Published Date: 2003-03-11 23:50:00
Subject: PRO> Smallpox vaccination, adverse events - USA (05)
Archive Number: 20030311.0592

SMALLPOX VACCINATION, ADVERSE EVENTS - USA (05)
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A ProMED-mail post
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International Society for Infectious Diseases
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Date: Mon, 10 Mar 2003 16:10:18 -0600
From: Kathy LeDell <Kathy.Ledell@state.mn.us>

The issue of appropriate dressings to prevent transmission of
vaccinia from vaccinated healthcare workers to patients (and other
contacts) is a big one, especially as the federal government
considers recommending that states progress to phase 2 of the
vaccination program. In phase 2, all healthcare workers would be
offered vaccination for smallpox.
During their 17 Oct 2002 meeting, ACIP looked at what literature
was available on the use of more "modern" dressings for smallpox
vaccination site care, to come to its decision to recommend that
healthcare workers use a semipermeable membrane dressing over
their vaccination site when they are working in healthcare facilities.
There appear to be only 2 relevant studies on the efficacy of such
dressings:
Cooney EL, Collier AC, Greenberg PD, et. al. Safety of and
immunological response to a recombinant vaccinia virus vaccine
expressing HIV envelope glycoprotein. Lancet 1991; 337:567-72.
Graham BS, Belshe RB, Clements ML, et.al. Vaccination of
Vaccinia-Naive Adults with Human Immunodeficieny Virus Type 1
gp160 Recombinant Vaccinia Virus in a Blinded, Controlled,
Randomized Clinical Trial. JID 1992; 166:244-52.
Cooney, et al. was a clinical trial of recombinant vaccinia vaccine.
Although dressing barrier quality was not a focus of the study, some
attempts were made to assess it. In this clinical trial, one layer of
OpSite over gauze was used and "all cultures of swabs taken of the
outer surface of the dressing were negative for virus. None of the
household or sexual contacts showed rises in their serum vaccinia
neutralising antibody titers or cutaneous manifestations consistent
with vaccinia exposure." (p.570)
Graham, et. al. was another study of recombinant vaccinia vaccine.
In the beginning of that trial, one layer of OpSite without gauze was
used. When cultures were taken of the dressing, 12/66 were
positive for vaccinia. The protocol was then changed and 2 layers of
OpSite were used over gauze. They also instituted another change
that was probably the most critical: they began changing gloves
between removal of the old dressing and reapplying the new. They
then recovered virus from 3/103 dressings. It is not unlikely that the
earlier high number of positive cultures resulted from contamination
of the dressing by the person doing the dressing changes, not from
virus being disseminated from under the dressing. Adding the layer
of gauze under the dressing likely also helped.
These 2 additional studies mention the use of Tegaderm dressings,
but no assessment of the barrier quality of the dressing was
reported.
Frey SE, Couch RB, Tacket CO, et al. Clinical Responses to
Undiluted and Diluted Smallpox Vaccine. NEJM 2002; 346(17):1265-
74.
Frey SE, Newman FK, Cruz, J, et al. Dose-Related Effects of
Smallpox Vaccine. NEJM 2002; 346(17):1275- 80.
In November 2002, when the Minnesota Department of Health
received word that phase 1 was likely to proceed, it was clear that
the issue of appropriate dressings was critical if ACIP was not
recommending routine furloughing of vaccinated healthcare
workers. We wanted to be sure that we would be able to recommend
and provide a dressing that would be effective at preventing
transmission of vaccinia virus to patients.
We first looked at Smith Nephew (OpSite) and 3M (Tegaderm)
products, since they are the two largest manufacturers of
semipermeable membrane dressings. We were interested in
dressings that had an integrated gauze pad (island) because of the
ease of application of a one-piece dressing (as opposed to applying
a piece of gauze and then trying to put the semipermeable dressing
on top of that with one hand).
We also requested testing results for viral barrier effectiveness in
accordance with ASTM F 1671-97, "Standard Test Method for
Resistance of Materials Used in Protective Clothing to Penetration
by Bloodborne Pathogens Using Phi-X 174 Bacteriophage
Penetration as a Test System." Both OpSite and Tegaderm have
passed these testing criteria.
When we contacted Smith Nephew (OpSite) and 3M (Tegaderm) in
November 2002, we were the first government entity to contact
either of them. Just the Minnesota order of the OpSite product we
were interested in would have consumed Smith Nephew's worldwide
inventory of that particular product at that time.
Also, it should be noted that the OpSite products currently on the
market differ from the product mentioned in the Lancet and JID
references. The new product has less adhesive and is significantly
more permeable to water vapor than ordinary films in the presence
of moisture. Presumably this would result in less maceration at the
vaccination site when these dressings are worn [and possibly more
permeability to vaccinia virus? - Mod.JW]
After much consideration, MDH made the decision to order OpSite
Post-Op. We purchased enough dressings to provide 10 for 5000
potential phase 1 vaccinees, most of whom would be healthcare
workers. This particular product has been used in current smallpox
vaccine clinical trials, including a trial at Mayo Clinic, with good
results.
Semi-permeable dressings are expensive and the costs are an
important issue to consider. We received prices of $.76 per
dressing for OpSite Post-Op (9.5 cm x 8.5 cm) and $.74 per
dressing for Tegaderm + Pad (9 cm x 10.5 cm). The ACIP
recommends that these dressings can be worn for 3-5 days for
smallpox vaccination, unless a change is indicated sooner. If we go
to phase 2 and vaccinate an even larger number of healthcare
workers, the costs of these dressings will be substantial. Although
MDH purchased the dressings for vaccinees in phase 1, we would
not be able to do so for phase 2. If participating hospitals were
forced to absorb this cost, it would not be insignificant. [I would think
that a bulk price could be negotiated. - Mod.JW]
Additionally, ACIP recommends that each vaccinated healthcare
worker have the barrier quality of their dressing assessed [visually? -
Mod.JW] at the beginning of each shift that they work. This has
been difficult to operationalize for 3 (or more) shifts a day, 7 days a
week. These are all issues to be considered as phase 2 is
discussed.
--
Kathleen LeDell, MPH, RN
Acute Disease Investigation and Control Section
Minnesota Department of Health
717 Delaware Street SE
Minneapolis, MN 55414
<Kathy.Ledell@state.mn.us>
[The use of trade names and commer
cial sources is for identification only and does not imply
endorsement by ProMED-mail. ProMED-mail would like to thank
Ms. LeDell for this excellent discussion on an evaluation of existing
options and studies addressing appropriate barrier dressings for
use following smallpox vaccination. As more individuals are being
vaccinated, we are starting to see contact vaccinia cases, and
information such as given by Ms. LeDell is very timely and
important. - Mod.MPP]

