A Study to Assess the Safety and Immunogenicity of the Malaria Vaccine, R21, With Matrix-M1 Adjuvant

October 17, 2019 updated by: University of Oxford

A Phase Ib Randomised, Controlled, Single-blind Study to Assess the Safety, Immunogenicity of the Malaria Vaccine Candidate R21 With Matrix-M1 Adjuvant in West African Adult Volunteers

This is a study in which healthy adult volunteers will be given either an experimental Malaria vaccine or a saline control vaccine.

Each volunteer will receive three vaccinations in total. Volunteers will be randomly allocated to one of two groups:

Group 1 will receive a low dose of the Malaria vaccine on days 0, 28, and 56. Group 2 will receive a saline solution on days 0, 28, and 56.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A randomised, controlled, single-blind clinical trial to evaluate the safety and immunogenicity of the malaria vaccine candidate regime of three (3) doses of R21/Matrix-M1 compared with placebo, in healthy West African adult volunteers living in a malaria-endemic area.

The study will take place at the Centre National de Recherche et de Formation sur la Paludisme (CNRFP)/Unite de Recherche Clinique de Banfora (URC-B). Trial participants will be drawn from the Banfora Health Demographic system, which covers a total population of 30, 000.

Community sensitisation will be undertaken to engage the community with the study and recruit volunteers for participation in the study. The CNRFP study team will hold local community meetings and explain the study to the potentially eligible adult volunteers. During these meetings the investigators will explain the following: the need for a vaccine; the current status of vaccine development (including the fact that this is likely to be a prolonged process); the study screening and informed consent procedure; risks of vaccination and the unproven benefits of vaccination. It will be stressed that these are experimental vaccine regimens and cannot be guaranteed to provide protection, and that it will therefore still be necessary to seek treatment for possible malaria even after vaccination and they should continue to use other protective measures such as bed nets. It will be explained that to aid identification, a photograph of the volunteer will be taken if they are eligible to be enrolled in the trial.

After this meeting, based on the list of adults of suitable age for participation in the trial drawn from the DSS database, volunteers will be asked to participate in a public lottery that is made to randomly select participants who will be invited for a screening visit. All proposed volunteers thus selected will be invited to the Banfora clinical trials centre for the screening visit.

The Volunteer Information Sheet (VIS) will contain detailed information about the study and will be distributed to the proposed volunteers. The investigators will endeavour to ensure that all volunteers fully understand the risks. Any volunteer who appears to have less than complete understanding will be considered unable to give consent. If unable to sign, the volunteer will be asked to thumbprint the consent form in the presence of an impartial witness who will be present during the screening procedures and will countersign the consent form. Fully consented volunteers will undergo the full screening procedures. This consists of medical history, physical examination, and blood sampling for screening tests.

Volunteers will be randomised to receive either three (3) doses of R21/ Matrix-M1 or placebo (normal saline) as control. Simple randomisation into the study groups will be done by an independent statistician based at the University of Oxford. A randomisation code list will be generated by the independent statistician and its use guided by a clear Standard Operating Procedure (SOP). Allocation concealment will be employed by use of opaque sealed envelopes. As this is a single-blind clinical trial design, the laboratory scientists will be blinded to vaccine allocation until the end of the study.

Each volunteer will be monitored for one hour (or longer if necessary) after each vaccination. Each volunteer will be visited at home daily for 6 days after each vaccination (Days 0, 28, and 56) by a field worker for assessment and recording of any solicited and unsolicited AEs in diary cards. If necessary the volunteer will continue to be seen regularly until any observed AEs have resolved or stabilised. Scheduled visits at the CNRFP will be on Days 0, 7, 28, 35, 56, 63, 84, and 140. All volunteers will be followed up to Day 140 post-first vaccination for adverse events.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Burkina Faso
      • Ouagadougou, Burkina Faso
        • Centre National de Recherche et de Formatation sur le Paludisme (CNRFP)/Unite de Recherche Clinique de Banfora (URC-B)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

The volunteer must satisfy all the following criteria to be eligible for the study:

  • Healthy adults ages 18 to 45 years.
  • Willingness to remain in study area for the period of the study.
  • Able and willing (in the Investigator's opinion) to comply with all study requirements.
  • Women only: Must practice and show documented evidence of continuous effective contraception (e.g. depo-progesterone) or must be willing to take contraceptive measures not to become pregnant for the duration of the study. Willing to have pregnancy tests at screening and vaccination time points.
  • Agreement to refrain from blood donation during the course of the study.
  • Written informed consent to participate in the trial.

