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A Study of AdCh63 AMA1 Alone and With MVA AMA1

NCT01095055 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2011-03-28

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 AMA1, simian adenovirus encoding Plasmodium falciparum blood stage antigen, Apical Membrane Antigen -1. All volunteers recruited will be healthy adults. They will be primed with various doses of AdCh63 AMA1 administered intramuscularly. Some of the volunteers will receive a booster vaccination with MVA AMA1 administered via 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 AMA1

Group 1A - single dose of AdCH63 AMA1 5x10\^9 vp intramuscularly Group 2A - single dose of AdCH63 AMA1 5x10\^10 vp intramuscularly

BIOLOGICAL

AdCh63 AMa1 and MVA AMA1

Group 1B - single dose of AdCH63 AMA1 5x10\^9 vp intramuscularly and single dose of MVA AMA1 5x10\^8 pfu 8 weeks later intramuscularly Group 2B - single dose of AdCH63 AMA1 5x10\^10 vp intramuscularly and single dose of MVA AMA1 5x10\^8 pfu 8 weeks later intramuscularly

Sponsors & Collaborators

  • University of Oxford

    lead OTHER

Principal Investigators

  • Adrian VS Hill · Oxford Vaccine Group, Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Churchill Hospital

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
2010-03-31
Primary Completion
2010-10-31
Completion
2010-10-31

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 NCT01095055 on ClinicalTrials.gov