LACTIN-V is being registered in South Africa for use in the FRESH clinical study. FRESH follows young women at risk for HIV and, among other objectives, regularly checks the parameters of their vaginal microbiome. Many women in the study have microbiota depleted of normal Lactobacillus strains, which leaves them vulnerable to infections, including HIV. One arm of the study hopes to show that LACTIN-V could decrease genital tract inflammation and lower their HIV acquisition risk.

Catalyst Global’s regulatory support includes regulatory planning, facilitation of the pre-registration (Type C) meeting with the South African regulatory authority, preparation and submission of the clinical trial application to the regulatory authority and the ethics committees, and subsequent protocol amendment submission and ongoing support.  

Our team communicates with the regulatory authority and the ethics committees throughout the study to facilitate the finalization of the regulatory processes needed prior to clinical trial initiation. We also provide assistance for the submission and renewal of clinical trial insurance, including reviewing drafts of study documents such as the protocol and informed consent to ensure compliance with requirements and communicating with the sponsor, UCSF. 

Countries:

South Africa

Project duration:

2017 – 2022

Funder:

University of California, San Francisco (UCSF) 

Product:

Biotherapeutic product aimed at reducing HIV transmission (LACTIN-V)