VIR260007_PWS.docx

Performance Work Statement

U.S. Naval Medical Research Unit SOUTH – Research Support Services

I. INTRODUCTION

The mission of the Armed Forces Health Surveillance Division (AFHSD) - Global Emerging Infections Surveillance (GEIS) Branch is to contribute to the protection of all Department of Defense healthcare beneficiaries, especially deployed U.S. military personnel, and the global community through an integrated worldwide surveillance system for emerging infectious diseases.

The U.S. Naval Medical Research Unit SOUTH (NAMRU SOUTH), an AFHSD-GEIS partner, leads the study entitled “Zika virus and other tropical pathogens in Latin America”, which addresses lines of efforts identified by USSOUTHCOM and targeted by AFHSD-GEIS.

II. BACKGROUND

AFHSD-GEIS provides direction, funding, and oversight to surveillance networks throughout many regions of the world. Working in conjunction with their host nations, these partners conduct disease surveillance in civilian- and military-relevant geographic areas, conduct risk assessments, support rapid outbreak response, provide accurate and actionable data for decision-makers, and encourage research and innovation.

In 1990, NAMRU SOUTH in Peru began a sentinel surveillance program to determine the etiology of febrile illnesses in Iquitos. In 2000, this was extended to other regions of Peru, and to additional Latin American countries: Ecuador, Colombia, Bolivia, Paraguay, Honduras, and Guatemala. This project has been instrumental in the discovery and epidemiology of new pathogens, the characterization of clinical symptoms circulating in the USSOUTHCOM AOR, the description of novel manifestations associated with various tropical pathogens, and the transmission dynamics of pathogens throughout the USSOUTHCOM AOR, to support operational readiness and Force Health Protection.

Respiratory and vector-borne infections are two essential GEIS-surveillance priorities. Latin America possesses a wide spectrum of viral, bacterial, and parasitic agents as varied as its geography and people. These pathogens are among the leading causes of morbidity and mortality in human and domestic animal populations worldwide. The threat of infection continues to increase due to rapid population growth, expanding urbanization, extensive air travel, environmental changes, and a paucity of effective intervention strategies. Some of the more noteworthy re-emerging and emerging diseases include COVID-19 caused by SARS-CoV-2, influenza A (H1N1) pdm09, dengue, malaria, yellow fever, Venezuelan Equine Encephalitis (VEE), Oropouche fever, Mayaro fever, and rickettsiosis, among others. Recently, influenza, SARS-CoV-2, chikungunya, Zika, and Oropouche viruses infections were found to play an important role in the causes of acute febrile illness in South and Central America and are a major threat to deployed military troops.

This study aims to collect samples for surveillance of acute febrile or exanthematous illnesses in Urabá, Colombia. Urabá is a critical geographic and epidemiological region in Colombia located close to the border with Panama. As a migratory corridor between Central and South America, it is characterized by high population mobility and a significant risk of introduction and sustained transmission of emerging and reemerging arboviruses. Strengthening surveillance systems in this region is essential for timely detection, risk assessment, and response to public health threats.

Samples will be collected from military and civilian populations with acute febrile or exanthematous syndromes, as defined by the protocol case definition, to determine their etiology.

III. GENERAL REQUIREMENTS

The study site will be located in the Urabá region, Antioquia, Colombia.

The contractor will identify dengue and other vector-borne and rodent-borne diseases in collected specimens.

The contractor shall provide demographic and laboratory test results to NAMRU SOUTH in a de-identified manner.

IV. PERFORMANCE REQUIREMENTS

The requirement is for a one-year, 12-month base period of performance from May 4, 2026 to May 3, 2027.

The contractor will provide general classes of services, including (but not limited to) project management, provision of clinical samples, laboratory testing, shipment of samples, data analysis, and reporting.

Laboratory molecular testing will be performed by the contractor in response to NAMRU SOUTH requirements.

Monitoring activities will be conducted by NAMRU SOUTH, and monitoring visits and reports will be coordinated periodically. Frequent communication, such as monthly teleconferences, is expected during the study.

Where required, the contractor will follow all provisions of the non-human use protocol approved by the NAMRU SOUTH Institutional Review Board (IRB).

