Evidence map›Paper›PMID 28152326›Full record

Trial reportHuman vaccines & immunotherapeutics2017

Safety and immunogenicity of GamEvac-Combi, a heterologous VSV- and Ad5-vectored Ebola vaccine: An open phase I/II trial in healthy adults in Russia.

I V Dolzhikova, O V Zubkova, A I Tukhvatulin, A S Dzharullaeva, N M Tukhvatulina, D V Shcheblyakov, M M Shmarov, E A Tokarskaya, Y V Simakova, D A Egorova and 26 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Human vaccines & immunotherapeutics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05162482 (Immunogenicity and Safety of Heterologous Combinations of COVID-19 Vaccines Available Under Emergency Use Authorization in Pakistan), which is not on this map. Cited by 58 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
58citing papers in PubMed, 1 pooled it
7.4field-weighted citation impact, top 2% 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.

NCT05162482 phase2unknown statusnot on this mapstarted 2022, after this paper: background citation

Immunogenicity and Safety of Heterologous Combinations of COVID-19 Vaccines Available Under Emergency Use Authorization in Pakistan: A Randomized Phase II Trial

TypeinterventionalSponsorAga Khan University Hospital, PakistanRan2022 to 2024Enrolled1,680ConditionsCOVID 19 VaccineArmsBIBP (CNBG, Sinopharm) WIV, CanSinoBIO, AstraZeneca ChAdOx
3 · Its place in the literature

Who cites it

58 citing papers in PubMed, 1 synthesis or guideline pooled it, 132 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Review
  6. Article
  7. Article
  8. Vaccines for preventing Ebola virus disease.The Cochrane database of systematic reviews · 2024
    Article
  9. Article
  10. Review
  11. Review
  12. Article
  13. Article
  14. Vaccines · 2023
    Article
  15. Review
  16. Review
  17. Review
  18. Review
  19. Viral vector vaccines.Current opinion in immunology · 2022
    Review
  20. 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

36 authors at 2 institutions in 1 country.

