Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2020
Safety, Tolerability, and Immunogenicity of Plasmodium falciparum Sporozoite Vaccine Administered by Direct Venous Inoculation to Infants and Young Children: Findings From an Age De-escalation, Dose-Escalation, Double-blind, Randomized Controlled Study in Western Kenya.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02687373 (Safety, Tolerability and Efficacy of PfSPZ Vaccine Administered by Direct Venous Inoculation), which is not on this map. Cited by 22 papers, 1 of them a synthesis that pooled 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.
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.
Safety, Tolerability and Efficacy of PfSPZ Vaccine Administered by Direct Venous Inoculation (DVI) to Healthy Children and Infants 5 Months Through 9 Years of Age Living in an Area of High Malaria Transmission in Western Kenya: Age De-escalation and Dose Escalation and a Double Blind, Randomized Placebo-Controlled Trial for Safety and Efficacy
Who cites it
22 citing papers in PubMed, 1 synthesis or guideline pooled it, 36 citations in OpenAlex.
- Pooled it
- Safety, tolerability and immunogenicity of a condensed, multi-dose prime regimen of PfSPZ Vaccine for the prevention of Plasmodium falciparum malaria infection.Malaria journal · 2025Trial
- Innate immune activation restricts priming and protective efficacy of the radiation-attenuated PfSPZ malaria vaccine.JCI insight · 2024Trial
- Safety and protective efficacy of PfSPZ Vaccine administered to HIV-negative and -positive Tanzanian adults.The Journal of clinical investigation · 2024Trial
- Safety and Immunogenicity of Radiation-Attenuated PfSPZ Vaccine in Equatoguinean Infants, Children, and Adults.The American journal of tropical medicine and hygiene · 2023Trial
- A randomized controlled trial showing safety and efficacy of a whole sporozoite vaccine against endemic malaria.Science translational medicine · 2022Trial
- Safety, immunogenicity and efficacy of PfSPZ Vaccine against malaria in infants in western Kenya: a double-blind, randomized, placebo-controlled phase 2 trial.Nature medicine · 2021Trial
- Genetic metrics decodeFrontiers in genetics · 2026Article
- Successful insertion and expression of a tetracycline transactivator in Anopheles stephensi associated with increased egg production and decreased hatching rate.Parasites & vectors · 2025Article
- Role of malaria exposure and off-target responses on RTS,S/AS02NPJ vaccines · 2025Article
- Assessment of Health Status and Creation of a Registry of Potential Research Participants Aged 1.5 to 50 Years on Bioko Island, Equatorial Guinea.The American journal of tropical medicine and hygiene · 2025Article
- Malaria vaccine efficacy, safety, and community perception in Africa: a scoping review of recent empirical studies.Infection · 2024Article
- Controlled Human Malaria Infection Studies in Africa-Past, Present, and Future.Current topics in microbiology and immunology · 2024Review
- Ethics of age de-escalation in pediatric vaccine trials: Attending to the case of COVID-19.Vaccine · 2023Article
- A genetically engineeredScience translational medicine · 2022Article
- A PfSPZ vaccine immunization regimen equally protective against homologous and heterologous controlled human malaria infection.NPJ vaccines · 2022Article
- Five decades of clinical assessment of whole-sporozoite malaria vaccines.Frontiers in immunology · 2022Review
- Increased levels of anti-PfCSP antibodies in post-pubertal females versus males immunized with PfSPZ Vaccine does not translate into increased protective efficacy.Frontiers in immunology · 2022Article
- Recent clinical trials inform the future for malaria vaccines.Communications medicine · 2021Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
27 authors at 6 institutions in 2 countries.
Funding
Abstract
backgroundThe whole Plasmodium falciparum sporozoite (PfSPZ) vaccine is being evaluated for malaria prevention. The vaccine is administered intravenously for maximal efficacy. Direct venous inoculation (DVI) with PfSPZ vaccine has been safe, tolerable, and feasible in adults, but safety data for children and infants are limited.
methodsWe conducted an age de-escalation, dose-escalation randomized controlled trial in Siaya County, western Kenya. Children and infants (aged 5-9 years, 13-59 months, and 5-12 months) were enrolled into 13 age-dose cohorts of 12 participants and randomized 2:1 to vaccine or normal saline placebo in escalating doses: 1.35 × 105, 2.7 × 105, 4.5 × 105, 9.0 × 105, and 1.8 × 106 PfSPZ, with the 2 highest doses given twice, 8 weeks apart. Solicited adverse events (AEs) were monitored for 8 days after vaccination, unsolicited AEs for 29 days, and serious AEs throughout the study. Blood taken prevaccination and 1 week postvaccination was tested for immunoglobulin G antibodies to P. falciparum circumsporozoite protein (PfCSP) using enzyme-linked immunosorbent assay.
resultsRates of AEs were similar in vaccinees and controls for solicited (35.7% vs 41.5%) and unsolicited (83.9% vs 92.5%) AEs, respectively. No related grade 3 AEs, serious AEs, or grade 3 laboratory abnormalities occurred. Most (79.0%) vaccinations were administered by a single DVI. Among those in the 9.0 × 105 and 1.8 × 106 PfSPZ groups, 36 of 45 (80.0%) vaccinees and 4 of 21 (19.0%) placebo controls developed antibodies to PfCSP (P < .001).
conclusionsPfSPZ vaccine in doses as high as 1.8 × 106 can be administered to infants and children by DVI, and was safe, well tolerated, and immunogenic. CLINICAL TRIALS REGISTRATION: NCT02687373.
Indexed as
Identifiers
What OpenQuestion holds
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 OpenQuestion graph.