Malaria Vaccine for Children in Mali

NCT00740090 | Completed Phase 1

• 2 other identifiers: 99990819408-I-N194
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the safety and immune response of children to an experimental malaria vaccine called AMA1-C1/Alhydrogel® (Registered Trademark) + CPG 7909. Malaria is an infection of red blood cells caused by a parasite, Plasmodium falciparum, that is spread by certain kinds of mosquitoes. It affects at least 300 million people worldwide each year, with more than 1 million deaths, mostly among children less than 5 years of age in sub-Saharan Africa. Malaria is the leading cause of death and illness among the general population of Mali in West Africa. Increasing drug resistance to P. falciparum and widespread resistance of mosquitoes to pesticides are reducing the ability to control the disease through these strategies. AMA1 C1 is made from a synthetic protein similar to a P. falciparum protein. It is combined with Alhydrogel and CPG 7909, substances added to vaccines to make them work better. Children between 1 and 4 years of age who live in Bancoumana, Mali, and are in general good health may be eligible for this study. Candidates are screened with a medical history, physical examination, and blood and urine tests. Participants are randomly assigned to receive three injections (shots) of either AMA1-C1 or a control rabies inactivated vaccine called Imovax® (Registered Trademark). The shots are given in the thigh muscle on study days 0, 56 and 180. After each shot, participants are observed in the clinic for 30 minutes. They return to the clinic for a physical examination six or seven times between each shot and then four more times over a 9-month period after the last shot. Blood samples are drawn at several of these visits to check for side effects of the vaccine and to measure the response to it. The total duration of the study is 21 months. ...

Conditions

Malaria; Malaria Infection

Keywords

Malaria; Reactogenicity, Safety, Immunogenicity; Maleria Endemic; Plasmodium Falciparum; Dose Escalating

Outcome Measures

Primary Outcomes (1)

• The incidence and severity of systemic and local adverse events.

Secondary Outcomes (1)

• Antibody response determined by ELISA, to the AMA1-FVO and AMA1-3D7 proteins at selected time points. Inhibition of P. falciparum FVO and 3D7 parasite growth in vitro determined at selected time points.

Interventions

AMA1-C1/Alhydrogel plus CPG 7909 DRUG

Eligibility Criteria

• Age: 1 Year - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Males or females aged greater than or equal to 1 to less than 4 years
• Known residents of the village of Bancoumana, Mali or its surrounding area
• Good general health as determined by means of the screening procedure
• Available for the duration of the trial (24 months from enrollment)
• Willingness to have child participate in the study as evidenced by parents/legal guardians signing or fingerprinting the informed consent document

You may not qualify if:

• Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, chronic infectious or renal disease by history, physical examination, and/or laboratory studies including urinalysis.
• Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the volunteer or the parent/legal guardian to understand and cooperate with the study protocol.
• Pre-existing known autoimmune diseases including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, or autoimmune thrombocytopenia.
• Laboratory evidence of possible autoimmune disease determined by anti-dsDNA titer that equals or exceeds 25 IU.
• Laboratory evidence of liver disease (alanine aminotransferase \[ALT\] greater than the upper limit of normal of the testing laboratory).
• Laboratory evidence of renal disease (serum creatinine greater than the upper limit of normal of the testing laboratory, or more than trace protein or blood on urine dipstick testing confirmed by repeat testing).
• Laboratory evidence of hematologic disease (absolute leukocyte count less than 3000/mm(3) or greater than 14,500/mm(3), absolute lymphocyte count less than 1000/mm(3), platelet count less than 120,000/mm(3), or hemoglobin less than 8.5 g/dL).
• Other condition that, in the opinion of the investigator, would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol.
• Participation in another investigational vaccine or drug trial within 30 days of starting this study, or while this study is ongoing.
• History of a severe allergic reaction or anaphylaxis.
• History of allergy to nickel.
• Severe asthma. This will be defined as:
• Asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past two years or that requires the use of oral or parenteral corticosteroids.
• Clinically significant reactive airway disease that does not respond to bronchodilators.
• Positive screening test for anti-Hepatitis C virus (anti-HCV).

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Malaria Research and Training Center

Bamako, Mali

Location

Related Publications (3)

• Sachs J, Malaney P. The economic and social burden of malaria. Nature. 2002 Feb 7;415(6872):680-5. doi: 10.1038/415680a.

  PMID: 11832956 BACKGROUND

• Richie TL, Saul A. Progress and challenges for malaria vaccines. Nature. 2002 Feb 7;415(6872):694-701. doi: 10.1038/415694a.

  PMID: 11832958 BACKGROUND

• Triglia T, Healer J, Caruana SR, Hodder AN, Anders RF, Crabb BS, Cowman AF. Apical membrane antigen 1 plays a central role in erythrocyte invasion by Plasmodium species. Mol Microbiol. 2000 Nov;38(4):706-18. doi: 10.1046/j.1365-2958.2000.02175.x.

  PMID: 11115107 BACKGROUND

MeSH Terms

Conditions

Malaria; Malaria, Falciparum

Interventions

ProMune

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 21, 2008
• First Posted: August 22, 2008
• Study Start: August 11, 2008
• Primary Completion: June 9, 2009
• Last Updated: July 2, 2017

Record last verified: 2009-06-09

Locations

MA (1)