Rhesus macaques, nonhuman primates for HIV Prevention Studies

Background The CDC Laboratory Branch supports the Division of HIV Prevention’s goals in HIV prevention as they pertain to clinical studies, viral transmission, diagnosis and incidence, intervention research with microbicides, vaccines, and chemoprophylaxis as well as investigates other human and zoonotic retroviruses. The lab conducts and develops multiple preclinical HIV intervention studies using nonhuman primate (NHP) models for HIV detection, quantitation, isolation, evolution, and surveillance including drug resistance. Supply Description The contractor shall provide 20 male or female Indian rhesus macaques, meeting the following specifications: 1. Rhesus macaques must be between the ages of 4 and 8 years. The Contractor shall provide proof of the date of birth for each primate to the COR. 2. The contractor shall ensure that all rhesus macaques shall have tested negative for tuberculosis (TB), tested for the presence of a measles antibody titer, tested negative to simian retroviruses (SRV) by polymerase chain reaction (PCR), tested negative for antibodies to SRV, simian T-lymphotropic viruses (STLV), and simian immunodeficiency virus (SIV), been tested for the presence of internal and external parasites (include the testing modality used for internal parasitism and macaques shall have tested negative for Trichuris spp.), and tested negative by PCR for microbiology (e.g. Shigella, Campylobacter, Salmonella, Yersinia). All rhesus macaques shall have been genetically typed and found negative for the Mamu A*01, Mamu B*08 and Mamu B*17 major histocompatibility class-I alleles. 3. The contractor shall ensure that the macaques shall not have participated in prior studies with, or been exposed to HIV, SIV, SHIV or other retrovirus studies. 4. All macaques must have a breeder’s statement and/or Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) export permits and declaration forms available. This must be provided to the COR and CDC veterinarian for each macaque. 5. All macaques must have been maintained in complex social and physical environments for behavioral and medical health. 6. All macaques shall have had no invasive protocol related surgical procedures. Hysterectomized macaques are not acceptable. 7. All macaques shall have been confirmed NOT to be pregnant at time of selection or shipment. Note: CDC reserves the right to request further information based on history of pathogens noted in macaque’s medical records and reserves the right to deny the selection of macaques based on the medical history and/or diagnostic testing. Additional testing may be required for animals who lived in or currently live in areas with known endemic pathogens of clinical concern (e.g. Coccidioides). The Contractor shall perform the tasks specified below: 1. To provide 20 healthy male or female Indian rhesus macaques, the Contractor shall identify 25 or more potential macaques meeting the specifications listed above and provide medical histories/records (see below for criteria) to the CDC for review for selection of 20 potential candidates and several alternates. Medical History/records criteria: a. Country, place and date of origin b. Macaque ID number (must match visible tattoo) c. Date of birth and Sex d. Most recent weights with dates obtained e. Dates and result of all TB tests (all must be negative) f. Dates, results, and external laboratory that performed testing for SIV, SRV, STLV, measles, internal and external parasites (including Trichuris spp.), and microbiology (e.g. Shigella, Campylobacter, Salmonella, Yersinia) must be negative by PCR. g. Dates and results of Macacine alphaherpesvirus 1 (B virus) antibody test h. Copies of all clinical records for each macaque since birth including any noted behavioral evaluations i. Pair or group housing history when available, and all available behavioral/socialization information j. All macaques shall have a breeder’s statement and/or CITES export permits and declaration forms. 2. CDC will select 20 potential macaques and several alternate macaques that meet the specifications listed above and will notify the Contractor 2-4 weeks after receiving the complete medical records. Note: CDC reserves the right to request further information based on history of pathogens noted in macaque’s medical records and reserves the right to deny the selection of macaques based on the medical records/tests. Post potential selection Testing and Examination (potential 20 and several alternates) The Contractor shall perform the following testing and exam (“a” and “b” below), gather results and records and send to CDC for further review and acceptability. If the COR or CDC veterinarian rejects a macaque for any reason after post selection testing and examination, the contractor shall identify substitute candidates meeting the requirements and provide all documentation for the substituted macaque. The Contractor shall provide the actual paperwork of all results received from outside diagnostic laboratory testing to the COR. a. Week 1, testing: start within 15 business days of the COR’s notification. i .First TB Test (Note: Three tests required in all at two-week intervals. Must be negative) ii. Microbiology by PCR (i.e. Shigella, Campylobacter, Salmonella, Yersinia, E.coli (EAEC, EPEC, ETEC, STEC, EIEC), and giardia) iii. Ova and parasite (i.e. Trichuris and