Malaria, FalciparumPhase 1AMA1-DiCoNCT02014727
Safety and Immunogenicity of Recombinant Pichia Pastoris AMA1-DiCo Candidate Malaria Vaccine With GLA-SE and Alhydrogel ® as Adjuvant in Healthy Malaria Non-Exposed European and Malaria Exposed African Adults
A Phase 1 study testing Group A1 : 50µg AMA1-DiCo + Alhydrogel and Group A2 : 50 µg AMA1-DiCo+ GLA-SE in people with Malaria, Falciparum, run by Institut National de la Santé Et de la Recherche Médicale, France at 2 sites in 2 countries.
Trial summary
The primary objective is to evaluate the safety of 3 doses given at D0, W4, and W26 of 50 µg dosage of AMA1-DiCo adjuvanted either with GLA-SE or Alhydrogel® in healthy European adults not previously exposed to the parasite P.falciparum and in healthy African adults exposed to the parasite. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria, Falciparum
- What is being tested?
- Group A1 : 50µg AMA1-DiCo + Alhydrogel and Group A2 : 50 µg AMA1-DiCo+ GLA-SE
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2014to Jul 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age > 20 and < 45 years healthy female and male
- General good health based on history and clinical examination.
- Written informed consent obtained before any trial procedure.
- Female and male volunteers practicing contraception before and up to four (4) weeks after the third vaccination.
- Available to participate in follow-up for the duration of trial.
- Reachable by phone during the whole trial period.
- Volunteers should be affiliated to a social security regimen
Who cannot join
- Positive pregnancy test
- Active breast feeding
- Previous participation in any malaria vaccine trial
- History of blood transfusion within the last 6 months
- 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.
- Any clinically significant laboratory abnormalities on screened blood samples outside the normal range, as defined at the clinical trial site.
Show all 18Show fewer
- Enrolment in any other clinical trial during the whole trial period
- 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.
- Any confirmed or suspected immunosuppressive or immunodeficiency condition during the whole trial period
- Volunteers unable to be closely followed for social, geographic or psychological reasons.
- Previous history of drug or alcohol abuse interfering with normal social function during a period of one year prior to enrolment in the trial.
- History of anaphylaxis or Known severe hypersensitivity to any of the vaccine components (adjuvant or antigen or excipient)
- 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.
- Positive HIV, HBV (Ag HBS) and HCV tests.
- History of malaria or travel in malaria endemic areas within the past twenty-six weeks.
- Positive serology for malaria antigen PfAMA-1
- Intention to travel to malaria endemic countries during the trial period.
- -
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
France1 site
CIC BT 505 de vaccinologie Cochin Pasteur. Hôpital Cochin Bâtiment Lavoisier 27 rue du faubourg St Jacques.
Paris, 75014
About this study
Official title: Safety and Immunogenicity of Recombinant Pichia Pastoris AMA1-DiCo Candidate Malaria Vaccine With GLA-SE and Alhydrogel ® as Adjuvant in Healthy Malaria Non-Exposed European and Malaria Exposed African Adults:a Staggered Phase Ia/Ib, Randomised, Double-blind, Multi-Centre Trial
The primary objective is to evaluate the safety of 3 doses given at D0, W4, and W26 of 50 µg dosage of AMA1-DiCo adjuvanted either with GLA-SE or Alhydrogel® in healthy European adults not previously exposed to the parasite P.falciparum and in healthy African adults exposed to the parasite. The safety and the tolerability of the vaccine will be assessed on the rate of solicited and unsolicited events/reactions. The safety profile will include local and systemic reactions/events as well as the biological safety, based on a clinically significant change of the baseline value of the main biological criteria.
Read the detailed description
The project aims are :
-To evaluate the safety of 50 µg AMA1-DiCo malaria vaccine candidate with GLA-SE and Alhydrogel® as adjuvant, in healthy European adults not previously exposed to the parasite Plasmodium falciparum and in healthy African adults exposed to the parasite.
T-o assess the humoral immune response to the vaccine antigens by measuring the level of IgG in all volunteers.
To assess the cellular immune response by measuring the T cell cytokines IL-5 and IFNγ production following in vitro stimulation with the vaccine antigens in all volunteers.
Design :
This trial is a staggered Phase Ia/Ib, Randomised, Double-blind, Multi-center Centre trial.
Two different adjuvants will be assessed, Alhydrogel® and GLA-SE. One dosage of 50 µg/3 injections of AMA1-DiCo will be evaluated for each adjuvant.
Sixty six (66) healthy volunteers will be included into the 2 following cohorts (A and B):
Cohort A: 30 Non-exposed European Volunteers (France) Cohort B: 36 Malaria Exposed African Volunteers (Burkina Faso)
The non-exposed European volunteers (cohort A) will be randomised in a 1:1 ratio into two groups of 15 volunteers per group.
The malaria exposed African volunteers (cohort B) will be randomised in a 1:1 ratio, into two groups of 18 volunteers per group.
European Volunteers: Cohort A (30):
Group A1 (15): 50µg AMA1-DiCo + Alhydrogel® Group A2 (15): 50 µg AMA1-DiCo+ GLA-SE
African Volunteers Cohort B (36) :
Group B1 (18): 50 µg AMA1-DiCo + GLA-SE Group B2 (18): Placebo (isotonic saline solution)
In order to start recruitment in cohort B (Africa), the safety will be evaluated on the data of all European volunteers until Day 7 after 1st immunisation of the last European volunteer Data will be presented to an Independent Data safety Monitoring Board (DSMB) that will be appointed for this trial
- Conditions
- Malaria, Falciparum
- Being tested
- Group A1 : 50µg AMA1-DiCo + Alhydrogel, Group A2 : 50 µg AMA1-DiCo+ GLA-SE, Group B2 : Placebo
- Keywords
- Malaria vaccine, phase 1,, AMA1-DiCO
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A1 : 50µg AMA1-DiCo + AlhydrogelBiological
Group A2 : 50 µg AMA1-DiCo+ GLA-SEBiological
Group B2 : PlaceboBiological
| Study group | Role | What they receive |
|---|---|---|
| AMA1-DiCo + Alhydrogel | Experimental | AMA1-DiCo: 50µg Alhydrogel® : 0.85 mg Al3+ per dose Route : Intramuscular Vaccination schedule : Do, W4, W26 Receives: Biological: Group A1 : 50µg AMA1-DiCo + Alhydrogel |
| AMA1-DiCo+ GLA-SE | Experimental | Group A2 (15) : European volunteer : AMA1-DiCo + GLA-SE
AMA1-DiCo: 50µg
GLA-SE 2.5 µg GLA per dose
Route : Intramuscular Vaccination schedule : Do, W4, W26 Receives: Biological: Group A2 : 50 µg AMA1-DiCo+ GLA-SE |
| AMA1-DiCo + GLA-SE | Experimental | Group B1 (18) : African volunteer : AMA1-DiCo + GLA-SE
AMA1-DiCo: 50µg
GLA-SE 2.5 µg GLA per dose
Route : Intramuscular Vaccination schedule : Do, W4, W26 Receives: Biological: Group A2 : 50 µg AMA1-DiCo+ GLA-SE |
| Placebo | Placebo comparator | Group B2 (18) : African volunteer : Placebo
Placebo : isotonic saline solution
Route : Intramuscular Vaccination schedule : Do, W4, W26 Receives: Biological: Group B2 : Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse events
The safety profile will be assessed in all volunteers on the following criteria:
- Immediate reactogenicity (reactions within 60 minutes after each vaccination).
- Local and systemic reactogenicity measured from Day 0 to Week 2 after each vaccination.
- Any unsolicited adverse event between the first vaccination and four weeks after the third vaccination.
- Any SAE occurring from the inclusion throughout the trial.
Measured: Up to four weeks after the third vaccination.
Secondary outcomes (1)
The humoral and cellular responses
The humoral response to the vaccine antigens (DiCo1, DiCo2 and DiCo3) will be assessed by measuring the level of IgG by ELISA on samples obtained at screening visit Day 0, Week 4, 5, 8, 26, 27, 30 and 52.
The cellular immune response will be assessed by measuring the T cell cytokine IL-5, and IFNg production by ELISpot following in vitro stimulation with the vaccine antigens on samples obtained at Day 0, Week 26, 30 and 52.
Measured: 6 months after the last vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionMar 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malaria, FalciparumStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- EVI Industries, Inc., BPRC, Recherche Clinique Paris Descartes Necker Cochin Sainte Anne, Centre national de recherche et de formation sur le paludisme
- Responsible party
- Sponsor
- Investigators
- Odile Launay, Professor, Principal investigator, CIC BT505 Cochin Pasteur Groupe Hospitalier Cochin Broca Hotel Dieu. Bâtiment Lavoisier 27, rue du Faubourg Saint-Jacques 75679 PARIS Cedex 14, France odile.launay@cch.aphp.frSodiomon Sirima, Doctor, Principal investigator, Centre National de Recherche et de Formation sur le Paludisme (CNRFP 01 BP 2208 Ouagadougou 01 1487, Avenue KumdaYonré, Burkina Faso s.sirima.cnlp@fasonet.bf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02014727
- Sponsor's protocol ID
- C12-18 AMA-DiCo
- Other IDs
- 2013-001920-20
- Acronym
- AMA1-DiCo
- Status last verified
- Sep 2015
- First submitted
- 12 Dec 2013
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sirima SB, Durier C, Kara L, Houard S, Gansane A, Loulergue P, Bahuaud M, Benhamouda N, Nebie I, Faber B, Remarque E, Launay O; AMA1-DiCo Study Group. Safety and immunogenicity of a recombinant Plasmodium falciparum AMA1-DiCo malaria vaccine adjuvanted with GLA-SE or Alhydrogel(R) in European and African adults: A phase 1a/1b, randomized, double-blind multi-centre trial. Vaccine. 2017 Oct 27;35(45):6218-6227. doi: 10.1016/j.vaccine.2017.09.027. Epub 2017 Sep 22.
PubMed 28947345
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of Recombinant Pichia Pastoris AMA1-DiCo Candidate Malaria Vaccine With GLA-SE and Alhydrogel ® as Adjuvant in Healthy Malaria Non-Exposed European and Malaria Exposed African Adults:a Staggered Phase Ia/Ib, Randomised, Double-blind, Multi-Centre Trial
- ClinicalTrials.gov ID
- NCT02014727
- Acronym / sponsor ID
- AMA1-DiCo / C12-18 AMA-DiCo
- Conditions
- Malaria, Falciparum
- Keywords
- Malaria vaccine, phase 1,, AMA1-DiCO
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Collaborators
- EVI Industries, Inc., BPRC, Recherche Clinique Paris Descartes Necker Cochin Sainte Anne, Centre national de recherche et de formation sur le paludisme
- Study start
- Jan 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 18 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to evaluate the safety of 3 doses given at D0, W4, and W26 of 50 µg dosage of AMA1-DiCo adjuvanted either with GLA-SE or Alhydrogel® in healthy European adults not previously exposed to the parasite P.falciparum and in healthy African adults exposed to the parasite. The safety and the tolerability of the vaccine will be assessed on the rate of solicited and unsolicited events/reactions. The safety profile will include local and systemic reactions/events as well as the biological safety, based on a clinically significant change of the baseline value of the main biological criteria.
Detailed description
The project aims are :
-To evaluate the safety of 50 µg AMA1-DiCo malaria vaccine candidate with GLA-SE and Alhydrogel® as adjuvant, in healthy European adults not previously exposed to the parasite Plasmodium falciparum and in healthy African adults exposed to the parasite.
T-o assess the humoral immune response to the vaccine antigens by measuring the level of IgG in all volunteers.
To assess the cellular immune response by measuring the T cell cytokines IL-5 and IFNγ production following in vitro stimulation with the vaccine antigens in all volunteers.
Design :
This trial is a staggered Phase Ia/Ib, Randomised, Double-blind, Multi-center Centre trial.
Two different adjuvants will be assessed, Alhydrogel® and GLA-SE. One dosage of 50 µg/3 injections of AMA1-DiCo will be evaluated for each adjuvant.
Sixty six (66) healthy volunteers will be included into the 2 following cohorts (A and B):
Cohort A: 30 Non-exposed European Volunteers (France) Cohort B: 36 Malaria Exposed African Volunteers (Burkina Faso)
The non-exposed European volunteers (cohort A) will be randomised in a 1:1 ratio into two groups of 15 volunteers per group.
The malaria exposed African volunteers (cohort B) will be randomised in a 1:1 ratio, into two groups of 18 volunteers per group.
European Volunteers: Cohort A (30):
Group A1 (15): 50µg AMA1-DiCo + Alhydrogel® Group A2 (15): 50 µg AMA1-DiCo+ GLA-SE
African Volunteers Cohort B (36) :
Group B1 (18): 50 µg AMA1-DiCo + GLA-SE Group B2 (18): Placebo (isotonic saline solution)
In order to start recruitment in cohort B (Africa), the safety will be evaluated on the data of all European volunteers until Day 7 after 1st immunisation of the last European volunteer Data will be presented to an Independent Data safety Monitoring Board (DSMB) that will be appointed for this trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AMA1-DiCo + Alhydrogel | Experimental | Biological: Group A1 : 50µg AMA1-DiCo + AlhydrogelAMA1-DiCo: 50µg Alhydrogel® : 0.85 mg Al3+ per dose Route : Intramuscular Vaccination schedule : Do, W4, W26 |
| AMA1-DiCo+ GLA-SE | Experimental | Biological: Group A2 : 50 µg AMA1-DiCo+ GLA-SEGroup A2 (15) : European volunteer : AMA1-DiCo + GLA-SE AMA1-DiCo: 50µg GLA-SE 2.5 µg GLA per dose Route : Intramuscular Vaccination schedule : Do, W4, W26 |
| AMA1-DiCo + GLA-SE | Experimental | Biological: Group A2 : 50 µg AMA1-DiCo+ GLA-SEGroup B1 (18) : African volunteer : AMA1-DiCo + GLA-SE AMA1-DiCo: 50µg GLA-SE 2.5 µg GLA per dose Route : Intramuscular Vaccination schedule : Do, W4, W26 |
| Placebo | Placebo comparator | Biological: Group B2 : PlaceboGroup B2 (18) : African volunteer : Placebo Placebo : isotonic saline solution Route : Intramuscular Vaccination schedule : Do, W4, W26 |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age > 20 and < 45 years healthy female and male
- General good health based on history and clinical examination.
- Written informed consent obtained before any trial procedure.
- Female and male volunteers practicing contraception before and up to four (4) weeks after the third vaccination.
- Available to participate in follow-up for the duration of trial.
Key exclusion criteria (18 listed)
- Positive pregnancy test
- Active breast feeding
- Previous participation in any malaria vaccine trial
- History of blood transfusion within the last 6 months
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group A1 : 50µg AMA1-DiCo + Alhydrogel | Biological | AMA1-DiCo + Alhydrogel |
| Group A2 : 50 µg AMA1-DiCo+ GLA-SE | Biological | AMA1-DiCo + GLA-SE, AMA1-DiCo+ GLA-SE |
| Group B2 : Placebo | Biological | Placebo |
Primary outcome
Number of Adverse events
Time frame: Up to four weeks after the third vaccination.
The safety profile will be assessed in all volunteers on the following criteria: * Immediate reactogenicity (reactions within 60 minutes after each vaccination). * Local and systemic reactogenicity measured from Day 0 to Week 2 after each vaccination. * Any unsolicited adverse event between the first vaccination and four weeks after the third vaccination. * Any SAE occurring from the inclusion throughout the trial.
1 secondary outcome
The humoral and cellular responses
Time frame: 6 months after the last vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Results publication: PubMed 28947345Sirima SB, Durier C, Kara L, Houard S, Gansane A, Loulergue P, Bahuaud M, Benhamouda N, Nebie I, Faber B, Remarque E, Launay O; AMA1-DiCo Study Group. Safety and immunogenicity of a recombinant Plasmodium falciparum AMA1-DiCo malaria vaccine adjuvanted with GLA-SE or Alhydrogel(R) in European and African adults: A phase 1a/1b, randomized, double-blind multi-centre trial. Vaccine. 2017 Oct 27;35(45):6218-6227. doi: 10.1016/j.vaccine.2017.09.027. Epub 2017 Sep 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Odile Launay, Professor principal investigator
CIC BT505 Cochin Pasteur Groupe Hospitalier Cochin Broca Hotel Dieu. Bâtiment Lavoisier 27, rue du Faubourg Saint-Jacques 75679 PARIS Cedex 14, France odile.launay@cch.aphp.fr
Sodiomon Sirima, Doctor principal investigator
Centre National de Recherche et de Formation sur le Paludisme (CNRFP 01 BP 2208 Ouagadougou 01 1487, Avenue KumdaYonré, Burkina Faso s.sirima.cnlp@fasonet.bf
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Group A1 : 50µg AMA1-DiCo + Alhydrogel and Group A2 : 50 µg AMA1-DiCo+ GLA-SE in people with Malaria, Falciparum, run by Institut National de la Santé Et de la Recherche Médicale, France at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Burkina Faso, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse events (time frame: Up to four weeks after the third vaccination.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02014727, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.