Evidence map›Paper›PMID 29669026›Full record

Trial reportThe Journal of infectious diseases2018

First-in-Human Randomized, Controlled Trial of Mosaic HIV-1 Immunogens Delivered via a Modified Vaccinia Ankara Vector.

Lindsey R Baden, Stephen R Walsh, Michael S Seaman, Yehuda Z Cohen, Jennifer A Johnson, J Humberto Licona, Rachel D Filter, Jane A Kleinjan, Jon A Gothing, Julia Jennings and 27 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02218125 (A Phase I Study of Modified Vaccinia Ankara With Mosaic HIV Inserts in Healthy, HIV-Uninfected Adults, Some of Whom Have Previously Received an Adenovirus Type 26 ENVA.01 Vaccine), which is not on this map. Cited by 30 papers.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed
3.2field-weighted citation impact, top 8% 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.

NCT02218125 phase1completednot on this map

A Phase I Study of Modified Vaccinia Ankara With Mosaic HIV Inserts in Healthy, HIV-Uninfected Adults, Some of Whom Have Previously Received an Adenovirus Type 26 ENVA.01 Vaccine

TypeinterventionalSponsorCrucell Holland BVRan2014 to 2015Enrolled25ConditionsHealthyArmsMVA Mosaic, Placebo
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 45 citations in OpenAlex.

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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

37 authors at 9 institutions in 4 countries.

Lindsey R BadenDivision of Infectious Diseases, Brigham and Women's Hospital, Boston.
Stephen R WalshDivision of Infectious Diseases, Brigham and Women's Hospital, Boston.
Michael S SeamanHarvard Medical School, Beth Israel Deaconess Medical Center, Boston.
Yehuda Z CohenHarvard Medical School, Beth Israel Deaconess Medical Center, Boston.
Jennifer A JohnsonDivision of Infectious Diseases, Brigham and Women's Hospital, Boston.
J Humberto LiconaDivision of Infectious Diseases, Brigham and Women's Hospital, Boston.
Rachel D FilterDivision of Infectious Diseases, Brigham and Women's Hospital, Boston.
Jane A KleinjanDivision of Infectious Diseases, Brigham and Women's Hospital, Boston.
Jon A GothingDivision of Infectious Diseases, Brigham and Women's Hospital, Boston.
Julia JenningsCenter for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston.
Lauren PeterCenter for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston.
Joseph NkololaCenter for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston.
Peter AbbinkCenter for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston.
Erica N BorducchiCenter for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston.
Marinela KirilovaCenter for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston.
Kathryn E StephensonHarvard Medical School, Beth Israel Deaconess Medical Center, Boston.
Poonam PeguUS Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring.
Michael A EllerUS Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring.
Hung V TrinhUS Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring.
Mangala RaoUS Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring.
Julie A AkeUS Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring.
Michal SarneckiJanssen Vaccines, Bern, Switzerland.
Steven NijsCrucell Holland, Janssen, Johnson & Johnson, Leiden, the Netherlands.
Katleen CallewaertCrucell Holland, Janssen, Johnson & Johnson, Leiden, the Netherlands.
Hanneke SchuitemakerCrucell Holland, Janssen, Johnson & Johnson, Leiden, the Netherlands.
Jenny HendriksCrucell Holland, Janssen, Johnson & Johnson, Leiden, the Netherlands.
Maria G PauCrucell Holland, Janssen, Johnson & Johnson, Leiden, the Netherlands.
Frank TomakaJanssen Pharmaceutical Research and Development, Titusville, New Jersey.
Bette T KorberTheoretical Biology and Biophysics Group, Los Alamos National Laboratory, New Mexico.
Galit AlterHarvard Medical School, Beth Israel Deaconess Medical Center, Boston.
Raphael DolinHarvard Medical School, Beth Israel Deaconess Medical Center, Boston.
Patricia L EarlLaboratory of Viral Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.
Bernard MossLaboratory of Viral Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.
Nelson L MichaelUS Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring.
Merlin L RobbUS Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring.
Dan H BarouchHarvard Medical School, Beth Israel Deaconess Medical Center, Boston.
IPCAVD006/RV380/HIV-V-A002 Study Group
Brigham and Women's Hospital · USHadassah Medical Center · ILJanssen (Netherlands) · NLHenry M. Jackson Foundation · USWalter Reed Army Institute of Research · USNational Institutes of Health · USJanssen (Switzerland) · CHJanssen (United States) · USLos Alamos National Laboratory · US

