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Safety, Immunogenicity and ex Vivo Efficacy of Pfs25-IMX313/Matrix-M in Healthy Volunteers in Bagamoyo, Tanzania.

Primary Purpose

Malaria,Falciparum

Status
Recruiting
Phase
Phase 1
Locations
Tanzania
Study Type
Interventional
Intervention
Pfs25-IMX313 (10ug)/Matrix-M (50ug)
Pfs25-IMX313 (50ug)/Matrix-M (50ug)
Pfs25-IMX313 (50ug)/Matrix-M (50ug) & Pfs25-IMX313 (10ug)/Matrix-M (50ug)
Sponsored by
University of Oxford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malaria,Falciparum focused on measuring Vaccine

Eligibility Criteria

5 Years - 45 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Healthy adult aged 18 to 45 years or children aged 5-12 years.
  2. Planned long-term (at least 30 months from the date of recruitment) or permanent residence in Bagamoyo town.
  3. Adults with a Body Mass Index (BMI) 18 to 30 Kg/m2; or children (5-12 years) with the BMI between 13 and 25 Kg/m2.
  4. Able and willing (in the Investigator's opinion) to comply with all study requirements.
  5. Agreement to refrain from blood donation for the duration of the study
  6. Written informed consent to participate in the trial.
  7. Women only: Must practice continuous effective contraception* for the duration of the study.

Exclusion Criteria:

  1. Use of immunoglobulins or blood products (e.g., blood transfusion) at any time in the past.
  2. Receipt of any vaccine in the 14 days preceding enrolment, or planned receipt of any other vaccine within 14 days following each vaccination.
  3. Receipt of an investigational product in the 30 days preceding enrolment, or planned receipt during the study period.
  4. Concurrent involvement in another clinical trial or planned involvement during the study period
  5. Prior receipt of an investigational vaccine likely to impact on interpretation of the trial data, as assessed by the Investigator
  6. 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).
  7. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine (e.g. egg products)
  8. Any history of anaphylaxis in reaction to vaccinations
  9. Pregnancy, lactation or intention to become pregnant during the study.
  10. History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).
  11. History of serious psychiatric condition that may affect participation in the study.
  12. Any other serious chronic illness requiring hospital specialist supervision.
  13. Suspected or known injecting drug abuse in the 5 years preceding enrolment.
  14. Seropositive for hepatitis B surface antigen (HBsAg) or hepatitis C (HCV IgG).
  15. Volunteers unable to be closely followed for social, geographic or psychological reasons.
  16. Any clinically significant abnormal finding on biochemistry or haematology blood tests, urinalysis or clinical examination. In the event of clinically significant abnormal test results, confirmatory repeat tests will be requested. Procedures for identifying laboratory values meeting exclusion criteria will be described in a study specific SOP.
  17. 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.

Sites / Locations

  • Ifakara Health Institute Clinical Trial FacilityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Groups 1A & 1B

Groups 2A & 2B

Groups 3A & 3B

Group 3C

Groups 4A & 4B

Group 4C

Arm Description

Volunteers aged 18-45 years will receive doses of Pfs25-IMX313 (10µg)/Matrix-M (50µg) intramuscularly at months 0, 1 and 2

Volunteers aged 18-45 years will receive doses of Pfs25-IMX313 (50µg)/Matrix-M (50µg) intramuscularly at months 0, 1 and 2

Volunteers aged 5-12 years will receive doses of Pfs25-IMX313 (10µg)/Matrix-M (50µg) intramuscularly at months 0, 1 and 2

Volunteers aged 5-12 years will receive doses of Pfs25-IMX313 (10µg)/Matrix-M (50µg) intramuscularly at months 0, 1 and 6.5

Volunteers aged 5-12 years will receive doses of Pfs25-IMX313 (50µg)/Matrix-M (50µg) intramuscularly at months 0, 1 and 6.5

Volunteers aged 5-12 years will receive doses of Pfs25-IMX313 (50µg)/Matrix-M (50µg) intramuscularly at months 0 and 1 and a dose of Pfs25-IMX313 (10µg)/Matrix-M (50µg) intramuscularly at month 6.5

Outcomes

Primary Outcome Measures

Determine the safety of Pfs25IMX313-Matrix-M in healthy Tanzanian adults and children naturally exposed to malaria.
Occurrence of solicited symptoms after each vaccination during a 7-day surveillance period (day of vaccination and days 1, 2, 3 and 7 after vaccination).
Determine the safety of Pfs25IMX313-Matrix-M in healthy Tanzanian adults and children naturally exposed to malaria.
Occurrence of unsolicited symptoms after each vaccination during a 30-day surveillance period (day of vaccination and 30 subsequent days).
Determine the safety of Pfs25IMX313-Matrix-M in healthy Tanzanian adults and children naturally exposed to malaria.
Occurrence of serious adverse events throughout the study period.

