New TB vaccine candidate enters human testing
NCT ID NCT07647107
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests an experimental tuberculosis vaccine called Lipovaxin in healthy adults aged 18 to 40 in Indonesia. The vaccine is given as two shots, 28 days apart, and compared to a placebo. The main goals are to check if the vaccine is safe and whether it triggers an immune response against TB.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Lipovaxin tuberculosis vaccine
- What this could lead to
- If successful, this could pave the way for a new vaccine to prevent tuberculosis, a major global health threat.
- What could go wrong
- This is an early Phase 1 trial with only 60 participants, focused on safety and immune response, not yet on preventing disease. The vaccine may not produce strong enough immunity or could cause side effects.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 40 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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.
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.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cipto Mangunkusumo Hospital, Jl. Pangeran Diponegoro No. 71, Kenari, Jakarta Pusat, DKI Jakarta.
Jakarta Pusat, DKI Jakarta, 10430, Indonesia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Once-Daily HIV pill with food match Twice-Daily dosing during TB treatment?
- Can simple sputum and urine tests catch tuberculosis earlier?
- Can a common virus be turned into a TB vaccine? scientists test VIR-1778
- Fish oil meets TB drugs: can Omega-3 help clear infection faster?
- Can starting TB treatment immediately save lives in HIV sepsis?
- Can a 4-Drug combo cut TB treatment time in half?