NCT05022212

Phase 2 Trial of LACTIN-V in Women at High Risk of HIV Acquisition

Completed Phase 2 Results posted Last updated 13 August 2024

What this trial tests

Phase 2 trial testing LACTIN-V in Bacterial Vaginosis in 45 participants. Completed in 31 March 2023.

Timeline

10 May 2021

Primary endpoint
31 March 2023

31 March 2023

Quick facts

Lead sponsor	University of California, San Francisco
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	45
Start date	10 May 2021
Primary completion	31 March 2023
Estimated completion	31 March 2023
Sites	1 location across South Africa

Drugs / interventions tested

• LACTIN-V — full drug profile →
• Placebo

Conditions studied

• Bacterial Vaginosis — all drugs for Bacterial Vaginosis →
• HIV Infections — all drugs for HIV Infections →

Sponsor

University of California, San Francisco

Who can join

Adults 18 to 23, female only, with Bacterial Vaginosis or HIV Infections. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Genital Tract Inflammation Primary · over 64 days

The proportion of participants with decreased genital tract proinflammatory cytokines and HIV target cells over 64 days of follow up, compared to levels at baseline. The outcome will be a change in immune parameters after treatment with LACTIN-V in comparison to placebo (proinflammatory cytokines in genital fluid, activated endocervical HIV target cells and the anti-HIV effect of vaginal secretions), measured as the number and proportions of endocervical CD4+ HIV target cells (i.e., CD4+/CCR5+/HLA-DR+/CD38+ T cells) at Day 64. Decreased inflammation will be defined using a measure of \>1 log

Group	Value	95% CI
LACTIN-V	3
Placebo	2

Number of Participants With Lactobacillus-dominant Vaginal Microbiota Primary · over 64 days

The proportion of participants with Lactobacillus-dominant vaginal microbiota in young South African women. Measured will be dominance of Lactobacillus crispatus (defined as \> 50% relative abundance) after the intervention. Our primary outcome is measured at Day 36 (after 4 weeks of treatment with LACTIN-V), and at Day 64 (following the post- dosing phase).

L. crispatus dominant vaginal bacterial community (> 50% relative abundance) on Day 36

Group	Value	95% CI
LACTIN-V	13
Placebo	0

L. crispatus dominant vaginal bacterial community (> 50% relative abundance) on Day 64

Group	Value	95% CI
LACTIN-V	8
Placebo	1

Number of Participants With Vaginal Colonization of L. Crispatus CTV-05 Primary · over 64 days

The proportion of participants experiencing successful colonization with L. crispatus CTV-05 following dose of study product through the final visit (Day 64) in the LACTIN-V arm. This primary outcome is measured at Day 36 (after 4 weeks of treatment with LACTIN-V), and at Day 64 (following the post- dosing phase).

Detection of L. crispatus CTV-05 at Day 36

Group	Value	95% CI
LACTIN-V	22
Placebo	1

Detection of L. crispatus CTV-05 at Day 64

Group	Value	95% CI
LACTIN-V	15
Placebo	1

Number of Participants With Vaginal Dysbiosis Indicated by a Nugent Score 4-10 on Vaginal Gram Stain Primary · over 64 days

The proportion of participants with a positive test for vaginal dysbiosis (Nugent Score 4-10 on vaginal Gram Stain) in each study arm by Day 36 and Day 64. The Nugent Score has values from 0 -10. 0-3 describes an optimal vaginal microbiome with lactobacilli but little bacterial diversity, 4-6 is an intermediate score, and 7-10 characterizes a vaginal microbiome with few lactobacilli and an overgrowth of pathogens.

Nugent Score 4-10 on Vaginal Gram Stain at Day 36

Group	Value	95% CI
LACTIN-V	12
Placebo	6

Nugent Score 4-10 on Vaginal Gram Stain at Day 64

Group	Value	95% CI
LACTIN-V	15
Placebo	6

Number of Participants Reporting Any Solicited Adverse Events (AEs) Through the Final Visit Primary · over 64 days

Overall Safety of LACTIN-V and the applicator will be measured by the proportion of participants reporting any solicited Adverse Events (AEs) through the final visit on Day 64, compared between study arms.