I V Dolzhikovaa Federal Research Centre of Epidemiology and Microbiology named after Honorary Academician N. F. Gamaleya , Ministry of Health , Moscow, Russia.
O V Zubkovaa Federal Research Centre of Epidemiology and Microbiology named after Honorary Academician N. F. Gamaleya , Ministry of Health , Moscow, Russia.
A I Tukhvatulina Federal Research Centre of Epidemiology and Microbiology named after Honorary Academician N. F. Gamaleya , Ministry of Health , Moscow, Russia.
A S Dzharullaevaa Federal Research Centre of Epidemiology and Microbiology named after Honorary Academician N. F. Gamaleya , Ministry of Health , Moscow, Russia.
N M Tukhvatulinaa Federal Research Centre of Epidemiology and Microbiology named after Honorary Academician N. F. Gamaleya , Ministry of Health , Moscow, Russia.
D V Shcheblyakova Federal Research Centre of Epidemiology and Microbiology named after Honorary Academician N. F. Gamaleya , Ministry of Health , Moscow, Russia.
M M Shmarova Federal Research Centre of Epidemiology and Microbiology named after Honorary Academician N. F. Gamaleya , Ministry of Health , Moscow, Russia.
E A Tokarskayaa Federal Research Centre of Epidemiology and Microbiology named after Honorary Academician N. F. Gamaleya , Ministry of Health , Moscow, Russia.
Y V Simakovaa Federal Research Centre of Epidemiology and Microbiology named after Honorary Academician N. F. Gamaleya , Ministry of Health , Moscow, Russia.
D A Egorovaa Federal Research Centre of Epidemiology and Microbiology named after Honorary Academician N. F. Gamaleya , Ministry of Health , Moscow, Russia.
D N Scherbinina Federal Research Centre of Epidemiology and Microbiology named after Honorary Academician N. F. Gamaleya , Ministry of Health , Moscow, Russia.
I L Tutykhinaa Federal Research Centre of Epidemiology and Microbiology named after Honorary Academician N. F. Gamaleya , Ministry of Health , Moscow, Russia.
A A Lysenkoa Federal Research Centre of Epidemiology and Microbiology named after Honorary Academician N. F. Gamaleya , Ministry of Health , Moscow, Russia.
A V Kostarnoya Federal Research Centre of Epidemiology and Microbiology named after Honorary Academician N. F. Gamaleya , Ministry of Health , Moscow, Russia.
P G Ganchevaa Federal Research Centre of Epidemiology and Microbiology named after Honorary Academician N. F. Gamaleya , Ministry of Health , Moscow, Russia.
T A Ozharovskayaa Federal Research Centre of Epidemiology and Microbiology named after Honorary Academician N. F. Gamaleya , Ministry of Health , Moscow, Russia.
B V Belugina Federal Research Centre of Epidemiology and Microbiology named after Honorary Academician N. F. Gamaleya , Ministry of Health , Moscow, Russia.
L V Kolobukhinaa Federal Research Centre of Epidemiology and Microbiology named after Honorary Academician N. F. Gamaleya , Ministry of Health , Moscow, Russia.
V B Pantyukhovc 48 Central Research Institute , Ministry of Defense , Sergiev Posad-6, Russia.
S I Syromyatnikovac 48 Central Research Institute , Ministry of Defense , Sergiev Posad-6, Russia.
I V Shatokhinac 48 Central Research Institute , Ministry of Defense , Sergiev Posad-6, Russia.
T V Sizikovac 48 Central Research Institute , Ministry of Defense , Sergiev Posad-6, Russia.
I G Rumyantsevac 48 Central Research Institute , Ministry of Defense , Sergiev Posad-6, Russia.
A F Andrusc 48 Central Research Institute , Ministry of Defense , Sergiev Posad-6, Russia.
N V Boyarskayac 48 Central Research Institute , Ministry of Defense , Sergiev Posad-6, Russia.
A N Voytyukc 48 Central Research Institute , Ministry of Defense , Sergiev Posad-6, Russia.
V F Babirad No. 7 Main Military Clinical Hospital named after academician N. N. Burdenko , Ministry of Defense , Posad-7, Russia.
S V Volchikhinad No. 7 Main Military Clinical Hospital named after academician N. N. Burdenko , Ministry of Defense , Posad-7, Russia.
D A Kutaevc 48 Central Research Institute , Ministry of Defense , Sergiev Posad-6, Russia.
A N Bel'skihb Military Medical Academy named after S. M. Kirov , Ministry of Defense , Saint Petersburg , Russia.
K V Zhdanovb Military Medical Academy named after S. M. Kirov , Ministry of Defense , Saint Petersburg , Russia.
S M Zakharenkob Military Medical Academy named after S. M. Kirov , Ministry of Defense , Saint Petersburg , Russia.
S V Borisevichc 48 Central Research Institute , Ministry of Defense , Sergiev Posad-6, Russia.
D Y Logunova Federal Research Centre of Epidemiology and Microbiology named after Honorary Academician N. F. Gamaleya , Ministry of Health , Moscow, Russia.
B S Naroditskya Federal Research Centre of Epidemiology and Microbiology named after Honorary Academician N. F. Gamaleya , Ministry of Health , Moscow, Russia.
A L Gintsburga Federal Research Centre of Epidemiology and Microbiology named after Honorary Academician N. F. Gamaleya , Ministry of Health , Moscow, Russia.
Ministry of Health of the Russian Federation · RUS. M. Kirov Military Medical Academy · RU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Ebola hemorrhagic fever, also known as Ebola virus disease or EVD, is one of the most dangerous viral diseases in humans and animals. In this open-label, dose-escalation clinical trial, we assessed the safety, side effects, and immunogenicity of a novel, heterologous prime-boost vaccine against Ebola, which was administered in 2 doses to 84 healthy adults of both sexes between 18 and 55 years. The vaccine consists of live-attenuated recombinant vesicular stomatitis virus (VSV) and adenovirus serotype-5 (Ad5) expressing Ebola envelope glycoprotein. The most common adverse event was pain at the injection site, although no serious adverse events were reported. The vaccine did not significantly impact blood, urine, and immune indices. Seroconversion rate was 100 %. Antigen-specific IgG geometric mean titer at day 42 was 3,277 (95 % confidence interval 2,401-4,473) in volunteers immunized at full dose. Neutralizing antibodies were detected in 93.1 % of volunteers immunized at full dose, with geometric mean titer 20. Antigen-specific response in peripheral blood mononuclear cells was also detected in 100 % of participants, as well as in CD4+ and CD8+ T cells in 82.8 % and 58.6 % of participants vaccinated at full dose, respectively. The data indicate that the vaccine is safe and induces strong humoral and cellular immune response in up to 100 % of healthy adult volunteers, and provide a rationale for testing efficacy in Phase III trials. Indeed, the strong immune response to the vaccine may elicit long-term protection. This trial was registered with grls.rosminzdrav.ru (No. 495*), and with zakupki.gov.ru (No. 0373100043215000055).

Indexed as

Healthy VolunteersAdenoviridaeAdolescentAdultAnimalsAntibodies, NeutralizingAntibodies, ViralCD4-Positive T-LymphocytesCD8-Positive T-LymphocytesDrug CarriersDrug-Related Side Effects and Adverse ReactionsEbola VaccinesFemaleHemorrhagic Fever, EbolaHumansImmunoglobulin GAntibodies, NeutralizingAntibodies, ViralDrug CarriersEbola VaccinesImmunoglobulin GVaccines, SyntheticAd5EbolaEbola virus diseaseheterologous vaccinationprime-boostvaccineVSVZEBOV

Identifiers

PMID28152326
PMCPMC5360131
OpenAlexW2584009705

What OpenQuestion holds

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LicenceCC BY-NC
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.