Study of AERAS-402 in Healthy Infants | NCT01198366

NCT01198366

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
European and Developing Countries Clinical Trials Partnership (EDCTP)	OTHER_GOV

Oversight Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dose Finding Gr 1 placebo x 2	Placebo Comparator	Subjects received two doses (x2) of placebo (sterile buffer) on study days 0 and 28.	Biological: Placebo
Dose Finding Gr 2 AERAS-402 (1.5 x 10^10 vp) x2	Experimental	Subjects received two doses (x2) of AERAS-402 (1.5 x 10^10 vp) on study days 0 and 28.	Biological: AERAS-402 1.5 x 10^10 vp
Dose Finding Gr 3 AERAS-402 (3.0 x 10^10 vp) x 2	Experimental	Subjects received two doses (x2) of AERAS-402 (3.0 x 10^10 vp) on study days 0 and 28.	Biological: AERAS-402 3.0 x 10^10 vp
Dose Finding Gr 4 AERAS-402 (1.0 x 10^11 vp) x 2	Experimental	Subjects received two doses (x2) of AERAS-402 (1.0 x 10^11 vp) on study days 0 and 28.	Biological: AERAS-402 1.0 x 10^11 vp
Expanded Safety Phase Gr 5 AERAS-402 (1.0 X 10^11 vp) x 3	Experimental	Subjects received 3 doses (x3) of AERAS-402 (1.0 X 10^11 vp) on days 0, 28 and 280.	Biological: AERAS-402 1.5 x 10^10 vp

Name	Type	Description	Arm Group Labels	Other Names
AERAS-402 1.5 x 10^10 vp	Biological		Dose Finding Gr 2 AERAS-402 (1.5 x 10^10 vp) x2 Expanded Safety Phase Gr 5 AERAS-402 (1.0 X 10^11 vp) x 3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse Events Collected Per Subject	Adverse Events (AEs) are recorded for 28 days post vaccination Serious Adverse Events (SAEs) are recorded for the entire study period to assess the safety profile	Up to 24 months post vaccination

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Cells Expressing Various Cytokines Will be Measured by Intracellular Cytokine Staining (ICS) in All Subjects	To evaluate the immunogenicity of AERAS-402 compared to controls, flow cytometric ICS of CD4 and CD8 T cells producing any of three cytokines (IFN-γ, TNF-α, and/or IL-2) alone or in combination after stimulation with a peptide pool of mycobacterial peptides. Dimethylsulfoxide (DMSO) subtracted responses are presented.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Parent/legal guardian has completed the written informed consent process
Is age greater than or equal to 112 days (16 weeks) and less than or equal 182 days (26 weeks) on Study Day 0
Has general good health, confirmed by medical history and physical examination
Is up to date on all Expanded Program of Immunization (EPI) immunizations for his/her age with a minimum of 14 days between the last EPI vaccination and administration of study vaccine on Study Day 0
Has ability to complete follow-up period of 728 days as required by the protocol
Parent/legal guardian is able and willing to stay in contact with the study site for the duration of the study and to provide updated contact information as necessary, and has no current plans to move from the study area for the duration of the study
Has completed simultaneous enrollment in Aeras Vaccine Development Registry protocol
Had BCG vaccination ≥ 3 months prior to randomization documented by medical card

Exclusion Criteria:

Acute illness, evidence of any significant active infection or temperature >=37.5°C on the day of randomization
Used immunosuppressive medication within 45 days before entry into the study (inhaled and topical corticosteroids are permitted)
Received immunoglobulin or blood products within 45 days before entry into the study
Ever received any investigational drug therapy or investigational vaccine
History or laboratory evidence of individual immunodeficiency virus (HIV-1) infection
History of allergic disease or reactions to any component of the study vaccine
Previous medical history that may compromise the safety of the participant in the study
Evidence of a new acute illness that may compromise the safety of the participant in the study
Inability to discontinue daily medications during the study
History or evidence of any systemic disease on physical examination or any acute or chronic illness that may interfere with the evaluation of the safety or immunogenicity of the vaccine, e.g., including masses between the leg and abdomen (e.g., inguinal hernia or lymphadenopathy)
History or evidence of active tuberculosis
A positive QuantiFERON®-TB Gold In-Tube test
A household contact with active TB disease

