NCT07647107 A Phase I Study of Lipovaxin Tuberculosis Vaccine in Adult Healthy Populations
| NCT ID | NCT07647107 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | PT Bio Farma |
| Condition | Tuberculosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-09-08 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 60 participants in total. It began in 2026-09-08 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A Phase I, Double-Blind, Randomized, Placebo Controlled Trial to Evaluate Safety and Immunogenicity of Lipovaxin Tuberculosis Vaccine (Bio Farma) in Healthy Populations Aged 18-40 Years in Indonesia
Eligibility Criteria
Inclusion Criteria 1. Clinically Healthy participants aged 18-40 years; 2. Participants have been informed properly regarding the study and signed the informed consent form. 3. Participants will commit to comply with the instructions of the investigator and the schedule of the trial; 4. Participants must have a negative IGRA and sputum. 5. Clinically normal laboratory values for ureum, creatinine, SGOT, SGPT, complete blood count (CBC), urinalysis, coagulation test (PT, aPTT), total cholesterol, Globulin/Albumin ratio and CRP Exclusion Criteria: 1. Those who are currently diagnosed with tuberculosis or have a history of tuberculosis (positive IGRA or GenXpert sputum test or chest Xray suggestive of TB) and/or history of tuberculosis treatment; including TB Preventive Treatment (TPT); 2. There are serious chronic diseases, or the disease is in the advanced stage that cannot be controlled smoothly, such as diabetes and thyroid disease; 3. Currently suffering from or within 2 years of any of the following serious diseases, such as: advanced tumor, autoimmune disease, progressive atherosclerosis, acute exacerbation of the chronic obstructive pulmonary disease, acute or progressive liver or kidney disease, congestive heart failure, etc.; based on interview with participants 4. Those with known or suspected (or high-risk) immune function impairments or abnormalities, such as those receiving more than 20mg/day of systemic glucocorticoids for 14 consecutive days within the last 4 weeks, immunosuppressants within 3 months, and Those who received protein preparations or blood products or plasma extracts outside the gastrointestinal tract within 3 months; 5. People with allergic constitution, such as those with a history of allergy to two or more drugs or foods; a history of severe allergy to any component of the test vaccine, such as: anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenia Purpura, dyspnea, angioedema, etc.; or a history of the above-mentioned serious side effects after using any vaccine or drug in the past; history of bronchial asthma; 6. Current patients with HIV antibody positive for human immunodeficiency virus; 7. Women who are pregnant, breastfeeding, or have a positive urine pregnancy test during the screening period, or before vaccination, or who have childbearing plans during the study period; 8. Subjects receive any vaccination within 1 month before and after dosing; 9. Those who have participated in any other clinical research and used the investigational drug within 3 months before this clinical research; 10. Any other situation that the researcher believes may affect the evaluation of the research.
Frequently Asked Questions
Who can join the NCT07647107 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 40 Years, studying Tuberculosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07647107 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07647107 currently recruiting?
Yes, NCT07647107 is actively recruiting participants. Visit ClinicalTrials.gov or contact PT Bio Farma to inquire about joining.
Where is the NCT07647107 trial being conducted?
This trial is being conducted at Jakarta Pusat, Indonesia.
Who is sponsoring the NCT07647107 clinical trial?
NCT07647107 is sponsored by PT Bio Farma. The trial plans to enroll 60 participants.