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Safety and Immunogenicity of ChAd63 RH5 and MVA RH5 in Adults, Young Children and Infants Living in Tanzania

NCT03435874 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2019-09-04

No results posted yet for this study

Summary

This is a dose-escalation, age de-escalation randomised double-blind controlled Phase Ib trial to assess the safety, tolerability and immunogenicity of ChAd63-RH5 administered with MVA-RH5 in a heterologous prime-boost regimen. Adults (18-35 years), young children (1-6 years) and infants (6-11 months) will be enrolled in the study. Safety data will be collected for each of the vaccination regimens. The humoral and cellular immune responses generated by each of these regimens will be assessed.

Conditions

  • Malaria,Falciparum

Interventions

BIOLOGICAL

ChAd63 RH5

Vaccine

BIOLOGICAL

MVA RH5

Vaccine

BIOLOGICAL

Rabies Vaccine

Vaccine

Sponsors & Collaborators

  • Ifakara Health Institute

    collaborator OTHER

  • Medical Research Council

    collaborator OTHER_GOV

  • University of Oxford

    lead OTHER

Principal Investigators

  • Angela M Minassian · University of Oxford

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
6 Months
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-12
Primary Completion
2019-07-11
Completion
2019-07-11

Countries

  • Tanzania

Study Locations

More Related Trials

Entities

Companies

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 NCT03435874 on ClinicalTrials.gov