Evidence map›Paper›PMID 37160281›Full record

Trial reportThe American journal of tropical medicine and hygiene2023

Safety and Immunogenicity of Radiation-Attenuated PfSPZ Vaccine in Equatoguinean Infants, Children, and Adults.

Said A Jongo, Vicente Urbano Nsue Ndong Nchama, L W Preston Church, Ally Olotu, Stephen R Manock, Tobias Schindler, Ali Mtoro, Natasha Kc, Orrin Devinsky, Elcin Zan and 35 more

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The American journal of tropical medicine and hygiene, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
2.0field-weighted citation impact, top 14% 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, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Article
  5. Article
  6. 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

45 authors at 10 institutions in 4 countries.

Said A JongoIfakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.
Vicente Urbano Nsue Ndong NchamaMinistry of Health and Social Welfare, Government of Equatorial Guinea, Malabo, Equatorial Guinea.
L W Preston ChurchSanaria Inc., Rockville, Maryland.
Ally OlotuIfakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.
Stephen R ManockSanaria Inc., Rockville, Maryland.
Tobias SchindlerSwiss Tropical and Public Health Institute, Allschwil, Switzerland.
Ali MtoroIfakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.
Natasha KcSanaria Inc., Rockville, Maryland.
Orrin DevinskyNew York University Langone Medical Center, New York, New York.
Elcin ZanNew York University Langone Medical Center, New York, New York.
Ali HamadIfakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.
Elizabeth NyakarunguIfakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.
Maxmillian MpinaIfakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.
Anna DealSwiss Tropical and Public Health Institute, Allschwil, Switzerland.
José Raso BijeriMinistry of Health and Social Welfare, Government of Equatorial Guinea, Malabo, Equatorial Guinea.
Martin Eka Ondo MangueMinistry of Health and Social Welfare, Government of Equatorial Guinea, Malabo, Equatorial Guinea.
Beltrán Ekua Ntutumu PasialoMinistry of Health and Social Welfare, Government of Equatorial Guinea, Malabo, Equatorial Guinea.
Genaro Nsue NguemaMinistry of Health and Social Welfare, Government of Equatorial Guinea, Malabo, Equatorial Guinea.
Matilde Riloha RivasMinistry of Health and Social Welfare, Government of Equatorial Guinea, Malabo, Equatorial Guinea.
Mwajuma ChembaIfakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.
Kamaka K RamadhaniIfakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.
Eric R JamesSanaria Inc., Rockville, Maryland.
Thomas C StablerSanaria Inc., Rockville, Maryland.
Yonas AbebeSanaria Inc., Rockville, Maryland.
Pouria RiyahiSanaria Inc., Rockville, Maryland.
Elizabeth S SaverinoSanaria Inc., Rockville, Maryland.
Julian SaxSwiss Tropical and Public Health Institute, Allschwil, Switzerland.
Salome HoschSwiss Tropical and Public Health Institute, Allschwil, Switzerland.
Anneth TumboIfakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.
Linda GondweIfakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.
J Luis SeguraSwiss Tropical and Public Health Institute, Allschwil, Switzerland.
Carlos Cortes FallaMCD Global Health, Silver Spring, Maryland.
Wonder Philip PhiriMCD Global Health, Silver Spring, Maryland.
Dianna E B HergottMCD Global Health, Silver Spring, Maryland.
Guillermo A GarcíaMCD Global Health, Silver Spring, Maryland.
Carl MaasMarathon EG Production, Ltd., Malabo Dos, Equatorial Guinea.
Tooba MurshedkarSanaria Inc., Rockville, Maryland.
Peter F BillingsleySanaria Inc., Rockville, Maryland.
Marcel TannerSwiss Tropical and Public Health Institute, Allschwil, Switzerland.
Mitoha Ondo'o AyekabaMinistry of Health and Social Welfare, Government of Equatorial Guinea, Malabo, Equatorial Guinea.
B Kim Lee SimSanaria Inc., Rockville, Maryland.
Claudia DaubenbergerSwiss Tropical and Public Health Institute, Allschwil, Switzerland.
Thomas L RichieSanaria Inc., Rockville, Maryland.
Salim AbdullaIfakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.
Stephen L HoffmanSanaria Inc., Rockville, Maryland.
Sanaria · USIfakara Health Institute · TZSwiss Tropical and Public Health Institute · CHMedical Care Development International · USNational University of Equatorial Guinea · GQGovernment of Equatorial Guinea · GQUniversity of Basel · CHNYU Langone Health · USProtein Potential (United States) · USMarathon Oil (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The radiation-attenuated Plasmodium falciparum sporozoites (PfSPZ) Vaccine has demonstrated safety and immunogenicity in 5-month-old to 50-year-old Africans in multiple trials. Except for one, each trial has restricted enrollment to either infants and children or adults < 50 years old. This trial was conducted in Equatorial Guinea and assessed the safety, tolerability, and immunogenicity of three direct venous inoculations of 1.8 × 106 or 2.7 × 106 PfSPZ, of PfSPZ Vaccine, or normal saline administered at 8-week intervals in a randomized, double-blind, placebo-controlled trial stratified by age (6-11 months and 1-5, 6-10, 11-17, 18-35, and 36-61 years). All doses were successfully administered. In all, 192/207 injections (93%) in those aged 6-61 years were rated as causing no or mild pain. There were no significant differences in solicited adverse events (AEs) between vaccinees and controls in any age group (P ≥ 0.17). There were no significant differences between vaccinees and controls with respect to the rates or severity of unsolicited AEs or laboratory abnormalities. Development of antibodies to P. falciparum circumsporozoite protein occurred in 67/69 vaccinees (97%) and 0/15 controls. Median antibody levels were highest in infants and 1-5-year-olds and declined progressively with age. Antibody responses in children were greater than in adults protected against controlled human malaria infection. Robust immunogenicity, combined with a benign AE profile, indicates children are an ideal target for immunization with PfSPZ Vaccine.

Indexed as

Malaria, FalciparumMalaria VaccinesAdultAnimalsChildChild, PreschoolDouble-Blind MethodEquatorial GuineaHumansImmunogenicity, VaccineInfantMiddle AgedPlasmodium falciparumSporozoitesVaccines, AttenuatedMalaria VaccinesVaccines, Attenuated

Identifiers

PMID37160281
PMCPMC10324022
OpenAlexW4376121455

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.