Bacterial VaginosisPhase 2NCT05022212

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

A Phase 2 study testing LACTIN-V in people with Bacterial Vaginosis and HIV Infections, run by University of California, San Francisco at 1 site in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 23 years, women only
Conditions the study is for: Bacterial Vaginosis, HIV Infections
What is being tested?: LACTIN-V
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 45 participants
Where: 1 siteSouth Africa
Study dates: 10 May 2021to 31 Mar 2023
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 23 years
Women only
No healthy volunteers
Adult

Who may be able to join

FRESH study participant.
Capable of reading and writing English or isiZulu and voluntarily provide written informed consent to participate in the study and comply with all study procedures
HIV-negative
Nugent score 4-10 on vaginal Gram stain
Otherwise healthy women, 18-23 years of age on the day of enrolment
Regular predictable menstrual cycles or amenorrhoeic for at least 3 months due to use of a long-acting progestin.

Show all 15Show fewer

Willing to complete 7-day course of oral metronidazole.
Willing to be asked questions about personal medical health and sexual history
Willing to apply study agent vaginally and comply with study examinations
Willing to self-administer Study Product on dosing days that do not coincide with regular FRESH study visits.
Agree to try to abstain from sexual intercourse 12 hours prior to study visits that include a gynaecological exam (Randomization Visit 3, Follow-up Visit 11, Final Visit 19).
Agree to try to abstain from sexual intercourse for 12 hours after study product administration to ensure that the product will remain inside the vagina.
Agree to abstain from the use of any other vaginal product throughout the trial period from the time of enrolment through the end of the study.
Note: Intravaginal products include contraceptive creams such as Gynol II, gels, foams, sponges, lubricants not approved by the study investigators, tampons and douches.
Must be stable on a reliable method of long-acting birth control and agree to remain on, for the duration of the study (if of childbearing potential) or, of non-childbearing potential (permanently sterile).

Who cannot join

Urogenital infection (as tested during the FRESH Week 5 Study Visit, reported within 30 days of detection at the LACTIN-V Enrolment Visit).
Note: Urogenital infection includes urinary tract infection, Trichomonas (T.) vaginalis, Neisseria (N.) gonorrhoeae, Chlamydia (C.) trachomatis, Mycoplasma genitalium.
Diagnosis of two or more outbreaks of N. gonorrhoeae, C. trachomatis, T. vaginalis, Mycoplasma genitalium, or herpes simplex virus (herpes genitalis) within 6 months prior to enrolment.
Subject is ineligible if menstrual cycle length is less than 21 days
Subject is ineligible if deep epithelial disruption is observed on genital examination noted on or before the Randomization Visit
Positive for HIV (as tested during the FRESH Week 5 Study Visit, within 30 days of the LACTIN-V Enrolment Visit).

Show all 20Show fewer

Current pregnancy or within 2 months of last pregnancy
Vaginal or systemic antibiotic or antifungal therapy within 21 days of enrolment
Use of disulfiram within past 2 weeks or other contraindication to use of metronidazole
Any condition requiring regular periodic use of systemic antibiotics during participation in the trial
Investigational drug use other than LACTIN-V within 30 days or 10 half- lives of the drug, whichever is longer, of Enrolment Visit
Other planned participation in an investigational drug study while participating in this study
Intrauterine device (IUD) insertion or removal, pelvic surgery, cervical cryotherapy or cervical laser treatment within the last 2 months prior to enrolment
Use of vaginal ring (e.g, NuvaRing) within 3 days of enrolment or during the course of the study
Hysterectomy
Unwilling to complete 7 days of oral metronidazole (twice daily) with the last dose taken no later than 48 hours prior to randomization (minimum of 12 of 14 doses required)
Use of new long-acting hormonal treatments. Participant may be enrolled if stable (>1 month) on existing therapy as determined by the principal investigator (PI)
Known allergy to any component of LACTIN-V/placebo or metronidazole or to nitroimidazole derivatives or latex (condoms)
Any social, medical, or psychiatric condition including history of drug or alcohol abuse that in the opinion of the investigator would make it difficult for the participant to comply with study procedures
Any serious or chronic illness, deemed incompatible with study participation by the study doctor, including immunosuppression due to cancer chemotherapy, systemic corticosteroids.

