This program’s purpose is to support NAMRU-2 to improve disease surveillance activities, evaluate novel diagnostics products and therapeutic interventions, test disease control strategies, and develop local expertise via training to detect and respond to emergent disease threats. Vysnova’s goal is to understand and combat infectious diseases and vector-borne illnesses including Malaria, Dengue, Chikungunya as well as the burden and distribution of Swine Flu, Bird Flu, SARS-CoV-2, MERS-CoV, and other emerging infectious diseases.

Problem:

Obtaining approvals for a clinical trial is complex and timely including our clinical trial entitled “Safety, Tolerability, the Pharmacokinetics of Tafenoquine after Weekly and Escalating Monthly Doses of Tafenoquine in Healthy Vietnamese Volunteers” in Vietnam.  There have been so many changes in the protocol from the initial version to a finalized one and each change might require approval from the leadership of the involved parties. In addition, due to the COVID situation, it takes much longer to obtain approvals from the Vietnam Ministry of Health, the U.S. Naval Medical Research Center IRB, and the U.S. Navy Human Research Protection Official (HRPO).

The Work:

Vysnova has accelerated this approval process by providing appropriate instructions to the local partners, responding to any requirement for changes immediately as well as providing all required documents as quickly as possible. We also followed up with our local partners and NAMRU-2 regularly to get immediate updates on the approval process.

The Vysnova impact:

We were able to obtain the IRB approvals from the Vietnam MOH and NMRC in December 2021 and expect to receive the final HRPO approval in January 2022. The team plans to start the sample collection activities in February 2022 and expects to complete this study by December 2022. This research would help combat the spread of drug-resistant malaria in and from Vietnam by monitoring the effectiveness of current malaria treatment therapies, testing drug susceptibility of malaria parasites, and developing new malaria treatment modalities.