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A Study of AdCh63 ME-TRAP Alone and With MVA ME-TRAP

NCT00890019 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2012-08-22

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

AdCh63 ME-TRAP

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

BIOLOGICAL

AdCh63 ME-TRAP; MVA ME-TRAP

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)

Sponsors & Collaborators

  • University of Oxford

    lead OTHER

Principal Investigators

  • Adrian VS Hill, Professor · University of Oxford

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2011-08-31
Completion
2011-09-30

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00890019 on ClinicalTrials.gov