Evidence map›Paper›PMID 30796818›Full record

Trial reportThe Journal of infectious diseases2019

Safety and Immunogenicity of a 2-Dose Heterologous Vaccination Regimen With Ad26.ZEBOV and MVA-BN-Filo Ebola Vaccines: 12-Month Data From a Phase 1 Randomized Clinical Trial in Uganda and Tanzania.

Zacchaeus Anywaine, Hilary Whitworth, Pontiano Kaleebu, George Praygod, Georgi Shukarev, Daniela Manno, Saidi Kapiga, Heiner Grosskurth, Samuel Kalluvya, Viki Bockstal and 5 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02376400 (A Phase 1 Study to Evaluate the Safety, Tolerability and Immunogenicity of Heterologous Prime-Boost Regimens Using MVA-BN®-Filo and Ad26.ZEBOV Administered in Different Sequences and Schedules in Healthy Adults), which is not on this map. Cited by 84 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
84citing papers in PubMed, 2 pooled it
16.2field-weighted citation impact, top 1% 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.

NCT02376400 phase1completednot on this map

A Phase 1 Study to Evaluate the Safety, Tolerability and Immunogenicity of Heterologous Prime-Boost Regimens Using MVA-BN®-Filo and Ad26.ZEBOV Administered in Different Sequences and Schedules in Healthy Adults

TypeinterventionalSponsorCrucell Holland BVRan2015 to 2016Enrolled78ConditionsHealthyArmsMVA-BN-Filo, Ad26.ZEBOV, Placebo
3 · Its place in the literature

Who cites it

84 citing papers in PubMed, 2 syntheses or guidelines pooled it, 150 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Trial
  14. Trial
  15. Review
  16. Article
  17. Developing the next-generation of adenoviral vector vaccines.Human vaccines & immunotherapeutics · 2025
    Review
  18. Emerging and Pandemic Pathogens: Lessons Learned From a Clinical Research Network.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Review
  19. Article
  20. Article

24 more citing papers are in PubMed but not listed here.

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

15 authors at 6 institutions in 4 countries.

Zacchaeus AnywaineMedical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.
Hilary WhitworthLondon School of Hygiene and Tropical Medicine, London, United Kingdom.
Pontiano KaleebuMedical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda.
George PraygodMwanza Research Center, National Institute for Medical Research, Mwanza, Tanzania.
Georgi ShukarevJanssen Vaccines and Prevention, Leiden, the Netherlands.
Daniela MannoLondon School of Hygiene and Tropical Medicine, London, United Kingdom.
Saidi KapigaLondon School of Hygiene and Tropical Medicine, London, United Kingdom.
Heiner GrosskurthLondon School of Hygiene and Tropical Medicine, London, United Kingdom.
Samuel KalluvyaBugando Medical Center, Mwanza, Tanzania.
Viki BockstalJanssen Vaccines and Prevention, Leiden, the Netherlands.
Dickson AnumendemJanssen Vaccines and Prevention, Leiden, the Netherlands.
Kerstin LuhnJanssen Vaccines and Prevention, Leiden, the Netherlands.
Cynthia RobinsonJanssen Vaccines and Prevention, Leiden, the Netherlands.
Macaya DouoguihJanssen Vaccines and Prevention, Leiden, the Netherlands.
Deborah Watson-JonesLondon School of Hygiene and Tropical Medicine, London, United Kingdom.
Janssen (Netherlands) · NLLondon School of Hygiene & Tropical Medicine · GBMwanza Intervention Trials Unit · TZNational Institute for Medical Research · TZUganda Virus Research Institute · UGBugando Medical Centre · TZ

Funding

Medical Research Council G0901756Medical Research Council MC_UU_00027/1Medical Research Council MR/K012126/1Medical Research Council MR/R010161/1NIAID NIH HHS HHSN272200800056C
6 · The paper itself

Abstract

backgroundEbola vaccine development was accelerated in response to the 2014 Ebola virus infection outbreak. This phase 1 study (VAC52150EBL1004) assessed safety, tolerability, and immunogenicity of heterologous 2-dose Ad26.ZEBOV, MVA-BN-Filo vaccination regimens in the Lake Victoria Basin of Tanzania and Uganda in mid-level altitude, malaria-endemic settings.

methodsHealthy volunteers aged 18-50 years from Tanzania (n = 25) and Uganda (n = 47) were randomized to receive placebo or active vaccination with Ad26.ZEBOV or MVA-BN-Filo (first vaccination), followed by MVA-BN-Filo or Ad26.ZEBOV (second vaccination) dose 2, respectively, with intervals of 28 or 56 days.

resultsSeventy-two adults were randomized to receive vaccine (n = 60) or placebo (n = 12). No vaccine-related serious adverse events were reported. The most frequent solicited local and systemic adverse events were injection site pain (frequency, 70%, 66%, and 42% per dose for MVA-BN-Filo, Ad26.ZEBOV, and placebo, respectively) and headache (57%, 56%, and 46%, respectively). Adverse event patterns were similar among regimens. Twenty-one days after dose 2, 100% of volunteers demonstrated binding antibody responses against Ebola virus glycoprotein, and 87%-100% demonstrated neutralizing antibody responses. Ad26.ZEBOV dose 1 vaccination induced more-robust initial binding antibody and cellular responses than MVA-BN-Filo dose 1 vaccination.

conclusionsHeterologous 2-dose vaccination with Ad26.ZEBOV and MVA-BN-Filo against Ebola virus is well tolerated and immunogenic in healthy volunteers. CLINICAL TRIALS REGISTRATION: NCT02376400.

Indexed as

AdolescentAdultAntibodies, NeutralizingAntibodies, ViralAntibody FormationDisease OutbreaksEbola VaccinesEbolavirusFemaleHealthy VolunteersHemorrhagic Fever, EbolaHumansMaleMiddle AgedTanzaniaUgandaAntibodies, NeutralizingAntibodies, ViralEbola VaccinesMVA vaccineVaccines, DNAViral VaccinesAd26.ZEBOVEbola vaccineheterologous 2-doseMVA-BN-Filosafety and immunogenicity

Identifiers

PMID30796818
PMCPMC6548900
OpenAlexW2917849476

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.