Trial locations and contacts

1 site in 1 country.

South Africa1 site

FRESH (Females Rising through Education, Support and Health) Clinical Research Site
Durban, KwaZulu-Natal, 4066

Other trials in South Africa

About this study

Official title: Phase 2 Placebo-controlled Randomized Trial of LACTIN-V (Lactobacillus Crispatus CTV-05) Among Women at High Risk of HIV Acquisition in Durban, South Africa

Read the detailed description

We will conduct a randomized, placebo-controlled trial of the vaginal live biotherapeutic product LACTIN-V in 60 young South African women.

After being informed about the study and potential risks, all participants giving written informed consent will be enrolled if they meet eligibility criteria. At enrollment on Day 1, they will start a 7-day course of standard oral metronidazole treatment for bacterial vaginosis. Women who completed their metronidazole treatment will be randomized 2:1 to LACTIN-V vs. placebo. Within 8-48 hours of the final metronidazole dose, women will receive the study product for five consecutive days, followed by twice weekly for three additional weeks. Women will be followed during the dosing (4 weeks) and post-dosing phase (4 weeks) for a total of 64 days.

Conditions: Bacterial Vaginosis, HIV Infections
Being tested: LACTIN-V, Placebo
Keywords: Vaginal microbiome, bacterial Vaginosis, HIV infections
Medical subject headings: Vaginosis, Bacterial, HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LACTIN-VDrug
Also called Lactobacillus crispatus CTV-05
administered vaginally
PlaceboDrug
administered vaginally

Study groups in NCT05022212
Study group	Role	What they receive
LACTIN-V	Active comparator	LACTIN-V contains a naturally occurring human vaginal strain of Lactobacillus (L.) crispatus CTV- 05. At a potency of 2 x 109 cfu/dose, it is preserved in powder formulation, and applied by a vaginal applicator. Women will receive the study product for five consecutive days, followed by twice weekly for three additional weeks. Women will be followed during the dosing (4 weeks) and post-dosing phase (4 weeks) for a total of 64 days. Receives: Drug: LACTIN-V
Placebo	Placebo comparator	A matching placebo formulation without L. crispatus CTV-05 is supplied in an identical applicator containing just the powder formulation. Women will receive the placebo for five consecutive days, followed by twice weekly for three additional weeks. Women will be followed during the dosing (4 weeks) and post-dosing phase (4 weeks) for a total of 64 days. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Genital Tract Inflammation
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 log10 decrease in 3/8 markers between baseline and Day 64.
Measured: over 64 days
Number of Participants With Lactobacillus-dominant Vaginal Microbiota
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).
Measured: over 64 days
Number of Participants With Vaginal Colonization of L. Crispatus CTV-05
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).
Measured: over 64 days
Number of Participants With Vaginal Dysbiosis Indicated by a Nugent Score 4-10 on Vaginal Gram Stain
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.
Measured: over 64 days
Number of Participants Reporting Any Solicited Adverse Events (AEs) Through the Final Visit
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.
Measured: over 64 days
Number of Participants Willing to Use This Type of Product in the Future
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)
Measured: over 36 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 May 202131 Mar 2023

