Evidence map›Paper›PMID 28464026›Full record

ArticlePLoS neglected tropical diseases2017

Safety and immunogenicity of the Na-GST-1 hookworm vaccine in Brazilian and American adults.

David J Diemert, Janaína Freire, Vanderson Valente, Carlo Geraldo Fraga, Frederico Talles, Shannon Grahek, Doreen Campbell, Amar Jariwala, Maria Victoria Periago, Martin Enk and 10 more

Erratum issued 2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase I
In one paragraph

Article in PLoS neglected tropical diseases, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 41 papers.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed
6.8field-weighted citation impact, top 2% 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.

NCT01261130 phase1completednot on this map

Phase 1 Study of the Safety and Immunogenicity of Na-GST-1/Alhydrogel® With or Without GLA-AF in Brazilian Adults

TypeinterventionalSponsorBaylor College of MedicineRan2011 to 2014Enrolled102ConditionsHookworm Infection, Hookworm DiseaseArms10 μg Na-GST-1/Alhydrogel, 30 μg Na-GST-1/Alhydrogel, 100 μg Na-GST-1/Alhydrogel, 10 μg Na-GST-1/ Alhydrogel/GLA-AF, 30 μg Na-GST-1/Alhydrogel/GLA-AF
NCT01385189 phase1completednot on this map

Phase I Study of the Safety and Immunogenicity of Na-GST-1/Alhydrogel® With Different Doses of the Novel Immunostimulant GLA-AF in Healthy Adults

TypeinterventionalSponsorBaylor College of MedicineRan2012 to 2015Enrolled40ConditionsHookworm Infection, Hookworm DiseaseArms10 μg Na-GST-1/Alhydrogel, 30 μg Na-GST-1/Alhydrogel, 100 μg Na-GST-1/Alhydrogel, 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg), 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)
3 · Its place in the literature

Who cites it

41 citing papers in PubMed, 79 citations in OpenAlex.

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  20. The yin and yang of human soil-transmitted helminth infections.International journal for parasitology · 2021
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors at 6 institutions in 2 countries.

David J DiemertDepartment of Microbiology, Immunology and Tropical Medicine, School of Medicine and Health Sciences, The George Washington University, Washington DC, United States of America.
Janaína FreireCentro de Pesquisas René Rachou, Fundação Oswaldo Cruz, Belo Horizonte, Minas Gerais, Brazil.
Vanderson ValenteCentro de Pesquisas René Rachou, Fundação Oswaldo Cruz, Belo Horizonte, Minas Gerais, Brazil.
Carlo Geraldo FragaCentro de Pesquisas René Rachou, Fundação Oswaldo Cruz, Belo Horizonte, Minas Gerais, Brazil.
Frederico TallesCentro de Pesquisas René Rachou, Fundação Oswaldo Cruz, Belo Horizonte, Minas Gerais, Brazil.
Shannon GrahekDepartment of Microbiology, Immunology and Tropical Medicine, School of Medicine and Health Sciences, The George Washington University, Washington DC, United States of America.
Doreen CampbellDepartment of Microbiology, Immunology and Tropical Medicine, School of Medicine and Health Sciences, The George Washington University, Washington DC, United States of America.
Amar JariwalaDepartment of Microbiology, Immunology and Tropical Medicine, School of Medicine and Health Sciences, The George Washington University, Washington DC, United States of America.
Maria Victoria PeriagoCentro de Pesquisas René Rachou, Fundação Oswaldo Cruz, Belo Horizonte, Minas Gerais, Brazil.
Martin EnkCentro de Pesquisas René Rachou, Fundação Oswaldo Cruz, Belo Horizonte, Minas Gerais, Brazil.
Maria Flávia GazzinelliSchool of Nursing, Federal University of Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.
Maria Elena BottazziDepartment of Pediatrics, Section of Pediatric Tropical Medicine, Sabin Vaccine Institute and Texas Children's Hospital Center for Vaccine Development, National School of Tropical Medicine, Baylor College of Medicine, Houston, TX, United States of America.
Robert HamiltonJohns Hopkins University School of Medicine, Baltimore, MD, United States of America.
Jill BrelsfordDepartment of Microbiology, Immunology and Tropical Medicine, School of Medicine and Health Sciences, The George Washington University, Washington DC, United States of America.
Anna YakovlevaDepartment of Microbiology, Immunology and Tropical Medicine, School of Medicine and Health Sciences, The George Washington University, Washington DC, United States of America.
Guangzhao LiDepartment of Microbiology, Immunology and Tropical Medicine, School of Medicine and Health Sciences, The George Washington University, Washington DC, United States of America.
Jin PengDepartment of Microbiology, Immunology and Tropical Medicine, School of Medicine and Health Sciences, The George Washington University, Washington DC, United States of America.
Rodrigo Correa-OliveiraCentro de Pesquisas René Rachou, Fundação Oswaldo Cruz, Belo Horizonte, Minas Gerais, Brazil.
Peter HotezDepartment of Pediatrics, Section of Pediatric Tropical Medicine, Sabin Vaccine Institute and Texas Children's Hospital Center for Vaccine Development, National School of Tropical Medicine, Baylor College of Medicine, Houston, TX, United States of America.
Jeffrey BethonyDepartment of Microbiology, Immunology and Tropical Medicine, School of Medicine and Health Sciences, The George Washington University, Washington DC, United States of America.
George Washington University · USFundação Oswaldo Cruz · BRJohns Hopkins University · USSabin Vaccine Institute · USTexas Children's Hospital · USUniversidade Federal de Minas Gerais · BR

