A Phase I Study of Lipovaxin Tuberculosis Vaccine in Adult Healthy Populations

NCT07647107 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: TB-0125
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Tuberculosis; TB Infection

Keywords

TB vaccine; Tuberculosis; Lipovaksin TB

Outcome Measures

Primary Outcomes (3)

• 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)

  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)

  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.

  D0, 14 days after 1st injection (sentinel), 28 days after 2nd injection

Secondary Outcomes (2)

• Cellular Immunogenicity

  D0 and 14 days after 2nd dose.

• Humoral Immunogenicity

  D0 and 28 days after 2nd dose.

Study Arms (3)

Control

PLACEBO COMPARATOR

NacL 0.9%

Biological: Placebo

Middle Dose

EXPERIMENTAL

Middle Dose (20 ug) LipovaxinS4-EAH

Biological: LipovaxinS4-EAH (Middle Dose)

High Dose

EXPERIMENTAL

High Dose (25 ug) LipovaxinS4-EAH

Biological: LipovaksinS4-EAH (High Dose)

Interventions

LipovaxinS4-EAH (Middle Dose) BIOLOGICAL

0,5 mL of Middle Dose LipovaxinS4-EAH. Administered twice, 28 days apart

Middle Dose

Placebo BIOLOGICAL

0,5 mL of Placebo containing NaCl 0.9%. Administered twice, 28 days apart

Control

LipovaksinS4-EAH (High Dose) BIOLOGICAL

0,5 mL of HIgh Dose LipovaxinS4-EAH. Administered twice, 28 days apart

High Dose

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• PT Bio Farma: lead
• Fakultas Kedokteran Universitas Indonesia: collaborator
• Dr Cipto Mangunkusumo General Hospital: collaborator

Study Sites (1)

Cipto Mangunkusumo Hospital, Jl. Pangeran Diponegoro No. 71, Kenari, Jakarta Pusat, DKI Jakarta.

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 15, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: June 15, 2026

Record last verified: 2026-06

Locations

ID (1)