The following elements are required:

A. FIELD WORK ACTIVITIES

The Contractor shall:

a. Obtain all ethical approvals and regulatory permits required for enrolling human subjects and collecting human specimens in Urabá, Antioquia, Colombia, and shipping specimens to NAMRU SOUTH as required.

b. Coordinate the implementation of surveillance activities through passive or active sample collection.

c. Collect whole blood and serum samples from at least 120 subjects.

d. Collect epidemiological data and biological specimens as defined by the governing non-human use protocol.

e. Packaging and local shipment of samples from the field site to a central laboratory for testing.

f. The contractor will provide feedback on site performance, identify problems early, and provide solutions.

B. LABORATORY ACTIVITIES

The Contractor shall:

a. Perform at least a dengue rapid test on collected specimens on site. Other rapid tests will be performed, depending on the availability of tests provided by NAMRU SOUTH.

b. Perform molecular tests (RT-qPCR) for, but not limited to, dengue, chikungunya, Mayaro, Oropouche, Venezuelan equine encephalitis, and yellow fever viruses on at least 90% of specimens collected from volunteers with febrile or exanthematous illnesses at least once a month.

c. Perform molecular tests (RT-qPCR) for Leptospira on at least 50% of specimens collected from volunteers with febrile or exanthematous illnesses at least every two months.

d. Perform indirect immunofluorescence assay against spotted fever group rickettsiosis on at least 50% of specimens collected from volunteers with febrile or exanthematous illnesses at least every two months.

e. Perform a molecular test (FilmArray) on at least 10% of specimens collected from volunteers with febrile or exanthematous illnesses that are negative for RT-PCR. This activity will depend on the availability of equipment and reagents provided by NAMRU SOUTH.

f. Label and store samples under proper cold-chain conditions (-70°C to -80°C).

g. Prepare biological samples for shipment to NAMRU SOUTH or the designated laboratory, ensuring they are kept in proper cold-chain conditions. NAMRU SOUTH delivery address:

U.S. Embassy – NAMRU SOUTH Ref: Departamento de Virología Unidad de Investigación Médica de la Marina de los EE. UU.- NAMRU SOUTH Av. Venezuela cuadra 36 s/n Bellavista–Callao Perú

C. DATA MANAGEMENT

The Contractor shall:

a. Upload into a database with a unique identification number provided by NAMRU SOUTH, the following variables: demographic information (occupation, age, sex, enrollment site up to the district level), data on the onset of symptoms, sample collection data, laboratory test results, and other relevant epidemiological data as requested by NAMRU SOUTH.

b. Provide weekly and monthly reports to NAMRU SOUTH.

c. All tasks shall be performed in accordance with the IRB-approved government research protocol. In no instance shall Contract personnel perform an inherently governmental function.

d. Performed data transfer using DoD SAFE (https://safe.apps.mil/), which transfers files encrypted while in transit.

e. Provide input for reports and scientific manuscripts preparation and participate in authorship of the resulting publication.

D. EQUIPMENT, SUPPLIES, AND MATERIALS

a. The contractor will cover the costs of supplies and materials needed for sample collection, transport, storage, and laboratory processing of human specimens.

b. Depending on funding availability, NAMRU SOUTH will provide FilmArray testing panels for up to 12 subjects, Rickettsia and Hantavirus rapid tests for at least 50 subjects.

c. Government furnished equipment: NAMRU SOUTH will provide the following equipment to the contractor when available. These will be returned to NAMRU SOUTH at the end of the contract.

i. BioFire FilmArray 2.0, Serial number: 2FA08813-I.

ii. Laptop Hewlett Packard, Model ProBook 640-5 Serial number: 5CG0354YML (accessory to 2FA08813-I).

iii. The BioFire FilmArray will be located at Instituto Colombiano de Medicina Tropical, Apartado site, Antioquia, Colombia, or another location as requested by NAMRU SOUTH.

E. DELIVERABLES

The materials and services specifically listed and requested must be delivered in a timely manner and must be of good quality. Deliverables by date are:

a. Collect a minimum of 120 clinical samples.

b. Perform dengue rapid test on at least 120 samples on the field.

c. Perform other available rapid tests on at least 50 samples on the field.

d. Perform molecular tests for vector-borne viruses on at least 108 samples.

e. Perform molecular tests for Leptospira for at least 50 negative samples by RT-qPCR for vector-borne viruses.

f. Perform indirect immunofluorescence assay against spotted fever group rickettsiosis for at least 50 negative samples by RT-qPCR for vector-borne viruses.

g. Perform molecular tests (FilmArray) on at least 12 negative samples.

h. Perform data transfer using DoD SAFE (https://safe.apps.mil/) to the Principal Investigator at NAMRU SOUTH.

i. Send weekly reports.

j. Send complete technical reports monthly.