A Phase Ia Study to Assess Safety and Immunogenicity of the Plasmodium Falciparum Malaria Vaccine Candidate Pfs25-IMX313 in Matrix-M1 Adjuvant in Healthy Adults Living in the UK
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Malaria,Falciparum
- Sponsor
- University of Oxford
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Assessment of safety and reactogenicity through collection of data on the frequency, duration and severity of solicited and unsolicited adverse events.
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
Brief Summary
This is an open label, single-site, first-in-human, Phase Ia study to assess safety and immunogenicity of the Plasmodium falciparum malaria vaccine candidate Pfs25-IMX313 in Matrix-M1 adjuvant in healthy adults living in the UK
Volunteers will receive 3 doses of vaccine over 2 months and will be followed up for approximately 8 months.
Detailed Description
This Phase 1a clinical trial is designed primarily to assess the safety and tolerability of the Pfs25-IMX313/Matrix-M transmission blocking vaccine in healthy adult volunteers. An important secondary objective is to to assess the immune response to the vaccine. 8 volunteers will receive 3 doses of 10µg Pfs25-IMX313 in 50 µg Matrix-M1 on days 0, 28 and 56. Blood samples will be taken for safety testing and to collect information about the immune response. Any symptoms that occur after vaccination will also be recorded. Healthy volunteers aged 18-45 will be recruited in England at the Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The volunteer must satisfy all the following criteria to be eligible for the study:
- •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 General Practitioner.
- •Women only: Must practice continuous effective contraception for the duration of the study
- •Agreement to refrain from blood donation for the duration of the study
- •Written informed consent to participate in the trial.
Exclusion Criteria
- •The volunteer may not enter the study if any of the following apply:
- •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) at any time in the past.
- •Receipt of any vaccine in the 30 days preceding enrolment, or planned receipt of any other vaccine within 30 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)
Outcomes
Primary Outcomes
Assessment of safety and reactogenicity through collection of data on the frequency, duration and severity of solicited and unsolicited adverse events.
Time Frame: 8 months
The following parameters will be assessed: * Frequency, duration and severity of solicited local reactogenicity signs and symptoms for 7 days following each vaccination * Frequency, duration and severity of solicited systemic reactogenicity signs and symptoms for 7 days following the vaccination * Frequency, duration and severity of unsolicited adverse events for 28 days following the vaccination * Change from baseline for safety haematological and biochemical laboratory measures, which will presented according to local grading scales, for 28 days following vaccination * Frequency, duration and severity of serious adverse events during the whole study duration
Secondary Outcomes
- Ex-vivo efficacy of the Pfs25-IMX313/Matrix-M1 vaccine, when administered to healthy adult volunteers(8 months)
- Humoral and cellular immunogenicity of the Pfs25-IMX313/Matrix-M1 vaccine, when administered to healthy adult volunteers(8 months)