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

NCT ID: NCT04271306

Last Updated: 2025-01-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-25
• Study Completion Date: 2024-02-19

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).

Conditions

Malaria,Falciparum

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Groups 1A & 1B

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

Group Type: EXPERIMENTAL

Pfs25-IMX313 (10ug)/Matrix-M (50ug)

Intervention Type: BIOLOGICAL

3 doses of Pfs25-IMX313/Matrix-M at Pfs25-IMX313(10µg)/Matrix-M (50µg)

Groups 2A & 2B

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

Group Type: EXPERIMENTAL

Pfs25-IMX313 (50ug)/Matrix-M (50ug)

Intervention Type: BIOLOGICAL

3 doses of Pfs25-IMX313/Matrix-M at Pfs25-IMX313(50µg)/ Matrix-M (50µg)

Groups 3A & 3B

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

Group Type: EXPERIMENTAL

Pfs25-IMX313 (10ug)/Matrix-M (50ug)

Intervention Type: BIOLOGICAL

3 doses of Pfs25-IMX313/Matrix-M at Pfs25-IMX313(10µg)/Matrix-M (50µg)

Group 3C

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

Group Type: EXPERIMENTAL

Pfs25-IMX313 (10ug)/Matrix-M (50ug)

Intervention Type: BIOLOGICAL

3 doses of Pfs25-IMX313/Matrix-M at Pfs25-IMX313(10µg)/Matrix-M (50µg)

Groups 4A & 4B

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

Group Type: EXPERIMENTAL

Pfs25-IMX313 (50ug)/Matrix-M (50ug)

Intervention Type: BIOLOGICAL

3 doses of Pfs25-IMX313/Matrix-M at Pfs25-IMX313(50µg)/ Matrix-M (50µg)

Group 4C

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

Group Type: EXPERIMENTAL

Pfs25-IMX313 (50ug)/Matrix-M (50ug) & Pfs25-IMX313 (10ug)/Matrix-M (50ug)

Intervention Type: BIOLOGICAL

2 doses of Pfs25-IMX313/Matrix-M at Pfs25-IMX313(50µg)/ Matrix-M (50µg) followed by one at Pfs25-IMX313(10µg)/Matrix-M (50µg)

Interventions

Pfs25-IMX313 (10ug)/Matrix-M (50ug)

3 doses of Pfs25-IMX313/Matrix-M at Pfs25-IMX313(10µg)/Matrix-M (50µg)

Intervention Type: BIOLOGICAL

Pfs25-IMX313 (50ug)/Matrix-M (50ug)

3 doses of Pfs25-IMX313/Matrix-M at Pfs25-IMX313(50µg)/ Matrix-M (50µg)

Intervention Type: BIOLOGICAL

Pfs25-IMX313 (50ug)/Matrix-M (50ug) & Pfs25-IMX313 (10ug)/Matrix-M (50ug)

2 doses of Pfs25-IMX313/Matrix-M at Pfs25-IMX313(50µg)/ Matrix-M (50µg) followed by one at Pfs25-IMX313(10µg)/Matrix-M (50µg)

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ifakara Health Institute

OTHER

Sponsor Role: collaborator

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Angela Minassian

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Locations

Ifakara Health Institute Clinical Trial Facility

Bagamoyo, , Tanzania

Countries

Tanzania

Other Identifiers

VAC082

Identifier Type: -

Identifier Source: org_study_id