Walter Reed Army Institute of Research, Silver Spring, MD

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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

Primary Contact: Walter Reed Army Institute of Research
City: Silver Spring
State: MD
Zip: 20910-7500


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.

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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