Study of AERAS-402 in Healthy Infants

NCT01198366 | Completed Phase 1 Results DMC

• 1 other identifier: C-029-402
• Study Type: interventional
• Target: 487
• Locations: 3 countries
• Sites: 7

Brief Summary

AERAS-402 will be given to infants of at least 16 weeks of age who have already been vaccinated with BCG to determine if AERAS-402 will increase protection of infants to tuberculosis.

Conditions

Tuberculosis

Keywords

Tuberculosis; Vaccine; Immunogenicity; Prevention of Tuberculosis

Outcome Measures

Primary Outcomes (1)

• 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 (4)

• Percentage of Cells Expressing Various Cytokines Will be Measured by Intracellular Cytokine Staining (ICS) in All Subjects

  28 days post last vaccination

• Interferon-gamma (IFN-gamma) Enzyme-linked Immunospot (ELISpot) Response: Spot Forming Units/10^6 PBMC According to ELISpot Assay

  28 days post last vaccination

• Antigen-specific Antibody Response - Mean Optical Density (Mean OD)

  28 day post last vaccination

• Percentage of Subjects Converting From a Negative QuantiFERON Test (QFT) to Positive QFT After Vaccination

  up to 24 months post vaccination

Study Arms (6)

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

Expanded Safety Phase Gr 5 Placebo x3

PLACEBO COMPARATOR

Subjects received 3 doses (x3) of placebo (sterile buffer) on days 0, 28 and 280.

Biological: Placebo

Interventions

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

AERAS-402 3.0 x 10^10 vp BIOLOGICAL

Dose Finding Gr 3 AERAS-402 (3.0 x 10^10 vp) x 2

AERAS-402 1.0 x 10^11 vp BIOLOGICAL

Dose Finding Gr 4 AERAS-402 (1.0 x 10^11 vp) x 2

Placebo BIOLOGICAL

Dose Finding Gr 1 placebo x 2; Expanded Safety Phase Gr 5 Placebo x3

Eligibility Criteria

• Age: 112 Days - 182 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aeras: lead
• European and Developing Countries Clinical Trials Partnership (EDCTP): collaborator

Study Sites (7)

Boro Heath Center

Boro, Kenya

Location

KEMRI/CDC Research and Public Heath Collaboration

Kisumu, 40100, Kenya

Location

Siaya District Hospital

Siaya, Kenya

Location

CISM: Centro de Investigacao em Saude de Manhica

Manhiça, 1929, Mozambique

Location

Univeristy of Cape Town

Cape Town, 7925, South Africa

Location

Perinatal HIV Research Unit (PHRU) Chris Hani Baragwanath Hospital

Soweto, 1864, South Africa

Location

SATVI: Worcester

Worcester, 6850, South Africa

Location

Related Publications (1)

• 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.

  PMID: 25936724 BACKGROUND

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Product Director
• Organization: Aeras

blandry@aeras.org

301-547-2919

Study Officials

• Robert Walker

  Aeras

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2010
• First Posted: September 10, 2010
• Study Start: September 1, 2010
• Primary Completion: January 1, 2014
• Study Completion: April 1, 2014
• Last Updated: May 8, 2017
• Results First Posted: August 4, 2015

Record last verified: 2017-03

Locations

KE (3); MO (1); ZA (3)