First posted26 Aug 2021
Study start10 May 2021
Primary completion31 Mar 2023
Study completion31 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Bacterial VaginosisStudies of the same condition, open and under way.
More trials run by University of California, San FranciscoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: We will conduct a randomized, placebo-controlled trial of the vaginal live biotherapeutic product LACTIN-V in 60 young South African women, randomizing women 2:1 to LACTIN-V vs. placebo.
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05022212
Sponsor's protocol ID: LV-007
Other IDs: 1R01HD098978
Status last verified: Jul 2024
First submitted: 7 May 2021
Last updated: 13 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Gosmann C, Anahtar MN, Handley SA, Farcasanu M, Abu-Ali G, Bowman BA, Padavattan N, Desai C, Droit L, Moodley A, Dong M, Chen Y, Ismail N, Ndung'u T, Ghebremichael MS, Wesemann DR, Mitchell C, Dong KL, Huttenhower C, Walker BD, Virgin HW, Kwon DS. Lactobacillus-Deficient Cervicovaginal Bacterial Communities Are Associated with Increased HIV Acquisition in Young South African Women. Immunity. 2017 Jan 17;46(1):29-37. doi: 10.1016/j.immuni.2016.12.013. Epub 2017 Jan 10.
PubMed 28087240
Mitchell C, Manhart LE, Thomas K, Fiedler T, Fredricks DN, Marrazzo J. Behavioral predictors of colonization with Lactobacillus crispatus or Lactobacillus jensenii after treatment for bacterial vaginosis: a cohort study. Infect Dis Obstet Gynecol. 2012;2012:706540. doi: 10.1155/2012/706540. Epub 2012 May 30.
PubMed 22693410
Cohen CR, Wierzbicki MR, French AL, Morris S, Newmann S, Reno H, Green L, Miller S, Powell J, Parks T, Hemmerling A. Randomized Trial of Lactin-V to Prevent Recurrence of Bacterial Vaginosis. N Engl J Med. 2020 May 14;382(20):1906-1915. doi: 10.1056/NEJMoa1915254.
PubMed 32402161
Hemmerling A, Harrison W, Schroeder A, Park J, Korn A, Shiboski S, Cohen CR. Phase 1 dose-ranging safety trial of Lactobacillus crispatus CTV-05 for the prevention of bacterial vaginosis. Sex Transm Dis. 2009 Sep;36(9):564-9. doi: 10.1097/OLQ.0b013e3181a74924.
PubMed 19543144
Hemmerling A, Harrison W, Schroeder A, Park J, Korn A, Shiboski S, Foster-Rosales A, Cohen CR. Phase 2a study assessing colonization efficiency, safety, and acceptability of Lactobacillus crispatus CTV-05 in women with bacterial vaginosis. Sex Transm Dis. 2010 Dec;37(12):745-50. doi: 10.1097/OLQ.0b013e3181e50026.
PubMed 20644497
Cohen CR, Duerr A, Pruithithada N, Rugpao S, Hillier S, Garcia P, Nelson K. Bacterial vaginosis and HIV seroprevalence among female commercial sex workers in Chiang Mai, Thailand. AIDS. 1995 Sep;9(9):1093-7. doi: 10.1097/00002030-199509000-00017.
PubMed 8527084
Mitchell C, Fredricks D, Agnew K, Hitti J. Hydrogen Peroxide-Producing Lactobacilli Are Associated With Lower Levels of Vaginal Interleukin-1beta, Independent of Bacterial Vaginosis. Sex Transm Dis. 2015 Jul;42(7):358-63. doi: 10.1097/OLQ.0000000000000298.
PubMed 26222747
Ngugi BM, Hemmerling A, Bukusi EA, Kikuvi G, Gikunju J, Shiboski S, Fredricks DN, Cohen CR. Effects of bacterial vaginosis-associated bacteria and sexual intercourse on vaginal colonization with the probiotic Lactobacillus crispatus CTV-05. Sex Transm Dis. 2011 Nov;38(11):1020-7. doi: 10.1097/OLQ.0b013e3182267ac4.
PubMed 21992977
Hemmerling A, Govender V, Dong K, Dong M, Pillay S, Ndung'u T, Bhoola A, Moodley J, Casillas G, Lagenaur L, Mitchell CM, Kwon DS, Cohen CR. Acceptability of the live biotherapeutic LACTIN-V (Lactobacillus crispatus CTV-05) among young women at high risk of HIV acquisition in South Africa: data from the phase 2 placebo-controlled trial. Front Reprod Health. 2025 Mar 25;7:1544458. doi: 10.3389/frph.2025.1544458. eCollection 2025.
PubMed 40206350
Hemmerling A, Mitchell CM, Demby S, Ghebremichael M, Elsherbini J, Xu J, Xulu N, Shih J, Dong K, Govender V, Pillay V, Ismail N, Casillas G, Moodley J, Bergerat A, Brunner T, Liebenberg L, Ngcapu S, Mbano I, Lagenaur L, Parks TP, Ndung'u T, Kwon DS, Cohen CR. 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. Lancet Microbe. 2025 Jun;6(6):101037. doi: 10.1016/j.lanmic.2024.101037. Epub 2025 Apr 4.
PubMed 40194532

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
Randomized, Open-label
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A Study to Test New Investigational Drugs (LCFA-01and LC103) for Bacterial Vaginosis (BV) Treatment
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Recruiting
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Study at a glance

