A Study to Compare Two Dosing Regimens for a New Malaria Vaccine

NCT06141057 | Active Not Recruiting Phase 1

• 1 other identifier: BIO-002
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Malaria is a major public health problem. There were around 240 million cases of malaria and 627,000 deaths worldwide in 2020. Most of the deaths are in children under five living in Africa. It is a major problem for those who live in affected areas and for travellers. There is a great need for a safe, effective malaria vaccine. This study is being done to evaluate an experimental malaria vaccine for its safety and also look at the body's immune response to the vaccine. The vaccine tested in this study is called and "RH5.1". This is given with an adjuvant called "Matrix-M". This is a substance to improve the body's response to a vaccination. The aim is to use the vaccines and adjuvant to help the body make an immune response against parts of the malaria parasite. This study will assess:

1. 1.The safety of the vaccines in healthy participants.
2. 2.The response of the human immune system to the vaccines.

Conditions

Malaria; Malaria,Falciparum; Protozoan Infections; Parasitic Disease; Infections; Vector Borne Diseases

Keywords

RH5.1; Matrix-M

Outcome Measures

Primary Outcomes (4)

• To assess the safety of RH5.1 soluble protein in Matrix-M in healthy adult volunteers by assessing the occurrence of solicited reactogenicity following each vaccinations

  Occurrence of solicited local/systemic reactogenicity signs and symptoms for 7 days. following each vaccination. These will be tabulated, detailing frequency, duration and severity of signs and symptoms.

  7 days following each vaccination

• To assess the safety of RH5.1 soluble protein in Matrix-M in healthy adult volunteers by assessing the occurrence of unsolicited adverse events following each vaccinations

  Occurrence of unsolicited adverse events for 28 days following the vaccination. These will be tabulated, detailing frequency, duration and severity of AEs.

  28 days following each vaccination

• To assess the safety of RH5.1 soluble protein in Matrix-M in healthy adult volunteers by comparing safety laboratory measures following each vaccinations

  Change from baseline for safety laboratory measures for 28 days following vaccination. Haematological and biochemical laboratory values will be presented according to local grading scales.

  28 days following each vaccination

• To assess the safety of RH5.1 soluble protein in Matrix-M in healthy adult volunteers by assessing the occurrence of serious adverse events

  Occurrence of serious adverse events during the whole study duration. These will be tabulated, detailing frequency, duration and severity of SAEs.

  During Whole study duration (547 days)

Secondary Outcomes (3)

• To assess the humoral immunogenicity of RH5.1 soluble protein with Matrix-M when administered to healthy volunteers at different doses.

  From a number of key timepoints (Baseline up to day 547)

• To compare the anti-RH5 serum IgG functional immunogenicity between the two groups receiving soluble RH5.1 at different doses by assessing purified IgG versus GIA titration (quality analysis)

  After each vaccinations (D0, D28 and D182)

• To compare differences in the innate immune responses following the first and third vaccinations and correlated these with adverse event data and adaptive immune responses

  7, 28 days following first and third vaccinations

Study Arms (2)

Group 1: Delayed regimen

EXPERIMENTAL

12 volunteers receiving three doses of 10 µg RH5.1 with 50 µg of Matrix-M on days 0, 28 and 182 via intramuscular (IM) injection in the deltoid region of the non-dominant arm

Biological: Matrix M with RH5.1

Group 2: Delayed Fractional Regimen

EXPERIMENTAL

12 volunteers receiving two doses of 50 µg RH5.1 with 50 µg of Matrix-M on days 0, 28 and one dose of 10 µg RH5.1 with 50 µg of Matrix-M on day 182 via intramuscular (IM) injection in the deltoid region of the non-dominant arm

Biological: Matrix M with RH5.1

Interventions

Matrix M with RH5.1 BIOLOGICAL

50 µg of Matrix-M adjuvant with RH5.1 at different doses on days 0 and 28.

Group 1: Delayed regimen; Group 2: Delayed Fractional Regimen

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult aged 18 to 50 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
• Participants of childbearing potential only: must practice continuous effective contraception for the duration of the study (see section 9.9)
• 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) or previous participation in any malaria (vaccine) trial or controlled human malaria infection (CHMI) study
• 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 involving an investigational product 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
• Pregnancy, lactation or intention to become pregnant during the study
• Body mass index of \<18.5 or \>35
• 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

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Sheffield Teaching Hospitals, Royal Hallamshire Hospital

Sheffield, S10 2JF, United Kingdom

Location

MeSH Terms

Conditions

Malaria; Malaria, Falciparum; Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases

Interventions

Matrix-M

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases

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: July 14, 2023
• First Posted: November 21, 2023
• Study Start: June 6, 2023
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: October 4, 2024

Record last verified: 2024-10

Locations

GB (1)