Secondary Outcome Measures

Determine the Pfs25 specific antibody responses following immunization with different vaccination regimens in healthy Tanzanian adults and children.
Pfs25 antibody levels elicited by Pfs25IMX313-Matrix-M as measured by ELISA at each time point where serology samples are analysed.
Determine the transmission blocking activity of Pfs25 specific antibodies elicited by the different vaccination regimens in healthy Tanzanian adults and children using Standard Membrane Feeding Assay (SMFA) and Direct Membrane feeding assay (DMFA).
Transmission blocking activity (TBA) of induced antibody as measured in standard membrane feeding assays (SMFA) and Direct Membrane feeding assays (DMFA).
Determine the transmission blocking activity of Pfs25 specific antibodies elicited by the different vaccination regimens in healthy Tanzanian adults and children using Standard Membrane Feeding Assay (SMFA) and Direct Membrane feeding assay (DMFA).
Correlation of TBA with antibody levels at each time point where the membrane feeding assays are conducted.
Select the best vaccination regimen based on the peak Pfs25 specific antibodies after final immunization, their duration and transmission blocking activity by standard membrane feeding assay (SMFA) and direct membrane feeding assay (DMFA).
The vaccination schedule that lead to the highest peak and duration of anti-Pfs25 antibody response post vaccination, and the highest transmission blocking activity (TBA) as measured by standard membrane feeding assay (SMFA) and direct membrane feeding assay (DMFA).

