VAC077: Safety and Immunogenicity of the Pfs25-IMX313/Matrix-M Vaccine

NCT04130282 | Terminated Phase 1 DMC

• 1 other identifier: VAC077
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open label, single-site, first-in-human, Phase Ia study to assess safety and immunogenicity of the Plasmodium falciparum malaria vaccine candidate Pfs25-IMX313 in Matrix-M1 adjuvant in healthy adults living in the UK Volunteers will receive 3 doses of vaccine over 2 months and will be followed up for approximately 8 months.

Conditions

Malaria,Falciparum

Keywords

Pfs25

Outcome Measures

Primary Outcomes (1)

• Assessment of safety and reactogenicity through collection of data on the frequency, duration and severity of solicited and unsolicited adverse events.

  The following parameters will be assessed: * Frequency, duration and severity of solicited local reactogenicity signs and symptoms for 7 days following each vaccination * Frequency, duration and severity of solicited systemic reactogenicity signs and symptoms for 7 days following the vaccination * Frequency, duration and severity of unsolicited adverse events for 28 days following the vaccination * Change from baseline for safety haematological and biochemical laboratory measures, which will presented according to local grading scales, for 28 days following vaccination * Frequency, duration and severity of serious adverse events during the whole study duration

  8 months

Secondary Outcomes (2)

• Humoral and cellular immunogenicity of the Pfs25-IMX313/Matrix-M1 vaccine, when administered to healthy adult volunteers

  8 months

• Ex-vivo efficacy of the Pfs25-IMX313/Matrix-M1 vaccine, when administered to healthy adult volunteers

  8 months

Study Arms (1)

Group 1

EXPERIMENTAL

8 volunteers receiving 3 doses of 10µg Pfs25-IMX313 in 50 µg Matrix-M1 on days 0, 28 and 56

Biological: Pfs25-IMX313/Matrix-M1

Interventions

Pfs25-IMX313/Matrix-M1 BIOLOGICAL

3 doses of 10µg Pfs25-IMX313 in 50 µg Matrix-M1 on days 0, 28 and 56

Group 1

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 adult aged 18 to 45 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.
• Women only: Must practice continuous effective contraception for the duration of the study
• Agreement to refrain from blood donation for the duration 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:
• History of clinical malaria (any species).
• Travel to a clearly malaria endemic locality during the study period or within the preceding six months.
• Use of immunoglobulins or blood products (e.g., blood transfusion) at any time in the past.
• Receipt of any vaccine in the 30 days preceding enrolment, or planned receipt of any other vaccine within 30 days following each vaccination
• Receipt of an investigational product in the 30 days preceding enrolment, or planned receipt during the study period.
• Concurrent involvement in another clinical trial or planned involvement during the study period
• Prior receipt of an investigational vaccine likely to impact on interpretation of the trial data, as assessed by the Investigator
• 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 (e.g. egg products)
• Any history of anaphylaxis in reaction to vaccinations
• Pregnancy, lactation or 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 that may affect participation in the study.
• Any other serious chronic illness requiring hospital specialist supervision.

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

CCVTM, University of Oxford, Churchill Hospital

Oxford, OX3 7LE, United Kingdom

Location

MeSH Terms

Conditions

Malaria, Falciparum

Interventions

Matrix-M

Condition Hierarchy (Ancestors)

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

Study Officials

• Angela Minassian, PhD

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2019
• First Posted: October 17, 2019
• Study Start: September 27, 2019
• Primary Completion: September 22, 2020
• Study Completion: September 22, 2020
• Last Updated: September 29, 2020

Record last verified: 2020-09

Locations

GB (1)