NCT00890019

Brief Summary

This is an open label phase I study, to assess the safety of a novel malaria vaccine, AdCh63 ME-TRAP, simian adenovirus encoding Plasmodium falciparum antigens. This follows promising phase I clinical studies of MVA ME-TRAP and preclinical studies of AdCh63 and MVA ME-TRAP used together in prime-boost regimes. All volunteers recruited will be healthy adults. They will be primed with various doses of AdCh63 ME-TRAP administered intradermally or intramuscularly. Some of the volunteers will receive a booster vaccination with MVA ME-TRAP at various doses administered via the intradermal or intramuscular route. Safety data will be collected for each of the eight regimens. Secondary aims of this study will be to assess the immune responses generated by each of these regimes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2007

Longer than P75 for phase_1

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

Study Start

First participant enrolled

July 1, 2007

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 29, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

August 22, 2012

Status Verified

August 1, 2012

Enrollment Period

4.1 years

First QC Date

April 28, 2009

Last Update Submit

August 21, 2012

Conditions

Malaria

Outcome Measures

Primary Outcomes (1)

  • To assess the safety of a new malaria vaccine, AdCh63 ME-TRAP, when administered individually and sequentially with MVA ME-TRAP in a prime-boost regime to healthy volunteers

    24 months

Secondary Outcomes (1)

  • To assess the cellular immune response generated, and whether this is affected by immunity to human adenovirus, by AdCh63 ME-TRAP when administered individually and sequentially with MVA ME-TRAP in a prime-boost regime to healthy volunteers

    24 months

Study Arms (2)

1A, 2A, 3A, 4A, 5A, 6A, 7A

EXPERIMENTAL

AdCh63 ME-TRAP

Biological: AdCh63 ME-TRAP

1B, 2B, 3B, 4B, 6B, 7B, 7C

EXPERIMENTAL

AdCh63 ME-TRAP; MVA ME-TRAP

Biological: AdCh63 ME-TRAP; MVA ME-TRAP

Interventions

AdCh63 ME-TRAPBIOLOGICAL

1. A:Intradermal injection 1x10\^8 vp at day 0 2. A:Intradermal injection 1x10\^9 vp at day 0 3. A:Intradermal injection 1x10\^10 vp at day 0 4. A:Intradermal injection 5x10\^10 vp at day 0 5:Intramuscular injection 1x10\^10 vp at day 0 6A:Intramuscular injection 5x10\^10 vp at day 0 7A: Intramuscular injection 2x10\^11 vp at day 0

Also known as: Simian adenovirus expressing P. falciparum antigens ME-TRAP
1A, 2A, 3A, 4A, 5A, 6A, 7A
AdCh63 ME-TRAP; MVA ME-TRAPBIOLOGICAL

1. B: AdCh63 ME-TRAP intradermally at dose of 1x10\^8 vp at day 0; MVA ME-TRAP intradermally at dose of 2x10\^8 pfu at day 56 (+/- 7 days) 2. B: AdCh63 ME-TRAP intradermally at dose of 1x10\^9 vp at day 0; MVA ME-TRAP intradermally at dose of 2x10\^8 pfu at day 56 (+/- 7 days) 3. B: AdCh63 ME-TRAP intradermally at dose of 1x10\^10 vp at day 0; MVA ME-TRAP intradermally at dose of 2x10\^8 pfu at day 56 (+/- 7 days) 4. B: AdCh63 ME-TRAP intradermally at dose of 5x10\^10 vp at day 0; MVA ME-TRAP intradermally at dose of 2x10\^8 pfu at day 56 (+/- 7 days) 6B: AdCh63 ME-TRAP intramuscularly at dose of 5x10\^10 vp at day 0; MVA ME-TRAP intradermally at dose of 2x10\^8 pfu at day 56 (+/- 7 days) 7B and 7C: AdCh63 ME-TRAP intramuscularly at dose of 2x10\^11 vp at day 0; MVA ME-TRAP intradermally at dose of 2x10\^8 pfu at day 56 (+/- 7 days)

Also known as: Simian adenovirus, modified vaccinia Ankara virus
1B, 2B, 3B, 4B, 6B, 7B, 7C

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adults aged 18 to 50 years
  • Able and willing (in the Investigator's opinion) to comply with all study requirements
  • Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner
  • Willing to use barrier contraception until three months after the last vaccination
  • For females only negative pregnancy test on the day(s) of vaccination
  • Agreement to refrain from blood donation during the course of the study
  • Written informed consent

You may not qualify if:

  • Participation in another research study involving an investigational product in the 30 days preceding enrolment, or planned use during the study period
  • Prior receipt of a recombinant MVA vaccine containing a relevant antigen (for those in B groups) or adenoviral vaccine, (all volunteers).
  • Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
  • Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed)
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products, Kathon.
  • History of clinically significant contact dermatitis
  • Any history of anaphylaxis in reaction to vaccination
  • History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
  • History of serious psychiatric condition
  • Any other serious chronic illness requiring hospital specialist supervision
  • Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week
  • Suspected or known injecting drug abuse
  • Seropositive for hepatitis B surface antigen (HBsAg)
  • Seropositive for hepatitis C virus (antibodies to HCV)
  • Seropositive for simian adenovirus 63 (antibodies to AdCh63) at a titre \>1 ;200
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Lister Ward, Department of Infection and Tropical Medicine, Northwick Park Hospital

Harrow, Middlesex, HA1 3UJ, United Kingdom

Location

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

Oxford, Oxfordshire, OX3 7LJ, United Kingdom

Location

Related Publications (1)

  • O'Hara GA, Duncan CJ, Ewer KJ, Collins KA, Elias SC, Halstead FD, Goodman AL, Edwards NJ, Reyes-Sandoval A, Bird P, Rowland R, Sheehy SH, Poulton ID, Hutchings C, Todryk S, Andrews L, Folgori A, Berrie E, Moyle S, Nicosia A, Colloca S, Cortese R, Siani L, Lawrie AM, Gilbert SC, Hill AV. Clinical assessment of a recombinant simian adenovirus ChAd63: a potent new vaccine vector. J Infect Dis. 2012 Mar 1;205(5):772-81. doi: 10.1093/infdis/jir850. Epub 2012 Jan 24.

    PMID: 22275401DERIVED

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Adrian VS Hill, Professor

    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

April 28, 2009

First Posted

April 29, 2009

Study Start

July 1, 2007

Primary Completion

August 1, 2011

Study Completion

September 1, 2011

Last Updated

August 22, 2012

Record last verified: 2012-08

Locations

GB(2)