A Phase Ia Clinical Trial to Assess the Safety and Immuno... | NCT05385471

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1	Experimental	8+1 volunteers receiving three doses of 10 µg R78C 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 R78C and/or RH5.1
Group 2	Experimental	8+1 volunteers receiving three doses of 10 µg R78C + 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 R78C and/or RH5.1
Group 3	Experimental	8+1 volunteers receiving three doses of 10 µg RH5.1 with 50 µg of Matrix-M on days 0, 28 and 56 via intramuscular (IM) injection in the deltoid region of the non-dominant arm	Biological: Matrix M with R78C and/or RH5.1
Group 4	Experimental	8+1 volunteers receiving two doses of 10 µg R78C + 10 µg RH5.1 with 50 µg of Matrix-M on days 0, 28, one dose of 10 µg R78C with 50 µg of Matrix-M on day 182 and one dose of 10 µg RH5.1 with 50 µg of Matrix-M on day 210, all administered via intramuscular (IM) injection in the deltoid region of the non-dominant arm	Biological: Matrix M with R78C and/or RH5.1

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Matrix M with R78C and/or RH5.1	Biological	50 µg of Matrix-M adjuvant with R78C and/or RH5.1 at different doses and timepoints	Group 1 Group 2 Group 3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To assess the safety of R78C in Matrix-M™ and RH5.1 in Matrix-M in healthy adult volunteers at alone and in combination by assessing the occurrence of solicited local reactogenicity signs and symptoms for 7 days following each vaccination	Occurrence of solicited local reactogenicity signs and symptoms for 7 days following each vaccination. These will be tabulated, detailing frequency, duration and severity of AEs. Haematological and biochemical laboratory values will be presented according to local grading scales.	7 days following each vaccination
To assess the safety of R78C in Matrix-M™ and RH5.1 in Matrix-M in healthy adult volunteers at alone and in combination by assessing the occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following each vaccination	Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following each vaccination. These will be tabulated, detailing frequency, duration and severity of AEs. Haematological and biochemical laboratory values will be presented according to local grading scales.	7 days following each vaccination
To assess the safety of R78C in Matrix-M™ and RH5.1 in Matrix-M in healthy adult volunteers at alone and in combination by assessing the occurrence of unsolicited adverse events for 28 days following the vaccination	Occurrence of unsolicited adverse events for 28 days following the vaccination. These will be tabulated, detailing frequency, duration and severity of AEs. Haematological and biochemical laboratory values will be presented according to local grading scales.	28 days following the vaccination
To assess the safety of R78C in Matrix-M™ and RH5.1 in Matrix-M in healthy adult volunteers at alone and in combination, assessed through the number of participants with abnormal laboratory test results	Occurrence of change from baseline laboratory tests	28 days following vaccination

Secondary Outcomes

Measure	Description	Time Frame
To assess the humoral immunogenicity of R78C in Matrix-M™ and RH5.1 in Matrix-M when administered to healthy volunteers alone and in combination assessing antigen-specific IgG antibody levels, with comparison before and after vaccination	Serum ELISA response, quantitative antigen-specific IgG antibody levels (µg/mL readout) over time - analysis of peak responses and longevity, with comparison before and after vaccination

Eligibility Module

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 GP
Participants of childbearing potential only: must practice continuous effective contraception until 3 months after the final study vaccination (see section 9.10)
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:

The volunteer may not enter the study if any of the following apply:

History of clinical malaria (any species) or previous participation in any malaria vaccine trial or controlled human malaria infection trial
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 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 misuse as defined by an alcohol intake of greater than 25 standard UK units every week
Suspected or known injecting drug use in the 5 years preceding enrolment
Hepatitis B surface antigen (HBsAg) detected in serum
Seropositive for hepatitis C virus (antibodies to HCV) at screening (unless volunteer has taken part in a prior hepatitis C vaccine study with confirmed negative HCV antibodies prior to participation in that study, and negative HCV ribonucleic acid (RNA) PCR at screening for this study)
Volunteers unable to be closely followed for social, geographic or psychological reasons.
Any clinically significant abnormal finding on biochemistry or haematology blood tests, urinalysis or clinical examination. In the event of abnormal test results, confirmatory repeat tests will be requested.
Any other significant disease, disorder, or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data
Inability of the study team to contact the volunteer's GP to confirm medical history and safety to participate

ID	Term
D008288	Malaria
D011528	Protozoan Infections
D010272	Parasitic Diseases
D007239	Infections
D000096724	Mosquito-Borne Diseases
D000079426	Vector Borne Diseases