Name	Affiliation	Role
Robert Walker	Aeras	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Boro Heath Center		Boro			Kenya
KEMRI/CDC Research and Public Heath Collaboration

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25936724	Background	Tameris M, Hokey DA, Nduba V, Sacarlal J, Laher F, Kiringa G, Gondo K, Lazarus EM, Gray GE, Nachman S, Mahomed H, Downing K, Abel B, Scriba TJ, McClain JB, Pau MG, Hendriks J, Dheenadhayalan V, Ishmukhamedov S, Luabeya AK, Geldenhuys H, Shepherd B, Blatner G, Cardenas V, Walker R, Hanekom WA, Sadoff J, Douoguih M, Barker L, Hatherill M. A double-blind, randomised, placebo-controlled, dose-finding trial of the novel tuberculosis vaccine AERAS-402, an adenovirus-vectored fusion protein, in healthy, BCG-vaccinated infants. Vaccine. 2015 Jun 9;33(25):2944-54. doi: 10.1016/j.vaccine.2015.03.070. Epub 2015 Apr 28.

Arm/Group Information

ID	Title	Description
FG000	Dose Finding - Group 1	Subjects enrolled in Study Group 1 will receive two doses of placebo once on Study Day 0 and again on Study Day 28. Placebo: Sterile buffer
FG001	Dose Finding - Group 2	Subjects enrolled in Study Group 2 will receive two doses of AERAS-402 (1.5 x 10^10 vp) once on Study Day 0 and again on Study Day 28. AERAS-402 1.5 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.
FG002	Dose Finding - Group 3	Subjects enrolled in Study Group 3 will receive two doses of AERAS-402 (3.0 x 10^10 vp) once on Study Day 0 and again on Study Day 28. AERAS-402 3.0 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.
FG003	Dose Finding - Group 4	Subjects enrolled in Study Group 4 will receive two doses of AERAS-402 (1.0 x 10^11 vp) once on Study Day 0 and again on Study Day 28. AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.
FG004	Expanded Safety Phase - Group 5	Subjects received 3 doses of AERAS-402 (1 X 10^11 vp) on days 0, 28 and 280. AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.
FG005	Expanded Safety Phase - Group 5 Placebo	Subjects received 3 doses of placebo on days 0, 28 and 280. Placebo: Sterile buffer

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Dose Finding - Group 1	Subjects enrolled in Study Group 1 will receive two doses of placebo once on Study Day 0 and again on Study Day 28. Placebo: Sterile buffer
BG001	Dose Finding - Group 2

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Customized	≥112 days (16 weeks) and ≤182 days (26 weeks) on Study Day 0

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Adverse Events Collected Per Subject

Adverse Events (AEs) are recorded for 28 days post vaccination Serious Adverse Events (SAEs) are recorded for the entire study period to assess the safety profile

Subjects who received at least one vaccination.

Posted

Number

percentage of subjects with an AE

Up to 24 months post vaccination

ID	Title	Description
OG000	Dose Finding - Group 1	Subjects enrolled in Study Group 1 will receive two doses of placebo once on Study Day 0 and again on Study Day 28. Placebo: Sterile buffer
OG001	Dose Finding - Group 2	Subjects enrolled in Study Group 2 will receive two doses of AERAS-402 (1.5 x 10^10 vp) once on Study Day 0 and again on Study Day 28. AERAS-402 1.5 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Dose Finding - Group 1	Subjects received two doses of placebo (sterile buffer) on study days 0 and 28.

ID	Term
D009164	Mycobacterium Infections
D000193	Actinomycetales Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections