Evidence map›Paper›PMID 23056238›Full record

ArticlePloS one2012

Phase 1 study in malaria naïve adults of BSAM2/Alhydrogel®+CPG 7909, a blood stage vaccine against P. falciparum malaria.

Ruth D Ellis, Yimin Wu, Laura B Martin, Donna Shaffer, Kazutoyo Miura, Joan Aebig, Andrew Orcutt, Kelly Rausch, Daming Zhu, Anders Mogensen and 5 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase I
In one paragraph

Article in PloS one, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00889616 (Phase 1 Study of the Safety and Immunogenicity of BSAM-2/Alhydrogel +CPG 7909, an Asexual Blood Stage Vaccine for Plasmodium Falciparum Malaria in Adults in the US and in Bancoumana, Mali), which is not on this map. Cited by 39 papers.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed
5.7field-weighted citation impact, top 4% of its field
1 · What the graph read from it

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.

2 · The registry

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.

NCT00889616 phase1completednot on this map

Phase 1 Study of the Safety and Immunogenicity of BSAM-2/Alhydrogel +CPG 7909, an Asexual Blood Stage Vaccine for Plasmodium Falciparum Malaria in Adults in the US and in Bancoumana, Mali

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2009 to 2012Enrolled154ConditionsMalariaArmsBSAM2/Alhydrogel + CPG 7909
3 · Its place in the literature

Who cites it

39 citing papers in PubMed, 55 citations in OpenAlex.

  1. Trial
  2. Review
  3. Review
  4. Review
  5. Vaccine adjuvants: mechanisms and platforms.Signal transduction and targeted therapy · 2023
    Review
  6. Review
  7. Review
  8. Article
  9. Review
  10. Article
  11. Review
  12. Exploration of Pattern Recognition Receptor Agonists as Candidate Adjuvants.Frontiers in cellular and infection microbiology · 2021
    Review
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. A malaria vaccine protectsNPJ vaccines · 2017
    Article
  19. Article
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 4 institutions in 1 country.

Ruth D EllisLaboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIAID/NIH), Rockville, Maryland, United States of America.
Yimin Wu
Laura B Martin
Donna Shaffer
Kazutoyo Miura
Joan Aebig
Andrew Orcutt
Kelly Rausch
Daming Zhu
Anders Mogensen
Michael P Fay
David L Narum
Carole Long
Louis Miller
Anna P Durbin
National Institute of Allergy and Infectious Diseases · USNational Institutes of Health · USJohns Hopkins University · USVector Oncology (United States) · US

Funding

Malaria Parasite Receptors And Host Cell LigandsZIAAI000241 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI MILLER, LOUIS · 2009 to 2025
$15.3M
Host Immune Responses to Antigens of Malaria ParasitesZIAAI001020 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI LONG, CAROLE · 2009 to 2025
$13.6M
Intramural NIH HHS
6 · The paper itself

Abstract

unlabelledA Phase 1 dose escalating study was conducted in malaria naïve adults to assess the safety, reactogenicity, and immunogenicity of the blood stage malaria vaccine BSAM2/Alhydrogel®+ CPG 7909. BSAM2 is a combination of the FVO and 3D7 alleles of recombinant AMA1 and MSP1(42), with equal amounts by weight of each of the four proteins mixed, bound to Alhydrogel®, and administered with the adjuvant CPG 7909. Thirty (30) volunteers were enrolled in two dose groups, with 15 volunteers receiving up to three doses of 40 µg total protein at Days 0, 56, and 180, and 15 volunteers receiving up to three doses of 160 µg protein on the same schedule. Most related adverse events were mild or moderate, but 4 volunteers experienced severe systemic reactions and two were withdrawn from vaccinations due to adverse events. Geometric mean antibody levels after two vaccinations with the high dose formulation were 136 µg/ml for AMA1 and 78 µg/ml for MSP1(42). Antibody responses were not significantly different in the high dose versus low dose groups and did not further increase after third vaccination. In vitro growth inhibition was demonstrated and was closely correlated with anti-AMA1 antibody responses. A Phase 1b trial in malaria-exposed adults is being conducted.

trial registrationClinicaltrials.gov NCT00889616.

Indexed as

AdolescentAdultAluminum HydroxideAntibodies, ProtozoanAntigens, ProtozoanDose-Response Relationship, DrugDrug Administration ScheduleErythrocytesFemaleFollow-Up StudiesHeadacheHumansMalaria, FalciparumMalaria VaccinesMaleMembrane ProteinsAluminum HydroxideAntibodies, ProtozoanAntigens, Protozoanapical membrane antigen I, PlasmodiumMalaria VaccinesMembrane ProteinsMerozoite Surface Protein 1OligodeoxyribonucleotidesProMuneProtozoan ProteinsRecombinant Fusion Proteins

Identifiers

PMID23056238
PMCPMC3464250
OpenAlexW2042565293

What OpenQuestion holds

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LicenceCC0
Read underepoch 390

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.