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

NCT02925403 | Completed Phase 1 Results

• 1 other identifier: VAC060
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malaria

Outcome Measures

Primary Outcomes (4)

• Safety and Tolerability of Administration of R21/Matrix-M1 Assessed by the Occurrence of Solicited Local and Systemic Adverse Events.

  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.

  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.

  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.

  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.

Study Arms (3)

Group 1

ACTIVE COMPARATOR

10μg R21/Matrix-M1 on days 0, 28, and 56.

Biological: R21/Matrix-M1

Group 2

ACTIVE COMPARATOR

50μg R21/Matrix-M1 on days 0, 28, and 56.

Biological: R21/Matrix-M1

Group 3

PLACEBO COMPARATOR

Saline injection on days 0, 28, and 56.

Other: Saline

Interventions

R21/Matrix-M1 BIOLOGICAL

Group 1; Group 2

Saline OTHER

Group 3

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Centre National de Recherche et de Formatation sur le Paludisme (CNRFP)/Unite de Recherche Clinique de Banfora (URC-B)

Ouagadougou, Burkina Faso

Location

Related Publications (38)

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MeSH Terms

Conditions

Malaria

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Adrian V Hill, DPhil FRCP
• Organization: University of Oxford

vaccinetrials@ndm.ox.ac.uk

+44 1865 617610

Study Officials

• Alfred B Tiono

  Centre National de Recherche et de Formation sur la Paludisme, Ouagadougou, Burkina Faso

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2016
• First Posted: October 5, 2016
• Study Start: August 26, 2016
• Primary Completion: February 15, 2017
• Study Completion: February 15, 2017
• Last Updated: November 6, 2019
• Results First Posted: November 6, 2019

Record last verified: 2017-06

Locations

BU (1)