Short report: elevated levels of alanine aminotransferase and hepatitis A in the context of a pediatric malaria vaccine trial in a village in Mali.

A Phase 1 study of the apical membrane antigen malaria vaccine AMA1-C1/Alhydrogel was conducted in 2-3-year-old children in a village in Mali. A high frequency of elevated levels of alanine aminotransferase (ALT) caused by hepatitis A was seen, with 8 of 36 children diagnosed by specific IgM antibody over the course of the study. Hepatitis A is a common cause of asymptomatic elevations of ALT levels in children, particularly in less-developed settings.

Phase 1 study of a combination AMA1 blood stage malaria vaccine in Malian children.

Background: Apical Membrane Antigen-1 (AMA1) is one of the leading blood stage malaria vaccine candidates. AMA1-C1/Alhydrogel consists of an equal mixture of recombinant AMA1 from FVO and 3D7 clones of P. falciparum, adsorbed onto Alhydrogel.

Year-to-year variation in the age-specific incidence of clinical malaria in two potential vaccine testing sites in Mali with different levels of malaria transmission intensity.

To explore the feasibility of field sites for malaria vaccine trials, we conducted a prospective study of clinical malaria incidence during two consecutive transmission seasons in children and young adults living in two areas of Mali with different entomologic inoculation rates (EIRs). Approximately 200 subjects (3 months to 2 years of age) were enrolled per site and followed weekly. Malaria smears were performed monthly in all participants and when symptoms or signs of malaria were present.

Impact of a Plasmodium falciparum AMA1 vaccine on antibody responses in adult Malians.

Background: Apical Membrane Antigen 1 (AMA1) of Plasmodium falciparum merozoites is a leading blood-stage malaria vaccine candidate. Protection of Aotus monkeys after vaccination with AMA1 correlates with antibody responses.

Study Design/results: A randomized, controlled, double-blind phase 1 clinical trial was conducted in 54 healthy Malian adults living in an area of intense seasonal malaria transmission to assess the safety and immunogenicity of the AMA1-C1 malaria vaccine.

The etiology of severe anemia in a village and a periurban area in Mali.

Severe anemia is one of the major complications of malaria in Africa. We studied 2 populations, one in a village and the second in a periurban area in Mali, to understand the preventable factors in the disease. The 2 correlates of disease were parasitemia above 100 000 parasitized red blood cells per microliter (0.

Malaria incidence in relation to rice cultivation in the irrigated Sahel of Mali.

Seven repeated cross-sectional parasitological surveys, collecting a total of 13,912 blood samples, were carried out from September 1995 to February 1998 in three irrigated rice growing villages and three villages without irrigated agriculture in the area surrounding Niono, Mali. Parasite prevalence varied according to season and agricultural zone, but showed similar patterns for villages within the same zone. Overall, malaria prevalence was 47% in the villages without irrigated agriculture and 34% in the irrigated rice growing villages.

A high malaria reinfection rate in children and young adults living under a low entomological inoculation rate in a periurban area of Bamako, Mali.

In areas of intense malaria parasite transmission, preliminary studies of the rate of reinfection after curative therapy suggest that small sample size studies of vaccine efficacy are feasible. However, the effect of transmission rate, which may vary considerably between transmission seasons, on reinfection rate has not been assessed in areas of mesoendemicity with seasonal transmission. To address this question, the Plasmodium falciparum reinfection rate after curative therapy was measured in Sotuba, a Malian village with historically low transmission rates, as estimated by the entomological inoculation rate (EIR).