Evidence map›Paper›PMID 38793748›Full record

ArticleVaccines2024

Safety and Immunogenicity of an Accelerated Ebola Vaccination Schedule in People with and without Human Immunodeficiency Virus: A Randomized Clinical Trial.

Julie A Ake, Kristopher Paolino, Jack N Hutter, Susan Biggs Cicatelli, Leigh Anne Eller, Michael A Eller, Margaret C Costanzo, Dominic Paquin-Proulx, Merlin L Robb, Chi L Tran and 17 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Vaccines, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02598388 (A Randomized, Observer-blind, Placebo-controlled, Two-part, Phase 2 Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Prime-boost Regimens of the Candidate Prophylactic Vaccines for Ebola Ad26.ZEBOV and MVA-BN-Filo), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT02598388 phase2completednot on this map

A Randomized, Observer-blind, Placebo-controlled, Two-part, Phase 2 Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Prime-boost Regimens of the Candidate Prophylactic Vaccines for Ebola Ad26.ZEBOV and MVA-BN-Filo

TypeinterventionalSponsorJanssen Vaccines & Prevention B.V.Ran2015 to 2018Enrolled578ConditionsHemorrhagic Fever, EbolaArmsAd26.ZEBOV, MVA-BN-Filo, Placebo
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Guideline
  2. Article
  3. Review
  4. 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

27 authors.

Julie A AkeU.S. Military HIV Research Program, Center for Infectious Disease Research, Walter Reed Army Institute of Research, Silver Spring, MD 20910, USA.
Kristopher PaolinoClinical Trials Center, Center for Enabling Capabilities, Walter Reed Army Institute of Research, Silver Spring, MD 20910, USA.ORCID 0000-0001-5779-9704
Jack N HutterClinical Trials Center, Center for Enabling Capabilities, Walter Reed Army Institute of Research, Silver Spring, MD 20910, USA.
Susan Biggs CicatelliICON Government and Public Health Solutions, Silver Spring, MD 20901, USA.ORCID 0009-0000-8730-9040
Leigh Anne EllerU.S. Military HIV Research Program, Center for Infectious Disease Research, Walter Reed Army Institute of Research, Silver Spring, MD 20910, USA.
Michael A EllerU.S. Military HIV Research Program, Center for Infectious Disease Research, Walter Reed Army Institute of Research, Silver Spring, MD 20910, USA.ORCID 0000-0003-3905-4877
Margaret C CostanzoU.S. Military HIV Research Program, Center for Infectious Disease Research, Walter Reed Army Institute of Research, Silver Spring, MD 20910, USA.
Dominic Paquin-ProulxU.S. Military HIV Research Program, Center for Infectious Disease Research, Walter Reed Army Institute of Research, Silver Spring, MD 20910, USA.ORCID 0000-0003-1407-3414
Merlin L RobbU.S. Military HIV Research Program, Center for Infectious Disease Research, Walter Reed Army Institute of Research, Silver Spring, MD 20910, USA.
Chi L TranU.S. Military HIV Research Program, Center for Infectious Disease Research, Walter Reed Army Institute of Research, Silver Spring, MD 20910, USA.
Lalaine AnovaU.S. Military HIV Research Program, Center for Infectious Disease Research, Walter Reed Army Institute of Research, Silver Spring, MD 20910, USA.
Linda L JagodzinskiDiagnostics and Countermeasures Branch, Center for Infectious Diseases Research, Walter Reed Army Institute of Research, Silver Spring, MD 20910, USA.
Lucy A WardJoint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical, U.S. Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, Fort Detrick, MD 21702, USA.
Nicole KilgoreJoint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical, U.S. Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, Fort Detrick, MD 21702, USA.
Janice RusnakJoint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical, U.S. Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, Fort Detrick, MD 21702, USA.
Callie BoundsJoint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical, U.S. Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, Fort Detrick, MD 21702, USA.
Christopher S BadorrekJoint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical, U.S. Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, Fort Detrick, MD 21702, USA.
Jay W HooperVirology Division, U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), Fort Detrick, MD 21702, USA.
Steven A KwilasVirology Division, U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), Fort Detrick, MD 21702, USA.
Ine IlsbrouxJanssen Research & Development, 2340 Beerse, Belgium.
Dickson Nkafu AnumendemJanssen Research & Development, 2340 Beerse, Belgium.
Auguste GaddahJanssen Research & Development, 2340 Beerse, Belgium.ORCID 0009-0009-1545-6338
Georgi ShukarevJanssen Vaccines & Prevention B.V., 2333 Leiden, The Netherlands.ORCID 0000-0001-5154-7047
Viki BockstalJanssen Vaccines & Prevention B.V., 2333 Leiden, The Netherlands.
Kerstin LuhnJanssen Vaccines & Prevention B.V., 2333 Leiden, The Netherlands.
Macaya DouoguihJanssen Vaccines & Prevention B.V., 2333 Leiden, The Netherlands.
Cynthia RobinsonJanssen Vaccines & Prevention B.V., 2333 Leiden, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The safety and immunogenicity of the two-dose Ebola vaccine regimen MVA-BN-Filo, Ad26.ZEBOV, 14 days apart, was evaluated in people without HIV (PWOH) and living with HIV (PLWH). In this observer-blind, placebo-controlled, phase 2 trial, healthy adults were randomized (4:1) to receive MVA-BN-Filo (dose 1) and Ad26.ZEBOV (dose 2), or two doses of saline/placebo, administered intramuscularly 14 days apart. The primary endpoints were safety (adverse events (AEs)) and immunogenicity (Ebola virus (EBOV) glycoprotein-specific binding antibody responses). Among 75 participants (n = 50 PWOH; n = 25 PLWH), 37% were female, the mean age was 44 years, and 56% were Black/African American. AEs were generally mild/moderate, with no vaccine-related serious AEs. At 21 days post-dose 2, EBOV glycoprotein-specific binding antibody responder rates were 100% among PWOH and 95% among PLWH; geometric mean antibody concentrations were 6286 EU/mL (n = 36) and 2005 EU/mL (n = 19), respectively. A total of 45 neutralizing and other functional antibody responses were frequently observed. Ebola-specific CD4+ and CD8+ T-cell responses were polyfunctional and durable to at least 12 months post-dose 2. The regimen was well tolerated and generated robust, durable immune responses in PWOH and PLWH. Findings support continued evaluation of accelerated vaccine schedules for rapid deployment in populations at immediate risk. Trial registration: NCT02598388 (submitted 14 November 2015).

Indexed as

Ebola virusimmunogenicityvaccine safety

Identifiers

PMID38793748
PMCPMC11125575

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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.