A Study to Evaluate the Safety and Immunogenicity of Ad5-105K in Adults Aged 18 to 49 Years

Launched by CANSINO BIOLOGICS INC. · Dec 10, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new vaccine called Ad5-105K to see if it is safe and can help the body build protection against tuberculosis (TB) in healthy adults aged 18 to 49. The study will have two groups of participants: one group will receive the vaccine and the other group will receive a placebo, which is a substance with no active ingredients. The study is designed to ensure that both groups are similar in age and gender, allowing researchers to get clear results about the vaccine's effectiveness.

To participate, individuals need to be healthy, have a positive test for TB exposure (but no history of active TB disease), and agree to follow the study's requirements, like attending follow-up visits. Women who can become pregnant must have a negative pregnancy test and use contraception during the study. Participants can expect to receive a vaccine or a placebo and will be monitored for any reactions or side effects. It's important to note that this trial is not currently recruiting participants, so there will be no immediate opportunities to join.

Gender

ALL

Eligibility criteria

• 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 treatment, etc. (excluding local treatments, surface treatments for acute non-concurrent dermatitis or spray treatment for allergic rhinitis) in the past 6 months (internal time \<6 months).
• • History of, or plans to use, blood/plasma products or immunoglobulins within 60 days prior to study vaccination or at any time during the study period.
• • Uncontrolled severe hypertension (at the time of field measurement: systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥100 mmHg).
• • Suffering from a serious chronic disease or a condition that is in a progressive stage and cannot be adequately controlled (e.g., thyroid disease), or having known or suspected diseases that at investigators' discretion, may affect vaccination or immunogenicity test results (e.g., diagnosed with asthma within the last 20 years, severe respiratory disease, acute infection or active chronic disease, severe cardiovascular disease, severe liver or kidney disease, malignancy, severe infectious or allergic skin disease).
• • History of serious adverse reactions associated with the adenovirus vector-based vaccine and/or history of severe allergic reactions (e.g., systemic allergic reactions) to any component of the study vaccine.
• • Immunocompromised individuals with known or suspected immunodeficiency as determined by medical history and/or physical examination (e.g., HIV infection, or a history of pancreatic, liver, spleen, kidney disease, or a history of organ resection).
• • Bleeding constitution or condition associated with prolonged bleeding for which IM injection is contraindicated, in the opinion of the investigator.
• • History of administration of any vaccine within the past three months.
• • History of receiving experimental Mycobacterium tuberculosis (Mtb) vaccines or participation in other interventional studies within 28 days prior to screening and/or during study participation.