From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 2 Placebo-controlled Randomized Trial of LACTIN-V (Lactobacillus Crispatus CTV-05) Among Women at High Risk of HIV Acquisition in Durban, South Africa
ClinicalTrials.gov ID: NCT05022212
Acronym / sponsor ID: LV-007
Conditions: Bacterial Vaginosis, HIV Infections
Keywords: Vaginal microbiome, bacterial Vaginosis, HIV infections
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: University of California, San FranciscoUniversity, hospital or other
Collaborators: University of KwaZulu, Harvard University, Aurum Institute, Health Systems Trust, Osel, Inc., Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: 10 May 2021 (actual)
Primary completion: 31 Mar 2023 (actual)
Study completion: 31 Mar 2023 (actual)
First posted: 26 Aug 2021 (actual)
Results: Posted 13 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

We will conduct a randomized, placebo-controlled trial of the vaginal live biotherapeutic product LACTIN-V in 60 young South African women.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2
Model description: We will conduct a randomized, placebo-controlled trial of the vaginal live biotherapeutic product LACTIN-V in 60 young South African women, randomizing women 2:1 to LACTIN-V vs. placebo.

Arm	Type	Receives
LACTIN-V	Active comparator	Drug: LACTIN-VLACTIN-V contains a naturally occurring human vaginal strain of Lactobacillus (L.) crispatus CTV- 05. At a potency of 2 x 109 cfu/dose, it is preserved in powder formulation, and applied by a vaginal applicator. Women will receive the study product for five consecutive days, followed by twice weekly for three additional weeks. Women will be followed during the dosing (4 weeks) and post-dosing phase (4 weeks) for a total of 64 days.
Placebo	Placebo comparator	Drug: PlaceboA matching placebo formulation without L. crispatus CTV-05 is supplied in an identical applicator containing just the powder formulation. Women will receive the placebo for five consecutive days, followed by twice weekly for three additional weeks. Women will be followed during the dosing (4 weeks) and post-dosing phase (4 weeks) for a total of 64 days.

Who may qualify

Ages: 18 to 23 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (15 listed)

FRESH study participant.
Capable of reading and writing English or isiZulu and voluntarily provide written informed consent to participate in the study and comply with all study procedures
HIV-negative
Nugent score 4-10 on vaginal Gram stain
Otherwise healthy women, 18-23 years of age on the day of enrolment

Key exclusion criteria (20 listed)

Urogenital infection (as tested during the FRESH Week 5 Study Visit, reported within 30 days of detection at the LACTIN-V Enrolment Visit).
Note: Urogenital infection includes urinary tract infection, Trichomonas (T.) vaginalis, Neisseria (N.) gonorrhoeae, Chlamydia (C.) trachomatis, Mycoplasma genitalium.
Diagnosis of two or more outbreaks of N. gonorrhoeae, C. trachomatis, T. vaginalis, Mycoplasma genitalium, or herpes simplex virus (herpes genitalis) within 6 months prior to enrolment.
Subject is ineligible if menstrual cycle length is less than 21 days
Subject is ineligible if deep epithelial disruption is observed on genital examination noted on or before the Randomization Visit

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LACTIN-VAlso: Lactobacillus crispatus CTV-05administered vaginally	Drug	LACTIN-V
Placeboadministered vaginally	Drug	Placebo

Primary outcome

Number of Participants With Genital Tract Inflammation
Time frame: 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 log10 decrease in 3/8 markers between baseline and Day 64.
Number of Participants With Lactobacillus-dominant Vaginal Microbiota
Time frame: 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).
Number of Participants With Vaginal Colonization of L. Crispatus CTV-05
Time frame: 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).
Number of Participants With Vaginal Dysbiosis Indicated by a Nugent Score 4-10 on Vaginal Gram Stain
Time frame: 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.
Number of Participants Reporting Any Solicited Adverse Events (AEs) Through the Final Visit
Time frame: 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.
Number of Participants Willing to Use This Type of Product in the Future
Time frame: 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)

Results and safety

Results posted to the registry on 13 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LACTIN-V	32	32
Placebo	13	11

Primary outcome: Number of Participants With Genital Tract Inflammation

Time frame: over 64 days. Count of participants. Unit: Participants

Measure	LACTIN-V n = 30	Placebo n = 11
Value	3	2

Population analysed: Available samples at baseline and Day 64: LACTIN-V n=30, Placebo n=11. The comparison of the LACTIN-V vs. placebo arms was performed on a modified Intent to Treat (mITT) population, excluding one placebo participant who was erroneously dispensed two doses of LACTIN-V. Additionally, missing samples at Day 64 from two participants in the LACTIN-V group and one participant in the placebo group.

