Evidence map›Paper›PMID 31775762›Full record

ArticleMalaria journal2019

Comparison of immunogenicity and safety outcomes of a malaria vaccine FMP013/ALFQ in rhesus macaques (Macaca mulatta) of Indian and Chinese origin.

Monica L Martin, Alexis A Bitzer, Andrew Schrader, Elke S Bergmann-Leitner, Kim Soto, Xiaoyan Zou, Zoltan Beck, Gary R Matyas, Sheetij Dutta

Open access · goldAbstract readComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Malaria journal, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.8field-weighted citation impact, top 15% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 10 citations in OpenAlex.

  1. Article
  2. Article
  3. Restricted valency (NPNA)NPJ vaccines · 2022
    Article
  4. Liposomes as Adjuvants and Vaccine Delivery Systems.Biochemistry (Moscow) Supplement. Series A, Membrane and cell biology · 2022
    Article
  5. Article
  6. Optimization of aProceedings of the National Academy of Sciences of the United States of America · 2020
    Article
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

9 authors at 2 institutions in 1 country.

Monica L MartinDivision of Veterinary Medicine, Walter Reed Army Institute of Research, Silver Spring, MD, 20910, USA.
Alexis A BitzerStructural Biologics Laboratory, Malaria Biologics Branch, Walter Reed Army Institute of Research, Silver Spring, MD, 20910, USA.
Andrew SchraderDivision of Veterinary Medicine, Walter Reed Army Institute of Research, Silver Spring, MD, 20910, USA.
Elke S Bergmann-LeitnerImmunology Core, Malaria Biologics Branch, Walter Reed Army Institute of Research, Silver Spring, MD, 20910, USA.
Kim SotoStructural Biologics Laboratory, Malaria Biologics Branch, Walter Reed Army Institute of Research, Silver Spring, MD, 20910, USA.
Xiaoyan ZouMalaria Department, Naval Medical Research Center, Silver Spring, MD, 20910, USA.
Zoltan BeckMilitary HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, 20910, USA.
Gary R MatyasMilitary HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, 20910, USA.
Sheetij DuttaStructural Biologics Laboratory, Malaria Biologics Branch, Walter Reed Army Institute of Research, Silver Spring, MD, 20910, USA. sheetij.dutta.civ@mail.mil.
Walter Reed Army Institute of Research · USNaval Medical Research Command · US

Funding

United States Agency for International Development Inter-Agency Agreement
6 · The paper itself

Abstract

backgroundIndian-origin rhesus (InR) are preferred for research, but strict export restrictions continue to limit their use. Chinese-origin rhesus (ChR), although easier to procure, are genetically distinct from InR and differ in their immune response to infectious agents, such as the Simian Immunodeficiency Virus. The most advanced malaria vaccine, RTS,S (GlaxoSmithKline), is based on the circumsporozoite protein (CSP) of Plasmodium falciparum. The efficacy of RTS,S vaccine in the field remains low and short-lived; efforts are underway to improve CSP-based vaccines. Rhesus models can accelerate preclinical down-selection of the next generation of malaria vaccines. This study was used to determine if the safety and immunogenicity outcomes following vaccination with a CSP vaccine would differ in the InR and ChR models, given the genetic differences between the two sub-populations of rhesus.

methodsThe FMP013 vaccine, was composed of nearly full-length soluble P. falciparum CSP produced in Escherichia coli and was adjuvanted with the Army liposomal formulation (ALFQ). Three doses of the vaccine were administered in InR and ChR (n = 6) at 1-month intervals and the antibody and T cell responses were assessed.

resultsLocal and systemic toxicity profile of FMP013 vaccine in InR and ChR were similar and they revealed that the FMP013 vaccine was safe and caused only mild and transient inflammatory adverse reactions. Following the first 2 vaccines, there was a slower acquisition of antibodies to the CSP repeat region in ChR. However after the 3rd vaccination the titers in the two models were comparable. The ChR group repeat-specific antibodies had higher avidity and ChR group showed higher inhibition of liver stage development activity compared to InR. There was no difference in T-cell responses to the FMP013 vaccine between the two models.

conclusionsA difference in the quality of serological responses was detected between the two sub-populations of rhesus. However, both models confirmed that FMP013/ALFQ vaccine was safe, highly immunogenic, elicited functional antibodies and T-cell responses. Overall, the data suggests that rhesus of Indian and Chinese origins can be interchangeably used to compare the safety and immunogenicity of next-generation of malaria vaccines and adjuvants.

Indexed as

Immunogenicity, VaccineAnimalsChinaIndiaMacaca mulattaMalaria, FalciparumMalaria VaccinesProtozoan ProteinsSpecies Specificitycircumsporozoite protein, ProtozoanMalaria VaccinesProtozoan ProteinsALFQChinese originCircumsporozoite proteinCSPFMP013Indian originMacaqueMalariaRhesus

Identifiers

PMID31775762
PMCPMC6880475
OpenAlexW2991415971

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.