Clinical trials: Tuberculosis Vaccines
TB
Study of the Safety and Immunogenicity of Bacille Calmette Guerin (BCG) Vaccine
Tuberculosis (TB) kills about three million people annually. It is estimated that one third of the world's population are latently infected with Mycobacterium tuberculosis (M.tb).
- Trial name
- NCT00654316
- Testing
- BCG
- Where
- United Kingdom
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- University of Oxford
TB
Safety, Immunogenicity, and Impact of MVA85A, on the Immunogenicity of the EPI Vaccines
This study is preliminary to proving that this vaccine could protect against tuberculosis in humans. Although there is no proven data to show that infants will benefit directly from participation in this study by being protected…
- Trial name
- NCT00480454
- Testing
- MVA 85A
- Where
- The Gambia
- Volunteers
- 214 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Tuberculosis
A Phase I Study of the Safety and Immunogenicity of a Recombinant MVA Vaccine Encoding a Secreted Antigen From M. Tuberculosis, Antigen 85A, Delivered Intradermally by a Needle Injection in Healthy Volunteers Who Have Received BCG Immunisation 1 Month Previously
This is a phase I study to test the immunogenicity of a recombinant vaccine based on Modified Vaccinia Ankara (MVA) expressing the antigen 85A (from Mycobacterium tuberculosis).
- Trial name
- NCT00427453
- Testing
- MVA85A
- Where
- United Kingdom
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Tuberculosis
Safety of Tuberculosis Vaccine, MVA85A, Administered by the Aerosol Route and the Intradermal Route
This is a phase I trial to compare the safety and immunogenicity of candidate TB vaccine MVA85A administered by the aerosol inhaled route and the intradermal route in healthy BCG-vaccinated adult subjects.
- Trial name
- NCT01497769
- Testing
- Aerosol inhaled MVA85A, Intradermal MVA85A
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Tuberculosis
Phase 1 Clinical Trial of ID93+GLA-SE Vaccine in BCG-vaccinated Healthy Adolescent
The purpose of this study is to evaluate safety, immunogenicity of ID93+GLA-SE compared to placebo following three intramuscular (IM) injections on Days 0, 28 and 56 in BCG-vaccinated QFT-negative healthy adolescent.
- Trial name
- NCT03806699
- Testing
- ID93+GLA-SE
- Where
- South Korea
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Quratis Inc.
Tuberculosis
Study to Investigate the Safety and Efficacy of GC3107 (BCG Vaccine) in Healthy Adults
Healthy adults will be once administered GC3107(BCG Vaccine) Intradermally.
- Trial name
- NCT03363178
- Testing
- GC3107
- Where
- South Korea
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Green Cross Corporation
Tuberculosis
Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in Healthy Volunteers
This randomized, placebo-controlled, double-blind, safety and dose-finding Phase Ia trial will evaluate four dose levels of the BNT164 investigational vaccines (BNT164a1 and BNT164b1) to select a safe and tolerable dose in a…
- Trial name
- NCT05537038
- Testing
- BNT164a1, BNT164b1
- Where
- 3 sites in Germany
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Tuberculosis
Trial on the Safety of a New Liposomal Adjuvant System, CAF01, When Given With the Tuberculosis Subunit Vaccine Ag85B-ESAT-6 as Two Injections With Two Months Interval to Healthy Adult Volunteers
The purpose of this study is to evaluate the safety profile of CAF01, administering 50 µg Ag85B-ESAT-6 alone and 50 µg Ag85B-ESAT-6 with three escalating CAF01 dose levels, to four groups of healthy volunteers, injecting two…
- Trial name
- NCT00922363
- Testing
- 50 µg Ag85B-ESAT-6 alone, 50 µg Ag85B-ESAT-6 + 125/25 µg CAF01, 50 µg Ag85B-ESAT-6 + 313/63 µg CAF01
- Where
- Netherlands
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Statens Serum Institut
Tuberculosis
A Study to Evaluate Safety and Immunogenicity of AERAS-402
This Phase I study will be conducted as a randomized, double-blind, placebo-controlled study in healthy adult subjects who are HIV-negative, BCG-vaccinated, and have no evidence of tuberculosis infection.
- Trial name
- NCT01378312
- Testing
- AERAS 402
- Where
- India
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Aeras
Tuberculosis
Vitamin D Supplementation Enhances Immune Response to Bacille-Calmette-Guerin (BCG) Vaccination in Infants
The purpose of this study is to determine whether a single oral dose of vitamin D given to infants prior to Bacille-Calmette-Guerin (BCG) vaccination will enhance the immune response to BCG vaccination.
