Safety and Immunogenicity of Pvs25-IMX313/Matrix-M1 Vaccine

NCT05270265 | Terminated Early Phase 1 Results DMC

• 1 other identifier: VAC084
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, single-centre, non-randomised, first-in-human Phase Ia study to assess the safety and immunogenicity of the Pvs25-IMX313 vaccine, administered in Matrix-M1 adjuvant.

Conditions

Malaria, Vivax

Keywords

Pvs25-IMX313; Matrix-M1

Outcome Measures

Primary Outcomes (5)

• Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms

  Number of participants in each group who reported solicited local reactogenicity signs and symptoms in the 7 days following each vaccination. Solicited local reactogenicity signs and symptoms are collected through participant-reported e-diaries.

  7 days following each vaccination

• Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms.

  Number of participants in each group who reported solicited systemic reactogenicity signs and symptoms in the 7 days following each vaccination. Solicited systemic reactogenicity signs and symptoms are collected through participant-reported e-diaries.

  7 days following each vaccination

• Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Unsolicited Adverse Events.

  Unsolicited adverse events were collected for 28 days following each vaccination through participant-reported e-diaries.

  28 days following each vaccination

• Safety of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Occurrence of Abnormal Laboratory Test Results

  Occurrence of change from baseline laboratory test results

  28 days following vaccination

• Safety and Tolerability of the Pvs25-IMx313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Serious Adverse Events

  Number of serious adverse events reported per group throughout the study period.

  Whole duration of the study period (8 months following enrolment)

Secondary Outcomes (4)

• Humoral Immunogenicity of the Pvs25-IMX313/Matrix-M1 Vaccine When Administered to Healthy Adult Volunteers: Humoral Responses to the Pvs25 Protein

  Days 1, 29, 57, 140 and 240.

• Cellular Immunogenicity of the Pvs25-IMX313/Matrix-M1 Vaccine When Administered to Healthy Adult Volunteers: Cellular Responses to the Pvs25 Protein.

  Days 1, 29, 57, 140 and 240.

• Ex Vivo Efficacy of the Pvs25-IMX313/Matrix-M1 Vaccine When Administered to Healthy Adult Volunteers: Transmission-Reducing Activity

  Days 1, 29, 57, 140 and 240.

• Ex Vivo Efficacy of the Pvs25-IMX313/Matrix-M1 Vaccine When Administered to Healthy Adult Volunteers: Transmission-Blocking Activity

  Days 1, 29, 57, 140 and 240.

Study Arms (3)

Group 1 (low dose)

EXPERIMENTAL

8-10 volunteers receiving three doses of 10 µg Pvs25-IMX313 in 50 µg Matrix-M1 on days 0, 28 and 56 via intramuscular injection (IM) in the deltoid region of the arm

Biological: Pvs25-IMX313/Matrix-M1

Group 2 (standard dose)

EXPERIMENTAL

8-10 volunteers receiving three doses of 50 µg Pvs25-IMX313 in 50 µg Matrix-M1 on days 0, 28 and 56 via intramuscular injection (IM) in the deltoid region of the arm

Biological: Pvs25-IMX313/Matrix-M1

Group 3 (fractional dose)

EXPERIMENTAL

8-10 volunteers receiving two doses of 50 µg Pvs25-IMX313 in 50 µg Matrix-M1 on days 0 and 28, followed by one dose of 10 µg Pvs25-IMX313 in 50 µg Matrix-M1 on day 56 via intramuscular injection (IM) in the deltoid region of the arm

Biological: Pvs25-IMX313/Matrix-M1

Interventions

Pvs25-IMX313/Matrix-M1 BIOLOGICAL

Three doses of Pvs25-IMX313 in Matrix-M1 at different concentrations

Group 1 (low dose); Group 2 (standard dose); Group 3 (fractional dose)

Eligibility Criteria

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

You may qualify if:

• 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 GP.
• Volunteers with the potential to become pregnant only: must practice continuous effective contraception for the duration of the study. Acceptable forms of contraception for volunteers of child-bearing potential are: Established use of oral, injected or implanted hormonal methods of contraception, Placement of an intrauterine device or intrauterine system, Male sterilization (if the vasectomised partner is the sole partner for the participant), True abstinence from sex with sperm-producing partners, when this is in line with the preferred and usual lifestyle of the participant (periodic abstinence and withdrawal are not acceptable methods of contraception).
• Agreement to refrain from blood donation for the duration of the study.
• Able and willing to provide written informed consent to participate in the trial.

You may not qualify if:

• 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) in the last three months.
• Receipt of any vaccine in the 30 days preceding enrolment, or planned receipt of any other vaccine within 30 days following each study vaccination, with the exception of --COVID-19 vaccines, which should not be received between 14 days before to 7 days after any study 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.
• 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 current alcohol abuse as defined by an alcohol intake of greater than 25 standard UK units every week.

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, Vivax

Interventions

Matrix-M

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Angela M Minassian
• Organization: University of Oxford

angela.minassian@bioch.ox.ac.uk

1865 611424

Study Officials

• Angela M Minassian, DPhil FRCP

  Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford, United

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: March 8, 2022
• Study Start: February 9, 2022
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: January 15, 2026
• Results First Posted: January 15, 2026

Record last verified: 2024-08

Locations

GB (1)