Trial · NCT00953927

A Study of MVA85A in Healthy Infants

NCT00953927, Phase 2, Completed, Aeras; results first posted 2013-12-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of MVA85A in Healthy Infants. Trials, record NCT00953927. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00953927

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of MVA85A in Healthy Infants
NCT number: NCT00953927
Status: Completed
Phases: Phase 2
Enrollment: 2,797 participants, actual
Lead sponsor: Aeras
Conditions: Tuberculosis
Interventions: MVA85A/AERAS-485, Candida Skin Test Antigen
First posted: 2009-08-06
Last updated: 2016-05-24
Results first posted: 2013-12-12

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	To Evaluate the Safety Profile of MVA85A/AERAS-485 in Bacillus Calmette-Guerin (BCG) -Vaccinated, HIV-negative Infants.	AEs recorded 28 days post-vaccination; SAEs recorded for entire study period.	Adverse events (AE) were collected for 28 days after vaccination. The subject's parent or guardian recorded information regarding occurrences of solicited adverse events in diary cards through 7 days after vaccination. Serious adverse events (SAE) were collected from the time of study vaccine dosing throughout the entire study. A safety cohort (the first 330 infants enrolled) also had serum chemistry and hematology testing up to 28 days post-vaccination.
Secondary	To Evaluate the Efficacy of the MVA85A/AERAS-485 Vaccine Compared to Controls in Prevention of Tuberculosis Using an Endpoint Derived From Epidemiological Cohort Surveys in BCG Vaccinated Infants.	15 to 36 months post-vaccination	The number (percentage) of subjects with a diagnosis of tuberculosis based on clinically-derived tuberculosis (TB) diagnostic criteria were summarized by treatment group for all subjects.
Secondary	To Evaluate the Immunogenicity of the MVA85A/AERAS-485 Vaccine Compared to Controls as Described by Flow Cytometric Intracellular Cytokine Staining of CD4 and CD8 T Cells.	28 days post-vaccination	Intracellular cytokine staining (ICS) assay immune response was expressed as the percentage of cluster of differentiation 4 (CD4) and cluster of differentiation 8 (CD8) T cells producing any one of three cytokines (IFN-γ, TNF-α, or IL-2) or any combination of the three cytokines simultaneously after stimulation with an Ag85A peptide pool on a subset of infants.
Secondary	To Evaluate the Immunogenicity of the MVA85A/AERAS-485 Vaccine Compared to Controls as Described by the ex Vivo Enzyme Linked Immunospot (ELISPOT) Test Used in Previous MVA85A/AERAS-485 Human Trials.	7 days post-vaccination	An ex vivo IFN-γ ELISPOT assay was used to assess specific T cell responses to an Ag85A peptide pool for a subset of infants.
Secondary	To Evaluate the Immunogenicity of the MVA85A/AERAS-485 Vaccine Compared to Controls as Described by the University of Capetown (UCT) Whole Blood Intracellular Cytokine Assay.	28 days post-vaccination	Frequencies of CD4 and CD8 T cells expressing cytokines (IFN-γ, IL-2 and TNF-α) following stimulation of whole blood with an Ag85A peptide pool were also measured by flow cytometry for a subset of infants.
Secondary	To Discover Correlates of Protection From Tuberculosis in Infants Vaccinated With MVA85A/AERAS-485.	15 to 36 months post-vaccination	Investigations for determining correlates of immune protection to TB will not be completed as planned because the study did not show TB protection in MVA85A/AERAS-485 recipients.
Secondary	To Evaluate the QuantiFERON Conversion Rate at Final Study Assessment in MVA85A/AERAS-485 Recipients Compared to Controls in Infants Without a Diagnosis of Tuberculosis During the Trial.	15 to 36 months post-vaccination	The number (percentage) of infants with QuantiFERON conversions at any time on the study were summarized by treatment group.

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	To Evaluate the Safety Profile of MVA85A/AERAS-485 in Bacillus Calmette-Guerin (BCG) -Vaccinated, HIV-negative Infants.	AEs recorded 28 days post-vaccination; SAEs recorded for entire study period.	All subjects vaccinated.	percentage of all subjects vaccinated	NUMBER
SECONDARY	To Evaluate the Efficacy of the MVA85A/AERAS-485 Vaccine Compared to Controls in Prevention of Tuberculosis Using an Endpoint Derived From Epidemiological Cohort Surveys in BCG Vaccinated Infants.	15 to 36 months post-vaccination	Per protocol population	participants with a diagnosis of TB	NUMBER
SECONDARY	To Evaluate the Immunogenicity of the MVA85A/AERAS-485 Vaccine Compared to Controls as Described by Flow Cytometric Intracellular Cytokine Staining of CD4 and CD8 T Cells.	28 days post-vaccination	Pre-specified population subset	percentage of cytokine expressing cells	MEDIAN
SECONDARY	To Evaluate the Immunogenicity of the MVA85A/AERAS-485 Vaccine Compared to Controls as Described by the ex Vivo Enzyme Linked Immunospot (ELISPOT) Test Used in Previous MVA85A/AERAS-485 Human Trials.	7 days post-vaccination	Pre-specified population subset	SFC per million PBMCs	MEDIAN
SECONDARY	To Evaluate the Immunogenicity of the MVA85A/AERAS-485 Vaccine Compared to Controls as Described by the University of Capetown (UCT) Whole Blood Intracellular Cytokine Assay.	28 days post-vaccination	Pre-specified population subset	percentage of cytokine expressing cells	MEDIAN
SECONDARY	To Discover Correlates of Protection From Tuberculosis in Infants Vaccinated With MVA85A/AERAS-485.	15 to 36 months post-vaccination
SECONDARY	To Evaluate the QuantiFERON Conversion Rate at Final Study Assessment in MVA85A/AERAS-485 Recipients Compared to Controls in Infants Without a Diagnosis of Tuberculosis During the Trial.	15 to 36 months post-vaccination	Per protocol population who were quantiferon negative at baseline.	participants	NUMBER

Source ClinicalTrials.gov

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
To Evaluate the Safety Profile of MVA85A/AERAS-485 in Bacillus Calmette-Guerin (BCG) -Vaccinated, HIV-negative Infants.	Investigational Vaccine		95.9	95% Confidence Interval 94.7 to 96.8	percentage of all subjects vaccinated
To Evaluate the Safety Profile of MVA85A/AERAS-485 in Bacillus Calmette-Guerin (BCG) -Vaccinated, HIV-negative Infants.	Control Group		83.7	95% Confidence Interval 81.7 to 85.6	percentage of all subjects vaccinated
To Evaluate the Efficacy of the MVA85A/AERAS-485 Vaccine Compared to Controls in Prevention of Tuberculosis Using an Endpoint Derived From Epidemiological Cohort Surveys in BCG Vaccinated Infants.	Investigational Vaccine		32		participants with a diagnosis of TB
To Evaluate the Efficacy of the MVA85A/AERAS-485 Vaccine Compared to Controls in Prevention of Tuberculosis Using an Endpoint Derived From Epidemiological Cohort Surveys in BCG Vaccinated Infants.	Control Group		39		participants with a diagnosis of TB
To Evaluate the Immunogenicity of the MVA85A/AERAS-485 Vaccine Compared to Controls as Described by Flow Cytometric Intracellular Cytokine Staining of CD4 and CD8 T Cells.	Investigational Vaccine	Percent cytokine expressing CD4 cells	0.012	95% Confidence Interval 0.003 to 0.038	percentage of cytokine expressing cells
To Evaluate the Immunogenicity of the MVA85A/AERAS-485 Vaccine Compared to Controls as Described by Flow Cytometric Intracellular Cytokine Staining of CD4 and CD8 T Cells.	Control Group	Percent cytokine expressing CD4 cells	0.003	95% Confidence Interval 0.000 to 0.011	percentage of cytokine expressing cells
To Evaluate the Immunogenicity of the MVA85A/AERAS-485 Vaccine Compared to Controls as Described by Flow Cytometric Intracellular Cytokine Staining of CD4 and CD8 T Cells.	Investigational Vaccine	Percent cytokine expressing CD8 cells	0.007	95% Confidence Interval 0.000 to 0.011	percentage of cytokine expressing cells
To Evaluate the Immunogenicity of the MVA85A/AERAS-485 Vaccine Compared to Controls as Described by Flow Cytometric Intracellular Cytokine Staining of CD4 and CD8 T Cells.	Control Group	Percent cytokine expressing CD8 cells	0.000	95% Confidence Interval 0.000 to 0.010	percentage of cytokine expressing cells
To Evaluate the Immunogenicity of the MVA85A/AERAS-485 Vaccine Compared to Controls as Described by the ex Vivo Enzyme Linked Immunospot (ELISPOT) Test Used in Previous MVA85A/AERAS-485 Human Trials.	Investigational Vaccine		143.000	95% Confidence Interval 107.000 to 295.350	SFC per million PBMCs
To Evaluate the Immunogenicity of the MVA85A/AERAS-485 Vaccine Compared to Controls as Described by the ex Vivo Enzyme Linked Immunospot (ELISPOT) Test Used in Previous MVA85A/AERAS-485 Human Trials.	Control Group		1.000	95% Confidence Interval 0.000 to 2.000	SFC per million PBMCs

