Evidence map›Paper›PMID 26711509›Full record

Trial reportThe American journal of tropical medicine and hygiene2016

Safety, Immunogenicity, and Protective Efficacy of Intradermal Immunization with Aseptic, Purified, Cryopreserved Plasmodium falciparum Sporozoites in Volunteers Under Chloroquine Prophylaxis: A Randomized Controlled Trial.

Guido J H Bastiaens, Maurits P A van Meer, Anja Scholzen, Joshua M Obiero, Mansoureh Vatanshenassan, Tim van Grinsven, B Kim Lee Sim, Peter F Billingsley, Eric R James, Anusha Gunasekera and 9 more

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The American journal of tropical medicine and hygiene, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 43 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 1 pooled it
6.0field-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.

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

43 citing papers in PubMed, 1 synthesis or guideline pooled it, 67 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Safety and Differential Antibody and T-Cell Responses to theThe American journal of tropical medicine and hygiene · 2019
    Trial
  4. Trial
  5. Trial
  6. Trial
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Controlled Human Malaria Infection Studies in Africa-Past, Present, and Future.Current topics in microbiology and immunology · 2024
    Review
  13. Malaria Vaccines: Progress to Date.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2023
    Review
  14. Article
  15. Article
  16. Review
  17. Article
  18. Review
  19. Review
  20. 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

19 authors.

Guido J H Bastiaens
Maurits P A van Meer
Anja Scholzen
Joshua M Obiero
Mansoureh Vatanshenassan
Tim van Grinsven
B Kim Lee Sim
Peter F Billingsley
Eric R James
Anusha Gunasekera
Else M Bijker
Geert-Jan van Gemert
Marga van de Vegte-Bolmer
Wouter Graumans
Cornelus C Hermsen
Quirijn de Mast
André J A M van der Ven
Stephen L Hoffman
Robert W Sauerwein

Funding

Universal Attenuated Sporozoite Vaccine and Challenge SystemR44AI058375 · NIAID · SANARIA, INC. · PI HOFFMAN, STEPHEN LEV · 2006 to 2018
$9.9M
NIAID NIH HHS R44 AI058375NIAID NIH HHS R44AI058375
6 · The paper itself

Abstract

Immunization of volunteers under chloroquine prophylaxis by bites of Plasmodium falciparum sporozoite (PfSPZ)-infected mosquitoes induces > 90% protection against controlled human malaria infection (CHMI). We studied intradermal immunization with cryopreserved, infectious PfSPZ in volunteers taking chloroquine (PfSPZ chemoprophylaxis vaccine [CVac]). Vaccine groups 1 and 3 received 3× monthly immunizations with 7.5 × 10(4) PfSPZ. Control groups 2 and 4 received normal saline. Groups 1 and 2 underwent CHMI (#1) by mosquito bite 60 days after the third immunization. Groups 3 and 4 were boosted 168 days after the third immunization and underwent CHMI (#2) 137 days later. Vaccinees (11/20, 55%) and controls (6/10, 60%) had the same percentage of mild to moderate solicited adverse events. After CHMI #1, 8/10 vaccinees (group 1) and 5/5 controls (group 2) became parasitemic by microscopy; the two negatives were positive by quantitative real-time polymerase chain reaction (qPCR). After CHMI #2, all vaccinees in group 3 and controls in group 4 were parasitemic by qPCR. Vaccinees showed weak antibody and no detectable cellular immune responses. Intradermal immunization with up to 3 × 10(5) PfSPZ-CVac was safe, but induced only minimal immune responses and no sterile protection against Pf CHMI.

Indexed as

AdolescentAdultAnimalsAnophelesAntimalarialsChloroquineCryopreservationDouble-Blind MethodHumansImmunizationInjections, IntradermalInsect Bites and StingsMalaria, FalciparumMalePatient SafetyPlasmodium falciparumAntimalarialsChloroquine

Identifiers

PMID26711509
PMCPMC4775905
OpenAlexW2234108055

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.