Evidence map›Paper›PMID 28131393›Full record

Trial reportVaccine2017

Predictors of durable immune responses six months after the last vaccination in preventive HIV vaccine trials.

Yunda Huang, Lily Zhang, Holly Janes, Nicole Frahm, Abby Isaacs, Jerome H Kim, David Montefiori, M Julie McElrath, Georgia D Tomaras, Peter B Gilbert

3 registry-linked trialsOpen access · greenAbstract readClinical Trial, Phase IClinical Trial, Phase IIClinical Trial, Phase III
In one paragraph

Trial report in Vaccine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
0.6field-weighted citation impact, top 40% 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.

NCT00223080 phase3completednot on this map

A Phase III Trial of Aventis Pasteur Live Recombinant ALVAC-HIV (vCP1521) Priming With VaxGen gp120 B/E (AIDSVAX B/E) Boosting in HIV-uninfected Thai Adults

TypeinterventionalSponsorU.S. Army Medical Research and Development CommandRan2003 to 2009Enrolled16,402ConditionsHIV InfectionArmsALVAC-HIV vCP1521 + AIDSVAX, ALVAC Placebo + AIDSVAX Placebo
NCT00820846 phase2completednot on this map

A Phase 2a Clinical Trial to Evaluate the Safety and Immunogenicity of a Prime-boost Vaccine Regimen of pGA2/JS7 DNA and MVA/HIV62, in Healthy, HIV Uninfected Vaccinia-naive Adult Participants

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2009 to 2014Enrolled299ConditionsHIV InfectionsArmspGA2/JS7 DNA vaccine, Placebo, MVA/HIV62 vaccine
NCT01799954 phase1completednot on this map

A Phase 1 Double Blind Placebo-controlled Clinical Trial to Evaluate the Safety and to Compare the Priming Ability of NYVAC Alone Versus NYVAC + AIDSVAX® B/E, and DNA Alone Versus DNA + AIDSVAX® B/E When Followed by NYVAC + AIDSVAX® B/E Boosts in Healthy, HIV-1-uninfected Adult Participants

TypeinterventionalSponsorHIV Vaccine Trials NetworkRan2012 to 2014Enrolled96ConditionsHIV InfectionsArmsDNA-HIV-PT123, NYVAC-HIV-PT1, NYVAC-HIV-PT4, AIDSVAX® B/E, Placebo for DNA/NYVAC
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Pooled it
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  3. Trial
  4. Article
  5. Article
  6. Review
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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

10 authors at 3 institutions in 2 countries.

Yunda HuangVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave. N., Seattle, WA 98109, USA; Public Health Sciences Division, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave. N., Seattle, WA 98109, USA; Department of Global Health, University of Washington, 1510 San Juan Rd., Seattle, WA 98195, USA. Electronic address: yunda@scharp.org.
Lily ZhangVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave. N., Seattle, WA 98109, USA; Public Health Sciences Division, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave. N., Seattle, WA 98109, USA. Electronic address: yzhang2@scharp.org.
Holly JanesVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave. N., Seattle, WA 98109, USA; Public Health Sciences Division, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave. N., Seattle, WA 98109, USA; Department of Biostatistics, University of Washington, 1705 NE Pacific St., Seattle, WA 98195, USA. Electronic address: hjanes@fredhutch.org.
Nicole FrahmVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave. N., Seattle, WA 98109, USA; Department of Global Health, University of Washington, 1510 San Juan Rd., Seattle, WA 98195, USA. Electronic address: nfrahm@fredhutch.org.
Abby IsaacsVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave. N., Seattle, WA 98109, USA; Public Health Sciences Division, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave. N., Seattle, WA 98109, USA. Electronic address: aisaacs@scharp.org.
Jerome H KimU.S. Military HIV Research Program, Walter Reed Army Institute of Research, 503 Robert Grant Ave., Silver Spring, MD 20910, USA; International Vaccine Institute, 1 Gwanak-ro, Gwanak-gu, Seoul, South Korea. Electronic address: Jerome.Kim@ivi.int.
David MontefioriDuke Human Vaccine Institute, Genome Court, MSRB II, Durham, NC 27710, USA. Electronic address: david.montefiori@duke.edu.
M Julie McElrathVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave. N., Seattle, WA 98109, USA; Department of Global Health, University of Washington, 1510 San Juan Rd., Seattle, WA 98195, USA; Department of Laboratory Medicine, University of Washington, 1959 NE Pacific St., Seattle, WA 98195, USA; Department of Medicine, University of Washington, 1959 NE Pacific St., Seattle, WA 98195, USA. Electronic address: jmcelrat@fredhutch.org.
Georgia D TomarasDuke Human Vaccine Institute, Genome Court, MSRB II, Durham, NC 27710, USA. Electronic address: gdt@duke.edu.
Peter B GilbertVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave. N., Seattle, WA 98109, USA; Public Health Sciences Division, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave. N., Seattle, WA 98109, USA; Department of Biostatistics, University of Washington, 1705 NE Pacific St., Seattle, WA 98195, USA. Electronic address: pgilbert@scharp.org.
University of Washington · USFred Hutch Cancer Center · USInternational Vaccine Institute · KR

