TuberculosisPhase 1NCT07647107
A Phase I Study of Lipovaxin Tuberculosis Vaccine in Adult Healthy Populations
A Phase 1 study testing LipovaxinS4-EAH (Middle Dose) and LipovaksinS4-EAH (High Dose) in people with Tuberculosis and TB Infection, run by PT Bio Farma at 1 site in Indonesia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis, TB Infection
- What is being tested?
- LipovaxinS4-EAH (Middle Dose) and LipovaksinS4-EAH (High Dose)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIndonesia
- Study dates
- Aug 2026to Aug 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Clinically Healthy participants aged 18-40 years;
- Participants have been informed properly regarding the study and signed the informed consent form.
- Participants will commit to comply with the instructions of the investigator and the schedule of the trial;
- Participants must have a negative IGRA and sputum.
- 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
Who cannot join
- 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);
- There are serious chronic diseases, or the disease is in the advanced stage that cannot be controlled smoothly, such as diabetes and thyroid disease;
- 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
- 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;
- 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;
- Current patients with HIV antibody positive for human immunodeficiency virus;
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- 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;
- Subjects receive any vaccination within 1 month before and after dosing;
- Those who have participated in any other clinical research and used the investigational drug within 3 months before this clinical research;
- Any other situation that the researcher believes may affect the evaluation of the research.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site
Cipto Mangunkusumo Hospital, Jl. Pangeran Diponegoro No. 71, Kenari, Jakarta Pusat, DKI Jakarta.
Jakarta Pusat, DKI Jakarta, 10430
Sri R Hadinegoro
Nina D Putri
About this study
Official title: 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
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
Read the detailed description
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.
- Conditions
- Tuberculosis, TB Infection
- Being tested
- LipovaxinS4-EAH (Middle Dose), LipovaksinS4-EAH (High Dose), Placebo
- Keywords
- TB vaccine, Tuberculosis, Lipovaksin TB
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LipovaxinS4-EAH (Middle Dose)Biological
0,5 mL of Middle Dose LipovaxinS4-EAH. Administered twice, 28 days apart
LipovaksinS4-EAH (High Dose)Biological
0,5 mL of HIgh Dose LipovaxinS4-EAH. Administered twice, 28 days apart
PlaceboBiological
0,5 mL of Placebo containing NaCl 0.9%. Administered twice, 28 days apart
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | NacL 0.9% Receives: Biological: Placebo |
| Middle Dose | Experimental | Middle Dose (20 ug) LipovaxinS4-EAH Receives: Biological: LipovaxinS4-EAH (Middle Dose) |
| High Dose | Experimental | High Dose (25 ug) LipovaxinS4-EAH Receives: Biological: LipovaksinS4-EAH (High Dose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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.
Measured: D0, 14 days after 1st injection (sentinel), 28 days after 2nd injection
Secondary outcomes (2)
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
Measured: 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
Measured: D0 and 28 days after 2nd dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study startAug 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PT Bio Farma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fakultas Kedokteran Universitas Indonesia, Dr Cipto Mangunkusumo General Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07647107
- Sponsor's protocol ID
- TB-0125
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07647107
- Acronym / sponsor ID
- TB-0125
- Conditions
- Tuberculosis, TB Infection
- Keywords
- TB vaccine, Tuberculosis, Lipovaksin TB
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- PT Bio FarmaIndustry (pharma, biotech, devices)
- Collaborators
- Fakultas Kedokteran Universitas Indonesia, Dr Cipto Mangunkusumo General Hospital
- Study start
- Aug 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Biological: PlaceboNacL 0.9% |
| Middle Dose | Experimental | Biological: LipovaxinS4-EAH (Middle Dose)Middle Dose (20 ug) LipovaxinS4-EAH |
| High Dose | Experimental | Biological: LipovaksinS4-EAH (High Dose)High Dose (25 ug) LipovaxinS4-EAH |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Clinically Healthy participants aged 18-40 years;
- Participants have been informed properly regarding the study and signed the informed consent form.
- Participants will commit to comply with the instructions of the investigator and the schedule of the trial;
- Participants must have a negative IGRA and sputum.
- 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
Key exclusion criteria (10 listed)
- 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);
- There are serious chronic diseases, or the disease is in the advanced stage that cannot be controlled smoothly, such as diabetes and thyroid disease;
- 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
- 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;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LipovaxinS4-EAH (Middle Dose)0,5 mL of Middle Dose LipovaxinS4-EAH. Administered twice, 28 days apart | Biological | Middle Dose |
| LipovaksinS4-EAH (High Dose)0,5 mL of HIgh Dose LipovaxinS4-EAH. Administered twice, 28 days apart | Biological | High Dose |
| Placebo0,5 mL of Placebo containing NaCl 0.9%. Administered twice, 28 days apart | Biological | Control |
Primary outcome
Local and systemic reactions
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
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)
Any AEs and SAEs
Time frame: until 6 months after 2nd injection
Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
Laboratory changes
Time frame: D0, 14 days after 1st injection (sentinel), 28 days after 2nd injection
Laboratory changes in D0, 14 days after 1st dose (sentinel group) and 28 days after 2nd dose.
2 secondary outcomes
Cellular Immunogenicity
Time frame: D0 and 14 days after 2nd dose.
Humoral Immunogenicity
Time frame: D0 and 28 days after 2nd dose.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LipovaxinS4-EAH (Middle Dose) and LipovaksinS4-EAH (High Dose) in people with Tuberculosis and TB Infection, run by PT Bio Farma at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local and systemic reactions (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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.