New malaria vaccine candidate moves to human safety tests
NCT ID NCT02014727
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tested a new malaria vaccine called AMA1-DiCo in 66 healthy adults—some in Europe never exposed to malaria, and some in Africa who were. The vaccine was given with one of two adjuvants (GLA-SE or Alhydrogel) to boost immune response. The main goal was to check safety and see how well the body's immune system responds to the vaccine.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AMA1-DiCo malaria vaccine with either GLA-SE or Alhydrogel adjuvant
- What this could lead to
- If successful, this could pave the way for a more effective malaria vaccine that works against different strains of the parasite.
- What could go wrong
- This is an early Phase 1 trial with only 66 participants, focused on safety, not yet on preventing malaria. The vaccine may not produce strong enough immunity or could cause side effects.
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
-
66 people
The number who actually took part.
- Start date
-
Jan 2014
- Finished
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Jul 2015
- Lead sponsor
-
A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
20 to 45 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: 1. Age \> 20 and \< 45 years healthy female and male 2. General good health based on history and clinical examination. 3. Written informed consent obtained before any trial procedure. 4. Female and male volunteers practicing contraception before and up to four (4) weeks after the third vaccination. 5. Available to participate in follow-up for the duration of trial. 6. Reachable by phone during the whole trial period. 7. Volunteers should be affiliated to a social security regimen Exclusion Criteria: 1. Positive pregnancy test 2. Active breast feeding 3. Previous participation in any malaria vaccine trial 4. History of blood transfusion within the last 6 months 5. Symptoms, physical signs or laboratory values suggestive of systemic disorders, including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric and other conditions, which could interfere with the interpretation of the trial results or compromise the health of the volunteers. 6. Any clinically significant laboratory abnormalities on screened blood samples outside the normal range, as defined at the clinical trial site. 7. Enrolment in any other clinical trial during the whole trial period 8. Intake of chronic medication, especially immunosuppressive agents (steroids, immunomodulating or immunosuppressive drugs) during the thirteen weeks preceding the screening visit or during the trial period except topical steroid use including intranasal. 9. Any confirmed or suspected immunosuppressive or immunodeficiency condition during the whole trial period 10. Volunteers unable to be closely followed for social, geographic or psychological reasons. 11. Previous history of drug or alcohol abuse interfering with normal social function during a period of one year prior to enrolment in the trial. 12. History of anaphylaxis or Known severe hypersensitivity to any of the vaccine components (adjuvant or antigen or excipient) 13. Vaccination or gamma globulin: 4 weeks prior and after each vaccination if a vaccination is necessary during this period, the volunteer will be withdrawn from the study. 14. Positive HIV, HBV (Ag HBS) and HCV tests. 15. History of malaria or travel in malaria endemic areas within the past twenty-six weeks. 16. Positive serology for malaria antigen PfAMA-1 17. Intention to travel to malaria endemic countries during the trial period. \-
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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
-
CIC BT 505 de vaccinologie Cochin Pasteur. Hôpital Cochin Bâtiment Lavoisier 27 rue du faubourg St Jacques.
Paris, 75014, France
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CNRFP
Ouagadougou, Ouagadougou, Burkina Faso
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New malaria drug interaction study launches in healthy volunteers
- New malaria shots could replace daily pills
- New malaria antibody enters first human safety tests
- Breastfeeding moms with malaria: do drugs reach baby?
- New malaria pill shows promise in early trial