Evidence map›Paper›PMID 35338131›Full record

Trial reportNature communications2022

Randomized clinical trial to assess the protective efficacy of a Plasmodium vivax CS synthetic vaccine.

Myriam Arévalo-Herrera, Xiomara Gaitán, Michelle Larmat-Delgado, María Alejandra Caicedo, Sonia M Herrera, Juliana Henao-Giraldo, Angélica Castellanos, Jean-Christophe Devaud, André Pannatier, José Oñate and 2 more

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

Trial report in Nature communications, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02083068 (Evaluation of the Protective Efficacy of a Vaccine Derived From the Synthetic CS Protein of Plasmodium Vivax), which is not on this map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
7.0field-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.

NCT02083068 phase2completednot on this map

Evaluation of the Protective Efficacy of a Vaccine Derived From the Synthetic CS Protein of Plasmodium Vivax

TypeinterventionalSponsorMalaria Vaccine and Drug Development CenterRan2014 to 2017Enrolled32ConditionsMalariaArmsVaccine PvCS N+C+R, Vaccine PvCS N+C, SSN Montanide ISA-51
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 1 synthesis or guideline pooled it, 30 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. mRNA-LNP vaccine encoding theMolecular therapy. Nucleic acids · 2025
    Article
  5. Article
  6. Article
  7. Review
  8. Review
  9. Article
  10. Cross-reactivity of rbioRxiv : the preprint server for biology · 2024
    Article
  11. Article
  12. Vaccination withScience translational medicine · 2023
    Article
  13. Article
  14. Review
  15. Impact of a blood-stage vaccine onmedRxiv : the preprint server for health sciences · 2022
    Article
  16. Frontiers in immunology · 2022
    Review
  17. The challenges ofFrontiers in immunology · 2022
    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

12 authors at 3 institutions in 2 countries.

Myriam Arévalo-HerreraMalaria Vaccine and Drug Development Center (MVDC), Cali, Colombia.
Xiomara GaitánMalaria Vaccine and Drug Development Center (MVDC), Cali, Colombia.
Michelle Larmat-DelgadoMalaria Vaccine and Drug Development Center (MVDC), Cali, Colombia.
María Alejandra CaicedoMalaria Vaccine and Drug Development Center (MVDC), Cali, Colombia.
Sonia M HerreraCaucaseco Scientific Research Center, Cali, Colombia.
Juliana Henao-GiraldoMalaria Vaccine and Drug Development Center (MVDC), Cali, Colombia.
Angélica CastellanosMalaria Vaccine and Drug Development Center (MVDC), Cali, Colombia.
Jean-Christophe DevaudCentre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.
André PannatierCentre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.
José OñateCentro Médico Imbanaco, Cali, Colombia.
Giampietro CorradinBiochemistry Department, University of Lausanne, Epalinges, Switzerland.
Sócrates HerreraMalaria Vaccine and Drug Development Center (MVDC), Cali, Colombia. sherrera@inmuno.org.ORCID http://orcid.org/0000-0001-6354-0184
Caucaseco Scientific Research Center · COUniversity Hospital of Lausanne · CHUniversity of Lausanne · CH

Funding

Development of a P. vivax immunization and sporozoite challenge model for humanR01HL086488 · NHLBI · MALARIA VACCINE DEVELOPMENT CENTER · PI HERRERA, SOCRATES · 2008 to 2011
$1.2M
NHLBI NIH HHS R01 HL086488
6 · The paper itself

Abstract

A randomized, double-blind, controlled vaccine clinical trial was conducted to assess, as the primary outcome, the safety and protective efficacy of the Plasmodium vivax circumsporozoite (CS) protein in healthy malaria-naïve (phase IIa) and semi-immune (phase IIb) volunteers. Participants (n = 35) were randomly selected from a larger group (n = 121) and further divided into naïve (n = 17) and semi-immune (n = 18) groups and were immunized at months 0, 2, and 6 with PvCS formulated in Montanide ISA-51 adjuvant or placebo (adjuvant alone). Specific antibodies and IFN-γ responses to PvCS were determined as secondary outcome; all experimental volunteers developed specific IgG and IFN-γ. Three months after the last immunization, all participants were subjected to controlled human malaria infection. All naive controls became infected and drastic parasitemia reduction, including sterile protection, developed in several experimental volunteers in phase IIa (6/11) (54%, 95% CI 0.25-0.84) and phase IIb (7/11) (64%, 95% CI 0.35-0.92). However, no difference in parasitemia was observed between the phase IIb experimental and control subgroups. In conclusion, this study demonstrates significant protection in both naïve and semi-immune volunteers, encouraging further PvCS vaccine clinical development. Trial registration number NCT02083068. This trial was funded by Colciencias (grant 529-2009), NHLBI (grant RHL086488 A), and MVDC/CIV Foundation (grant 2014-1206).

Indexed as

MalariaMalaria VaccinesAntibodies, ProtozoanHumansMineral OilParasitemiaPlasmodium vivaxProtozoan ProteinsVaccines, SyntheticAntibodies, ProtozoanMalaria VaccinesMineral OilMonatide (IMS 3015)Protozoan ProteinsVaccines, Synthetic

Identifiers

PMID35338131
PMCPMC8956637
OpenAlexW4221079888

What Socratic 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 Socratic graph.