NCT02600975

Brief Summary

This is a clinical trial in which healthy volunteers will be administered an experimental malaria vaccine, R21. The R21 vaccine will be administered with the adjuvant AS01B. All vaccinations will be administered intramuscularly. Each volunteer will receive three vaccinations in total. There are two different vaccine schedules: Group 1 will receive R21 10µg with AS01B on days 0, 28, and 56. Group 2 will receive R21 50µg with AS01B on days 0, 28, and 56. The study will assess the safety of the vaccine, and the immune responses to the vaccination. Immune responses are measured by tests on blood samples. Healthy adult volunteers will be recruited in Oxford and Southampton, England.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 9, 2015

Completed
29 days until next milestone

Study Start

First participant enrolled

December 8, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2017

Completed
Last Updated

June 20, 2017

Status Verified

June 1, 2017

Enrollment Period

1.1 years

First QC Date

November 6, 2015

Last Update Submit

June 19, 2017

Conditions

Malaria

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability of administration of R21 with adjuvant AS01B. This will be done by recording the number of participants who experience adverse events, and the severity of any adverse events.

    34 weeks

Study Arms (2)

Group 1

ACTIVE COMPARATOR

10µg of R21 with AS01B on days 0, 28, and 56.

Biological: R21 with ASO1B

Group 2

ACTIVE COMPARATOR

50µg of R21 with AS01B on days 0, 28, and 56.

Biological: R21 with ASO1B

Interventions

R21 with ASO1BBIOLOGICAL

R21 with ASO1B

Group 1Group 2

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • The volunteer must satisfy all the following criteria to be eligible for the study:
  • Healthy adults aged 18 to 50 years
  • Able and willing (in the Investigator's opinion) to comply with all study requirements
  • Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner
  • For females only, willingness to practice continuous effective contraception (see below) during the study and a negative pregnancy test on the day(s) of screening and vaccination
  • Agreement to refrain from blood donation during the course of the study
  • Provide written informed consent

You may not qualify if:

  • The volunteer may not enter the study if any of the following apply:
  • Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period
  • Prior receipt of an investigational malaria vaccine likely to impact on interpretation of the trial data.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
  • Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed)
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
  • Any history of anaphylaxis in relation to vaccination
  • Pregnancy, lactation or willingness/intention to become pregnant during the study
  • History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
  • History of serious psychiatric condition likely to affect participation in the study
  • Any other serious chronic illness requiring hospital specialist supervision
  • Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week
  • Suspected or known injecting drug abuse in the 5 years preceding enrolment
  • Seropositive for hepatitis B surface antigen (HBsAg)
  • Seropositive for hepatitis C virus (antibodies to HCV)
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CCVTM, University of Oxford

Oxford, OX3 7LE, United Kingdom

Location

NIHR Wellcome Trust Clinical Research Facility

Southampton, SO16 6YD, United Kingdom

Location

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2015

First Posted

November 9, 2015

Study Start

December 8, 2015

Primary Completion

January 19, 2017

Study Completion

January 19, 2017

Last Updated

June 20, 2017

Record last verified: 2017-06

Locations

GB(2)