NCT01683773

Brief Summary

This trial will investigate the administration of two new tuberculosis vaccines, called AERAS-402 and MVA85A. The purpose of this trial is to assess what happens when both of these vaccines are given one after the other. The trial will assess the safety of both vaccines and also their ability to stimulate an immune response within the body. It is hoped that when these two vaccines are given in sequence, the combined immune response is even better than when each vaccine is used individually.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2012

Completed
8 days until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 12, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

September 17, 2014

Status Verified

September 1, 2014

Enrollment Period

1.9 years

First QC Date

August 24, 2012

Last Update Submit

September 16, 2014

Conditions

Tuberculosis

Keywords

TuberculosisPhase IMVA85AAERAS-402

Outcome Measures

Primary Outcomes (1)

  • Safety of AERAS-402 followed by MVA85A

    To evaluate the safety profile of multiple doses of AERAS-402 alone, compared to one and two doses of AERAS-402 followed by MVA85A in healthy, BCG vaccinated adults, measured by number and severity of local and systemic adverse events

    3 months after final vaccination

Secondary Outcomes (1)

  • Immunogenicity of AERAS-402 followed by MVA85A

    12-18 months after first vaccination

Study Arms (3)

Group A

EXPERIMENTAL

Two doses of AERAS-402 (1x10\^11 vp intramuscular injection) followed by one dose of MVA85A (1x10\^8 pfu intradermal injection)

Biological: AERAS-402Biological: MVA85A

Group B

EXPERIMENTAL

One dose of AERAS-402 (1x10\^11 vp intramuscular injection) followed by one dose of MVA85A (1x10\^8 pfu intradermal injection)

Biological: AERAS-402Biological: MVA85A

Group C

EXPERIMENTAL

Three doses of AERAS-402 (1x10\^11 vp intramuscular injection)

Biological: AERAS-402

Interventions

AERAS-402BIOLOGICAL

Intramuscular needle injection 1x10\^11 vp

Also known as: Ad35 TB-S
Group AGroup BGroup C
MVA85ABIOLOGICAL

Intradermal needle injection 1x10\^8 pfu

Also known as: AERAS-485
Group AGroup B

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects must meet all of the following criteria to enter the trial:
  • Healthy adult aged 18-55 years
  • Resident in or near Oxford (for CCVTM) or Birmingham (for WTCRF; and able to travel to Oxford for vaccinations) for the duration of the trial period
  • No relevant findings in medical history or on physical examination
  • Confirmation of prior vaccination with BCG not less than 6 months prior to projected trial vaccination date (by visible BCG scar on examination or written documentation)
  • Allow the Investigators to discuss the individual's medical history with their GP
  • Use effective contraception for the duration of the trial period (females only)
  • Refrain from blood donation during the trial
  • Give written informed consent
  • Allow the Investigator to register subject details with a confidential database to prevent concurrent entry into clinical trials
  • Agrees to avoid elective surgery for the duration of the trial
  • Has a body mass index (BMI) between 18 and 33 (weight/height2) by nomogram
  • Able and willing (in the Investigator's opinion) to comply with all the trial requirements

You may not qualify if:

  • Subjects must meet none of the following criteria to enter the trial:
  • Laboratory evidence at screening of latent M. tb infection as indicated by a positive ELISPOT response to ESAT6 or CFP10 antigens
  • Clinical, radiological, or laboratory evidence of current active TB disease
  • Shared a residence within one year prior to day 0 with an individual on anti-tuberculosis treatment or with culture- or smear-positive pulmonary tuberculosis
  • Previous treatment for active or latent tuberculosis infection
  • Received a TST within 90 days prior to day 0
  • Received a systemic antibiotic within 14 days prior to day 0
  • Inability to discontinue daily medications other than the following during the trial: oral contraceptives, vitamins, nonprescription nutritional supplements, aspirin, antihistamines, antihypertensives, antidepressants, inhaled steroids, bronchodilators, and any other stable, regular medication not deemed to have an impact on safety or immunogenicity.
  • Previous vaccination with candidate vaccine MVA85A or candidate vaccine FP85A or any other recombinant MVA or adenoviral vaccine; AERAS-402; or any other investigational M. tb vaccine
  • Clinically significant history of skin disorder, allergy, immunodeficiency (including HIV), autoimmune disease, cancer (except BCC or CIS), cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, neurological illness, psychiatric disorder, drug or alcohol abuse
  • History of serious psychiatric condition
  • Concurrent oral or systemic steroid medication or the concurrent use of other immunosuppressive agents
  • History of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the trial vaccine, including eggs
  • Any abnormality of screening blood or urine tests that is deemed to be clinically significant or that may compromise the safety of the subject in the triala
  • Positive HBsAg, HCV or HIV antibodies
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Churchill Hospital

Oxford, Oxfordshire, OX3 7LE, United Kingdom

Location

The Wellcome Trust Clinical Research Facility (WTCRF), University of Birmingham

Birmingham, West Midlands, B15 2TH, United Kingdom

Location

Related Publications (1)

  • Sheehan S, Harris SA, Satti I, Hokey DA, Dheenadhayalan V, Stockdale L, Manjaly Thomas ZR, Minhinnick A, Wilkie M, Vermaak S, Meyer J, O'Shea MK, Pau MG, Versteege I, Douoguih M, Hendriks J, Sadoff J, Landry B, Moss P, McShane H. A Phase I, Open-Label Trial, Evaluating the Safety and Immunogenicity of Candidate Tuberculosis Vaccines AERAS-402 and MVA85A, Administered by Prime-Boost Regime in BCG-Vaccinated Healthy Adults. PLoS One. 2015 Nov 3;10(11):e0141687. doi: 10.1371/journal.pone.0141687. eCollection 2015.

    PMID: 26529238DERIVED

Related Links

MeSH Terms

Conditions

Tuberculosis

Interventions

AERAS-402MVA 85A

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Helen McShane

    University of Oxford

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2012

First Posted

September 12, 2012

Study Start

September 1, 2012

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

September 17, 2014

Record last verified: 2014-09

Locations

GB(2)