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S. A. E. N.
"Exposing the truth to wipe
out animal experimentation"
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Facility Reports and Information
Walter Reed Army Institute of Research, Silver Spring, MD
DOD Funding of Animal Cruelty 2005:
M2: Infectious Diseases - 1
Title: Evaluation of a candidate tetravalent recombinant subunit
dengue vaccine using the rhesus macaque challenge model.
Research Category: M2: Infectious Diseases
FY: 2005 Funding (in dollars): $ 100000
Responsible Organization: WALTER REED ARMY INSTITUTE OF
RESEARCH
Primary Contact: Walter Reed Army Institute of Research
City: Silver Spring
State: MD
Zip: 20910-7500
Keywords: LABORATORY ANIMALS INDIAN OR CHINESE ORIGIN DENGUE
VIRUS VACCINE PROTECTION
Objective:
The hypothesis is that NHPs vaccinated with the tetravalent
recombinant subunit dengue vaccine will be rendered immune to challenge
by wild-type dengue viruses (all 4 serotypes). Immunity will be defined
as the absence or reduction of viremia after challenge. The primary
study objective (endpoint) is to determine whether vaccinated NHPs are
immunized and protected against viremia induced by wild-type dengue
virus challenge strains at least six months after primary vaccination.
Approach:
The purpose of this study is to determine if vaccinated non-human
primates (NHPs) (rhesus macaques) are protected against all 4 serotypes
of dengue virus (dengue virus types 1, 2, 3, and 4) by a tetravalent,
recombinant subunit dengue vaccine candidate (tetravalent vaccine). The
tetravalent vaccine contains a mixture of recombinant antigens
representing all four serotypes, along with an adjuvant to stimulate the
appropriate immune responses to the antigens. Before testing the vaccine
in humans, we must demonstrate that the vaccine is safe and effective in
NHPs; that it induces antibody and T-cell responses against all four
dengue virus serotypes, and protects vaccinated animals against
challenge with live dengue viruses. Therefore, following vaccination the
animals' humoral and cellular immune responses will be measured, and six
months after primary vaccination the animals will be challenged by
exposure to live dengue viruses. In non-immune animals the challenge
viruses will replicate and will be detected in the blood (viremia), but
immune animals should show no viremia. Since protection against viremia
in NHPs is thought to correlate with protection against disease in
humans, the most important endpoint of this part of the study will be to
determine if the tetravalent vaccine protects vaccinated rhesus monkeys
against viremia after challenge with wild-type dengue viruses. In
addition, measurement of the antibody and T-cell responses of challenged
animals will allow us to further assess the vaccine's efficacy. The
results from these experiments will allow us to determine if the vaccine
is suitable for clinical development.
________________________________________
Research was conducted in compliance with the Animal Welfare Act and
other Federal statutes and regulations relating to the use of animals in
research and was reviewed and approved by the Institute's Animal Care
and Use Committee.
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Rats, mice, birds, amphibians and other animals have been excluded from coverage by the Animal Welfare Act. Therefore research facility reports do not include these animals. As a result of this situation, a blank report, or one with few animals listed, does not mean that a facility has not performed experiments on non-reportable animals. A blank form does mean that the facility in question has not used covered animals (primates, dogs, cats, rabbits, guinea pigs, hamsters, pigs, sheep, goats, etc.). Rats and mice alone are believed to comprise over 90% of the animals used in experimentation. Therefore the majority of animals used at research facilities are not even counted.
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