Clinical trials: Tuberculosis Vaccines
Healthy
Phase II Clinical Trial of Safety and Immunogenicity of Recombinant Subunit Tuberculosis Vaccine GamTBvac
This is a double-blind, randomized (in 3:1 ratio -vaccine : placebo) study to assess the safety, reactogenicity and immunogenicity in healthy, BCG vaccinated adults.
- Trial name
- NCT03878004
- Testing
- GamTBvac vaccine
- Where
- 2 sites in Russia
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Tuberculosis
A Phase I Study of a New Tuberculosis (TB) Vaccine, MVA85A, in Healthy Volunteers With HIV
This is an open Phase I study of a candidate TB vaccine, MVA85A, in healthy subjects who are infected with HIV. It is designed to study the safety and immunogenicity of the vaccine.
- Trial name
- NCT00731471
- Testing
- MVA85A
- Where
- Senegal
- Volunteers
- 24 people
- Sponsor
- University of Oxford
Tuberculosis
A Safety and Immunogenicity Trial With an Adjuvanted Tuberculosis(TB) Subunit Vaccine
The purpose of this study is to evaluate the safety profile of an adjuvanted TB subunit vaccine administered at 0 and 2 months in healthy BCG-unvaccinated volunteers with no prior history of TB disease or known prior exposure to…
- Trial name
- THYB-01 (NCT01003093)
- Testing
- 50 microgram antigen (Ag85B + ESAT-6), 50 microgram antigen (Ag85B + ESAT-6) + 100 nmol KLK + 4 nmol ODN1a, 50 microgram antigen (Ag85B + ESAT-6) + 500 nmol KLK + 20 nmol ODN1a
- Where
- Netherlands
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Statens Serum Institut
Tuberculosis (TB)
Safety and Immunogenicity of a Mycobacterium Tuberculosis Vaccine MTBVAC in Healthy Indian Adults and Adolescents (BBV169/2024)
Phase II trial to establish the safety, reactogenicity, and immunogenicity of the MTBVAC with a licensed BCG vaccine as a comparator in both TB naïve (QFT PLUS negative) and TB exposed (QFT PLUS positive) healthy adults and…
- Trial name
- MTBVACph2 (NCT06997367)
- Testing
- MTBVAC, BCG Sii
- Where
- 2 sites in India
- Volunteers
- 164 people, healthy volunteers welcome
- Sponsor
- Bharat Biotech International Limited
Tuberculosis, HIV Infections
Efficacy Against TB Disease, Safety, and Immunogenicity of MVA85A/AERAS-485 in HIV-Infected Adults (C-030-485)
This is a phase II, proof of concept, randomized, double-blind, placebo-controlled study to evaluate the protective efficacy against TB disease, safety, and immunogenicity of MVA85A/AERAS-485 in healthy, HIV-infected adults.
- Trial name
- NCT01151189
- Testing
- MVA85A/AERAS-485
- Where
- 2 sites in Senegal, South Africa
- Volunteers
- 650 people
- Sponsor
- Aeras
Tuberculosis
Influence of Filarial Infections on Tuberculosis Disease and Tuberculosis Vaccination in Cameroon
Filarial nematodes modulate the host immune response to promote regulatory and T helper type 2 immune responses, which were shown to influence concomitant infections.
- Trial name
- MAP-TB (NCT04547738)
- Testing
- TB treatment according to national guidelines
- Where
- Cameroon
- Volunteers
- 2,500 people, healthy volunteers welcome
- Sponsor
- University Hospital, Bonn
Tuberculosis Infection, Tuberculosis
BCG Revaccination in Children and Adolescents
Bacille Calmette Guerin (BCG) vaccine is one of the most used vaccines of the world, to reduce the risks of natural tuberculous infection.
- Trial name
- BRiC (NCT05330884)
- Testing
- BCG vaccine, Oral Chemoprophylaxis
- Where
- India
- Volunteers
- 9,200 people, healthy volunteers welcome
- Sponsor
- Tuberculosis Research Centre, India
Tuberculosis, HIV Infections
Investigational Vaccine for the Prevention of Disseminated Tuberculosis in HIV Infected People
A significant number of HIV infected patients in Africa also have disseminated tuberculosis (infection throughout multiple organs). This type of tuberculosis is a significant cause of mortality in these patients.