Primary outcome: Number of Participants With Lactobacillus-dominant Vaginal Microbiota

Time frame: over 64 days. Count of participants. Unit: Participants

Measure	LACTIN-V n = 32	Placebo n = 12
L. crispatus dominant vaginal bacterial community (> 50% relative abundance) on Day 36	13	0
L. crispatus dominant vaginal bacterial community (> 50% relative abundance) on Day 64	8	1

Population analysed: The comparison of the LACTIN-V vs. placebo arms was performed on a modified Intent to Treat (mITT) population, excluding one placebo participant who was erroneously dispensed two doses of LACTIN-V. Available samples at Day 36: LACTIN-V n=32, Placebo n=12. Available samples at Day 64: LACTIN-V n=31, Placebo n=11.

Primary outcome: Number of Participants With Vaginal Colonization of L. Crispatus CTV-05

Time frame: over 64 days. Count of participants. Unit: Participants

Measure	LACTIN-V n = 32	Placebo n = 12
Detection of L. crispatus CTV-05 at Day 36	22	1
Detection of L. crispatus CTV-05 at Day 64	15	1

Population analysed: The comparison of the LACTIN-V vs. placebo arms was performed on a modified Intent to Treat (mITT) population, excluding one placebo participant who was erroneously dispensed two doses of LACTIN-V. Additionally, at Day 64 a missing sample from one participant in the placebo group. Available samples at Day 36: LACTIN-V n=32, Placebo n=12. Available samples at Day 64: LACTIN-V n=32, Placebo n=11.

Primary outcome: Number of Participants With Vaginal Dysbiosis Indicated by a Nugent Score 4-10 on Vaginal Gram Stain

Time frame: over 64 days. Count of participants. Unit: Participants

Measure	LACTIN-V n = 32	Placebo n = 12
Nugent Score 4-10 on Vaginal Gram Stain at Day 36	12	6
Nugent Score 4-10 on Vaginal Gram Stain at Day 64	15	6

Population analysed: The comparison of the LACTIN-V vs. placebo arms was performed on a modified Intent to Treat (mITT) population, excluding one placebo participant who was erroneously dispensed two doses of LACTIN-V. Additionally, at Day 36 a missing sample from one participant in the LACTIN-V group. Available samples at Day 36: LACTIN-V n=31, Placebo n=12. Available samples at Day 64: LACTIN-V n=32, Placebo n=12.

Adverse events

Time frame: 64 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LACTIN-V	0 of 32 (0%)	26 of 32 (81.3%)	0 of 32
Placebo	0 of 13 (0%)	9 of 13 (69.2%)	0 of 13

