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Could a Decades-Old smallpox vaccine stop mpox? colombia trial aims to find out

NCT ID NCT06223919

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This Phase 3 trial in Colombia tests the LC16m8 vaccine, originally developed for smallpox, to see if it can prevent mpox in people at high risk, such as men who have sex with men and those with HIV. About 8,686 participants will be randomly assigned to get the vaccine right away or after a delay. Researchers will compare infection rates and side effects between the groups over 180 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
LC16m8 (live attenuated vaccinia virus vaccine)
What this could lead to
If successful, this vaccine could help prevent mpox in high-risk populations, including people with HIV, and reduce severe illness.
What could go wrong
Mpox cases have dropped recently in Colombia, making it harder to measure effectiveness. The trial is also open-label, which can introduce bias.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 8,686 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2023

Expected to finish

Dec 2025

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

1. Inclusion Criteria: 1. Sex: Males and females 2. Age: ≥18 and ≤ 50 years old 3. Persons must be willing and sign the Informed Consent (I.C.). 4. Any of the following conditions including clinical conditions /manifestation: * People living with the HIV, with stable infection determined by participant´s being on antiretroviral therapy with a blood CD4+ cell count, ≥ 200 cells/mm3 in the last six months before study enrolment 5. Persons that use PrEP (HIV Pre-exposure prophylaxis). 6. Homosexual, Bisexual, or other men who have sex with men (MSM) with multiple sexual partners. Commercial sex workers (CSW) and partners CSW 7. A female participant is eligible to participate if the participant meets one of the inclusion criteria numbered -1, -2 or -3 above. The participant cannot be pregnant or lactating. Additionally, the female participant must meet one of the following conditions: * The participant has non-childbearing potential. To be considered of non-childbearing potential, a female must be post-menopausal for at least one year or surgically sterile. OR * The participant has a childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks before the vaccine administration until at least 2 months after the administration and have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 10 days before vaccination. 2. Exclusion Criteria: 1. Subjects with an unstable medical condition as determined by their initial medical history, physical examination, or laboratory results 2. Subjects with a terminal disease. 3. Subjects with a medical record of anaphylaxis caused by any of the vaccine's excipients or with previous undesired reactions to other vaccines such us (Allergic reactions, Guillain barre syndrome, Varicella zoster, or shingles). 4. Previous medical record of Mpox. 5. Subjects living with HIV with a CD4+ T cell count of fewer than 200 cells/mm3. 6. Pregnant or breastfeeding woman. 7. Active or medical record of atopic dermatitis or eczema, or with close contact with someone with an active or medical record of atopic dermatitis or eczema. 8. The presence of a skin condition with extensive breaks in the skin, such as burns, impetigo, contact dermatitis, or zoster (shingles), is not likely to heal by the day of vaccination. 9. Using immunosuppressive medications, in eye drops, by mouth, or topically (nasal sprays and inhaled corticosteroids are permissible). 10. Active or past malignancy except for cutaneous basal or squamous cell carcinomas. 11. An Autoimmune disease. 12. History of heart failure with decreased left ventricular ejection fraction (\<40%). 13. Medical record of splenectomy. 14. Medical record of solid organ or bone marrow transplantation. 15. Medical record of keloid scar development 16. Psychiatric condition that precludes compliance with the protocol. 17. People who received or plan to receive licensed live vaccines 30 days before or after study vaccination. 18. People who received or planned to receive immunoglobulin or other blood products 60 days before HIV screening. 19. People who received or plan to receive experimental drugs/vaccines 30 days before study vaccination or before study completion. 20. People who received or planned to receive systemic immunosuppressive therapy and radiation therapy 30 days before or after the study vaccination. 21. Use of systemic chemotherapy within five years before the study vaccination. 22. Medical record of smallpox vaccination and/or evidence of scarring at the vaccination site. 23. Allergies to streptomycin sulfate and/or erythromycin lactobionate.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Clinica Universitaria Colombia - Centro Medico Teusaquillo

    Bogotá, Bogota D.C., Colombia

  • Hospital Universitario San Ignacio

    Bogotá, Bogota D.C., Colombia

  • Infecto Clinicos

    Bogotá, Bogota D.C., Colombia

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