NCT00343005

Experimental Vaccine for Malaria in Adults in Mali

Completed Phase 1 Last updated 2 July 2017

What this trial tests

Phase 1 trial testing AMA1-C1 in Plasmodium Falciparum Malaria in 54 participants. Completed in 22 January 2008.

Timeline

23 April 2004

22 January 2008

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Primary purpose	treatment
Enrollment	54
Start date	23 April 2004
Estimated completion	22 January 2008
Sites	1 location across Mali

Drugs / interventions tested

• AMA1-C1 — full drug profile →
• AMA1-C1/alhydrogel Malaria Vaccine — full drug profile →

Conditions studied

• Plasmodium Falciparum Malaria — all drugs for Plasmodium Falciparum Malaria →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 45, any sex, with Plasmodium Falciparum Malaria. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will determine the highest dose of an experimental vaccine called AMA1-C1 that can safely be given to adults exposed to malaria. Malaria affects about 300 million to 500 million people worldwide each year, causing from 2 million to 3 million deaths, mostly among children under 5 years of age in sub-Saharan Africa. It is the leading cause of death and illness among the general population of Mali in West Africa. Increasing drug resistance to the malaria parasite, as well as widespread resistance of mosquitoes (the insects that transmit the parasite) to pesticides are reducing the ability to control malaria through these strategies. A vaccine that could reduce illness and death from malaria would be a valuable new resource in the fight against this disease. AMA1-C1 is an experimental vaccine developed by the NIAID. Early tests of AMA1-C1 in 30 healthy people in the United States found no serious harmful side effects of the vaccine. This study will look at the effect of AMA1-C1 in people in Mali who have been exposed to malaria.

Residents of Don gu bougou, Mali, who are between 18 and 45 years of age and are in general good health may be eligible for this study. Candidates are screened with a medical history and physical examination, blood and urine tests, and urine pregnancy test for women.

Participants are randomly assigned to receive three injections (shots) of either the experimental malaria vaccine or a hepatitis B vaccine that is approved and used in Mali. All shots are given in an upper arm muscle. After the first shot, the second is given 1 month later, and the third is given 12 months after the first. Subjects receiving AMA1-C1 will get one of three different doses - low, medium, or high - to find the dose that is safest and gives the best antibody response to the vaccine. After each shot, participants remain in the clinic for 30 minutes for observation. They return to the clinic 1, 2, 3, 7, and 14 days after each shot for a physical examination and to check for side effects. Blood samples are drawn before each shot and at selected return clinic visits to check for side effects and to measure the effect of the vaccine.

During the rainy seasons after the second and third vaccinations, subjects come to the clinic once a month for an examination and a blood test. During the dry season, subjects come to the clinic 3 months before the last shot is given for an examination and blood test. Additional blood tests may be done on participants who develop malaria.

If found to be safe in adults, further studies with this vaccine will be done in children exposed to malaria, as it is children who bear the brunt of this disease.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Impact of a Plasmodium falciparum AMA1 vaccine on antibody responses in adult Malians.
   Dicko A, Diemert DJ, Sagara I, Sogoba M, et al · · 2007 · cited 49× · PMID 17940609 · DOI 10.1371/journal.pone.0001045
2. Immunological responses against Plasmodium falciparum Apical Membrane Antigen 1 vaccines vary depending on the population immunized.
   Miura K, Zhou H, Diouf A, Tullo G, et al · · 2011 · cited 11× · PMID 21277408 · DOI 10.1016/j.vaccine.2011.01.043