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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Биопрепарат LipovaxinS4-EAH (Middle Dose)
  0,5 mL of Middle Dose LipovaxinS4-EAH. Administered twice, 28 days apart
• Биопрепарат LipovaksinS4-EAH (High Dose)
  0,5 mL of HIgh Dose LipovaxinS4-EAH. Administered twice, 28 days apart
• Биопрепарат Placebo
  0,5 mL of Placebo containing NaCl 0.9%. Administered twice, 28 days apart

Первичные конечные точки

• Local and systemic reactions [Срок оценки: 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 [Срок оценки: until 6 months after 2nd injection]
• Laboratory changes [Срок оценки: D0, 14 days after 1st injection (sentinel), 28 days after 2nd injection]

Вторичные конечные точки (2)

• Cellular Immunogenicity [Срок оценки: D0 and 14 days after 2nd dose.]
• Humoral Immunogenicity [Срок оценки: D0 and 28 days after 2nd dose.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Индонезия · 1 центр

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

Идентификаторы

NCT: NCT07647107 · TB-0125

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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