Who is sponsoring NCT01669096?

NCT01669096 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT01669096?

Interventions in NCT01669096: GSK Biologicals' investigational TB vaccine GSK 692342.

What condition does NCT01669096 study?

NCT01669096 studies Tuberculosis.

Is NCT01669096 still recruiting?

NCT01669096 is currently completed. Last updated 22 March 2019.

Are results published for NCT01669096?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-03-22 · How we verify

NCT01669096

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study in Healthy Adults to Evaluate Gene Activation After Vaccination With GlaxoSmithKline (GSK) Biologicals' Candidate Tuberculosis (TB) Vaccine GSK 692342

Completed Phase 2 Results posted Last updated 22 March 2019

What this trial tests

Phase 2 trial testing GSK Biologicals' investigational TB vaccine GSK 692342 in Tuberculosis in 20 participants. Completed in 24 May 2013.

Timeline

21 August 2012

Primary endpoint
6 December 2012

24 May 2013

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	20
Start date	21 August 2012
Primary completion	6 December 2012
Estimated completion	24 May 2013
Sites	1 location across Belgium

Drugs / interventions tested

GSK Biologicals' investigational TB vaccine GSK 692342 — full drug profile →

Conditions studied

Tuberculosis — all drugs for Tuberculosis →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 50, any sex, with Tuberculosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Concentration of Specific Interferon Gamma (IFN-γ) Antibodies Secreted in Serum Samples Primary · At Day 0 prior to Dose 1

Antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in femtogram per milliliter (fg/mL), as assessed by cytometric bead array (CBA) assay. The reference seropositivity cut-off value was equal to or above (≥) 7047 fg/mL.

Group	Value	95% CI
GSK 692342 Group	6279.7	4624.2 – 8527.7

Concentration of Specific Interferon Gamma (IFN-γ) Antibodies Secreted in Serum Samples Primary · At Day 30 post-Dose 1

Group	Value	95% CI
GSK 692342 Group	7035.1	5089.0 – 9725.5

Concentration of Specific Interferon Gamma (IFN-γ) Antibodies Secreted in Serum Samples Primary · At Day 31 post-Dose 2

Group	Value	95% CI
GSK 692342 Group	64288.5	33671.9 – 122743.5

Concentration of Specific Interferon Gamma (IFN-γ) Antibodies Secreted in Serum Samples Primary · At Day 37 post-Dose 2

Group	Value	95% CI
GSK 692342 Group	32710.5	23747.1 – 45057.0

Concentration of Specific Interferon Gamma (IFN-γ) Antibodies Secreted in Serum Samples Primary · At Day 40 post-Dose 2

Group	Value	95% CI
GSK 692342 Group	8851.2	5250.8 – 14920.4

Concentration of Specific Interferon Gamma (IFN-γ) Antibodies Secreted in Serum Samples Primary · At Day 44 post-Dose 2

Group	Value	95% CI
GSK 692342 Group	6755.1	4939.5 – 9238.0

Concentration of Specific Interferon Gamma (IFN-γ) Antibodies Secreted in Serum Samples Primary · At Day 47 post-Dose 2

Group	Value	95% CI
GSK 692342 Group	7245.0	5389.6 – 9739.3

Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation CD4+/CD8+ T Cells Expressing at Least Two Different Immune Markers Primary · At Day 0 prior to Dose 1

Among immune markers expressed were interleukin-2 (IL-2) and/or tumour necrosis factor-alpha (TNF-α) and/or interferon-gamma (IFN-γ) and/or cluster of differentiation 40-ligand (CD40-L) and/or IL-13 and/or IL-17. The analysis of cytokines expression was performed by flow cytometry using intracellular cytokine staining (ICS) on frozen peripheral blood mononuclear cell (PBMCs).

CD4+CD40-L+IL-2+TNF-α+IFN-γ+IL-17+IL-13

Group	Value	95% CI
GSK 692342 Group	97.0	1.0 – 224.0

CD8+CD40-L+IL-2+TNF-α+IFN-γ+IL-17+IL-13

Group	Value	95% CI
GSK 692342 Group	95.0	2.0 – 230.0

Frequency of M72 Fusion Protein Specific Cluster of Differentiation CD4+/CD8+ T Cells Expressing at Least Two Different Immune Markers Primary · At Day 60 post-Dose 2

Among immune markers expressed were interleukin-2 (IL-2) and/or tumour necrosis factor-alpha (TNF-α) and/or interferon-gamma (IFN-γ) and/or cluster of differentiation 40-ligand \[CD40-L\] and/or IL-13 and/or IL-17. The analysis of cytokines expression was performed by flow cytometry using intracellular cytokine staining (ICS) on frozen peripheral blood mononuclear cell (PBMCs).

CD4+CD40-L+IL-2+TNF-α+IFN-γ+IL-17+IL-13

Group	Value	95% CI
GSK 692342 Group	5200.0	485.0 – 15302.0

CD8+CD40-L+IL-2+TNF-α+IFN-γ+IL-17+IL-13

Group	Value	95% CI
GSK 692342 Group	134.0	54.0 – 635.5

Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M1 to M 14) Primary · At Day 0 prior -Dose 1

Expressed immune markers combinations for CD4+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M1=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(+); M2=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(-); M3=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(+); M4=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(-); M5=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(+); M6=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(-); M7=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(+); M8=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(-)+I

Group	Value	95% CI
GSK 692342 Group	1.0	1.0 – 1.0

Group	Value	95% CI
GSK 692342 Group	1.0	1.0 – 26.0

Group	Value	95% CI
GSK 692342 Group	1.0	1.0 – 1.0

Group	Value	95% CI
GSK 692342 Group	96.0	43.0 – 115.0

Group	Value	95% CI
GSK 692342 Group	1.0	1.0 – 1.0

Group	Value	95% CI
GSK 692342 Group	1.0	1.0 – 14.0

Group	Value	95% CI
GSK 692342 Group	1.0	1.0 – 1.0

Group	Value	95% CI
GSK 692342 Group	1.0	1.0 – 14.0

Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M15 to M28) Primary · At Day 0 prior-Dose 1

Expressed immune markers combinations for CD4+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M15=CD4.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(+); M16=CD4.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(-); M17=CD4.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(+); M18=CD4.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(-); M19=CD4.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(+); M20=CD4.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(-); M21=CD4.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(+); M22=CD4.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL

M15

Group	Value	95% CI
GSK 692342 Group	1.0	1.0 – 1.0

M16

Group	Value	95% CI
GSK 692342 Group	15.0	1.0 – 42.0

M17

Group	Value	95% CI
GSK 692342 Group	1.0	1.0 – 1.0

M18

Group	Value	95% CI
GSK 692342 Group	1.0	1.0 – 1.0

M19

Group	Value	95% CI
GSK 692342 Group	1.0	1.0 – 1.0

M20

Group	Value	95% CI
GSK 692342 Group	13.0	1.0 – 14.0

M21

Group	Value	95% CI
GSK 692342 Group	1.0	1.0 – 1.0

M22

Group	Value	95% CI
GSK 692342 Group	1.0	1.0 – 14.0

Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M29 to M42) Primary · At Day 0 prior - Dose 1

Expressed immune markers combinations for CD4+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M29=CD4.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(+); M30=CD4.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(-); M31=CD4.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(+); M32=CD4.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(-); M33=CD4.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(+); M34=CD4.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(-); M35=CD4.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(+); M36=CD4.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL

M29

Group	Value	95% CI
GSK 692342 Group	1.0	1.0 – 1.0

M30

Group	Value	95% CI
GSK 692342 Group	1.0	1.0 – 1.0

M31

Group	Value	95% CI
GSK 692342 Group	1.0	1.0 – 1.0

M32

Group	Value	95% CI
GSK 692342 Group	1.0	1.0 – 227.0

M33

Group	Value	95% CI
GSK 692342 Group	1.0	1.0 – 1.0

M34

Group	Value	95% CI
GSK 692342 Group	1.0	1.0 – 1.0

M35

Group	Value	95% CI
GSK 692342 Group	1.0	1.0 – 1.0

M36

Group	Value	95% CI
GSK 692342 Group	1.0	1.0 – 17.0

Adverse events — posted to ClinicalTrials.gov

Time frame: Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period following each dose and across doses; unsolicited AEs: During the 30-day (Days 0-29) post-vaccination period; pIMDs: during the entire study period (From Day 0 to Month 7).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

GSK 692342 Group

Serious: 1/20 (5%)

Deaths: 0/20

Serious adverse events (1 terms)

Reaction	System	GSK 692342 Group
Alcohol abuse	Psychiatric disorders	—

Other adverse events (25 terms — click to expand)

