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
AMA1-DiCo
2 other identifiers
interventional
66
2 countries
2
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2014
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 12, 2013
CompletedFirst Posted
Study publicly available on registry
December 18, 2013
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedDecember 4, 2025
September 1, 2015
1.2 years
December 12, 2013
November 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Up to four weeks after the third vaccination.
Secondary Outcomes (1)
The humoral and cellular responses
6 months after the last vaccination
Other Outcomes (1)
The quality of the cellular and humoral immune responses
Up to 6 months after the last vaccination
Study Arms (4)
AMA1-DiCo + Alhydrogel
EXPERIMENTALAMA1-DiCo: 50µg Alhydrogel® : 0.85 mg Al3+ per dose Route : Intramuscular Vaccination schedule : Do, W4, W26
AMA1-DiCo+ GLA-SE
EXPERIMENTALGroup 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
EXPERIMENTALGroup 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 COMPARATORGroup B2 (18) : African volunteer : Placebo Placebo : isotonic saline solution Route : Intramuscular Vaccination schedule : Do, W4, W26
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
CNRFP
Ouagadougou, Ouagadougou, Burkina Faso
CIC BT 505 de vaccinologie Cochin Pasteur. Hôpital Cochin Bâtiment Lavoisier 27 rue du faubourg St Jacques.
Paris, 75014, France
Related Publications (1)
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.
PMID: 28947345RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Odile Launay, Professor
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
- PRINCIPAL INVESTIGATOR
Sodiomon Sirima, Doctor
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
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2013
First Posted
December 18, 2013
Study Start
January 1, 2014
Primary Completion
March 1, 2015
Study Completion
July 1, 2015
Last Updated
December 4, 2025
Record last verified: 2015-09