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New treatment option for Malaria,Falciparum
Official title A Study to Assess the Experimental Malaria Vaccines R78C and RH5.1 Combined With R21/Matrix-M (a "Multi-stage" Malaria Vaccine)
ClinicalTrials.gov ID: NCT06958198
What this study is testing
What is R21?
R21 is an investigational medicine, being studied as a potential treatment for malaria,falciparum.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase Ib age de-escalation, dose escalation, open-label study to assess the safety and immunogenicity of the multi-stage malaria vaccine candidate R21 plus RH5.1 and/or R78C in Matrix-M in adults aged 18-35 years and children aged 5-17 months in Burkina Faso.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 35. Healthy volunteers may be eligible.
You may be able to join if
- Only participants who meet all the will be enrolled into the trial:
- Group 1: Healthy adult aged 18-35 years at the time of first study vaccination
- Group 2-6: Healthy child aged 5-17 months at the time of first study vaccination
- Group 1: Female participants must be non-pregnant (as demonstrated by a negative urine pregnancy . test), and practice continuous effective...
- Participant or parent/guardian provides signed/thumb-printed informed consent
You likely can't join if
- The participant may not enter the trial if ANY of the following apply:
- Clinically significant congenital abnormalities as judged by the PI or other delegated individual.
- Clinically significant skin disorder (psoriasis, contact dermatitis, etc.), cardiovascular disease, respiratory disease, endocrine disorder, liver...
- History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).
- Children with weight-for-age Z score of less than -3 or other clinical signs of malnutrition.
- History of allergic reaction, significant IgE-mediated event, or anaphylaxis to immunisation.
See the full eligibility criteria
- Only participants who meet all the will be enrolled into the trial:
- Group 1: Healthy adult aged 18-35 years at the time of first study vaccination
- Group 2-6: Healthy child aged 5-17 months at the time of first study vaccination
- Group 1: Female participants must be non-pregnant (as demonstrated by a negative urine pregnancy . test), and practice continuous effective contraception until three months after the final study vaccination
- Participant or parent/guardian provides signed/thumb-printed informed consent
- Participant (and parent/guardian for child participants) resident in the study area villages, and anticipated to be available for vaccination and the duration of follow-up -
- The participant may not enter the trial if ANY of the following apply:
- Clinically significant congenital abnormalities as judged by the PI or other delegated individual.
- Clinically significant skin disorder (psoriasis, contact dermatitis, etc.), cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness...
- History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).
- Children with weight-for-age Z score of less than -3 or other clinical signs of malnutrition.
- History of allergic reaction, significant IgE-mediated event, or anaphylaxis to immunisation.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- Sickle cell disease.
- Clinically significant laboratory abnormality at grade 2 or above as judged by the PI or other delegated individual.
- Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate.
- Receipt of any vaccine in the 14 days preceding enrolment, or planned receipt of any other vaccine within 28 days following each study vaccination.
- History of vaccination with any malaria vaccine.
- Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period.
- Suspected or known current alcohol misuse.
- Suspected or known injecting drug use in the 5 years preceding enrolment.
- Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.
- Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
- Seropositive for hepatitis B surface antigen (HBsAg), hepatitis C (HCV IgG) or HIV. For children, any history of vertical exposure to HIV infection.
- 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...
- Any significant disease, disorder or situation which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the...
- Anaphylactic reaction following administration of vaccine.
- Pregnancy. The following adverse events constitute contraindications to administration of vaccine at that point in time; if any one of these adverse events occurs at the time scheduled for vaccination, the participant...
- Acute disease at the time of vaccination (acute disease is defined as the presence of a moderate or severe illness with or without fever or symptoms suggestive of possible COVID-19 disease). All vaccines can be...
- Temperature of \>37.5°C (99.5°F) at the time of vaccination.
The study team makes the final eligibility decision.
Where it's taking place
- Siglé, Boulkiemdé Province, Burkina Faso
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 5 months to 35 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Siglé, Boulkiemdé Province, Burkina Faso. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.