Statement of Work Q0262.pdf

Statement of Work Hereford Cross Calves for use in Study of

Effects of BCG-RB51 co-administration on the immune response to RB51 and BCG

GENERAL INFORMATION

1.0 Scope of Work. The objective of the current project is to develop improved brucellosis and tuberculosis vaccines and understand the immunologic characteristics associated with vaccine-mediated protection against Brucella abortus or Mycobacterium bovis. In this study, the effects of co-administration of Mycobacterium bovis bacillus Calmette Guerin (BCG) and Brucella abortus strain RB51 (RB51) on the respective immune response will be assessed. BCG is a live, attenuated M. bovis strain, widely used as a vaccine for the prevention of human tuberculosis. It has become increasingly evident, that vaccination with BCG can offer off-target, non-antigenspecific benefits, which enhance immunogenicity or protection against other infections. When delivered via the intravenous route, BCG has also been shown to be more immunogenic than when delivered subcutaneously. Similarly, RB51 is a live attenuated strain of B. abortus, and the commercial vaccine for bovine brucellosis. Unlike BCG, possible immunomodulatory effects of RB51 have not been tested. However, recent work in our laboratory has demonstrated that co-administration of RB51 with a modified live viral vaccine does result in partial enhancement of viral vaccine responses, suggesting an immunomodulatory effect. As we work towards improving current brucellosis and tuberculosis vaccination protocols, we propose to use RB51-BCG co-administration as a potential means to enhance vaccine responses. The goals of this study are to determine if BCG-RB51 co-administration will enhance their respective immune responses and to determine the immune mechanisms driving that effect.

2.0 Background. Brucellosis and tuberculosis have a major economic impact on producers worldwide. Additionally, as zoonotic agents, they are a source of public health concerns. The control of animal brucellosis and tuberculosis is the most effective way of controlling disease in humans. Therefore, the development of improved vaccination approaches for use in animals, will improve both animal and human health.

CONTRACTOR REQUIREMENTS

3.0 Technical Requirements for this purchase include:

• Breed – must be Hereford Breed Crossed calves.

• 32 Females – they must not be bred.

• Age – minimum 4 months to maximum of 6 months of age, at the time of delivery. Date of Birth must be confirmed between USDA and Vendor PRIOR to animal arrival to USDA location in Ames, IA.

• Animals must be uniform in size and weight – this must be confirmed between USDA and Vendor PRIOR to animal arrival to USDA location in Ames, IA.

• Animals must not receive any vaccinations for Brucellosis – specifically the RB51 vaccine.

• Calves must come from a Tuberculosis Free herd.

• Calves shall demonstrate no signs of clinical illness.

• Calves shall have sound legs and good eyes.

• Calves shall be confirmed sourced from the same farm.

• Calves must be sourced from a farm within 75 miles of Ames to limit transport time of the animals on the trailer for young animals.

• Pre-Purchase blood work may be requested from the time of award until the arrival of animals to confirm vaccination titer levels of animals PRIOR to arrival at USDA in Ames, IA.

• Calves cannot have any titer to Brucellosis and may need to be pre-purchase tested.

• Communication between Animal Resources Unit (ARU) personnel and possible vendors must be open from the time of solicitation to the arrival of animals to ensure all requirements are confirmed. This communication may include group or individual animal health status, pre-purchase blood work results, housing and feeding information that could be subject to change within this time frame.

• Animal Resources Unit and the funding unit will exclude calves prior to arrival that do not meet the SOW requirements.

• To obtain 32 animals that meet the SOW specifications; the vendor may need to obtain a group larger than 32 to allow for alternate animals to replace any that become sick or do not meet the health requirements.

• Certificate of Veterinary Inspection Required on all animals.

• No Ring Worm on any animal – this must be verified by ARU prior to animal arrival

• No pink eye on any animal - this must be verified by ARU prior to animal arrival

• Animal shall be deliverable onsite in one delivery at USDA on or near October 16th, 2023.

• Qty animals to be delivered: 32.

4.0 Place of Delivery: USDA, 1920 Dayton Avenue, Ames, IA 50010