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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-40
SponsorPT Bio Farma

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 volunteers

Qualifiers

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

Design model

Sequential

Treatments tested in this trial

  • LipovaxinS4-EAH (Middle Dose)

    Biological/Vaccine

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

  • LipovaksinS4-EAH (High Dose)

    Biological/Vaccine

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

  • Placebo

    Biological/Vaccine

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

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: ControlPlacebo comparator 1 intervention
Group B: Middle DoseExperimental treatment 1 intervention
Group C: High DoseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

Any AEs and SAEs

Any Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame
until 6 months after 2nd injection
3

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

Secondary outcomes

1

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.
2

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

PT Bio Farma

Lead sponsor

Fakultas Kedokteran Universitas Indonesia

Collaborator

Dr Cipto Mangunkusumo General Hospital

Collaborator

This trial is not recruiting at the moment. You can still explore other options: