TuberculosisPhase 2NCT00707967

Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in HIV-positive Adults.

A Phase 2 study testing GSK's candidate Mycobacterium tuberculosis vaccine 692342 in people with Tuberculosis, run by GlaxoSmithKline at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study will assess the safety and immunogenicity of a GSK Biologicals' candidate TB vaccine (692342) administered at 0, 1 month to HIV-positive adults living in Switzerland. Read more about this study

Who is it for?: Ages 18 to 50 years
Conditions the study is for: Tuberculosis
What is being tested?: GSK's candidate Mycobacterium tuberculosis vaccine 692342
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 37 participants
Where: 1 siteSwitzerland
Study dates: 30 Jun 2008to 27 May 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Subjects who the Investigator believes that they can and will comply with the requirements of the protocol.
A male or female between, and including, 18 and 50 years of age at the time of the first vaccination.
Written informed consent obtained from the subject prior to any study procedure.
Subjects must be HIV-positive and must have:
received Highly Active Antiretroviral therapy for a minimum of 12 consecutive months prior to screening
documented suppressed HIV-1 RNA levels following HAART-treatment.

Show all 12Show fewer

a protocol defined CD4+ T cell count at screening
If the subject is female, she must be of non-childbearing potential, or she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of vaccination.
Clinically acceptable laboratory values prior to randomisation as determined by the Investigator.
No evidence of TB disease with no pulmonary pathology as confirmed by chest X-ray.
No history of extrapulmonary TB.
No history of chemotherapy for TB.

Who cannot join

Any change in antiretroviral drug regimen within 12 weeks prior to screening.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Administration of a registered live vaccine not foreseen by the study within 30 days preceding the first dose of study vaccine and administration of a registered inactivated vaccine within 14 days preceding the first dose of study vaccine.
History of previous administration of experimental Mycobacterium tuberculosis vaccines.
History of previous exposure to experimental products containing components of the experimental vaccine.
Chronic administration of immunosuppressive or other immune-modifying drugs within six months prior to the first vaccine dose.

Show all 15Show fewer

Administration of any immunoglobulins, any immunotherapy and/or any blood products within the three months preceding the first dose of study vaccination, or planned administrations during the study period.
Any condition or illness (acute, chronic or history) or medication, which in the opinion of the Investigator might interfere with the evaluation of the safety or immunogenicity of the vaccine.
Planned participation or participation in another experimental protocol during the study period.
A family history of congenital or hereditary immunodeficiency. •Any chronic drug therapy, other than HAART or prophylaxis for opportunistic HIV-related infections to be continued during the study period. Vitamins and/or dietary supplements, birth control pills, anti-histamines for seasonal allergies and SSRIs are allowed.
Subjects taking any of the following medication: systemic steroids, interleukins, systemic interferons or systemic chemotherapy.
History of allergic reactions or anaphylaxis to any vaccine.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
History of chronic alcohol consumption and/or drug abuse which in the Investigator's opinion would put the subject at risk.
Pregnant female, lactating female or female planning to become pregnant or stop contraception.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

GSK Investigational Site
Lausanne, 1011

Other trials in Switzerland

About this study

Official title: Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine (692342) in HIV-positive Adults.

This study will assess the safety and immunogenicity of a GSK Biologicals' candidate TB vaccine (692342) administered at 0, 1 month to HIV-positive adults living in Switzerland.

Conditions: Tuberculosis
Being tested: GSK's candidate Mycobacterium tuberculosis vaccine 692342, Control vaccine with the adjuvant system., Control vaccine with physiological saline
Keywords: Tuberculosis vaccine
Medical subject headings: Tuberculosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GSK's candidate Mycobacterium tuberculosis vaccine 692342Biological
Intramuscular injection, 2 doses at 0, 1 month
Control vaccine with the adjuvant system.Biological
Intramuscular injection, 2 doses at 0, 1 month
Control vaccine with physiological salineBiological
Intramuscular injection, 2 doses at 0, 1 month

Study groups in NCT00707967
Study group	Role	What they receive
Group A	Experimental	Subjects receiving the candidate vaccine Receives: Biological: GSK's candidate Mycobacterium tuberculosis vaccine 692342
Group B	Placebo comparator	Subjects receiving the adjuvant Receives: Biological: Control vaccine with the adjuvant system.
Group C	Placebo comparator	Subjects receiving physiological saline Receives: Biological: Control vaccine with physiological saline

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects With Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. Relationship analysis was not performed.
Measured: During the 7-day period (Days 0-6) post vaccination following each dose
Number of Subjects With Solicited General Symptoms
Assessed solicited general symptoms were fatigue, temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastrointestinal symptoms (gastro) [nausea, vomiting, diarrhoea and/or abdominal pain], headache, malaise and myalgia. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.
Measured: During the 7-day period (Days 0-6) post vaccination following each dose
Number of Subjects With Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Measured: During the 30-day period (Days 0-29) post vaccination
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity
Measured: During the entire study period, from Day 0 up to Day 210
Number of Subjects With Normal Biochemical and Haematological Levels
Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophil [EOS]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.
Measured: At Day 0, 7, 30, 37 and 60
Number of Subjects With Normal Haematological Levels
Among biochemical and haematological parameters assessed were haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.
Measured: At Day 0, 7, 30, 37 and 60
Number of Subjects With Normal Haematological Levels
Among biochemical and haematological parameters assessed were platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.
Measured: At Day 0, 7, 30, 37 and 60
Number of Subjects With Biochemical and Haematological Levels Below Normal
Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophil [EOS]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.
Measured: At Day 0, 7, 30, 37 and 60
Number of Subjects With Haematological Levels Below Normal
Among biochemical and haematological parameters assessed were haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.
Measured: At Day 0, 7, 30, 37 and 60
Number of Subjects With Haematological Levels Below Normal
Among biochemical and haematological parameters assessed were [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.
Measured: At Day 0, 7, 30, 37 and 60
Number of Subjects With Biochemical and Haematological Levels Above Normal
Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophil [EOS]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.
Measured: At Day 0, 7, 30, 37 and 60
Number of Subjects With Haematological Levels Above Normal
Among biochemical and haematological parameters assessed were haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.
Measured: At Day 0, 7, 30, 37 and 60
Number of Subjects With Haematological Levels Above Normal
Among biochemical and haematological parameters assessed were [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.
Measured: At Day 0, 7, 30, 37 and 60

Secondary outcomes (5)

Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines
Among cytokines expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).
Measured: At Day 0, 30, 60 and 210
Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule
Expressed cytokine combinations for CD4+ T cells were CD40-L and interleukin-2 [IL-2] or interferon-gamma [IFN-γ] or tumour necrosis factor-alpha [TNF-α]; IL-2 and CD40-L, or IFN-γ, or TNF-α; IFN-γ and CD40-L, or IL-2, or TNF-α; TNF-α and CD40-L, or IL-2, or IFN-γ.
For CD8+ T cells no vaccine induced responses were observed, thus results are presented only for the frequency of M72-specific CD8+ T cells expressing at least two cytokines.
Measured: At Day 0, 30, 60 and 210
Cell Count of CD4+ T Cells
CD4+ T cell counts are defined by values greater than (>) 200 cells per cubic millimeters (mm3) at screening for enrolment into the study.
Measured: At Day 0, 30, 60 and 210
Anti-M72 Specific Antibody Concentrations
Concentrations given in Enzyme-Linked Immunosorbent Assay units per milliliter (EL.U/mL) were expressed in Geometric Mean Concentrations (GMCs).
Measured: At Day 0, 30, 60 and 210
Number of Subjects With Significant Highly Active Anti-Retroviral Therapy (HAART) Changes
Recorded significant HAART change refers to one subject switching the Combivir drug to Truvada as planned by personal physician, with no relationship to vaccination, prior to study enrolment.
Measured: From Day 60 to Day 210

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jun 200827 May 2009

First posted1 Jul 2008 (estimated)
Study start30 Jun 2008
Primary completion27 May 2009
Study completion27 May 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for TuberculosisStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00707967
Sponsor's protocol ID: 111517
Status last verified: Nov 2016
First submitted: 27 Jun 2008
Last updated: 24 Aug 2018
Results posted: Yes, on ClinicalTrials.gov

Publications

Thacher EG, Cavassini M, Audran R, Thierry AC, Bollaerts A, Cohen J, Demoitie MA, Ejigu D, Mettens P, Moris P, Ofori-Anyinam O, Spertini F. Safety and immunogenicity of the M72/AS01 candidate tuberculosis vaccine in HIV-infected adults on combination antiretroviral therapy: a phase I/II, randomized trial. AIDS. 2014 Jul 31;28(12):1769-81. doi: 10.1097/QAD.0000000000000343.
PubMed 24911353
Roy-Ghanta S, Van der Most R, Li P, Vaughn DW. Responses to A(H1N1)pdm09 influenza vaccines in participants previously vaccinated with seasonal influenza vaccine: a randomized, observer-blind, controlled study. J Infect Dis. 2014 Nov 1;210(9):1419-30. doi: 10.1093/infdis/jiu284. Epub 2014 May 26.
PubMed 24864125

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
Short-term Antibiotic Therapy in Mycobacterium Avium Complex Pulmonary Disease
Mycobacterium Avium Complex Pulmonary Disease
RecruitingObservational study
Paradoxical Tuberculosis Reactions in Patients Without HIV Infection
Tuberculosis
Not yet recruitingPhase 2
Re-evaluating the Duration in Children of TB Treatment
Tuberculosis
RecruitingPhase 1/2
A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
Tuberculosis
Active, not recruitingPhase 3
Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients
Tuberculosis, MDR

All Tuberculosis trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine (692342) in HIV-positive Adults.
ClinicalTrials.gov ID: NCT00707967
Acronym / sponsor ID: 111517
Conditions: Tuberculosis
Keywords: Tuberculosis vaccine
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 30 Jun 2008
Primary completion: 27 May 2009 (actual)
Study completion: 27 May 2009 (actual)
First posted: 1 Jul 2008 (estimated)
Results: Posted 6 Jan 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will assess the safety and immunogenicity of a GSK Biologicals' candidate TB vaccine (692342) administered at 0, 1 month to HIV-positive adults living in Switzerland.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Group A	Experimental	Biological: GSK's candidate Mycobacterium tuberculosis vaccine 692342Subjects receiving the candidate vaccine
Group B	Placebo comparator	Biological: Control vaccine with the adjuvant system.Subjects receiving the adjuvant
Group C	Placebo comparator	Biological: Control vaccine with physiological salineSubjects receiving physiological saline

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (12 listed)

Subjects who the Investigator believes that they can and will comply with the requirements of the protocol.
A male or female between, and including, 18 and 50 years of age at the time of the first vaccination.
Written informed consent obtained from the subject prior to any study procedure.
Subjects must be HIV-positive and must have:
If the subject is female, she must be of non-childbearing potential, or she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of vaccination.

Key exclusion criteria (15 listed)

Any change in antiretroviral drug regimen within 12 weeks prior to screening.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Administration of a registered live vaccine not foreseen by the study within 30 days preceding the first dose of study vaccine and administration of a registered inactivated vaccine within 14 days preceding the first dose of study vaccine.
History of previous administration of experimental Mycobacterium tuberculosis vaccines.
History of previous exposure to experimental products containing components of the experimental vaccine.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GSK's candidate Mycobacterium tuberculosis vaccine 692342Intramuscular injection, 2 doses at 0, 1 month	Biological	Group A
Control vaccine with the adjuvant system.Intramuscular injection, 2 doses at 0, 1 month	Biological	Group B
Control vaccine with physiological salineIntramuscular injection, 2 doses at 0, 1 month	Biological	Group C

Primary outcome

Number of Subjects With Solicited Local Symptoms
Time frame: During the 7-day period (Days 0-6) post vaccination following each dose
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. Relationship analysis was not performed.
Number of Subjects With Solicited General Symptoms
Time frame: During the 7-day period (Days 0-6) post vaccination following each dose
Assessed solicited general symptoms were fatigue, temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastrointestinal symptoms (gastro) [nausea, vomiting, diarrhoea and/or abdominal pain], headache, malaise and myalgia. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.
Number of Subjects With Unsolicited Adverse Events (AEs)
Time frame: During the 30-day period (Days 0-29) post vaccination
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: During the entire study period, from Day 0 up to Day 210
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity
Number of Subjects With Normal Biochemical and Haematological Levels
Time frame: At Day 0, 7, 30, 37 and 60
Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophil [EOS]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.
Number of Subjects With Normal Haematological Levels
Time frame: At Day 0, 7, 30, 37 and 60
Among biochemical and haematological parameters assessed were haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.
Number of Subjects With Normal Haematological Levels
Time frame: At Day 0, 7, 30, 37 and 60
Among biochemical and haematological parameters assessed were platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.
Number of Subjects With Biochemical and Haematological Levels Below Normal
Time frame: At Day 0, 7, 30, 37 and 60
Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophil [EOS]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.
Number of Subjects With Haematological Levels Below Normal
Time frame: At Day 0, 7, 30, 37 and 60
Among biochemical and haematological parameters assessed were haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.
Number of Subjects With Haematological Levels Below Normal
Time frame: At Day 0, 7, 30, 37 and 60
Among biochemical and haematological parameters assessed were [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.
Number of Subjects With Biochemical and Haematological Levels Above Normal
Time frame: At Day 0, 7, 30, 37 and 60
Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophil [EOS]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.
Number of Subjects With Haematological Levels Above Normal
Time frame: At Day 0, 7, 30, 37 and 60
Among biochemical and haematological parameters assessed were haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.
Number of Subjects With Haematological Levels Above Normal
Time frame: At Day 0, 7, 30, 37 and 60
Among biochemical and haematological parameters assessed were [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were - normal, below and above.

5 secondary outcomes

Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines
Time frame: At Day 0, 30, 60 and 210
Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule
Time frame: At Day 0, 30, 60 and 210
Cell Count of CD4+ T Cells
Time frame: At Day 0, 30, 60 and 210
Anti-M72 Specific Antibody Concentrations
Time frame: At Day 0, 30, 60 and 210
Number of Subjects With Significant Highly Active Anti-Retroviral Therapy (HAART) Changes
Time frame: From Day 60 to Day 210

Results and safety

Results posted to the registry on 6 Jan 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GSK692342 Group	22	22
Control Group	8	8
Placebo Group	7	7

Primary outcome: Number of Subjects With Solicited Local Symptoms

Time frame: During the 7-day period (Days 0-6) post vaccination following each dose. Number. Unit: Subjects

Measure	GSK692342 Group n = 22	Control Group n = 8	Placebo Group n = 7
Any Pain, Dose 1	20	6	1
Grade 3 Pain, Dose 1	1	0	0
Any Redness, Dose 1	9	2	0
Grade 3 Redness, Dose 1	2	0	0
Any Swelling, Dose 1	8	1	0
Grade 3 Swelling, Dose 1	2	0	0
Any Pain, Dose 2	20	7	2
Grade 3 Pain, Dose 2	3	0	0

Population analysed: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

Primary outcome: Number of Subjects With Solicited General Symptoms

Time frame: During the 7-day period (Days 0-6) post vaccination following each dose. Number. Unit: Subjects

Measure	GSK692342 Group n = 22	Control Group n = 8	Placebo Group n = 7
Any Fatigue, Dose 1	10	6	2
Grade 3 Fatigue, Dose 1	1	0	0
Related Fatigue, Dose 1	0	0	0
Any Gastro, Dose 1	4	2	1
Grade 3 Gastro, Dose 1	0	0	0
Related Gastro, Dose 1	0	0	0
Any Headache, Dose 1	7	4	2
Grade 3 Headache, Dose 1	0	0	0

Population analysed: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

Primary outcome: Number of Subjects With Unsolicited Adverse Events (AEs)

Time frame: During the 30-day period (Days 0-29) post vaccination. Number. Unit: Subjects

Measure	GSK692342 Group n = 22	Control Group n = 8	Placebo Group n = 7
Any AEs	21	6	5
Grade 3 AEs	11	2	0
Related AEs	4	0	0

Population analysed: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

Primary outcome: Number of Subjects With Serious Adverse Events (SAEs)

Time frame: During the entire study period, from Day 0 up to Day 210. Number. Unit: Subjects

Measure	GSK692342 Group n = 22	Control Group n = 8	Placebo Group n = 7
Value	2	0	0

Population analysed: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited local/general symptoms: during the 7-day period; Unsolicited AEs: during the 30-day period; SAEs: during the entire study period, from Day 0 up to Day 210.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GSK692342 Group	2 of 22 (9.1%)	21 of 22 (95.5%)	Not reported
Control Group	0 of 8 (0%)	8 of 8 (100%)	Not reported
Placebo Group	0 of 7 (0%)	6 of 7 (85.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24911353Thacher EG, Cavassini M, Audran R, Thierry AC, Bollaerts A, Cohen J, Demoitie MA, Ejigu D, Mettens P, Moris P, Ofori-Anyinam O, Spertini F. Safety and immunogenicity of the M72/AS01 candidate tuberculosis vaccine in HIV-infected adults on combination antiretroviral therapy: a phase I/II, randomized trial. AIDS. 2014 Jul 31;28(12):1769-81. doi: 10.1097/QAD.0000000000000343.
Derived from this study: PubMed 24864125Roy-Ghanta S, Van der Most R, Li P, Vaughn DW. Responses to A(H1N1)pdm09 influenza vaccines in participants previously vaccinated with seasonal influenza vaccine: a randomized, observer-blind, controlled study. J Infect Dis. 2014 Nov 1;210(9):1419-30. doi: 10.1093/infdis/jiu284. Epub 2014 May 26.

Related trials for Tuberculosis

RecruitingPhase 4
Short-term Antibiotic Therapy in Mycobacterium Avium Complex Pulmonary Disease
Mycobacterium Avium Complex Pulmonary Disease
RecruitingObservational study
Paradoxical Tuberculosis Reactions in Patients Without HIV Infection
Tuberculosis
Not yet recruitingPhase 2
Re-evaluating the Duration in Children of TB Treatment
Tuberculosis
RecruitingPhase 1/2
A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
Tuberculosis
Active, not recruitingPhase 3
Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients
Tuberculosis, MDR

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GSK's candidate Mycobacterium tuberculosis vaccine 692342 in people with Tuberculosis, run by GlaxoSmithKline at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects With Solicited Local Symptoms (time frame: During the 7-day period (Days 0-6) post vaccination following each dose). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00707967, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2018.