Trial reportPloS one2008
Phase 1 study of a combination AMA1 blood stage malaria vaccine in Malian children.
Trial report in PloS one, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00341250 (Randomized, Controlled, Phase 1/2 Study of the Safety and Immunogenicity of AMA1-C1/Alhydrogel Vaccine for Plasmodium Falciparum Malaria in Children in Doneguebougou and Bancoumana, Mali), which is not on this map. Cited by 34 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Randomized, Controlled, Phase 1/2 Study of the Safety and Immunogenicity of AMA1-C1/Alhydrogel Vaccine for Plasmodium Falciparum Malaria in Children in Doneguebougou and Bancoumana, Mali
Who cites it
34 citing papers in PubMed, 44 citations in OpenAlex.
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- Anaemia in a phase 2 study of a blood stage falciparum malaria vaccine.Malaria journal · 2011Trial
- Impact on malaria parasite multiplication rates in infected volunteers of the protein-in-adjuvant vaccine AMA1-C1/Alhydrogel+CPG 7909.PloS one · 2011Trial
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- Trial
- Lack of allele-specific efficacy of a bivalent AMA1 malaria vaccine.Malaria journal · 2010Trial
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- Safety and immunogenicity of an AMA1 malaria vaccine in Malian children: results of a phase 1 randomized controlled trial.PloS one · 2010Trial
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- A randomized controlled phase 2 trial of the blood stage AMA1-C1/Alhydrogel malaria vaccine in children in Mali.Vaccine · 2009Trial
- Short report: elevated levels of alanine aminotransferase and hepatitis A in the context of a pediatric malaria vaccine trial in a village in Mali.The American journal of tropical medicine and hygiene · 2008Trial
- Phase 1 trial of AMA1-C1/Alhydrogel plus CPG 7909: an asexual blood-stage vaccine for Plasmodium falciparum malaria.PloS one · 2008Trial
- Distribution of Plasmodium falciparum apical membrane antigen-1 cluster one loop haplotypes and their association with malaria symptoms in Bandiagara, Mali.BMC infectious diseases · 2026Article
- Profiling invasive Plasmodium falciparum merozoites using an integrated omics approach.Scientific reports · 2017Article
- Immunization with the Malaria Diversity-Covering Blood-Stage Vaccine CandidateFrontiers in immunology · 2017Article
- Merozoite surface proteins in red blood cell invasion, immunity and vaccines against malaria.FEMS microbiology reviews · 2016Review
- Limited antigenic diversity of Plasmodium falciparum apical membrane antigen 1 supports the development of effective multi-allele vaccines.BMC medicine · 2014Article
- Promoting good clinical laboratory practices and laboratory accreditation to support clinical trials in sub-Saharan Africa.The American journal of tropical medicine and hygiene · 2012Article
- The evolutionary consequences of blood-stage vaccination on the rodent malaria Plasmodium chabaudi.PLoS biology · 2012Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
18 authors at 3 institutions in 2 countries.
Funding
Abstract
backgroundApical 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. A Phase 1 study in semi-immune adults in Mali showed that the vaccine was safe and immunogenic, with higher antibody responses in those who received the 80 microg dose. The aim of this study was to assess the safety and immunogenicity of this vaccine in young children in a malaria endemic area.
designThis was a Phase 1 dose escalating study in 36 healthy children aged 2-3 years started in March 2006 in Donéguébougou, Mali. Eighteen children in the first cohort were randomized 2 ratio 1 to receive either 20 microg AMA1-C1/Alhydrogel or Haemophilus influenzae type b Hiberix vaccine. Two weeks later 18 children in the second cohort were randomized 2 ratio 1 to receive either 80 microg AMA1-C1/Alhydrogel or Haemophilus influenzae type b Hiberix vaccine. Vaccinations were administered on Days 0 and 28 and participants were examined on Days 1, 2, 3, 7, and 14 after vaccination and then about every two months. Results to Day 154 are reported in this manuscript.
resultsOf 36 volunteers enrolled, 33 received both vaccinations. There were 9 adverse events related to the vaccination in subjects who received AMA1-C1 vaccine and 7 in those who received Hiberix. All were mild to moderate. No vaccine-related serious or grade 3 adverse events were observed. There was no increase in adverse events with increasing dose of vaccine or number of immunizations. In subjects who received the test vaccine, antibodies to AMA1 increased on Day 14 and peaked at Day 42, with changes from baseline significantly different from subjects who received control vaccine.
conclusionAMA-C1 vaccine is well tolerated and immunogenic in children in this endemic area although the antibody response was short lived.
trial registrationClinicaltrials.gov NCT00341250.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.