Clinical trials: sponsored by Universitas Indonesia
Tuberculosis, TB Infection
A Phase I Study of Lipovaxin Tuberculosis Vaccine in Adult Healthy Populations
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
- Trial name
- NCT07647107
- Testing
- LipovaxinS4-EAH (Middle Dose), LipovaksinS4-EAH (High Dose)
- Where
- Indonesia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Malaria
Safety, Tolerability, Immunogenicity and Protective Efficacy of PfSPZ Vaccine and PfSPZ-CVac in Indonesian Adults Against Naturally-Transmitted Malaria
The study is a double-blind, randomized, placebo-controlled, Phase 2 clinical trial that will assess the safety, tolerability, immunogenicity and protective efficacy of PfSPZ Vaccine and PfSPZ-CVac against naturally occurring…
- Trial name
- NCT03503058
- Testing
- PfSPZ Vaccine, PfSPZ Challenge under chloroquine (CQ) chemoprophylaxis, Normal Saline
- Where
- 2 sites in Indonesia
- Volunteers
- 345 people, healthy volunteers welcome
- Sponsor
- Sanaria Inc.
Diabetic Kidney Disease (DKD)
Autologous Dendritic Cell as Adjunct Therapy for Diabetic Kidney Disease
The goal of this single-arm, open-label clinical trial is to evaluate the effects of subcutaneous autologous dendritic cell (DC) and lymphocyte administration on albuminuria and endothelial dysfunction in Type 2 Diabetes Mellitus…
- Trial name
- NCT06866158
- Testing
- Dendritic cell immunotherapy
- Where
- Indonesia
- Volunteers
- 80 people
- Sponsor
- PT. JES Kasih Nusantara Sejahterah
Vaccine
Persistence and Long-Term Protection of Vi Antibodies Induced by Vi-DT Conjugate Vaccines in Indonesian
Vi-DT Typhoid vaccine is a novel vaccine. This study will be done to know the long-term protection and persistent antibody by measured the antibody titer after 2,3,4 and 5 years after immunization.
- Trial name
- NCT04741828
- Testing
- Vi-DT Typhoid Conjugate Vaccine
- Where
- 2 sites in Indonesia
- Volunteers
- 188 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Common Cold, Sore-throat
Efficacy and Safety of Silfamin for Common Cold
This is a 2-arm, prospective, randomized, double-blind, placebo-controlled, and three-days-treatment clinical study comparing the efficacy and safety of Silfamin at a dose of 2 tablets@150 mg twice daily in subjects with common…
- Trial name
- NCT06497439
- Testing
- Silfamin
- Where
- 2 sites in Indonesia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Dexa Medica Group
Headache
Safety and Efficacy Predimenol for Headache
This is a prospective, double-blind, placebo-controlled and randomized study aimed to obtain a description of the efficacy and safety of Predimenol in alleviating headache.
- Trial name
- NCT06558006
- Testing
- Predimenol tablet
- Where
- 2 sites in Indonesia
- Volunteers
- 60 people
- Sponsor
- Dexa Medica Group
Cough
Safety and Efficacy Reconyl for Cough With/Without Sore Throat
This study is a prospective, randomized, double-blind and placebo-controlled study to find out if reconyl may relieve the acute cough with/without sore throat.
- Trial name
- NCT06510257
- Testing
- Reconyl
- Where
- 2 sites in Indonesia
- Volunteers
- 60 people
- Sponsor
- Dexa Medica Group
COVID-19
Immuno-bridging Study of COVID-19 Protein Subunit Recombinant Vaccine
Observer-blind, randomized, active-controlled prospective intervention study
- Trial name
- NCT05433285
- Testing
- COVID-19 Protein Subunit Recombinant Vaccine, Active Comparator
- Where
- 4 sites in Indonesia
- Volunteers
- 4,050 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
COVID-19
Safety and Immunogenicity Study of COVID-19 Protein Subunit Recombinant Vaccine
This trial is observer-blind, comparative, randomized, placebo-controlled phase 2 study. The population is healthy subjects aged 18 and above
- Trial name
- NCT05313035
- Testing
- SARS-CoV-2 protein subunit recombinant vaccine
- Where
- 3 sites in Indonesia
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
COVID-19
Safety and Immunogenicity Study of COVID-19 Protein Subunit Recombinant Vaccine Adjuvanted With Alum+CpG 1018
The study is an observer-blind, randomized, controlled prospective intervention study of Phase I. The primary objective is to evaluate the safety and immunogenicity of the SARS-CoV-2 protein subunit recombinant vaccine adjuvanted…
- Trial name
- NCT05228613
- Testing
- SARS-CoV-2 protein subunit recombinant vaccine, SARS-CoV-2 inactivated vaccine
- Where
- 2 sites in Indonesia
- Volunteers
- 175 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Breast Cancer
CYP2D6 Genotypes and Breast Cancer Clinical Outcomes in the Indonesian Population
The utilization of tamoxifen is considerably high in Indonesia, with about 170,000 tamoxifen prescriptions filed in 2015. It is metabolized by the enzyme CYP2D6, resulting in its active metabolite, endoxifen, which has been…
- Trial name
- NCT05501158
- Testing
- Tamoxifen
- Where
- Indonesia
- Volunteers
- 150 people
- Sponsor
- Nalagenetics Pte Ltd
Covid19
Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine
The study is an observer-blind, randomized, controlled prospective intervention study of Phase I. The primary objective is To evaluate the safety of the SARS-CoV-2 protein subunit recombinant vaccine within 7 days after each dose.
- Trial name
- NCT05067894
- Testing
- SARS-CoV-2 Protein Subunit Recombinant Vaccine, SARS-CoV-2 Inactivated Vaccine
- Where
- Indonesia
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
SARS-CoV2 Infection
Efficacy, Safety and Immunogenicity Study of SARS-CoV-2 Inactivated Vaccine
This phase III trial aims to assess the efficacy, safety and immunogenicity of SARS-CoV-2 Vaccine (inactivated) and lot-to-lot consistency evaluation
- Trial name
- COVID-19 (NCT04508075)
- Testing
- SARS-CoV-2 vaccine (inactivated)
- Where
- Indonesia
- Volunteers
- 1,620 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Dyslipidemias, Hypercholesterolemia
Cholesterol-lowering Effects of Plant Stanol Ester
Efficacy of plant stanols as esters on LDL-cholesterol reduction is well documented. LDL-cholesterol lowering efficacy of the ingredient administered in a smoothie is less well known.
- Conditions
- Dyslipidemias, Hypercholesterolemia, Hyperlipidemias
- Trial name
- NCT02316808
- Testing
- Plant stanol ester
- Volunteers
- 91 people, healthy volunteers welcome
- Sponsor
- Raisio Group
Oxidative Stress, Quality of Life
Effect of an Iridoid Enriched Beverage on Skin Autofluorescence
The objectives of this clinical trial are to evaluate the effectiveness of an iridoid enriched beverage containing noni and cornelian juices and olive leaf extract on advanced glycation end product levels.
- Conditions
- Oxidative Stress, Quality of Life, Metabolic Syndrome
- Trial name
- NCT01597076
- Testing
- iridoid enriched mixed fruit beverage
- Where
- Indonesia
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Tahitian Noni International, Inc.