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Safety and Immunogenicity of New Malaria Vaccine Candidate ChAd63 CS Administered Alone and With MVA CS

NCT01450280 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2012-11-29

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 CS, simian adenovirus encoding Plasmodium falciparum liver stage antigen, Circumsporozoite protein. All volunteers recruited will be healthy adults. They will be primed with various doses of AdCh63 CS administered intramuscularly. Some of the volunteers will receive a booster vaccination with MVA CS administered via intramuscular route. Safety data will be collected for each vaccination regimen. Secondary aim of this study will be to assess the immune responses generated by vaccination.

Conditions

Interventions

BIOLOGICAL

ChAd63 CS

ChAd63 CS 5x10\^9 vp intra-muscularly Day 0

BIOLOGICAL

ChAd63 CS, MVA CS

ChAd63 CS 5x10\^9 vp intra-muscularly Day 0; MVA CS 2x10\^8 pfu intra-muscularly Day 56

BIOLOGICAL

ChAd63 CS

ChAd63 CS 5x10\^10 vp intra-muscularly Day 0

BIOLOGICAL

ChAd63, MVA CS

ChAd63 CS 5x10\^10 vp intra-muscularly Day 0; MVA CS 2x10\^8 pfu intra-muscularly Day 56

Sponsors & Collaborators

  • University of Oxford

    lead OTHER

Principal Investigators

  • Sam McConkey · Clinical Research Centre Royal College of Surgeons in Ireland (RCSI)

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
2011-12-31
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • Ireland

Study Locations

More Related Trials

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 NCT01450280 on ClinicalTrials.gov