- Trial name
- BCG-25-D (NCT01288950)
- Testing
- Vitamin D3 (cholecalciferol)
- Where
- Mexico
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- University of California, San Diego
Tuberculosis Infection
Evaluation of ТВ/Flu-05Е Vaccine for the Prevention of Tuberculosis Infection in BCG-vaccinated Volunteers Aged 18-50 Years
The aim of the study is to investigate safety, reactogenicity and immunogenicity of the TB/Flu-05E single-dose intranasal vaccine for the prevention of Tuberculosis infection in BCG-vaccinated Volunteers aged 18-50 years.
- Trial name
- NCT05945498
- Testing
- TB/Flu-05E vaccine
- Where
- Russia
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Tatyana Zubkova
Tuberculosis (TB)
Safety and Immunogenicity of GSK Biological's Candidate Tuberculosis Vaccine Mtb72F/AS02A in Healthy PPD-positive Adults
This study will evaluate the safety, reactogenicity and immunogenicity of Mtb72F/AS02A in healthy European volunteers who are PPD-positive either via previous vaccination with BCG and/or conversion to PPD positivity through…
- Trial name
- NCT00146744
- Testing
- Mtb72F/AS02A
- Where
- Switzerland
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Tuberculosis
A Phase I Trial of a LTK63 Adjuvated Tuberculosis Nasal Subunit Vaccine (Ag85B-ESAT6)
The purpose of this study is to determine whether a subunit tuberculosis vaccine given as two nasal immunizations composed of a hybrid protein antigen from M.
- Trial name
- TMUVA-01 (NCT00440544)
- Testing
- Ag85B-ESAT6 fusion protein H1
- Where
- United Kingdom
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- St George's, University of London
Tuberculosis
Phase 1/II, Safety and Immunogenicity Study of AERAS-404 in BCG-Primed Infants
Phase I/II, randomized, double-blind, placebo-controlled, safety, immunogenicity and dose-range finding study of AERAS-404 Tuberculosis (TB) vaccine administered intramuscularly in Bacille Calmette-Guerin (BCG) primed infants.
- Trial name
- C-015-404 (NCT01861730)
- Testing
- AERAS-404
- Where
- 4 sites in South Africa
- Volunteers
- 243 people, healthy volunteers welcome
- Sponsor
- Aeras
Tuberculosis
Study in Healthy Adults to Evaluate Gene Activation After Vaccination With GlaxoSmithKline (GSK) Biologicals' Candidate Tuberculosis (TB) Vaccine GSK 692342
The purpose of this study is to assess the safety and immunogenicity of two doses of the TB vaccine administered according to a 0, 1 month schedule.
- Trial name
- NCT01669096
- Testing
- GSK Biologicals' investigational TB vaccine GSK 692342
- Where
- Belgium
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pulmonary Tuberculosis
Phase 1 ID93 + GLA-SE Vaccine Trial in Healthy Adult Volunteers
The purpose of this study is to determine the safety, tolerability, and immunogenicity in healthy adult subjects of an investigational vaccine being developed for the prevention of pulmonary tuberculosis.
- Trial name
- NCT01599897
- Testing
- ID93 + GLA-SE, ID93 alone
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Access to Advanced Health Institute (AAHI)
Tuberculosis
A Study of 2 Doses of a New TB Vaccine, MVA85A, in Healthy Volunteers Previously Vaccinated With BCG
The dose of recombinant MVA used in the TB trials to date is relatively low compared with other trials using recombinant MVAs which have used up to 2.5 x 108pfu (A Hill, personal communication).
- Trial name
- NCT00465465
- Testing
- MVA 85A
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Tuberculosis
A Phase Ⅱ Clinical Trial of the Recombinant Mycobacterium Tuberculosis Vaccine Freeze-dried (AEC/BC02)
The safety, tolerability and immunogenicity of lyophilized recombinant tuberculosis vaccine (AEC/BC02) were studied in a randomized, blind, controlled phase ⅱ A clinical study in patients 18 years and older with latent infection…
- Trial name
- NCT05284812
- Testing
- Low-dose freeze-dried recombinant tuberculosis vaccine (AEC / BC02), High-dose freeze-dried recombinant tuberculosis vaccine (AEC / BC02), High-dose adjuvant for freeze-dried recombinant tuberculosis vaccine (AEC / BC02)
- Where
- China
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Vitamin A Deficiency
Efficacy of Newborn Vitamin A Supplementation in Improving Immune Function
Vitamin A supplementation at birth may increase survival of infants through one year of age by reducing mortality from infectious diseases, though current studies are not conclusive on this point.
- Trial name
- NCT01583972
- Testing
- retinyl palmitate
- Where
- Bangladesh
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- USDA, Western Human Nutrition Research Center