Exclusion Criteria:

The volunteer may not enter the study if any of the following apply:

  • Hb less than 10.0g/dl
  • Receipt of an investigational product in the 30 days preceding enrolment, or planned receipt during the study period.
  • Prior receipt of an investigational malaria vaccine or any other investigational vaccine likely to impact on interpretation of the trial data.
  • Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent severe infections and chronic (more than 14 days) immunosuppressant or other immune-modifying drugs medication (for corticosteroids, this will mean prednisolone, or equivalent, ≥ 0.5mg/kg/day) within the past 6 months (inhaled and topical steroids are allowed).
  • Use of immunoglobulins or blood products within 3 months prior to enrolment.
  • History of allergic disease or hypersensitivity reactions likely to be exacerbated by any component of the study vaccines.
  • Any history of anaphylaxis post-vaccination.
  • History of clinically significant contact dermititis.
  • Pregnancy, lactation or intention to become pregnant during the study.
  • Disturbances of electrolyte balance, e.g. hypokalaemia or hypomagnesaemia.
  • History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).
  • History of serious psychiatric condition that may affect participation in the study.
  • History of splenectomy.
  • Any other serious chronic illness requiring hospital specialist supervision.
  • HIV or Hepatitis B surface antigen seropositivity.
  • Volunteers unable to be closely followed for social, geographic or psychological reasons.
  • Any clinically significant abnormal finding on biochemistry or haematology blood tests, urinalysis or clinical examination. In the event of abnormal test results, confirmatory repeat test will be requested.
  • Any other significant disease, disorder, or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
10μg R21/Matrix-M1 on days 0, 28, and 56.
Biological: R21/Matrix-M1
Active Comparator: Group 2
50μg R21/Matrix-M1 on days 0, 28, and 56.
Biological: R21/Matrix-M1
Placebo Comparator: Group 3
Saline injection on days 0, 28, and 56.
Other: Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Tolerability of Administration of R21/Matrix-M1 Assessed by the Occurrence of Solicited Local and Systemic Adverse Events.
Time Frame: Assessment of solicited AEs in the first 7 days post vaccination.
Occurrence of solicited local and systemic adverse events (i.e: pain, redness, swelling and pruritus at injection site and temperature, feverishness, myalgia, arthralgia, malaise, headache and nausea).
Assessment of solicited AEs in the first 7 days post vaccination.
Safety and Tolerability of R21/Matrix-M1 Assessed by the Occurrence of Unsolicited Adverse Events.
Time Frame: Unsolicited AEs to be assessed up to 28 days post vaccination.
Occurrence of unsolicited local and systemic adverse events. This will be done by recording the number of participants who experience unsolicited adverse events.
Unsolicited AEs to be assessed up to 28 days post vaccination.
Safety and Tolerability of R21/Matrix-M1 Assessed by the Occurrence of Serious Adverse Events.
Time Frame: 6 months
Occurrence of serious adverse events will be collected from enrolment until the end of the follow-up period.
6 months
Safety and Tolerability of R21/Matrix-M1 Assessed by the Occurrence of Laboratory Adverse Events.
Time Frame: At Day 0 (baseline), day 7 and day 28 post vaccination.
Occurrence of laboratory adverse events defined as clinically significant changes from baseline. Haematology (Full Blood Count) and Biochemistry (Kidney and Liver Function Tests) will be assessed.
At Day 0 (baseline), day 7 and day 28 post vaccination.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Investigators

  • Principal Investigator: Alfred B Tiono, Centre National de Recherche et de Formation sur la Paludisme, Ouagadougou, Burkina Faso

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2016

Primary Completion (Actual)

February 15, 2017

Study Completion (Actual)

February 15, 2017

Study Registration Dates

First Submitted

October 4, 2016

First Submitted That Met QC Criteria

October 4, 2016

First Posted (Estimate)

October 5, 2016

Study Record Updates

Last Update Posted (Actual)

November 6, 2019

Last Update Submitted That Met QC Criteria

October 17, 2019

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VAC060

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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