A Phase Ia Study to Assess Safety and Immunogenicity of the Plasmodium Vivax Malaria Vaccine Candidate Pvs25-IMX313 in Matrix-M1 Adjuvant in Healthy Adults Living in the UK
Overview
- Phase
- Early Phase 1
- Intervention
- Pvs25-IMX313/Matrix-M1
- Conditions
- Malaria, Vivax
- Sponsor
- University of Oxford
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms
- Status
- Terminated
- Last Updated
- 3 months ago
Overview
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.
Detailed Description
Volunteers will be recruited into one of three groups (n=8-10 per group) at the Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Oxford over approximately 18 months. All volunteers will receive three doses of Pvs25-IMX313 in Matrix-M1, administered intramuscularly and given four weeks apart. Enrolment will be staggered with clinical and safety reviews, follow-up visits and monitoring via a diary card.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Group 1 (low dose)
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
Intervention: Pvs25-IMX313/Matrix-M1
Group 2 (standard dose)
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
Intervention: Pvs25-IMX313/Matrix-M1
Group 3 (fractional dose)
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
Intervention: Pvs25-IMX313/Matrix-M1
Outcomes
Primary Outcomes
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms
Time Frame: 7 days following each vaccination
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.
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms.
Time Frame: 7 days following each vaccination
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.
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Unsolicited Adverse Events.
Time Frame: 28 days following each vaccination
Unsolicited adverse events were collected for 28 days following each vaccination through participant-reported e-diaries.
Safety of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Occurrence of Abnormal Laboratory Test Results
Time Frame: 28 days following vaccination
Occurrence of change from baseline laboratory test results
Safety and Tolerability of the Pvs25-IMx313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Serious Adverse Events
Time Frame: Whole duration of the study period (8 months following enrolment)
Number of serious adverse events reported per group throughout the study period.
Secondary Outcomes
- 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.)