Funding

LOC: HIV Vaccine Trials NetworkUM1AI068614 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Dan H. Barouch, Lawrence Corey · 2011 to 2026
$1175.6M
LC: HIV Vaccine Trials NetworkUM1AI068618 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Margaret Juliana McElrath · 2011 to 2026
$483.6M
SDMC: HIV Vaccine Trials NetworkUM1AI068635 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Peter B. Gilbert, Yunda Huang · 2011 to 2026
$385.9M
NIAID NIH HHS UM1 AI068614NIAID NIH HHS UM1 AI068618NIAID NIH HHS UM1 AI068635
6 · The paper itself

Abstract

backgroundThe evaluation of durable immune responses is important in HIV vaccine research and development. The efficiency of such evaluation could be increased by incorporating predictors of the responses in the statistical analysis. In this paper, we investigated whether and how baseline demographic variables and immune responses measured two weeks after vaccination predicted durable immune responses measured six months later.

methodsWe included data from seven preventive HIV vaccine regimens evaluated in three clinical trials: a Phase 1 study of four DNA, NYVAC and/or AIDSVAX vaccine regimens (HVTN096), a Phase 2 study of two DNA and/or MVA vaccine regimens (HVTN205), and a Phase 3 study of a single ALVAC/AIDSVAX regimen (RV144). Regularized random forests and linear regression models were used to identify and evaluate predictors of the positivity and magnitude of durable immune responses.

resultsWe analyzed 201 vaccine recipients with data from 10 to 127 immune response biomarkers, and 3-5 demographic variables. The best prediction of participants' durable response positivity based on two-week responses rendered up to close-to-perfect accuracy; the best prediction of participants' durable response magnitude rendered correlation coefficients between the observed and predicted responses ranging up to 0.91. Though prediction performances differed among biomarkers, durable immune responses were best predicted by the two-week response level of the same biomarker. Adding demographic information and two-week response levels of different biomarkers provided little or no improvement in the predictions.

conclusionsFor some biomarkers and for the vaccines we studied, two-week post-vaccination responses can well predict durable responses six months later. Therefore, if immune response durability is only assessed in a sub-sample of vaccine recipients, statistical analyses of durable responses will have increased efficiency by incorporating two-week response data. Further research is needed to generalize the findings to other vaccine regimens and biomarkers. Clinicaltrials.gov identifiers: NCT01799954, NCT00820846, NCT00223080.

Indexed as

Models, StatisticalVaccinationAdultAIDS VaccinesAntibodies, NeutralizingBiomarkersFemaleHIV-1HIV AntibodiesHIV InfectionsHumansImmunization, SecondaryMalePreventive MedicineTime FactorsAIDS VaccinesAntibodies, NeutralizingBiomarkersHIV AntibodiesBinding antibody multiplex arrayImmunogenicityIntracellular cytokine stainingRegularised random forestStatistical power

Identifiers

PMID28131393
PMCPMC5319823
OpenAlexW2582918647

What OpenQuestion holds

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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.