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A Phase I Study of Candidate Influenza Vaccines MVA-NP+M1 and ChAdOx1 NP+M1

NCT01818362 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2015-12-15

No results posted yet for this study

Summary

This will be a randomised observational phase 1 study in 48 healthy volunteers aged 18-50. The study is assessing safety and immunogenicity of viral vectored vaccines ChAdOx1 NP+M1 and MVA NP+M1 in heterologous prime-boost regimens. A crossover design will allow comparison of the two vaccines. Volunteers will be divided into 4 groups (n=12 in each group). Groups will be recruited simultaneously to control for seasonal changes in influenza. This is because at certain times of year there is likely to be a higher naturally acquired T cell response to influenza than at other times due to circulating influenza virus in the community.

The study has been extended to include 2 additional groups (group 5 \& 6), each containing 12 healthy adults aged 50 years or above. Group 5 will receive ChAdOx 1 NP+M1 on day 0, and group 6 will receive this with an additional boost of MVA-NP+M1 8 weeks later.

Conditions

Interventions

BIOLOGICAL

MVA NP+M1

MVA NP+M1 1.5 x 10⁸pfu intramuscularly.

BIOLOGICAL

ChAdOx1 NP+M1

ChAdOx1 NP+M1 2.5 x 10¹⁰vp intramuscularly.

Sponsors & Collaborators

  • University of Oxford

    lead OTHER

Principal Investigators

  • Adrian V S Hill, MD · University of Oxford

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2015-11-30
Completion
2015-11-30

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 NCT01818362 on ClinicalTrials.gov