Double vaccine attack on malaria shows promise in early trial
NCT ID NCT05357560
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested two different malaria vaccines—one targeting the blood stage and one the liver stage—alone and in combination. 107 healthy adults and infants in The Gambia received the vaccines to check safety and immune response. The goal is to see if combining them offers better protection against malaria.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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107 people
The number who actually took part.
- Started
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Jul 2023
- Finished
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Dec 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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5 months to 45 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Groups 1, 2 and 6-9: Healthy male or female infants aged 5-17 months at the time of enrolment with signed consent obtained from parents or guardians. * Groups 3-5: Healthy male or female adults aged 18-45 years at the time of enrolment with signed consent. * Groups 3-5 (Female participants only): Must be non-pregnant (as demonstrated by a negative urine pregnancy test), and practice continuous effective contraception for the 24 to 30 month duration of the study (see section 9.9). * Planned long-term (at least 24 months from the date of recruitment) or permanent residence in the study area. * Adults with a Body Mass Index (BMI) 18 to 30 Kg/m2; or infants with Z-score of weight-for-age within ±2SD. Exclusion Criteria: * Clinically significant congenital abnormalities as judged by the PI or other delegated individual * Clinically significant history of skin disorder (psoriasis, contact dermatitis etc.), allergy, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease and neurological illness as judged by the PI or other delegated individual. * 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 cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ). * History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g., Kathon, neomycin, betapropiolactone. * Any history of anaphylaxis in relation to vaccination. * 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 30 days preceding enrolment, or planned receipt of any other vaccine within 30 days following each study vaccination. This excludes COVID-19 vaccines, which should not be received between 14 days before to 7 days after any study vaccination, and EPI vaccines (for infants), which should not be received between 14 days before to 28 days after any study vaccination. * History of vaccination with previous malaria vaccines * Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment in adults or at any time for infants, or planned use during the study period. * Suspected or known current alcohol abuse. * Suspected or known injecting drug abuse in the 5 years preceding enrolment. * Seropositive for hepatitis B surface antigen (HBsAg), hepatitis C (HCV IgG) or HIV. For infants, any history of vertical exposure to HIV infection. * Any other finding which in the opinion of the PI or other delegated individual would increase the risk of an adverse outcome from participation in the trial. * Positive malaria by PCR screening. * 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. * Any other 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 participant's ability to participate in the trial. Vaccination and re-vaccination exclusion criteria The following events associated with vaccine immunisation constitute absolute contraindications to further administration of vaccine. If any of these events occur during the study, the participant must be withdrawn and followed until resolution of the event, as with any adverse event: * 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 may be vaccinated at a later date, or withdrawn at the discretion of the Investigator. The participant must be followed until resolution of the event as with any adverse event: * Acute disease at the time of administration of the IP (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 administered to persons with a minor illness such as diarrhoea or mild upper respiratory infection without fever, i.e. axillary temperature \< 37.5°C. * Temperature of \>37.5°C (99.5°F) at the time of vaccination. * Confirmed current COVID-19 infection, defined as ongoing symptoms with positive COVID-19 PCR swab or rapid antigen test taken during current illness or positive COVID-19 PCR swab or rapid antigen test within preceding 7 days without symptoms. Vaccinations will be delayed by a minimum of 7 days from the date of the first positive COVID-19 PCR swab, as long as symptoms are improving or resolved and there is no fever. It will be at the discretion of the Investigator to withdraw a participant if they develop severe COVID-19 disease.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Medical Research Council Unit, Fajara
Banjul, PO Box 273, The Gambia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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