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Investigational Vaccine	1,399
Overall Study	STARTED	Control Group	1,398
Overall Study	COMPLETED	Investigational Vaccine	1,294
Overall Study	COMPLETED	Control Group	1,303
Overall Study	NOT COMPLETED	Investigational Vaccine	105
Overall Study	NOT COMPLETED	Control Group	95

Source ClinicalTrials.gov

Adverse events204

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Rhinitis	Infections and infestations	Investigational Vaccine	65	1,399	67
other	Rhinitis	Infections and infestations	Control Group	79	1,396	79
other	Upper respiratory tract infection	Infections and infestations	Investigational Vaccine	183	1,399	192
other	Upper respiratory tract infection	Infections and infestations	Control Group	172	1,396	180
other	Hypophagia	Metabolism and nutrition disorders	Investigational Vaccine	321	1,399	389
other	Hypophagia	Metabolism and nutrition disorders	Control Group	285	1,396	357
other	Insomnia	Psychiatric disorders	Investigational Vaccine	398	1,399	513
other	Insomnia	Psychiatric disorders	Control Group	359	1,396	447
other	Hypersomnia	Nervous system disorders	Investigational Vaccine	376	1,399	478
other	Hypersomnia	Nervous system disorders	Control Group	324	1,396	419

1 to 10 of 204Source ClinicalTrials.gov

See all 204 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Investigational Vaccine
Total, all-cause mortality	Control Group
Total, other adverse events	Investigational Vaccine	1,319	1,399
Total, other adverse events	Control Group	1,064	1,396
Total, serious adverse events	Investigational Vaccine	257	1,399
Total, serious adverse events	Control Group	258	1,396

Source ClinicalTrials.gov

Papers7

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
23391465	BACKGROUND	PubMed
23410889	BACKGROUND	PubMed
24912498	DERIVED	PubMed
26226446	BACKGROUND	PubMed
26252568	BACKGROUND	PubMed
26554383	DERIVED	PubMed
31697647	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Investigational Vaccine vs Control Group: To Evaluate the QuantiFERON Conversion Rate at Final Study Assessment in MVA85A/AERAS-485 Recipients Compared to Controls in Infants Without a Diagnosis of Tuberculosis During the Trial.	Trial comparisons
Investigational Vaccine vs Control Group: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00953927

GET https://conductscience.org/api/trials/v1/NCT00953927/events?page=2

API reference For AI assistants