A Study to Evaluate the Safety and Immunogenicity of Ad5-105K in Adults Aged 18 to 49 Years (NCT06732583) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study to Evaluate the Safety and Immunogenicity of Ad5-105K in Adults Aged 18 to 49 Years
Indonesia36 participantsStarted 2025-11-13
Plain-language summary
This is a randomized, observer-blind, positive-controlled study. There will be 2 treatment groups (Group A and B). In each treatment group, 18 participants will be randomly assigned to receive either the investigational vaccine (Dose A or Dose B of Ad5-105K) or a placebo in a ratio of 2:1. The distribution of participant's gender and age should be balanced in each group.
Who can participate
Age range18 Years – 49 Years
SexALL
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Inclusion Criteria:
* Participants who, in the opinion of the investigator, are able and willing to comply with the requirements of the protocol (e.g., completion of diary cards, returning for follow-up visits).
* Healthy male or female participants aged 18 to 49 years, at the time of obtaining informed consent.
* Written (or thumb printed and witnessed) informed consent obtained from the participant.
* Positive IGRA test with no history of TB disease or treatment.
* Female participants of childbearing potential must have a negative urine pregnancy test at screening and on the day of vaccination. Male and female participants of childbearing potential must agree to use adequate contraception for the entire duration of their participation in the study.
* History of BCG vaccination.
Exclusion Criteria:
* Current TB disease, or a history of TB disease and/or treatment for TB (including Tuberculosis Preventive Therapy (TPT)).
* Known history of close or household contact with active TB patient.
* Axillary temperature ≥37.5°C.
* Presence of congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
* Lactating women.
* Individuals who smoke more than 10 cigarettes per day within the last 3 months and/or more than 2 cigars per day, and/or vapers who use more than 5 ml of e-liquid daily.
* Individuals with positive HIV, HBV, HCV, or TP (Treponema pallidum) test.
* History of immunosuppressive treatment, cytotoxic treatment, or glucocorticoid tr…