Evidence map›Paper›PMID 28077588›Full record

Trial reportThe Journal of infectious diseases2017

First-in-Human Evaluation of the Safety and Immunogenicity of an Intranasally Administered Replication-Competent Sendai Virus-Vectored HIV Type 1 Gag Vaccine: Induction of Potent T-Cell or Antibody Responses in Prime-Boost Regimens.

Julien Nyombayire, Omu Anzala, Brian Gazzard, Etienne Karita, Philip Bergin, Peter Hayes, Jakub Kopycinski, Gloria Omosa-Manyonyi, Akil Jackson, Jean Bizimana and 18 more

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01705990 (A Phase I Double-Blind, Randomized, Placebo-Controlled, Dose-Escalation Trial to Evaluate the Safety and Immunogenicity of a Sendai HIV Vaccine SeV-G), which is not on this map. Cited by 24 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 1 pooled it
3.3field-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.

NCT01705990 phase1completednot on this map

A Phase I Double-Blind, Randomized, Placebo-Controlled, Dose-Escalation Trial to Evaluate the Safety and Immunogenicity of a Sendai HIV Vaccine SeV-G(NP) Given Intranasally and Ad35-GRIN Administered Intramuscularly in Prime-Boost Regimens in HIV-Uninfected, Healthy Adult Volunteers

TypeinterventionalSponsorInternational AIDS Vaccine InitiativeRan2013Enrolled65ConditionsHIV InfectionsArmsSeV-G(NP) (0.2mL, 2x10^7 CIU), SeV-G(NP) (0.2mL, 2x10^8 CIU), Ad35-GRIN (0.5mL)
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 1 synthesis or guideline pooled it, 33 citations in OpenAlex.

  1. Pooled it
  2. Trial
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  6. Adenovirus-based vaccines-a platform for pandemic preparedness against emerging viral pathogens.Molecular therapy : the journal of the American Society of Gene Therapy · 2022
    Review
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  15. Imaging of intranasal drug delivery to the brain.American journal of nuclear medicine and molecular imaging · 2020
    Review
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  20. Review
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

28 authors at 6 institutions in 4 countries.

Julien NyombayireProjet San Francisco, Kigali, Rwanda.
Omu AnzalaKenya AIDS Vaccine Initiative Institute of Clinical Research, Nairobi.
Brian GazzardChelsea and Westminster Healthcare NHS Foundation Trust.
Etienne KaritaProjet San Francisco, Kigali, Rwanda.
Philip BerginHuman Immunology Laboratory, International AIDS Vaccine Initiative, London, United Kingdom.
Peter HayesHuman Immunology Laboratory, International AIDS Vaccine Initiative, London, United Kingdom.
Jakub KopycinskiHuman Immunology Laboratory, International AIDS Vaccine Initiative, London, United Kingdom.
Gloria Omosa-ManyonyiKenya AIDS Vaccine Initiative Institute of Clinical Research, Nairobi.
Akil JacksonChelsea and Westminster Healthcare NHS Foundation Trust.
Jean BizimanaProjet San Francisco, Kigali, Rwanda.
Bashir FarahKenya AIDS Vaccine Initiative Institute of Clinical Research, Nairobi.
Eddy SayeedInternational AIDS Vaccine Initiative, New York, New York.
Christopher L ParksInternational AIDS Vaccine Initiative, New York, New York.
Makoto InoueID Pharma, Tsukuba.
Takashi HironakaID Pharma, Tsukuba.
Hiroto HaraID Pharma, Tsukuba.
Tsugumine ShuID Pharma, Tsukuba.
Tetsuro MatanoUniversity of Tokyo.
Len DallyEmmes Corporation, Rockville, Maryland.
Burc BarinEmmes Corporation, Rockville, Maryland.
Harriet ParkInternational AIDS Vaccine Initiative, New York, New York.
Jill GilmourHuman Immunology Laboratory, International AIDS Vaccine Initiative, London, United Kingdom.
Angela LombardoInternational AIDS Vaccine Initiative, New York, New York.
Jean-Louis ExclerInternational AIDS Vaccine Initiative, New York, New York.
Patricia FastInternational AIDS Vaccine Initiative, New York, New York.
Dagna S LauferInternational AIDS Vaccine Initiative, New York, New York.
Josephine H CoxInternational AIDS Vaccine Initiative, New York, New York.
S001 Study Team
International AIDS Vaccine Initiative · USInternational HIV/AIDS Alliance · GBKenya AIDS Vaccine Initiative · KEChelsea and Westminster Hospital NHS Foundation Trust · GBEmmes (United States) · USThe University of Tokyo · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe report the first-in-human safety and immunogenicity assessment of a prototype intranasally administered, replication-competent Sendai virus (SeV)-vectored, human immunodeficiency virus type 1 (HIV-1) vaccine.

methodsSixty-five HIV-1-uninfected adults in Kenya, Rwanda, and the United Kingdom were assigned to receive 1 of 4 prime-boost regimens (administered at 0 and 4 months, respectively; ratio of vaccine to placebo recipients, 12:4): priming with a lower-dose SeV-Gag given intranasally, followed by boosting with an adenovirus 35-vectored vaccine encoding HIV-1 Gag, reverse transcriptase, integrase, and Nef (Ad35-GRIN) given intramuscularly (S

resultsAll vaccine regimens were well tolerated. Gag-specific IFN-γ enzyme-linked immunospot-determined response rates and geometric mean responses were higher (96% and 248 spot-forming units, respectively) in groups primed with SeV-Gag and boosted with Ad35-GRIN (S

conclusionsSeV-Gag primed functional, durable HIV-specific T-cell responses and boosted antibody responses. The prime-boost sequence appears to determine which arm of the immune response is stimulated. CLINICAL TRIALS REGISTRATION: NCT01705990.

Indexed as

Administration, IntranasalAdultAIDS VaccinesCD8-Positive T-LymphocytesFemaleGenes, ViralGenetic VectorsHIV-1HIV AntibodiesHIV InfectionsHumansImmunity, CellularImmunity, HumoralImmunization, SecondaryImmunogenicity, VaccineKenyaAIDS VaccinesHIV AntibodiesVaccines, DNAadenovirus 35HIV-1 vaccineimmunogenicityintranasal deliverymucosal responsesprime-boostreplication competentSendai virus vector

Identifiers

PMID28077588
PMCPMC5225252
OpenAlexW2539103046

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.