Full Information

First Posted
February 7, 2020
Last Updated
June 21, 2022
Sponsor
University of Oxford
Collaborators
Ifakara Health Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04271306
Brief Title
Safety, Immunogenicity and ex Vivo Efficacy of Pfs25-IMX313/Matrix-M in Healthy Volunteers in Bagamoyo, Tanzania.
Official Title
A Phase Ib Age De-escalation and Dose Escalation Open Label Clinical Trial of the Safety, Immunogenicity and ex Vivo Efficacy of a Candidate Malaria Vaccine Pfs25-IMX313/Matrix-M Administered Intramuscularly in Healthy Adults and Young Children in Tanzania.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 25, 2021 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford
Collaborators
Ifakara Health Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A phase Ib age de-escalation and dose escalation open label clinical trial of the safety, immunogenicity and ex-vivo efficacy of a candidate malaria vaccine Pfs25-IMX313/Matrix-M administered intramuscularly in healthy adults and young children in Tanzania
Detailed Description
This study aims to evaluate safety, immunogenicity, and transmission blocking activity of Pfs25IMX313-Matrix-M in healthy Tanzanian adults and children naturally exposed to malaria in Bagamoyo district, Tanzania. The study will enrol 45 volunteers comprising of 13 adults (18-45 years) and 32 children (5-12 years).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria,Falciparum
Keywords
Vaccine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Groups 1A & 1B
Arm Type
Experimental
Arm Description
Volunteers aged 18-45 years will receive doses of Pfs25-IMX313 (10µg)/Matrix-M (50µg) intramuscularly at months 0, 1 and 2
Arm Title
Groups 2A & 2B
Arm Type
Experimental
Arm Description
Volunteers aged 18-45 years will receive doses of Pfs25-IMX313 (50µg)/Matrix-M (50µg) intramuscularly at months 0, 1 and 2
Arm Title
Groups 3A & 3B
Arm Type
Experimental
Arm Description
Volunteers aged 5-12 years will receive doses of Pfs25-IMX313 (10µg)/Matrix-M (50µg) intramuscularly at months 0, 1 and 2
Arm Title
Group 3C
Arm Type
Experimental
Arm Description
Volunteers aged 5-12 years will receive doses of Pfs25-IMX313 (10µg)/Matrix-M (50µg) intramuscularly at months 0, 1 and 6.5
Arm Title
Groups 4A & 4B
Arm Type
Experimental
Arm Description
Volunteers aged 5-12 years will receive doses of Pfs25-IMX313 (50µg)/Matrix-M (50µg) intramuscularly at months 0, 1 and 6.5
Arm Title
Group 4C
Arm Type
Experimental
Arm Description
Volunteers aged 5-12 years will receive doses of Pfs25-IMX313 (50µg)/Matrix-M (50µg) intramuscularly at months 0 and 1 and a dose of Pfs25-IMX313 (10µg)/Matrix-M (50µg) intramuscularly at month 6.5
Intervention Type
Biological
Intervention Name(s)
Pfs25-IMX313 (10ug)/Matrix-M (50ug)
Intervention Description
3 doses of Pfs25-IMX313/Matrix-M at Pfs25-IMX313(10µg)/Matrix-M (50µg)
Intervention Type
Biological
Intervention Name(s)
Pfs25-IMX313 (50ug)/Matrix-M (50ug)
Intervention Description
3 doses of Pfs25-IMX313/Matrix-M at Pfs25-IMX313(50µg)/ Matrix-M (50µg)
Intervention Type
Biological
Intervention Name(s)
Pfs25-IMX313 (50ug)/Matrix-M (50ug) & Pfs25-IMX313 (10ug)/Matrix-M (50ug)
Intervention Description
2 doses of Pfs25-IMX313/Matrix-M at Pfs25-IMX313(50µg)/ Matrix-M (50µg) followed by one at Pfs25-IMX313(10µg)/Matrix-M (50µg)
Primary Outcome Measure Information:
Title
Determine the safety of Pfs25IMX313-Matrix-M in healthy Tanzanian adults and children naturally exposed to malaria.
Description
Occurrence of solicited symptoms after each vaccination during a 7-day surveillance period (day of vaccination and days 1, 2, 3 and 7 after vaccination).
Time Frame
Assessment of solicited symptoms in the first 7 days post vaccination
Title
Determine the safety of Pfs25IMX313-Matrix-M in healthy Tanzanian adults and children naturally exposed to malaria.
Description
Occurrence of unsolicited symptoms after each vaccination during a 30-day surveillance period (day of vaccination and 30 subsequent days).
Time Frame
Assessment of unsolicited symptoms in the first 30 days post vaccination
Title
Determine the safety of Pfs25IMX313-Matrix-M in healthy Tanzanian adults and children naturally exposed to malaria.
Description
Occurrence of serious adverse events throughout the study period.
Time Frame
Assessment of SAEs until the end of the study (approx 2 years)
Secondary Outcome Measure Information:
Title
Determine the Pfs25 specific antibody responses following immunization with different vaccination regimens in healthy Tanzanian adults and children.
Description
Pfs25 antibody levels elicited by Pfs25IMX313-Matrix-M as measured by ELISA at each time point where serology samples are analysed.
Time Frame
Duration of the study (approx 2 years)
Title
Determine the transmission blocking activity of Pfs25 specific antibodies elicited by the different vaccination regimens in healthy Tanzanian adults and children using Standard Membrane Feeding Assay (SMFA) and Direct Membrane feeding assay (DMFA).
Description
Transmission blocking activity (TBA) of induced antibody as measured in standard membrane feeding assays (SMFA) and Direct Membrane feeding assays (DMFA).
Time Frame
Duration of the study (approx 2 years)
Title
Determine the transmission blocking activity of Pfs25 specific antibodies elicited by the different vaccination regimens in healthy Tanzanian adults and children using Standard Membrane Feeding Assay (SMFA) and Direct Membrane feeding assay (DMFA).
Description
Correlation of TBA with antibody levels at each time point where the membrane feeding assays are conducted.
Time Frame
Duration of the study (approx 2 years)
Title
Select the best vaccination regimen based on the peak Pfs25 specific antibodies after final immunization, their duration and transmission blocking activity by standard membrane feeding assay (SMFA) and direct membrane feeding assay (DMFA).
Description
The vaccination schedule that lead to the highest peak and duration of anti-Pfs25 antibody response post vaccination, and the highest transmission blocking activity (TBA) as measured by standard membrane feeding assay (SMFA) and direct membrane feeding assay (DMFA).
Time Frame
Duration of the study (approx 2 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy adult aged 18 to 45 years or children aged 5-12 years. Planned long-term (at least 30 months from the date of recruitment) or permanent residence in Bagamoyo town. Adults with a Body Mass Index (BMI) 18 to 30 Kg/m2; or children (5-12 years) with the BMI between 13 and 25 Kg/m2. Able and willing (in the Investigator's opinion) to comply with all study requirements. Agreement to refrain from blood donation for the duration of the study Written informed consent to participate in the trial. Women only: Must practice continuous effective contraception* for the duration of the study. Exclusion Criteria: Use of immunoglobulins or blood products (e.g., blood transfusion) at any time in the past. Receipt of any vaccine in the 14 days preceding enrolment, or planned receipt of any other vaccine within 14 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. Suspected or known injecting drug abuse in the 5 years preceding enrolment. Seropositive for hepatitis B surface antigen (HBsAg) or hepatitis C (HCV IgG). 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 clinically significant abnormal test results, confirmatory repeat tests will be requested. Procedures for identifying laboratory values meeting exclusion criteria will be described in a study specific SOP. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angela Minassian
Phone
+44865611425
Email
angela.minassian@ndm.ox.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Ally Olotu
Phone
+255718927104
Email
aolotu@ihi.or.tz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela Minassian
Organizational Affiliation
University of Oxford
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ifakara Health Institute Clinical Trial Facility
City
Bagamoyo
Country
Tanzania
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Safety, Immunogenicity and ex Vivo Efficacy of Pfs25-IMX313/Matrix-M in Healthy Volunteers in Bagamoyo, Tanzania.

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