About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Sequential
Treatments tested in this trial
LipovaxinS4-EAH (Middle Dose)
Biological/Vaccine0,5 mL of Middle Dose LipovaxinS4-EAH. Administered twice, 28 days apart
LipovaksinS4-EAH (High Dose)
Biological/Vaccine0,5 mL of HIgh Dose LipovaxinS4-EAH. Administered twice, 28 days apart
Placebo
Biological/Vaccine0,5 mL of Placebo containing NaCl 0.9%. Administered twice, 28 days apart
Treatment groups
Trial outcomes
Primary outcomes
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)
Any AEs and SAEs
Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
Laboratory changes
Laboratory changes in D0, 14 days after 1st dose (sentinel group) and 28 days after 2nd dose.
Secondary outcomes
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
Humoral Immunogenicity
Geometric mean time (GMT), seropositive, seroconversion of total serum IgG antigen specific in D0 and 28 days after 2nd dose
Sponsors and contacts
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PT Bio Farma
Lead sponsor
Fakultas Kedokteran Universitas Indonesia
Collaborator
Dr Cipto Mangunkusumo General Hospital
Collaborator
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