Trial reportPloS one2007
Impact of a Plasmodium falciparum AMA1 vaccine on antibody responses in adult Malians.
Trial report in PloS one, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00343005 (Double-Blind, Randomized, Controlled, Phase 1 Study of the Safety and Immunogenicity of AMA1-C1/Alhydrogel Vaccine for Plasmodium Falciparum Malaria, in Semi-Immune Adults in Doneguebougou, Mali), which is not on this map. Cited by 40 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.
Double-Blind, Randomized, Controlled, Phase 1 Study of the Safety and Immunogenicity of AMA1-C1/Alhydrogel Vaccine for Plasmodium Falciparum Malaria, in Semi-Immune Adults in Doneguebougou, Mali
Who cites it
40 citing papers in PubMed, 62 citations in OpenAlex.
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- Memory B-cell and antibody responses induced by Plasmodium falciparum sporozoite immunization.The Journal of infectious diseases · 2014Trial
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- Safety and immunogenicity of a recombinant nonglycosylated erythrocyte binding antigen 175 Region II malaria vaccine in healthy adults living in an area where malaria is not endemic.Clinical and vaccine immunology : CVI · 2010Trial
- Lack of allele-specific efficacy of a bivalent AMA1 malaria vaccine.Malaria journal · 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
- Comparison of biological activity of human anti-apical membrane antigen-1 antibodies induced by natural infection and vaccination.Journal of immunology (Baltimore, Md. : 1950) · 2008Trial
- Phase 1 trial of AMA1-C1/Alhydrogel plus CPG 7909: an asexual blood-stage vaccine for Plasmodium falciparum malaria.PloS one · 2008Trial
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- A broadly cross-reactive i-body to AMA1 potently inhibits blood and liver stages of Plasmodium parasites.Nature communications · 2024Article
- Defining species-specific and conserved interactions of apical membrane protein 1 during erythrocyte invasion in malaria to inform multi-species vaccines.Cellular and molecular life sciences : CMLS · 2023Article
- Structural and immunological characterization of an epitope within the PAN motif of ectodomain I inPeerJ · 2021Article
- Reverse immunodynamics: a new method for identifying targets of protective immunity.Scientific reports · 2019Article
- Targets of complement-fixing antibodies in protective immunity against malaria in children.Nature communications · 2019Article
- A novel approach to identifying patterns of human invasion-inhibitory antibodies guides the design of malaria vaccines incorporating polymorphic antigens.BMC medicine · 2016Article
- Progress and prospects for blood-stage malaria vaccines.Expert review of vaccines · 2016Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
21 authors at 3 institutions in 2 countries.
Funding
Abstract
backgroundApical 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/
resultsA 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. AMA1-C1 contains an equal mixture of yeast-expressed recombinant proteins based on sequences from the FVO and 3D7 clones of P. falciparum, adsorbed on Alhydrogel. The control vaccine was the hepatitis B vaccine (Recombivax). Participants were enrolled into 1 of 3 dose cohorts (n = 18 per cohort) and randomized 2:1 to receive either AMA1-C1 or Recombivax. Participants in the first, second, and third cohorts randomized to receive AMA1-C1 were vaccinated with 5, 20 and 80 microg of AMA1-C1, respectively. Vaccinations were administered on days 0, 28, and 360, and participants were followed until 6 months after the final vaccination. AMA1-C1 was well tolerated; no vaccine-related severe or serious adverse events were observed. AMA1 antibody responses to the 80 microg dose increased rapidly from baseline levels by days 14 and 28 after the first vaccination and continued to increase after the second vaccination. After a peak 14 days following the second vaccination, antibody levels decreased to baseline levels one year later at the time of the third vaccination that induced little or no increase in antibody levels.
conclusionsAlthough the AMA1-C1 vaccine candidate was well-tolerated and induced antibody responses to both vaccine and non-vaccine alleles, the antibody response after a third dose given at one year was lower than the response to the initial vaccinations. Additionally, post-vaccination increases in anti-AMA1 antibody levels were not associated with significant changes in in vitro growth inhibition of P. falciparum.
trial registrationClinicalTrials.gov NCT00343005.
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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.