Evidence map›Paper›PMID 25264782›Full record

Trial reportPloS one2014

Homologous boosting with adenoviral serotype 5 HIV vaccine (rAd5) vector can boost antibody responses despite preexisting vector-specific immunity in a randomized phase I clinical trial.

Uzma N Sarwar, Laura Novik, Mary E Enama, Sarah A Plummer, Richard A Koup, Martha C Nason, Robert T Bailer, Adrian B McDermott, Mario Roederer, John R Mascola and 3 more

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

Trial report in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00709605 (A Phase I, Open Label, CT to Evaluate the Safety, Tolerability and Immunogenicity of a Multiclade Recombinant HIV-1 Adenoviral Vector Vaccine, VRC-HIVADV014-00-VP In Uninfected Adults Randomized to Needle or Biojector Methods of Intramuscular Injection), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.8field-weighted citation impact, top 30% 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.

NCT00709605 phase1completednot on this map

A Phase I, Open Label, CT to Evaluate the Safety, Tolerability and Immunogenicity of a Multiclade Recombinant HIV-1 Adenoviral Vector Vaccine, VRC-HIVADV014-00-VP In Uninfected Adults Randomized to Needle or Biojector Methods of Intramuscular Injection

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2008 to 2014Enrolled31ConditionsHIV InfectionsArmsVRC-HIVADV014-00-VP
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 5 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  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

13 authors at 2 institutions in 1 country.

Uzma N SarwarVaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, United States of America.
Laura NovikVaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, United States of America.
Mary E EnamaVaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, United States of America.
Sarah A PlummerVaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, United States of America.
Richard A KoupVaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, United States of America.
Martha C NasonBiostatistics Research Branch, Division of Clinical Research, NIAID, NIH, Bethesda, MD, United States of America.
Robert T BailerVaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, United States of America.
Adrian B McDermottVaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, United States of America.
Mario RoedererVaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, United States of America.
John R MascolaVaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, United States of America.
Julie E LedgerwoodVaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, United States of America.
Barney S GrahamVaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, United States of America.
VRC 015 study team
National Institute of Allergy and Infectious Diseases · USNational Institutes of Health · US

Funding

HIV Vaccine StudiesZIAAI005035 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI DROPULIC, LESIA K · 2009 to 2025
$89.4M
Testing of Blood Samples for Immune Response and Vaccine ResearchZIAAI005073 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI KOUP, RICHARD A · 2009 to 2025
$23.4M
NIAID Vaccine Immune T cell and Antibody Laboratory CoreZICAI005123 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI KOUP, RICHARD A · 2013 to 2016
$15.1M
6 · The paper itself

Abstract

backgroundNeedle-free delivery improves the immunogenicity of DNA vaccines but is also associated with more local reactogenicity. Here we report the first comparison of Biojector and needle administration of a candidate rAd5 HIV vaccine.

methodsThirty-one adults, 18-55 years, 20 naive and 11 prior rAd5 vaccine recipients were randomized to receive single rAd5 vaccine via needle or Biojector IM injection at 1010 PU in a Phase I open label clinical trial. Solicited reactogenicity was collected for 5 days; clinical safety and immunogenicity follow-up was continued for 24 weeks.

resultsOverall, injections by either method were well tolerated. There were no serious adverse events. Frequency of any local reactogenicity was 16/16 (100%) for Biojector compared to 11/15 (73%) for needle injections. There was no difference in HIV Env-specific antibody response between Biojector and needle delivery. Env-specific antibody responses were more than 10-fold higher in subjects receiving a booster dose of rAd5 vaccine than after a single dose delivered by either method regardless of interval between prime and boost.

conclusionsBiojector delivery did not improve antibody responses to the rAd5 vaccine compared to needle administration. Homologous boosting with rAd5 gene-based vectors can boost insert-specific antibody responses despite pre-existing vector-specific immunity.

trial registrationClinicaltrials.gov NCT00709605 NCT00709605.

Indexed as

Genetic VectorsAdenoviridaeAdolescentAdultAIDS VaccinesEnzyme-Linked Immunosorbent AssayHIV AntibodiesHumansMiddle AgedYoung AdultAIDS VaccinesHIV Antibodies

Identifiers

PMID25264782
PMCPMC4179264
OpenAlexW2067502052

What OpenQuestion holds

Textmetadata
LicenceCC0
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.