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

NCT04271306 | Terminated Phase 1 DMC

• 1 other identifier: VAC082
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Conditions

Malaria,Falciparum

Keywords

Vaccine

Outcome Measures

Primary Outcomes (3)

• 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).

  Assessment of solicited symptoms in the first 7 days post 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).

  Assessment of unsolicited symptoms in the first 30 days post vaccination

• 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.

  Assessment of SAEs until the end of the study (approx 2 years)

Secondary Outcomes (4)

• Determine the Pfs25 specific antibody responses following immunization with different vaccination regimens in healthy Tanzanian adults and children.

  Duration of the study (approx 2 years)

• 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).

  Duration of the study (approx 2 years)

• 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).

  Duration of the study (approx 2 years)

• 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).

  Duration of the study (approx 2 years)

Study Arms (6)

Groups 1A & 1B

EXPERIMENTAL

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

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

Groups 2A & 2B

EXPERIMENTAL

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

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

Groups 3A & 3B

EXPERIMENTAL

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

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

Group 3C

EXPERIMENTAL

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

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

Groups 4A & 4B

EXPERIMENTAL

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

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

Group 4C

EXPERIMENTAL

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

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

Interventions

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

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

Group 3C; Groups 1A & 1B; Groups 3A & 3B

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

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

Groups 2A & 2B; Groups 4A & 4B

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

Group 4C

Eligibility Criteria

• Age: 5 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oxford: lead
• Ifakara Health Institute: collaborator

Study Sites (1)

Ifakara Health Institute Clinical Trial Facility

Bagamoyo, Tanzania

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

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2020
• First Posted: February 17, 2020
• Study Start: May 25, 2021
• Primary Completion: February 19, 2024
• Study Completion: February 19, 2024
• Last Updated: January 27, 2025

Record last verified: 2025-01

Locations

TA (1)