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A Study to Assess the Safety and Immunogenicity of a New Influenza Vaccine Candidate MVA-NP+M1 in Healthy Adults

NCT00942071 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 58

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 influenza vaccine, MVA-NP+M1. All volunteers recruited will be healthy. Twelve volunteers will be administered with a single dose of 5 x 10\^7 pfu of MVA-NP+M1 via the Intradermal (ID) route (group 1). Sixteen volunteers will receive Intramuscular (IM) MVA-NP+M1. The first 8 volunteers will be administered a single dose of 5 x 10\^7 pfu of MVA-NP+M1 followed by a further eight receiving 2.5 x 10\^8 pfu of MVA-NP+M1 (group 2). The 3rd group will be split into 3 groups of 10 volunteers in the age ranges 50-59, 60-69 and 70 and above and administered intramuscularly with a single dose of 1.5 x 10\^8 pfu of MVA-NP+M1. Safety data will be collected. The secondary aim of this study will be to assess the cellular immune responses generated by each dose.

Conditions

Interventions

BIOLOGICAL

MVA-NP+M1

1\. Intradermal injection at 5 x 10\^7 pfu at day 0

BIOLOGICAL

MVA-NP+M1

2.Intramuscular injection at 5 x 10\^7 pfu/ml at day 0. Intramuscular injection at 2.5 x 10\^8 pfu/ml at day 0

BIOLOGICAL

MVA-NP+M1

3.Intramuscular injection at 1.5 x 10\^8 pfu/ml at day 0

Sponsors & Collaborators

  • Wellcome Trust

    collaborator OTHER

  • University of Oxford

    lead OTHER

Principal Investigators

  • Adrian VS Hill, D.Phil FRCP · University of Oxford

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2012-11-30
Completion
2012-11-30

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 NCT00942071 on ClinicalTrials.gov