New antibody shot shows promise against malaria in early trial
NCT ID NCT05891236
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tested a lab-made antibody called MAM01 in 63 healthy adults who had never had malaria. The goal was to see if it is safe and can prevent malaria infection when people are deliberately exposed to the parasite. The study is complete, but results are not yet public.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- MAM01 (a lab-made antibody that targets the malaria parasite)
- What this could lead to
- If successful, this antibody could provide temporary protection against malaria, especially for travelers or in outbreaks.
- What could go wrong
- This is a very early, small trial (63 people) in healthy adults who have never had malaria. It may not work in real-world settings or provide long-term protection.
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
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
63 people
The number who actually took part.
- Started
-
Aug 2023
- Finished
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Dec 2024
- Lead sponsor
-
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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18 to 50 years
- Sex
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Anyone
- Healthy volunteers
-
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: * Participants who are healthy as determined by medical evaluation including medical history, physical examination and laboratory tests * Body Mass Index (BMI) 18 to 30 kilograms per square meter (kg/m\^2) (inclusive) to a maximum of 220 pounds * Both males and females are eligible to participate as per the following: a. Female participants physically capable of pregnancy, have at least one negative pregnancy test during Screening, on the day of enrollment, prior to Investigational product (IP) administration, prior to CHM and at the start of antimalarial treatment, and who agree to use effective contraception to avoid pregnancy from 28 days before enrollment through 10 months after last administration of investigational product are eligible to participate. * Capable of giving signed Informed Consent which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and the trial protocol, and completion of a test of understanding if he/she may participate in the CHMI procedure * Reported completion of primary Coronavirus Disease (COVID) vaccine series is documented Exclusion criteria: * Acute illness or fever ≥99.5°Fahrenheit (F) (or ≥37.5 degrees Celsius) on day of dosing * Women who are pregnant or breastfeeding * Evidence and/or history of clinically significant medical condition(s) as judged by the Investigator, including malignancies, diabetes mellitus, and unstable or uncontrolled hypertension * A 5-year cardiovascular risk of ≥10% using the Gaziano nomogram * History of any autoimmune disease or immune deficiency or other impairment to the immune system, including but not limited to Human immunodeficiency virus (HIV), autoimmune conditions or immunosuppressive therapy * Participation in an interventional clinical trial and/or receipt of any investigational drug within 180 days prior to administration of trial drug on Day 0 * Anticipated use of medications known to cause drug reactions with chloroquine or atovaquone-proguanil (Malarone) such as cimetidine, metoclopramide, antacids, and kaolin Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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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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Center for Vaccine Development and Global Health, 685 W. Baltimore Street
Baltimore, Maryland, 21201, United States
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Other studies related to the condition(s) this trial covers.
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