Funding

CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR031988 · NCRR · CHILDREN'S RESEARCH INSTITUTE · PI JOSEPH, JILL G · 2010 to 2011
$8.2M
NCRR NIH HHS UL1 RR031988
6 · The paper itself

Abstract

Necator americanus Glutathione-S-Transferase-1 (Na-GST-1) plays a role in the digestion of host hemoglobin by adult N. americanus hookworms. Vaccination of laboratory animals with recombinant Na-GST-1 is associated with significant protection from challenge infection. Recombinant Na-GST-1 was expressed in Pichia pastoris and adsorbed to aluminum hydroxide adjuvant (Alhydrogel) according to current Good Manufacturing Practice. Two Phase 1 trials were conducted in 142 healthy adult volunteers in the United States and Brazil, first in hookworm-naïve individuals and then in residents of a N. americanus endemic area in Brazil. Volunteers received one of three doses of recombinant Na-GST-1 (10, 30, or 100 μg) adjuvanted with Alhydrogel, adjuvanted with Alhydrogel and co-administered with an aqueous formulation of Glucopyranosyl Lipid A (GLA-AF), or the hepatitis B vaccine. Vaccinations were administered via intramuscular injection on days 0, 56, and 112. Na-GST-1/Alhydrogel was well tolerated in both hookworm-naïve and hookworm-exposed adults, with the most common adverse events being mild to moderate injection site pain and tenderness, and mild headache and nausea; no vaccine-related severe or serious adverse events were observed. Antigen-specific IgG antibodies were induced in a dose-dependent fashion, with increasing levels observed after each vaccination in both trials. The addition of GLA-AF to Na-GST-1/Alhydrogel did not result in significant increases in specific IgG responses. In both the US and Brazil studies, the predominant IgG subclass induced against Na-GST-1 was IgG1, with lesser amounts of IgG3. Vaccination of both hookworm-naïve and hookworm-exposed adults with recombinant Na-GST-1 was safe, well tolerated, and resulted in significant antigen-specific IgG responses. Based on these results, this vaccine will be advanced into clinical trials in children and eventual efficacy studies.

trial registrationClinicalTrials.gov (NCT01261130 for the Brazil trial and NCT01385189 for the US trial).

Indexed as

Adjuvants, ImmunologicAdolescentAdultAluminum HydroxideAncylostomatoideaAnimalsAntibodies, HelminthAntigens, HelminthBrazilDrug-Related Side Effects and Adverse ReactionsFemaleGlucosidesGlutathione TransferaseHealthy VolunteersHepatitis B VaccinesHookworm InfectionsAdjuvants, ImmunologicAluminum HydroxideAntibodies, HelminthAntigens, Helminthglucopyranosyl lipid-AGlucosidesGlutathione TransferaseHepatitis B VaccinesImmunoglobulin GLipid AVaccines, Synthetic

Identifiers

PMID28464026
PMCPMC5441635
OpenAlexW2610353085

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.