cryptosporidium) b. Week 3, testing: i. Second TB Test, two weeks after the first ii. Measles, SIV, SRV, STLV, and Macacine alphaherpesvirus 1 (B virus) serology iii. SRV type D PCR The Contractor shall perform the following testing and exam (“a” below), provide results to the COR or CDC veterinarians. Medical exam records shall be gathered and sent to CDC COR and CDC veterinarian upon completion. a. Week 5, testing and exam: iv. Third TB test, two weeks after the second v. Microbiology by PCR (i.e. Shigella, Campylobacter, Salmonella, Yersinia, Ecoli (EAEC, EPEC, ETEC, STEC, EIEC), and giardia) vi. Ova and parasite (i.e. Trichuris and cryptosporidium) vii. Physical exam requirement-- The Contractor’s veterinarian(s) shall perform physical exams (including collection of blood for Complete Blood Count (CBC) and blood chemistry and urine for urinalysis) and weight determination with body condition scoring on the macaques. 1. (Note: Contractor’s Pre-delivery exam is also required 2-3 days prior to delivery date. Within 7 business days of receiving the third TB, fecal examination for internal parasites, and microbiology by PCR (e.g. Shigella, Campylobacter, Salmonella, Yersinia) testing, provide records and results to the COR or CDC veterinarians. CDC will notify or further confirm to the Contractor of post selected/acceptability of the macaques and provide confirmation of selected macaques. Note: If the COR or CDC veterinarian rejects a macaque for any reason after the third TB and second microbiology tests and the number remaining is less than 20, the contractor shall identify additional substitute/alternate candidate NHPs meeting the requirements and provide all documentation and testing for the substitution/alternate macaque (as specified in this statement of work). This replacement effort to screen additional macaques to bring the total to 20 shall not incur added cost to CDC. 3. Delivery instruction for 20 rhesus macaques After CDC’s notification, the Contractor shall coordinate with CDC, the delivery of the final 20 selected/approved macaques. Delivery date must be within four weeks of the initial CDC notification. The Contractor’s transport company must be USDA licensed as either a carrier or intermediate handler or if a secondary subcontractor is used, a contract carrier. Per 2022 USDA regulations, Contractor shall provide a copy of their transport ‘contingency plan’ for review by the COR and CDC veterinarians. Perform pre-delivery physical exams 2-3 days prior to delivery date to ensure safety and health of selected macaques. Prepare the exam records and send to CDC veterinarian before the delivery date of the macaques. The Contractor shall deliver the 20 rhesus macaques to the designated CDC Atlanta facility following the delivery requirement below: a. Schedule an appointment for delivery not less than 7 days in advance of delivery by contacting the COR and CDC veterinarian. b. Provide driver’s name and contact information at least 7 days prior to delivery, needed for security clearance at CDC. Driver(s) must be a US citizen(s). c. Delivery shall be during CDC’s regular business hours: 9:00AM to 3:00PM, ideally Tuesday through Thursday, except on Federal holidays. Driver should notify the CDC COR or veterinarian when they are approximately 60 minutes from the facility. Special arrangements must be made prior to delivery if outside of regular business hours or if a delivery day might include a Monday or Friday. d. Delivery Location: CDC, Roybal Campus, 1600 Clifton Road, NE, Building 23, Atlanta, GA 30329 (loading dock). Period of Performance June 29, 2024 – June 30, 2025 - Tasks must be performed to ensure that macaques can be delivered physically to CDC during 12 months. Delivery on or before June 30, 2025. Minimum Contractor Qualifications The contractor should have the capacity, license, insurance to provide and transport safely and treat humanely nonhuman primates and cages. Also, the contractor shall have or provide transportation company drivers that are US citizens for CDC security approval to access CDC campus. To transport macaques, the contractor must be USDA licensed as either a carrier or intermediate handler or, if a secondary subcontractor is used, a contract carrier. Per 2022 USDA regulations, contractor shall provide a copy of their transport ‘contingency plan’ for review by CDC COR, technical advisor, and veterinarians. The Contractor shall have macaque facilities fully accredited by AAALAC. The Contractor shall maintain its primates in complex social and physical environments in order to provide behaviorally and medically healthy macaques other than during diagnostic testing or as clinically necessary for treatment. The contractor shall have no history of providing macaques that had been exposed to TB or tested positive to TB, SIV, SRV, and/or STLV, Shigella, Campylobacter, Salmonella, Yersinia, and/or pregnant (if females) to the DHP Laboratory Branch in the past 15 years. Principal Investigators (PIs) and Veterinarians shall have a minimum of 4 years of experience working with Non-human Primates. The Contractor shall provide past performance history of selling Non-human Primates. The past performance history shall include no fewer than three (3) of the most recent contracts, preferably within the past five (5) years. All vendors must be registered in the System for Award Management (SAM) at www.sam.gov.