Reaction	System	GSK 692342 Group
Pain	General disorders	—
Fatigue	General disorders	—
Headache	Nervous system disorders	—
Malaise	General disorders	—
Myalgia	Musculoskeletal and connective tissue disorders	—
Pyrexia	General disorders	—
Gastrointestinal disorder	Gastrointestinal disorders	—
Swelling	General disorders	—
Erythema	Skin and subcutaneous tissue disorders	—
Feeling hot	General disorders	—
Sinusitis	Infections and infestations	—
Upper respiratory tract infection	Infections and infestations	—
Abdominal pain upper	Gastrointestinal disorders	—
Aphthous stomatitis	Gastrointestinal disorders	—
Arthralgia	Musculoskeletal and connective tissue disorders	—
Back pain	Musculoskeletal and connective tissue disorders	—
Cystitis	Infections and infestations	—
Diarrhoea	Gastrointestinal disorders	—
Dizziness	Nervous system disorders	—
Groin pain	Musculoskeletal and connective tissue disorders	—
Injection site warmth	General disorders	—
Migraine	Nervous system disorders	—
Muscular weakness	Musculoskeletal and connective tissue disorders	—
Pertussis	Infections and infestations	—
Rhinitis	Infections and infestations	—

Most-reported serious reactions: Alcohol abuse.

Data from ClinicalTrials.gov NCT01669096 adverse events section.

Sponsor's own description

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. In, addition, blood samples collected at different time points after vaccination will be analysed to see when exactly genes are activated by the vaccine using an assay called mRNA expression profiling. The different methods for mRNA expression profiling using whole blood samples versus Peripheral Blood Mononuclear cell(s) (PBMCs), will also be compared.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Lipids and Lipid Derivatives for RNA Delivery.
Zhang Y, Sun C, Wang C, Jankovic KE, et al · · 2021 · cited 423× · PMID 34279087 · DOI 10.1021/acs.chemrev.1c00244
mRNA vaccine: a potential therapeutic strategy.
Wang Y, Zhang Z, Luo J, Han X, et al · · 2021 · cited 286× · PMID 33593376 · DOI 10.1186/s12943-021-01311-z
Nanomedicines to Deliver mRNA: State of the Art and Future Perspectives.
Gómez-Aguado I, Rodríguez-Castejón J, Vicente-Pascual M, Rodríguez-Gascón A, et al · · 2020 · cited 144× · PMID 32093140 · DOI 10.3390/nano10020364
Key recent advances in TB vaccine development and understanding of protective immune responses against Mycobacterium tuberculosis.
Scriba TJ, Netea MG, Ginsberg AM. · · 2020 · cited 75× · PMID 33279383 · DOI 10.1016/j.smim.2020.101431
Lipid carriers for mRNA delivery.
Zhang W, Jiang Y, He Y, Boucetta H, et al · · 2023 · cited 74× · PMID 37799378 · DOI 10.1016/j.apsb.2022.11.026
Delivery of mRNA for regulating functions of immune cells.
Shi J, Huang MW, Lu ZD, Du XJ, et al · · 2022 · cited 49× · PMID 35337940 · DOI 10.1016/j.jconrel.2022.03.033
Scope and challenges of nanoparticle-based mRNA delivery in cancer treatment.
Karim ME, Haque ST, Al-Busaidi H, Bakhtiar A, et al · · 2022 · cited 31× · PMID 36422795 · DOI 10.1007/s12272-022-01418-x
Adjuvant-Associated Peripheral Blood mRNA Profiles and Kinetics Induced by the Adjuvanted Recombinant Protein Candidate Tuberculosis Vaccine M72/AS01 in Bacillus Calmette-Guérin-Vaccinated Adults.
van den Berg RA, De Mot L, Leroux-Roels G, Bechtold V, et al · · 2018 · cited 28× · PMID 29632533 · DOI 10.3389/fimmu.2018.00564

Verify or expand the search:

Other trials of GSK Biologicals' investigational TB vaccine GSK 692342

Trials testing the same drug.

NCT01424501 — Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in Adults With TB Disease · Phase 2 · terminated

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Currently open trials in the same condition.

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Other GlaxoSmithKline trials

Trials by the same sponsor.

NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam · Phase 2, PHASE3 · not yet recruiting
NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · Phase 1 · not yet recruiting
NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01669096 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 22 March 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01669096.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing