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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

NCT02014727 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2025-12-04

No results posted yet for this study

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.

Conditions

  • Malaria, Falciparum

Interventions

BIOLOGICAL

Group A1 : 50µg AMA1-DiCo + Alhydrogel

BIOLOGICAL

Group A2 : 50 µg AMA1-DiCo+ GLA-SE

BIOLOGICAL

Group B2 : Placebo

Sponsors & Collaborators

  • EVI Industries, Inc.

    collaborator OTHER

  • BPRC

    collaborator UNKNOWN

  • Recherche Clinique Paris Descartes Necker Cochin Sainte Anne

    collaborator OTHER

  • Centre national de recherche et de formation sur le paludisme

    collaborator OTHER_GOV

  • Institut National de la Santé Et de la Recherche Médicale, France

    lead OTHER_GOV

Principal Investigators

  • 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 [email protected]

  • Sodiomon Sirima, Doctor · Centre National de Recherche et de Formation sur le Paludisme (CNRFP 01 BP 2208 Ouagadougou 01 1487, Avenue KumdaYonré, Burkina Faso [email protected]

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-03-31
Completion
2015-07-31

Countries

  • Burkina Faso
  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02014727 on ClinicalTrials.gov