A Phase 1 interventional study of LipovaxinS4-EAH (Middle Dose) and LipovaksinS4-EAH (High Dose) in Tuberculosis and TB Infection, sponsored by PT Bio Farma. Not yet recruiting at 1 site in Indonesia. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-15.
Sponsored by PT Bio Farma · Phase 1, Interventional, and Treatment
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
The primary objectives of this trial is to assess the safety of Lipovaxin in adults aged 18-40 years while the secondary objectives are; (1) To assess the frequency of antigen-specific CD4 and CD8 T cell responses measured by expression of IFN-y, IL-2, or TNF-α between groups, and 2.) To assess serum changes in the levels of antigen-specific total IgG antibodies
Participants will be given two dose of 0.5 ml of Lipovaxin or control IM deltoid region of upper arm. A total of 60 participants will be recruited and randomized to either receive Medium-dose/ High-dose Lipovaksin or Control.
The recruitment will start with 6 sentinel participants, randomised to received mid dose or control vaccine. After evaluation of safety for mid dose of Lipovaksin TB, recruitment will be continued to recruit 24 participants to receive either mid dose or control vaccine. Additionally, 6 sentinel participants will also be recruited to receive either high dose or control vaccine. After evaluation of safety of high dose Lipovaksin TB, recruitment will be continued to recruit the 24 participants to receive either high dose or control vaccine.
All subjects will be evaluated for the local and systemic reactions and safety assessments in 30 minutes, 7 days and 28 days after 1st and 2nd injection. Additionally, the participants will be evaluated on the cellular and humoral immunogenicity in D0 and 14 days after 2nd dose of vaccination.
1,170 studies on the registry are indexed under Tuberculosis; 175 are open to participants now.
This study's planned enrollment of 60 is below the median of 150 across 820 interventional studies indexed under Tuberculosis.
Browse Tuberculosis studies →PT Bio Farma is the lead sponsor of 47 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NacL 0.9%
Biological: Placebo
Middle Dose (20 ug) LipovaxinS4-EAH
Biological: LipovaxinS4-EAH (Middle Dose)
High Dose (25 ug) LipovaxinS4-EAH
Biological: LipovaksinS4-EAH (High Dose)
0,5 mL of Middle Dose LipovaxinS4-EAH. Administered twice, 28 days apart
0,5 mL of HIgh Dose LipovaxinS4-EAH. Administered twice, 28 days apart
0,5 mL of Placebo containing NaCl 0.9%. Administered twice, 28 days apart
Local and systemic reactions
Local reactions and systemic events 30 minutes, 7 days and 28 days after 1st and 2nd dose of Vaccine/Placebo (additional 14 days after 1st dose for sentinel group)
Time frame: 30 minutes, 7 days and 28 days after 1st injection and 2nd injection for all group, and 30 minutes, 7 days and 28 days after 1st injection and 2nd injection and 14 days after 1st dose for sentinel group
Any AEs and SAEs
Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: until 6 months after 2nd injection
Laboratory changes
Laboratory changes in D0, 14 days after 1st dose (sentinel group) and 28 days after 2nd dose.
Time frame: D0, 14 days after 1st injection (sentinel), 28 days after 2nd injection
Cellular Immunogenicity
Intracellular cytokine staining of antigen specific T-cells (IFN-y, IL-2, or TNF-α) in D0 and 14 days after 2nd dose
Time frame: D0 and 14 days after 2nd dose.
Humoral Immunogenicity
Geometric mean time (GMT), seropositive, seroconversion of total serum IgG antigen specific in D0 and 28 days after 2nd dose
Time frame: D0 and 28 days after 2nd dose.
Start is estimated for Aug 2026; primary completion for Jul 2027, 11 months later.
Of 59 phase 1 interventional studies under Tuberculosis, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 25. This study's planned 11 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.