- Trial name
- NCT00052195
- Testing
- SRL-172
- Where
- Tanzania
- Volunteers
- 1,975 people, healthy volunteers welcome
- Sponsor
- Dartmouth-Hitchcock Medical Center
Tuberculosis
Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in Adults With TB Disease
This study will assess the safety and immunogenicity of GSK Biologicals' investigational tuberculosis (TB) vaccine (GSK 692342) compared to placebo when administered at 0, 1 months to human immunodeficiency virus (HIV) negative…
- Trial name
- NCT01424501
- Testing
- GSK Biologicals' investigational TB vaccine GSK 692342
- Where
- 6 sites in Estonia, Taiwan
- Volunteers
- 142 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Tuberculosis
Reactogenicity, Safety and Immunogenicity of a TB/FLU-04L Tuberculosis Vaccine
The study is a single centre, phase I, double-blind, randomized, placebo-controlled trial that explored the safety and immunogenicity of 2 doses (Day 1 and Day 21) TB/FLU-04L tuberculosis vaccine versus matched placebo in…
- Trial name
- NCT02501421
- Testing
- tuberculosis vaccine
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Research Institute for Biological Safety Problems
Tuberculosis
Study Evaluating Aerosol and Intradermal Administration of a Candidate Tuberculosis (TB) Vaccine, MVA85A, as a Way to Increase Immune Response and Avoid Anti-vector Immunity
Boost vaccinations sometimes have no effect because the body has got used to the vaccine and no longer reacts to it. We are therefore investigating whether vaccinating with aerosolised MVA85A (a candidate tuberculosis vaccine)…
- Trial name
- NCT01954563
- Testing
- MVA85A
- Where
- United Kingdom
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Tuberculosis
Randomized Controlled Trial of Percutaneous and Intradermal BCG Vaccination.
An open label, randomized, controlled, equivalency trial to compare the efficacy of the percutaneous route of administration with the intradermal route of administration of Japanese (Tokyo) 172 BCG, in the prevention of…
- Trial name
- NCT00242047
- Testing
- Japanese (Tokyo) 172 Bacille Calmette Guerin (BCG).
- Where
- South Africa
- Volunteers
- 12,000 people, healthy volunteers welcome
- Sponsor
- University of Cape Town
Tuberculosis
MVA85A Aerosol vs Intramuscular Vaccination in Adults With Latent Mycobacterium Tuberculosis (M. tb) Infection
TB040 is a clinical trial to investigate and compare the effects of a candidate Tuberculosis (TB) vaccine, MVA85A, administered by the aerosol inhaled route and the intramuscular route in healthy adult volunteers who are latently…
- Trial name
- NCT02532036
- Testing
- Aerosol inhaled MVA85A, Intramuscular MVA85A
- Where
- 5 sites in United Kingdom
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Respiratory Syncytial Virus Infection Prevention, Tuberculosis Prevention
rBCG-N-RSV Vaccine in Adults Aged 60 Years and Older
This Phase 2 clinical study will evaluate the safety of the rBCG-N-RSV vaccine compared to conventional BCG in adults older than 60 years.
- Trial name
- NCT07762014
- Testing
- Vaccination with rBCG-N-RSV, Vaccination with conventional BCG (BCG-WT)
- Where
- Greece
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Biothervax SpA
Tuberculosis
A Phase ⅠStudy of the Recombinant Mycobacterium Tuberculosis Vaccine Freeze-dried
There are four populations in Recombinant Mycobacterium tuberculosis Vaccine Freeze-dried (AEC/BC02) phase I clinical research. The clinical study adopt open research design.
- Trial name
- AEC/BC02 (NCT03026972)
- Testing
- Low dose adjuvant, High dose adjuvant, Low dose vaccine
- Where
- China
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
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
Safety and Immunogenicity Study of GSK Biologicals Tuberculosis Vaccines (692342) to Healthy Adults
This observer blind study will assess the safety and immunogenicity of different formulations of GSK Biologicals' 692342 tuberculosis vaccine in healthy adults aged 18 to 45 years with a positive PPD skin test.
- Trial name
- NCT00621322
- Testing
- GSK Biologicals' AS01B adjuvant, GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 1, GSK Biologicals' Candidate Tuberculosis Vaccine (692342) - Formulation 2
- Where
- Philippines
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Tuberculosis
Phase I Open Label BCG Clinical Trial Assessing TB Drugs and Vaccines
The purpose of the study is to develop a BCG challenge model for use in short term Phase I human trials capable of assessing the ability of TB drugs and/or vaccine-induced immune responses to impact in vivo mycobacterial…
- Trial name
- NCT05592223
- Testing
- BCG Vaccine USP, Isoniazid, Rifampin
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Fred Hutchinson Cancer Center
Tuberculosis
Safety and Immunogenicity Study of a Candidate Tuberculosis Vaccine in Human Immunodeficiency Virus (HIV)-Positive Adults
The purpose of the study is to assess the safety and immunogenicity of a GlaxoSmithKline (GSK) Biologicals' candidate tuberculosis vaccine (692342) administered to Human Immunodeficiency Virus (HIV)-positive adults aged 18 to 59…
- Trial name
- NCT01262976
- Testing
- GSK's investigational vaccine 692342, Physiological saline
- Where
- India
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Tuberculosis, HIV Infections
The Safety and Immunogenicity of a TB Vaccine; MVA85A, in Healthy Volunteers Who Are Infected With HIV
This study is designed to evaluate the safety of MVA85A in healthy volunteers in the UK who are infected with HIV. In phase I studies, a single vaccination with MVA85A, when administered at a dose of 5 x 10^7pfu intradermally…
- Trial name
- NCT00395720
- Testing
- MVA85A (TB vaccine), MVA 85A
- Where
- United Kingdom
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of Oxford