
so badly by the Ebola outbreak to find out.'

International Development Secretary Justine Greening said: 'Britain is a
world leader in medical research and the outcome of these DFID-funded trials
takes us a step closer to finding a vaccine that could help contain Ebola and
prevent future outbreaks.

'I would like to thank the volunteers who took part in this important
trial. They join thousands of British doctors, nurses, military personnel,
scientists and aid workers in the fight against this terrible disease.'

Dr Jeremy Farrar, Director of the Wellcome Trust, said: 'This study is very
encouraging as it provides good initial evidence that the GSK vaccine will be
safe to use in people. However, we still don't know whether it will provide
protection against Ebola infection in a real-world situation. That's why trials
in West Africa of this, and the other vaccines in development, must begin as
soon possible. This has been an amazing global collaboration which we are proud
to have supported.

'Falling infection rates in many of the affected regions increase the
urgency of this research. While it is wonderful news that the epidemic is
slowing in all three affected countries we cannot consider the crisis over
until there are no more people infected by Ebola across the whole region of
West Africa. Vaccines may yet play a crucial role in achieving this, and will
undoubtedly play a crucial role in protecting against future outbreaks of the
virus.'







Story Source:

The above story is based on materials provided by University
of Oxford. Note: Materials may be edited for content and length.







Journal Reference:

1.    Tommy Rampling, Katie Ewer, Georgina
Bowyer, Danny Wright, Egeruan B. Imoukhuede, Ruth Payne, Felicity Hartnell,
Malick Gibani, Carly Bliss, Alice Minhinnick, Morven Wilkie, Navin Venkatraman,
Ian Poulton, Natalie Lella, Rachel Roberts, Kailan Sierra-Davidson, Verena
Krähling, Eleanor Berrie, Francois Roman, Iris De Ryck, Alfredo Nicosia, Nancy
J. Sullivan, Daphne A. Stanley, Julie E. Ledgerwood, Richard M. Schwartz,
Loredana Siani, Stefano Colloca, Antonella Folgori, Stefania Di Marco, Riccardo
Cortese, Stephan Becker, Barney S. Graham, Richard A. Koup, Myron M. Levine,
Vasee Moorthy, Andrew J. Pollard, Simon J. Draper, W. Ripley Ballou, Alison
Lawrie, Sarah C. Gilbert, Adrian V.S. Hill. A Monovalent Chimpanzee
Adenovirus Ebola Vaccine — Preliminary Report.New England Journal of
Medicine, 2015; 150128140051005 DOI:10.1056/NEJMoa1411627

http://www.sciencedaily.com/releases/2015/01/150129094355.htm

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