See Also

Smallpox vaccination, adverse events - USA (04) 20030307.0569
Smallpox vaccination, adverse events - USA (03) 20030306.0557
Smallpox vaccination, adverse events - USA (02) 20030306.0556
Smallpox vaccination, adverse events - USA 20030301.0515
Smallpox vaccination, adverse event monitoring - USA
20030206.0324
Smallpox vaccination strategies 20030103.0018
2002
----
Smallpox vaccination strategy - Israel (04) 20021225.6123
Smallpox vaccination strategy - Israel (03) 20021222.6113
Smallpox vaccination strategies - USA (09) 20021213.6059
Smallpox vaccination strategies - UK 20021207.6002
Smallpox vaccination hazards (03) 20021017.5571
Smallpox vaccination strategy - Israel 20020820.5095
Smallpox vaccine hazards 20020817.5080
Smallpox vaccine, criticism of choice - UK 20020730.4892
Smallpox containment strategies - USA 20020711.4725
Smallpox vaccination (02) 20020710.4715
Smallpox vaccination strategies - USA 20020709.4710
Disease surveillance: enhancement (03) 20021107.5740
Disease surveillance: enhancement (02) 20020708.4696
Smallpox vaccine, ACIP recommendations - USA (02)
20020621.4560
Smallpox vaccine, ACIP recommendations - USA
20020620.4542
Smallpox vaccination 20020611.4468
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