Evidence map›Paper›PMID 38206875›Full record

ReviewJournal of travel medicine2024

Piloting delivery of PfSPZ vaccines for malaria through a cryogenic vaccine cold chain to travel and military medicine clinics.

Eric R James, L W Preston Church, Stephen L Hoffman, Thomas L Richie, Brian D Robertson, Patrick W Hickey, David J Schwartz, Patrick T Logan, Theresa D Asare, Macie L Jones and 9 more

Open access · greenAbstract readReview
In one paragraph

Review in Journal of travel medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.8field-weighted citation impact, top 33% 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

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. 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

19 authors at 6 institutions in 1 country.

Eric R JamesSanaria Inc, Rockville, MD 20850, USA.
L W Preston ChurchSanaria Inc, Rockville, MD 20850, USA.
Stephen L HoffmanSanaria Inc, Rockville, MD 20850, USA.
Thomas L RichieSanaria Inc, Rockville, MD 20850, USA.
Brian D RobertsonWalter Reed National Military Medical Center, Bethesda, MD 20889, USA.
Patrick W HickeyUniformed Services University of the Health Sciences, Bethesda, MD 20814, USA.
David J SchwartzWalter Reed National Military Medical Center, Bethesda, MD 20889, USA.
Patrick T LoganWalter Reed National Military Medical Center, Bethesda, MD 20889, USA.
Theresa D AsareWalter Reed National Military Medical Center, Bethesda, MD 20889, USA.
Macie L JonesWalter Reed National Military Medical Center, Bethesda, MD 20889, USA.
Jeannie L BayJoint Base Lewis-McChord/Madigan Army Medical Center, Lewis-McChord, WA 98431, USA.
Austin K RoschelJoint Base Lewis-McChord/Madigan Army Medical Center, Lewis-McChord, WA 98431, USA.
Jacqueline L PfeifferJoint Base Lewis-McChord/Madigan Army Medical Center, Lewis-McChord, WA 98431, USA.
Rebecca W AcostaTraveler's Medical Service, New York, NY 10022, USA.
Ethan SchiaviTraveler's Medical Service, New York, NY 10022, USA.
Alberto M AcostaTraveler's Medical Service, New York, NY 10022, USA.
Mark NoblePassport Health Silver Spring Travel Clinic, Silver Spring, MD 20903, USA.
Thomas HenkelPassport Health Silver Spring Travel Clinic, Silver Spring, MD 20903, USA.
Cebrina YoungPassport Health Silver Spring Travel Clinic, Silver Spring, MD 20903, USA.
Walter Reed National Military Medical Center · USSanaria · USMadigan Army Medical Center · USPassport Health · USSt. Luke's-Roosevelt Hospital Center · USUniformed Services University of the Health Sciences · US

Funding

Marketing Strategic Plan and Distribution Logistics for Sanaria PfSPZ Vaccine against Malaria.SB1AI077262 · NIAID · SANARIA, INC. · PI HOFFMAN, STEPHEN LEV · 2017 to 2019
$3.0M
Department of Defense W81XWH18C0326NIAID NIH HHS SB1 AI077262NIH HHS SB1AI077262
6 · The paper itself

Abstract

backgroundPfSPZ vaccines comprising Plasmodium falciparum (Pf) sporozoites (SPZ) have demonstrated > 90% protection against variant Pf malaria infections for at least 12 weeks; they are the only vaccines with the level of efficacy necessary to protect travellers. PfSPZ are eukaryotic cells stabilized by cryopreservation and distributed using a cryogenic (below -150 °C) cold chain. The Ebola vaccine and mRNA vaccines against SARS-CoV-2 pioneered uptake of vaccines requiring non-standard ultra-low temperature cold chains. The cryogenic cold chain using liquid nitrogen (LN2) vapour phase (LNVP) cryoshippers, is simpler, more efficient than -80, -20 or 2-8 °C cold chains, and does not use electricity. This study was conducted to evaluate implementation and integration of a cryogenically distributed vaccine at travel and military immunization clinics.

methodsWe conducted sequential 28-day studies evaluating vaccine shipping, storage, maintenance and accession at two US military and two civilian travel health/immunization clinics. In each clinic, personnel were trained in equipment use, procurement and handling of LN2, temperature monitoring and inventory record keeping by in-person or video instruction.

resultsSites required 2-4 h/person for two persons to assimilate and develop the expertise to manage vaccine storage and LNVP operations. LN2 for recharging cryoshippers was delivered every 1-2 weeks. Vaccine ordering, receipt, storage and inventory control was conducted effectively. Simulated single dose vaccine cryovial retrieval and thawing were performed successfully in different travel clinic settings. Continuous temperature monitoring at each site was maintained with only one short excursion above -150 °C (-145 °C) through shipping, use and reverse logistics. Staff, during and at study conclusion, provided feedback that has been incorporated into our models for cold chain logistics.

conclusionsThese studies demonstrated that the training in delivery, storage, administration and integration of PfSPZ vaccines can be successfully managed in different immunization clinic settings for travellers and military personnel.

Indexed as

Ebola VaccinesHemorrhagic Fever, EbolaMalaria, FalciparumMilitary MedicineCOVID-19 VaccinesHumansPlasmodium falciparumRefrigerationCOVID-19 VaccinesEbola VaccinesCryogenic temperature monitoringCryopreservationCryoshippersEukaryote vaccineliquid nitrogen vapor phasePersonnel trainingSub −150 °C cold chain

Identifiers

PMID38206875
PMCPMC10998499
OpenAlexW4390755092

What OpenQuestion holds

Textmetadata
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.