Group	Value	95% CI
LACTIN-V	26
Placebo	9

Number of Participants Willing to Use This Type of Product in the Future Primary · over 36 days

Acceptability of LACTIN-V and the applicator will be measured by standardized questionnaire about acceptability of the study product and participants' stated willingness to use this type of product in the future, in each study arm. (Question "I would use the product again", on Day 36)

Group	Value	95% CI
LACTIN-V	11
Placebo	3
LACTIN-V	11
Placebo	7
LACTIN-V	5
Placebo	3
LACTIN-V	2
Placebo	0

Adverse events — posted to ClinicalTrials.gov

Time frame: 64 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

LACTIN-V

Serious: 0/32 (0%)

Deaths: 0/32

Placebo

Serious: 0/13 (0%)

Deaths: 0/13

Other adverse events (29 terms — click to expand)

Reaction	System	LACTIN-V	Placebo
vaginal bleeding other than menstruation	Reproductive system and breast disorders	—	—
Abnormal vaginal discharge	Reproductive system and breast disorders	—	—
genital itching or burning	Reproductive system and breast disorders	—	—
abdominal pain / cramps	Reproductive system and breast disorders	—	—
headache	Nervous system disorders	—	—
Abnormal vaginal odor	Reproductive system and breast disorders	—	—
nausea	General disorders	—	—
pain/ burning with urination	Renal and urinary disorders	—	—
abnormal discharge	Reproductive system and breast disorders	—	—
headache	Nervous system disorders	—	—
external genital irritiation	Reproductive system and breast disorders	—	—
external genital swelling	Reproductive system and breast disorders	—	—
constipation	Gastrointestinal disorders	—	—
diarrhea	Gastrointestinal disorders	—	—
frequent urination	Renal and urinary disorders	—	—
vomiting	General disorders	—	—
urine odor	Renal and urinary disorders	—	—
toothache	Gastrointestinal disorders	—	—
pustule	Infections and infestations	—	—
folliculitis	Infections and infestations	—	—
chest discomfort	General disorders	—	—
eye infection, viral	Infections and infestations	—	—
viral skin infection	Infections and infestations	—	—
papular rash	Skin and subcutaneous tissue disorders	—	—
dizziness	Nervous system disorders	—	—
genital ulceration	Reproductive system and breast disorders	—	—
chlamydial infection	Infections and infestations	—	—
nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—
subcutaneous abscess	Infections and infestations	—	—

Data from ClinicalTrials.gov NCT05022212 adverse events section.

Sponsor's own description

The purpose of this study is to assess the impact of LACTIN-V, a vaginally administered live biotherapeutic product (LBP) that contains the human L. crispatus CTV-05 strain, on the vaginal microbiome of Lactobacillus-deficient young women in the South African FRESH study who are at high risk for HIV acquisition.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effect of the vaginal live biotherapeutic LACTIN-V (Lactobacillus crispatus CTV-05) on vaginal microbiota and genital tract inflammation among women at high risk of HIV acquisition in South Africa: a phase 2, randomised, placebo-controlled trial.
   Hemmerling A, Mitchell CM, Demby S, Ghebremichael M, et al · · 2025 · cited 13× · PMID 40194532 · DOI 10.1016/j.lanmic.2024.101037
2. Acceptability of the live biotherapeutic LACTIN-V (<i>Lactobacillus crispatus</i> CTV-05) among young women at high risk of HIV acquisition in South Africa: data from the phase 2 placebo-controlled trial.
   Hemmerling A, Govender V, Dong K, Dong M, et al · · 2025 · PMID 40206350 · DOI 10.3389/frph.2025.1544458