“Optimization of Aotus nancymaae non-human primate model for the development of multivalent Dengue vaccines using a self-amplifying RNA platform”.

The contractor will provide general classes of services including (but not limited to) project management, design and down selection of antigens for Dengue virus (DENV) vaccine, immunogenicity testing in a mice model, laboratory testing, shipment of samples (if needed), data analysis and reporting.

Monitoring activities will be conducted by NAMRU SOUTH and periodical monitoring visits and reports will be coordinated. Frequent communications such as monthly teleconferences are expected during the conduction of the study.

The following elements are required:

a. ANTIGEN DESIGN

A.1. LABORATORY ACTIVITIES

a.1.1. Antigen Design & Synthesis

a.1.2. RNA Manufacturing & Release

a.1.3. In vitro antigen characterization

b. EQUIPMENT, SUPPLIES AND MATERIALS

• The contractor will cover the costs of supplies and laboratory materials necessary for sample collection, transport, storage, and those for identification of novel antigens. The contractor shall provide the final vaccine candidates to NAMRU SOUTH to be tested for immunogenicity in the Aotus model.

c. SHIPMENTS

• The contractor shall perform shipments to NAMRU-SOUTH Lima facilities upon coordination with the NAMRU-SOUTH Parasitology. The delivery address is:

Parasitology – NAMRU-SOUTH

Av. Venezuela cd 36 S/N – Bellavista – Callao

• The Contractor shall include the following into the shipments of samples:

a. DENV vaccine candidates.

b. Mice samples for further immunogenicity studies if needed.

c. Any additional reagents to support Aotus vaccination procedures.

d. DELIVERABLES

The materials and services specifically listed and requested must be delivered in a timely manner and must be of good quality for pre-clinical administration.

• Immunogenicity studies performed in mice model.

• A minimum of 8 DENV vaccine candidates to test on the Aotus model.

• Enough quantity of vaccines expressed in micrograms per dose for testing immunogenicity in Aotus model.

• Sequence description of the vaccine candidates.

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e. SPECIAL REQUIREMENTS: A

f. TASK ORDERS: N/A

g. ANNUAL SCHEDULE:

Quarter 1

a) Organizational monthly meetings to discuss research progress and challenges.

b) Secure all ethical approvals and regulatory permits required for immunogenicity testing in the mice model.

c) Purchase of field and laboratory supplies.

d) Start synthesis of molecules.

e) Perform mice studies

Quarter 2

a) Evaluate immune responses in the mice model

b) Prepare the molecules to be tested in the Aotus model

c) Ship vaccine candidates to NAMRU SOUTH.

d) Send mice evaluation database, quality control of data analysis for preparation of manuscript.

Period of performance:

This PWS is for a one-year period of performance.