Limitations and caveats (from the sponsor): In consideration of a set of circumstances that complicated the study progress (a 1-year delay of study start because of COVID-19 in 2020, a further 4-month delay because of destruction of the clinic site during social unrest in July 2021, and expiration of study product in March 2023), the study team together with the DSMB and the sponsor NICHD decided to stop enrollment at the end of 2022 at n=45, instead of the initial goal of n=60.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 28087240Gosmann C, Anahtar MN, Handley SA, Farcasanu M, Abu-Ali G, Bowman BA, Padavattan N, Desai C, Droit L, Moodley A, Dong M, Chen Y, Ismail N, Ndung'u T, Ghebremichael MS, Wesemann DR, Mitchell C, Dong KL, Huttenhower C, Walker BD, Virgin HW, Kwon DS. Lactobacillus-Deficient Cervicovaginal Bacterial Communities Are Associated with Increased HIV Acquisition in Young South African Women. Immunity. 2017 Jan 17;46(1):29-37. doi: 10.1016/j.immuni.2016.12.013. Epub 2017 Jan 10.
Background: PubMed 22693410Mitchell C, Manhart LE, Thomas K, Fiedler T, Fredricks DN, Marrazzo J. Behavioral predictors of colonization with Lactobacillus crispatus or Lactobacillus jensenii after treatment for bacterial vaginosis: a cohort study. Infect Dis Obstet Gynecol. 2012;2012:706540. doi: 10.1155/2012/706540. Epub 2012 May 30.
Background: PubMed 32402161Cohen CR, Wierzbicki MR, French AL, Morris S, Newmann S, Reno H, Green L, Miller S, Powell J, Parks T, Hemmerling A. Randomized Trial of Lactin-V to Prevent Recurrence of Bacterial Vaginosis. N Engl J Med. 2020 May 14;382(20):1906-1915. doi: 10.1056/NEJMoa1915254.
Background: PubMed 19543144Hemmerling A, Harrison W, Schroeder A, Park J, Korn A, Shiboski S, Cohen CR. Phase 1 dose-ranging safety trial of Lactobacillus crispatus CTV-05 for the prevention of bacterial vaginosis. Sex Transm Dis. 2009 Sep;36(9):564-9. doi: 10.1097/OLQ.0b013e3181a74924.
Background: PubMed 20644497Hemmerling A, Harrison W, Schroeder A, Park J, Korn A, Shiboski S, Foster-Rosales A, Cohen CR. Phase 2a study assessing colonization efficiency, safety, and acceptability of Lactobacillus crispatus CTV-05 in women with bacterial vaginosis. Sex Transm Dis. 2010 Dec;37(12):745-50. doi: 10.1097/OLQ.0b013e3181e50026.
Background: PubMed 8527084Cohen CR, Duerr A, Pruithithada N, Rugpao S, Hillier S, Garcia P, Nelson K. Bacterial vaginosis and HIV seroprevalence among female commercial sex workers in Chiang Mai, Thailand. AIDS. 1995 Sep;9(9):1093-7. doi: 10.1097/00002030-199509000-00017.
Background: PubMed 26222747Mitchell C, Fredricks D, Agnew K, Hitti J. Hydrogen Peroxide-Producing Lactobacilli Are Associated With Lower Levels of Vaginal Interleukin-1beta, Independent of Bacterial Vaginosis. Sex Transm Dis. 2015 Jul;42(7):358-63. doi: 10.1097/OLQ.0000000000000298.
Background: PubMed 21992977Ngugi BM, Hemmerling A, Bukusi EA, Kikuvi G, Gikunju J, Shiboski S, Fredricks DN, Cohen CR. Effects of bacterial vaginosis-associated bacteria and sexual intercourse on vaginal colonization with the probiotic Lactobacillus crispatus CTV-05. Sex Transm Dis. 2011 Nov;38(11):1020-7. doi: 10.1097/OLQ.0b013e3182267ac4.
Derived from this study: PubMed 40206350Hemmerling A, Govender V, Dong K, Dong M, Pillay S, Ndung'u T, Bhoola A, Moodley J, Casillas G, Lagenaur L, Mitchell CM, Kwon DS, Cohen CR. Acceptability of the live biotherapeutic LACTIN-V (Lactobacillus crispatus CTV-05) among young women at high risk of HIV acquisition in South Africa: data from the phase 2 placebo-controlled trial. Front Reprod Health. 2025 Mar 25;7:1544458. doi: 10.3389/frph.2025.1544458. eCollection 2025.
Derived from this study: PubMed 40194532Hemmerling A, Mitchell CM, Demby S, Ghebremichael M, Elsherbini J, Xu J, Xulu N, Shih J, Dong K, Govender V, Pillay V, Ismail N, Casillas G, Moodley J, Bergerat A, Brunner T, Liebenberg L, Ngcapu S, Mbano I, Lagenaur L, Parks TP, Ndung'u T, Kwon DS, Cohen CR. 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. Lancet Microbe. 2025 Jun;6(6):101037. doi: 10.1016/j.lanmic.2024.101037. Epub 2025 Apr 4.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Craig R Cohen, MD MPH principal investigator

University of California, San Francisco

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LACTIN-V in people with Bacterial Vaginosis and HIV Infections, run by University of California, San Francisco at 1 site in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Genital Tract Inflammation (time frame: over 64 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05022212, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.