Could a common bacteria protect women in SA from HIV?

Sr Xoli Ceasar from the FRESH site in Umlazi, gives dosing instructions to the first participant enrolled in the Lactin-V trial.

An innovative study is launching this week in the Umlazi township, south of Durban in KwaZulu-Natal, in which young women will receive a novel treatment aimed at lowering HIV risk.

The treatment, called Lactin-V, is derived from a strain of bacteria known as Lactobacillus that is naturally abundant in women who have low levels of vaginal inflammation that is associated with decreased HIV risk. Prior studies in South Africa have shown that women who have a deficiency of Lactobacillus have higher levels of vaginal inflammation and up to three-to-four-fold higher risk of HIV infection.

The FRESH research team, along with Prof Thumbi Ndung'u (UKZN, HPP) and Prof Craig Cohen (UCSF, USA) gives the "V" sign for Lactin-V on launch day

Researchers aim to discover whether treatment with Lactin-V can protect women from HIV by altering the composition of the vaginal microbiome to one associated with lower inflammation in the vaginal tract.

This first-in-Africa trial will enrol 60 healthy young women between 18 and 23 years of age, each receiving 11 doses of Lactin-V over the course of four weeks. Lactin-V has already been tested in 228 women in the US and shown to be safe.

This study represents a collaboration between investigators from four institutions: the HIV Pathogenesis Programme (HPP) at the University of KwaZulu-Natal (UKZN), the Aurum Institute based in Johannesburg, the University of California San Francisco (UCSF) and the Ragon Institute of MGH, MIT and Harvard.

“There is a pressing need for new HIV prevention and cure strategies that are effective in our setting, but also acceptable and easy to access by young women who are disproportionately affected by HIV,” said Professor Thumbi Ndung’u, scientific director of the HPP at UKZN and a co-principal investigator of the Lactin-V study. “Launching this clinical trial is an important milestone. We’ve made great progress towards understanding how HIV is transmitted and causes disease on a molecular level and can now translate that knowledge into new interventions that may benefit the community and accelerate the goal of Aids elimination.”

The FRESH (Females Rising through Education, Support and Health) clinical research team finalises preparations at the FRESH clinic in Umlazi.

Lactin-V, which was developed by Osel in Mountain View, California, can be stored at room temperature. Because the Lactobacillus strain used in the therapy occurs naturally in the vagina and is associated with vaginal health, the product has an excellent pre-clinical and clinical safety profile. It is designed to be user-friendly, delivered in an applicator inserted like a tampon, which can be easily incorporated into women’s daily routine.

“If Lactin-V can lower the risk of HIV infection without requiring young women to alter their behaviour, it could be a game-changer,” said Dr Krista Dong, clinical director of the FRESH research site where the trial is being conducted and an investigator from the Ragon Institute.

“Umlazi is my community, so I welcome this study that aims to help our daughters and granddaughters avoid HIV infection,” said Reverend Lucky Mngomezulu, who is a member of the community advisory board that provides oversight for HPP initiatives like the Lactin-V trial. “I am grateful to see that scientists from here in South Africa and around the world are thinking of us.”

Financial support for the study is provided by the US National Institute of Health, NICHD Grant 1R01HD098978.

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