Search / Trial NCT06223919

Efficacy/Effectiveness, Safety, and Immunogenicity of LC16m8 Mpox Vaccine in Colombia

Launched by UNIVERSIDAD NACIONAL DE COLOMBIA · Jan 16, 2024

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Trial Information

Current as of December 30, 2024

Active, not recruiting

Keywords

Vaccines Monkeypox Mpox Mpox Virus

ClinConnect Summary

Hypothesis: LC16m8 is a safe and effective vaccine for high-risk immunocompromised populations, including those living with HIV.

Intervention evaluation plan: Vaccinate with LC16m8 those people randomly assigned to two groups: immediate and deferred vaccination 1:1 with a follow-up period of 180 days to evaluate new cases infected by MPXV.

General design: This research is being carried out within the framework of the mpox vaccination implementation program in Colombia. It comprises the following three complementary components:

* Study section 1: Parallel open sequential randomized contro...

Gender

ALL

Eligibility criteria

  • 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.

Trial Officials

Carlos A Álvarez

Principal Investigator

Universidad Nacional de Colombia

About Universidad Nacional De Colombia

The Universidad Nacional de Colombia, a prestigious institution renowned for its commitment to academic excellence and research innovation, serves as a leading clinical trial sponsor in Colombia. With a focus on advancing medical knowledge and improving healthcare outcomes, the university conducts rigorous clinical trials across various fields, including pharmacology, public health, and epidemiology. By leveraging its multidisciplinary expertise and state-of-the-art facilities, the Universidad Nacional de Colombia aims to foster collaborative research initiatives that address pressing health challenges both locally and globally, while adhering to the highest ethical standards and regulatory requirements.

Locations

Bogotá, , Colombia

Bogotá, , Colombia

Bogotá, , Colombia

Bogotá, , Colombia

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0