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New malaria vaccine candidate moves to human safety tests

NCT ID NCT02014727

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

  • CNRFP

    Ouagadougou, Ouagadougou, Burkina Faso

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