Clinical trials: Tuberculosis Vaccines
Tuberculosis
Safety Study of Tuberculosis Vaccines AERAS-402 and MVA85A
This trial will investigate the administration of two new tuberculosis vaccines, called AERAS-402 and MVA85A. The purpose of this trial is to assess what happens when both of these vaccines are given one after the other.
- Trial name
- NCT01683773
- Testing
- AERAS-402, MVA85A
- Where
- 2 sites in United Kingdom
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University of Oxford
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
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
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
Safety and Immunogenicity of MVA85A in Volunteers Latently Infected With TB.
This study is designed to evaluate the safety of MVA85A in healthy volunteers in the UK who are latently infected with M.tb. A single vaccination with MVA85A, when administeredat a dose of 5 x 107pfu intradermally, is safe in…
- Trial name
- NCT00456183
- Testing
- MVA 85A
- Where
- United Kingdom
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Tuberculosis
Evaluation of the Safety and Immunogenicity of the Recombinant Subunit Vaccine "GamTBvac" Against the Tuberculosis.
The study is aimed to evaluate the safety and immunogenicity of the medicinal product "GamTBvac" - a recombinant subunit vaccine against the tuberculosis.
- Trial name
- GamTBvac (NCT03255278)
- Testing
- Single GamTBvac vaccination (0.25 dose), Double GamTBvac vaccination (0.25 dose), Double GamTBvac vaccination (0.5 dose)
- Where
- Russia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
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
Phase 2a Clinical Trial of ID93+GLA-SE Vaccine in BCG-vaccinated Healthy Healthcare Workers
The purpose of this study is to evaluate the experimental tuberculosis (TB) vaccine called ID93+GLA-SE. The safety, immunogenicity, and efficacy of ID93+GLA-SE will be compared to placebo, after three intramuscular (IM)…
- Trial name
- NCT03806686
- Testing
- ID93+GLA-SE
- Where
- 3 sites in South Korea
- Volunteers
- 107 people, healthy volunteers welcome
- Sponsor
- Quratis Inc.
Tuberculosis
Should Low Birth Weight Infants Be Vaccinated With BCG Vaccine at Birth in Developing Countries?
The World Health Organization (WHO) currently recommends BCG vaccination at birth in developing countries. Pre-term infants should be vaccinated when they reach the chronological age of 40 weeks.
- Trial name
- NCT00146302
- Testing
- Bacille Calmette Guerin (BCG)
- Where
- Guinea-Bissau
- Volunteers
- 2,320 people
- Sponsor
- Bandim Health Project
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.
Tuberculosis, Polio
Mobile Phone SMS Messages and Automated Calls in Improving Vaccine Coverage Among Children in Pakistan
Routine childhood immunization (RCI) in Pakistan is well below the recommended coverage of 90% with rates as low as 16% in certain regions (Pakistan DHS 2012-3).
- Conditions
- Tuberculosis, Polio, Diphtheria, Pertussis
- Trial name
- NCT03341195
- Testing
- SMS messages and automated calls
- Volunteers
- 3,850 people, healthy volunteers welcome
- Sponsor
- Aga Khan University
Tuberculosis
Dose-escalation Safety and Immunogenicity Study to Compare MTBVAC to BCG in Newborns With a Safety Arm in Adults
Randomized, controlled, double blind clinical trial in 2 stages (adult stage, infant stage). The first stage includes 18 HIV uninfected, QFT negative, BCG vaccinated, adult participants, randomized 1:1 to receive BCG Vaccine SSI…
- Trial name
- MTBVAC-Ph1b (NCT02729571)
- Testing
- MTBVAC, BCG
- Where
- South Africa
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Biofabri, S.L
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
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.
This study is to assesss the safety and immunogenicity of vaccine based on Modified Vaccinia Ankara (MVA) expressing the 85A antigen (from Mycobacterium. tuberculosis).
- Trial name
- NCT00423566
- Testing
- MVA85A (Tuberculosis vaccine)
- Where
- United Kingdom
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- University of Oxford
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
Human Immunodeficiency Virus
Safety and Immunogenicity of a Mycobacterium Tuberculosis Vaccine M72/AS01E in Participants With Well-controlled HIV
The purpose of this study is to assess the safety and immunogenicity of M72/AS01E vaccination in virally suppressed, antiretroviral-treated participants with human immunodeficiency virus infection (HIV).
- Trial name
- MESA-TB (NCT04556981)
- Testing
- M72/AS01E Mycobacterium tuberculosis vaccine
- Where
- 6 sites in South Africa
- Volunteers
- 402 people
- Sponsor
- Gates Medical Research Institute
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
Prevention of TB Recurrence
Study to Check the Efficacy and Safety of Recombinant BCG Vaccine in Prevention of TB Recurrence
This is a Phase II/III trial with two groups of adults successfully cured of category 1 pulmonary TB receiving either VPM1002 or placebo.
- Trial name
- NCT03152903
- Testing
- VPM1002 (Recombinant BCG Vaccine)
- Where
- 10 sites in Bangladesh, India
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Serum Institute of India Pvt. Ltd.
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
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