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Percobaan calon vaksin Ebola yang aman, equally imunogenik di Afrika
Dua vaksin DNA eksperimental untuk mencegah virus Ebola dan virus Marburg ....,
dan menghasilkan respon imun yang sama pada orang dewasa sehat di Uganda seperti yang dilaporkan pada
orang dewasa di AS yang sehat awal tahun
ini. ...Temuan ini dari sidang pertama vaksin filovirus di Afrika.....read more
......................
Trial confirms
Ebola vaccine candidate safe, equally immunogenic in Africa
Date:
December 23, 2014
Source:
The Lancet
Summary:
Two experimental DNA
vaccines to prevent Ebola virus and the closely related Marburg virus are safe,
and generated a similar immune response in healthy Ugandan adults as reported
in healthy US adults earlier this year. The findings are from the first trial
of filovirus vaccines in Africa.
.................................
Two experimental DNA vaccines to prevent Ebola virus and the closely related
Marburg virus are safe, and generated a similar immune response in healthy
Ugandan adults as reported in healthy US adults earlier this year. The
findings, from the first trial of filovirus vaccines in Africa, are published
in The Lancet.
"This is the first study to show comparable safety and immune response
of an experimental Ebola vaccine in an African population," says lead
author Dr Julie Ledgerwood from the National Institutes of Allergy and
Infectious Diseases (NIAID) at the National Institutes of Health, USA.
"This is particularly encouraging because those at greatest risk of Ebola
live primarily in Africa, and diminished vaccine protection in African
populations has been seen for other diseases."
Scientists from the NIAID developed the DNA vaccines that code for Ebola
virus proteins from the Zaire and Sudan strains and the Marburg virus protein.
The vaccines contain the construction plans for the proteins on the outer
surface of the virus. Immune responses against these proteins have shown to be
highly protective in non-human primate models.
In this phase 1 trial, the Makerere University Walter Reed Program enrolled
108 healthy adults aged between 18 and 50 from Kampala, Uganda between
November, 2009 and April, 2010. Each volunteer was randomly assigned to receive
an intramuscular injection of either the Ebola vaccine (30 volunteers), Marburg
vaccine (30), both vaccines (30), or placebo (18) at the start of the study,
and again 4 weeks and 8 weeks later.
The vaccines given separately and together were safe and stimulated an
immune response in the form of neutralising antibodies and T-cells against the
virus proteins. Four weeks after the third injection, just over half of the
volunteers (57%; 17 of 30) had an antibody response to the Ebola Zaire protein
as did 14 of 30 participants who received both the Ebola and Marburg vaccines.
However, the antibodies were not long-lasting and returned to undetectable
levels within 11 months of vaccination.
Both DNA vaccines were well tolerated in Ugandan adults with similar
numbers of local and systemic reactions reported in all groups. Only one
serious adverse event (neutropenia; low white blood cell count) was reported in
a Marburg vaccine only recipient, but was not thought to be vaccine related.
According to Dr Ledgerwood, "These findings have already formed the
basis of a more potent vaccine, delivered using a harmless chimpanzee cold
virus, which is undergoing trials in the USA, UK, Mali, and Uganda in response
to the ongoing Ebola virus outbreak."
Writing in a linked Comment, Dr Saranya Sridhar from the Jenner Institute
at the University of Oxford in the UK says, "[This] study deserves to be
the focal point around which the broader question of vaccine development,
particularly for Africa, must be addressed. With the uncharitable benefit of
hindsight in view of the evolving 2014 Ebola outbreak, we must ask ourselves
whether a filovirus vaccine should have been in more advanced clinical
development. The international response to the present Ebola outbreak is an
exemplar of the speed and purpose with which clinical vaccine development can
progress and has set the benchmark against which future vaccine development
must be judged. This study is the first step on the aspirational road towards
the deployment of filovirus vaccines in Africa and must serve to shake the
metaphorical cobwebs that can stall our advance towards this destination."
Story Source:
The above story is based on materials provided by The Lancet. Note: Materials may be edited
for content and length.
Journal Reference:
1. Hannah Kibuuka, Nina M Berkowitz, Monica
Millard, Mary E Enama, Allan Tindikahwa, Arthur B Sekiziyivu, Pamela Costner,
Sandra Sitar, Deline Glover, Zonghui Hu, Gyan Joshi, Daphne Stanley, Meghan
Kunchai, Leigh Anne Eller, Robert T Bailer, Richard A Koup, Gary J Nabel, John
R Mascola, Nancy J Sullivan, Barney S Graham, Mario Roederer, Nelson L Michael,
Merlin L Robb, Julie E Ledgerwood. Safety and immunogenicity of Ebola
virus and Marburg virus glycoprotein DNA vaccines assessed separately and
concomitantly in healthy Ugandan adults: a phase 1b, randomised, double-blind,
placebo-controlled clinical trial. The Lancet, 2014; DOI: 10.1016/S0140-6736(14)62385-0
