A proposal by Professor Omar Hasan
Kasule Sr. MB ChB (MUK). M{H (Harvard), DrPH (Harvard)
1.0
BACKGROUND
1.1 The first case of MERS-Co was reported in
Jeddah in 2012[1]. Infection
has been confirmed to date in over 1000 patients about half of whom died from
the disease. The infection is severe requiring ICU admission with a high
mortality rate[2]. The
high mortality is due to co-morbidities, age above 65, low albumin, and male
gender[3]
[4].
1.2
The transmission cycle is not fully
known. Spread seems to be person to person either from family contacts or
hospital contacts. The majority of infections were reported from health care
workers or other patients[5].
Transmission of the infection was relatively low in healthcare workers in
contact with infected patients[6]
as well as household contacts[7].
Finding of the virus in camels and their handlers suggested an animal reservoir
but this has not yet been proved conclusively[8]
[9]
[10]
[11]
[12]
[13]
[14].
1.3
The Ministry of Health has undertaken
many measures to contain the infection inter alia public education, provision
of facilities for washing hands, surveillance etc. The infection shows seasonal
variations that may relate to patterns of human interactions, a reservoir host,
or virulent mutations. The virus seems stable[15]
[16]and
the epidemic cannot be due to virulent mutations.
1.4 Because of the large numbers of pilgrims who
come to Saudi Arabia every year, MERS-Co could become a world-wide epidemic.
There is an urgency to understand the epidemiological and virological aspects
of this infection in order to plan evidence-based prevention.
1.5 So far no antibiotic or vaccine has been
developed for the infection. Work is proceeding on monoclonal neutralizing
antibodies but there is no breakthrough yet[17]
[18].
Vaccine development faces obstacles of finding a suitable animal model. Pharmaceutical
companies are reluctant to invest in vaccine development because the number of
cases is so far too low[19]
to assure good returns on the investment
1.6 There is
no effective treatment. Ribaflavin and interferon have not been proved yet to
be effective[20]
1.7 Available epidemiological, virological, and
clinical knowledge does not provide an adequate base of evidence-based
knowledge to plan effective public health measures. The Ministry has therefore
launched the present research effort in priority areas.
2.0
PRIORITY AREAS OF RESEARCH
2.1
Epidemiology
2.1.1
Case control studies to refine the case
definition, describe the natural history, identify risk/susceptibility factors
of infection (sociodemographic, genetic, immunological, environmental,
behavioral, and co-morbidities)
2.1.2
Studies of time-space clustering of
cases of the disease to identify environmental factors
2.1.3
Identifying animal reservoirs/hosts and
working out the full transmission cycle
2.1.4
Risk factors of transmission to
healthcare workers and family members
2.1.5
Large sero epidemiological studies in
the general population and specific target populations such as animal handlers
2.1.6
Retrospective sero epidemiological
studies on stored serum and tissue samples to establish whether the virus or
its variants existed in the Kingdom before 2012
2.1.6
Study of the existing screening and
diagnostic tests: sensitivity, specificity, predictive value etc)
2.2
Virology
2.2.1
Sequencing the virus and identifying
virulence genes
2.2.1
Studying variations in viral properties (if
any) and their relation to virulence
2.3
Antiviral drugs
Basic and
applied research on monoclonal antibodies (neutralizing and others)
2.4
Immunization
Basic
and applied research on production of vaccines rapidly using genetic
engineering
2.5
Clinical studies
Clinical
trials of existing anti-virals like ribaflavin as well as interferons
2.6
Public health preventive measures
2.6.1
Population based and hospital-based
studies of knowledge, attitudes and practices regarding preventive measures
2.6.2
Assessment of compliance of hospitals
and health care workers with MERS-Co guidelines issues by the Ministry of
Health
2.6.3
Assessment of the impact of public
preventive measures undertaken since 2012.
3.0 APPLICATION FOR AND AWARD OF
RESEARCH GRANTS
3.1
Initial submission
3.1.1
A 1-2 page concept paper identifying the
knowledge gap to be covered by the research, the objectives, the methods, the
time line, and a list of researchers with degrees and current positions.
3.1.2
The concept paper shall be sent to Ahmad
Hersi Chairman of the Science Advisory Board at MOH ahersi@moh.gov who will review and
respond within one week whether a full proposal should be submitted.
3.2
Final submission
The full
proposal shall be submitted using the KASCT forms and following all KACST
requirements for funded research.
3.3
Review of the proposals
The
proposals shall be referred to local and international reviewers and a decision
shall be made within 4-8 weeks.
3.4
Research awards
3.4.1
Research awards shall be from the Ministry of Health under the authority of the
Deputy Minister for Public Health; first instalments shall be disbursed within
4 weeks of final approval.
3.4.2
KASCT guidelines will be followed in all
aspects of grant administration and follow up
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[6]
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[7]
N Engl J Med. 2014 Aug 28;371(9):828-35.
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5.
[9]
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1;60(3):369-77.
[16]
Trends
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[17] J Virol. 2014
Jul;88(14):7796-805.
[18] Proc Natl Acad Sci U S A. 2014 May 13;111(19):E2018-26.
[19] Expert
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[20] Int J
Infect Dis. 2014 Mar;20:42-6.