Funding

Harvard Clinical and Translational Science CenterUL1TR001102 · NCATS · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2013 to 2017
$106.2M
Harvard Medical School Vaccine Clinical Trials UnitUM1AI069412 · NIAID · BRIGHAM AND WOMEN'S HOSPITAL · PI Lindsey Robert Baden, Daniel R. Kuritzkes · 2012 to 2026
$57.2M
Harvard Clinical and Translational Science Center (UL1)UL1TR000170 · NCATS · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2012 to 2013
$31.4M
Preclinical Evaluation of Novel Ad/MVA and Ad/Protein HIV-1 VaccinesU19AI096040 · NIAID · BETH ISRAEL DEACONESS MEDICAL CENTER · PI SEAMAN, MICHAEL SCOTT · 2012 to 2016
$18.0M
Recombinant Virus VaccinesZIAAI000416 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI MOSS, BERNARD · 2009 to 2025
$17.3M
Project 2U19AI128751 · NIAID · BETH ISRAEL DEACONESS MEDICAL CENTER · PI BAROUCH, DAN H. · 2018 to 2022
$14.0M
Diversity of Immune Responses Elicited by HIV VaccinesK23AI114381 · NIAID · BETH ISRAEL DEACONESS MEDICAL CENTER · PI STEPHENSON, KATHRYN ELAINE · 2014 to 2018
$818k
Dermatotropic cellular immune responses induced by a novel smallpox vaccineK23AI085181 · NIAID · BETH ISRAEL DEACONESS MEDICAL CENTER · PI WALSH, STEPHEN R · 2010 to 2014
$645k
NCATS NIH HHS UL1 TR000170NCATS NIH HHS UL1 TR001102NIAID NIH HHS K23 AI085181NIAID NIH HHS K23 AI114381NIAID NIH HHS U19 AI096040NIAID NIH HHS U19 AI128751NIAID NIH HHS UM1 AI069412
6 · The paper itself

Abstract

Background: Mosaic immunogens are bioinformatically engineered human immunodeficiency virus type 1 (HIV-1) sequences designed to elicit clade-independent coverage against globally circulating HIV-1 strains. Methods: This phase 1, double-blinded, randomized, placebo-controlled trial enrolled healthy HIV-uninfected adults who received 2 doses of a modified vaccinia Ankara (MVA)-vectored HIV-1 bivalent mosaic immunogen vaccine or placebo on days 0 and 84. Two groups were enrolled: those who were HIV-1 vaccine naive (n = 15) and those who had received an HIV-1 vaccine (Ad26.ENVA.01) 4-6 years earlier (n = 10). We performed prespecified blinded cellular and humoral immunogenicity analyses at days 0, 14, 28, 84, 98, 112, 168, 270, and 365. Results: All 50 planned vaccinations were administered. Vaccination was safe and generally well tolerated. No vaccine-related serious adverse events occurred. Both cellular and humoral cross-clade immune responses were elicited after 1 or 2 vaccinations in all participants in the HIV-1 vaccine-naive group. Env-specific responses were induced after a single immunization in nearly all subjects who had previously received the prototype Ad26.ENVA.01 vaccine. Conclusions: No safety concerns were identified, and multiclade HIV-1-specific immune responses were elicited. Clinical Trials Registration: NCT02218125.

Indexed as

AdultAIDS VaccinesDouble-Blind MethodDrug CarriersDrug-Related Side Effects and Adverse ReactionsFemaleGenetic VectorsHIV-1HIV InfectionsHumansImmunity, CellularImmunity, HumoralLongitudinal StudiesMaleMiddle AgedPlacebosAIDS VaccinesDrug CarriersPlacebosVaccines, SubunitVaccines, Synthetic

Identifiers

PMID29669026
PMCPMC6047429
OpenAlexW2797813820

What OpenQuestion holds

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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.