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Phase Ia Study of ChAd63/MVA PvDBP

NCT01816113 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-05-08

No results posted yet for this study

Summary

This is an open label phase Ia study, to assess the safety of two novel malaria vaccines, ChAd63 PvDBP, with or without MVA PvDBP. Heterologous prime-boost with ChAd63-MVA is, to our knowledge, one of the most potent T cell-inducing subunit vaccine regimens which can importantly also induce antibodies. Previous clinical trials using this regimen expressing ME-TRAP, AMA1 \& MSP1, have shown that administering ChAd63 as a prime followed 8 weeks later by MVA as a boost is a very immunogenic schedule (32-34). For this reason, and to provide comparability with previous ChAd63-MVA trials, we propose to use a similar administration schedule.

Conditions

Interventions

BIOLOGICAL

ChAd63 PvDBP 5 x 10^9

1 dose of ChAd63 PvDBP 5 x 10\^9 vp intramuscularly

BIOLOGICAL

ChAd63 PvDBP 5 x 10^10

1 dose of ChAd63 PvDBP 5 x 10\^10 vp intramuscularly

BIOLOGICAL

MVA PvDBP 1 x 10^8

1 dose MVA PvDBP 1 x 108 pfu 8 weeks later intramuscularly

BIOLOGICAL

MVA PvDBP 2 x 10^8

1 dose MVA PvDBP 2 x 108 pfu 8 weeks later intramuscularly

Sponsors & Collaborators

  • University of Oxford

    lead OTHER

Principal Investigators

  • Adrian V S Hill, MD · 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
2013-04-30
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • United Kingdom

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 NCT01816113 on ClinicalTrials.gov