Statement of Work.pdf

Statement of Work (SOW) Project: Develop and test Mycoplasma mycoides subspecies mycoides Small Colony vaccines that induce immunity in cattle

GENERAL INFORMATION

1.0 Scope of Work:

The current USDA ARS project “Identification of Disease Mechanisms and Control Strategies for Bacterial Respiratory Pathogens in Ruminants, is proposed to work with cattle respiratory disease pathogens including Mycoplasma mycoides subspecies mycoides Small Colony (MmmSC), which is the causative agent of contagious bovine pleuropneumonia (CBPP). The overall goals and objectives related to MmmSC are to identify the host factors that drive the early innate immune response to MmmSC infection and develop and test MmmSC vaccines that induce early immunity in cattle.

2.0 Background:

The currently approved vaccine to control Contagious Bovine Pleuropneumonia (CBPP) consists of a live attenuated MmmSC vaccine; however, based on the findings from experimental and field studies, MmmSC vaccine appeared not to fully protect cattle from outbreaks of the disease. Given that scientists on this project have worked to develop Mycoplasma bovis vaccine, one of the objectives of this proposed study will be to develop a better vaccine to control CBPP.

CONTRACTOR REQUIREMENTS

3.0 Technical Requirements/Tasks:

The technical requirements for the proposed study are:

• The contractor shall screen and purchase 70 cattle (2-4 years old) – from a contagious bovine pleuropneumonia (CBPP)-free location.

• The contractor shall provide feed and other supplies for maintaining the cattle to be used in the study.

• The contractor shall provide routine care and veterinary care of the animals during the course of the experiments.

• The contractor shall provide necessary facilities for housing and daily care of animals being used in this project.

• The facilities being used must be approved by appropriate regulatory organizations for research involving the use of MmmSC.

• The contractor shall be responsible for euthanasia of animals and disposal of all contaminated materials and cleaning of contaminated surfaces according to approved regulatory protocols.

• The contractor shall provide all necessary personnel, equipment and other supplies as necessary to fulfill these obligations.

• During the course of the experiment, personnel must avoid contact with other animals at for up to five days after leaving the biocontainment area.

• The contractor shall administer live attenuated Mannheimia haemolytica expressing MmmSC antigens orally using palatable feed and intranasally using mucosal atomization device.

• The contractor shall administer adjuvanted MmmSC recombinant protein vaccine subcutaneously.

• The contractor shall prepare MmmSC inoculum and administer to lungs through intratracheal intubation.

• The contractor shall be responsible to collect periodic samples from vaccinated/challenge animals such as nasal swabs, blood, and tear samples.

• The contractor shall perform bacterial culture and serology, and necropsies and provide results to ARS within 60 days after sample collection (Microsoft Words or Excel files).

• The contractor shall perform necropsy, sample collection and histopathology and provide results to ARS within 120 days after sample collection (Microsoft Words or Excel files).

4.0 Government Furnished:

The USDA-ARS shall provide 2 vaccine formulations (1) live attenuated

Mannheimia haemolytica with and without expressing MmmSC antigens and (2) injectable adjuvanted MmmSC recombinant protein vaccine.

5.0 Deliverables / Schedule:

Item No.

Deliverable

Objective

Due

1 Acquisition of 70 CBPP-free animals for the project

Screen and purchase CBPP free animals (2-4 years old cattle).

No later than 90 days after awarded

2 Report bacterial colonization and serology findings

Vaccinate animals with ARS vaccine and determine bacterial colonization and immune responses.

Report findings within 60 days post-vaccination.

3 Challenge animals with MmmSC inoculum

Inoculate/challenge vaccinated animals with MmmSC inoculum.

Inoculate animals approximately 35 days post-vaccination.

4 Report bacterial, serology and pathology findings

Collect tissues for serological, bacteriological, and histochemical evaluation.

No later than 120 days after necropsy.

6.0 Travel:

The contractor will not be responsible for any travel but will receive two visits from USDA-ARS Researchers (Dr. Rohana Dassanayake and Dr. Robert Briggs), prior to onset of the study and during the study.

7.0 Data Rights:

The USDA-ARS and the contractor will jointly evaluate the animal study findings and write the manuscript(s).

8.0 Place of Performance:

Contractor’s selected facility

9.0 Period of Performance:

To be completed with 12 months from date of award

10.0 Technical Point of Contact:

Rohana P. Dassanayake, 515-337-7311, rohana.dassanayake@usda.gov