Malaria vaccines put to the test: can three new shots trigger protection?
NCT ID NCT07831226
First seen Sep 21, 2026 · Last updated Sep 21, 2026
Summary
Researchers are testing three experimental malaria vaccines (LYB014, LYB017, and LYB027) in healthy adults aged 18 to 50. Participants receive either a low or high dose of one vaccine combined with an immune-boosting adjuvant, or the adjuvant alone as a comparison. The trial tracks side effects and measures antibody levels to see whether the vaccines are safe and prompt an immune response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- three experimental recombinant malaria vaccines (LYB014, LYB017, LYB027) given with an immune-boosting adjuvant
- What this could lead to
- If the vaccines prove safe and trigger strong antibody responses, this could guide larger trials that test whether they protect people from malaria.
- What could go wrong
- This is an early phase 1 study in 72 healthy volunteers, so it can only show safety and immune signals, not whether the vaccines prevent malaria. Many experimental vaccines fail in later testing.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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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About 72 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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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18 to 50 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: * 1\) Healthy males or females aged 18-50 years (inclusive) at the time of screening. 2\) Written informed consent obtained from the participant before any assessment is performed. 3\) Participants who the investigator believes that they can and will comply with the requirements of the protocol. (e.g., complete the diary cards, and complete follow-up visits). 4\) Participants must have a Body Mass Index (BMI) between ≥18.0 and ≤35.0 kg/m2 at screening. 5\) Female participants who are not pregnant or lactating. Female participants with childbearing potential and their partners should use highly effective, medically accepted double-barrier contraception, or persistent lifestyle abstinence and will not have pregnancy and fertility plan and refrain from donating ovum from at least 28 days prior to study vaccination/Day 1 until study completion. * A woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. * Highly effective double-barrier contraception is defined as use of a condom AND one of the following from at least 28 days prior to study vaccination/Day 1 until study completion: birth control pills (The Pill), depot or injectable birth control, intrauterine device (IUD), NuvaRing®, implantable contraception (e.g., Implanon). * Female participants who have had bilateral tubal ligation and are willing to use a condom when sexually active with the opposite sex. * Note: There is no contraception requirement for female participants with non-childbearing potential (WNCBP) and WNCBP participants' male partners must use a condom from study vaccination/Day 1 until study completion. Female participants who are in same-sex relationships should use a barrier form of contraception (e.g., diaphragm) from study vaccination/Day 1 until study completion. 6\) Males participating in this study who are involved in heterosexual sexual activity with a female partner of childbearing potential must agree to use highly effective, medically accepted double-barrier contraception (as described above), or persistent lifestyle abstinence and refrain from donating sperm from at least 28 days prior to study vaccination until study completion. * Note: male participants who have undergone a vasectomy and are involved in heterosexual sexual activity with a female partner of childbearing potential are recommended to use double-barrier contraception. Male participants with WNCBP partners must use a condom only from study vaccination/Day 1 until study completion. Male Participants who are in same-sex relationships should use a barrier form of contraception (e.g., condom) from study vaccination/Day 1 until study completion. Exclusion Criteria: * 1\) Tympanic temperature \> 37.5°C at screening or prior to first vaccination. 2) Received a live attenuated vaccine within 28 days before first vaccination or received other vaccines within 14 days before first vaccination. 3\) Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period. 4\) Prior receipt of an investigational malaria vaccine or any other investigational vaccine likely to impact on interpretation of the trial data. 5\) Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate. 6\) 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). 7\) Any acute disease or acute attack of chronic diseases or using antipyretic, analgesic or anti-allergic drugs (e.g., acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.) within 24 h prior to the first vaccination. 8\) Allergies to any component of the investigational vaccine. 9) Any history of anaphylaxis in relation to vaccination. 10) History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ, the above two types of carcinomas must be fully resolved for at least 3 months before screening). 11\) History of serious psychiatric or neurological condition likely to affect participation in the study (except history of childhood or febrile seizures; history of anxiety, depression, or attention-deficit/hyperactivity disorder (ADHD) that remains stable, with no required medication for the conditions for at least 6 months prior to screening, and no clinically significant worsening requiring intervention). 12\) Congenital or acquired autoimmune disease. 13) Any other serious chronic illness requiring hospital specialist supervision. 14\) A positive urine drug test (except positive cotinine results due to casual and social smoking) or alcohol breath test at screening or Day 1. 15\) Weekly cigarette consumption exceeding 5 cigarettes, and unwilling to completely abstain from smoking during their stay at the clinical site. 16\) Positive test for hepatitis C virus (HCV), hepatitis B surface antigen (HbsAg), human immunodeficiency virus (HIV) at screening. 17\) History of clinical malaria (any species). 18) Travel to a malaria endemic region during the study period or within 4 weeks prior to first vaccination. 19\) Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis. 20\) Have donated blood or plasma within 7 days prior to screening. 21) Any other significant disease, disorder or finding which may significantly increase the risk to the participant because of participation in the study, affect the ability of the participant to participate in the study or impair interpretation of the study data. 22\) Other conditions that may impact the participant's safety or influence the assessment of vaccine response, as determined by the investigator.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Nucleus Network Pty Ltd.
Melbourne, Australia
More trials for these conditions
Other studies related to the condition(s) this trial covers.