Evidence map›Paper›PMID 24091694›Full record

Trial reportJournal of acquired immune deficiency syndromes (1999)2014

Immunogenicity of ALVAC-HIV vCP1521 in infants of HIV-1-infected women in Uganda (HPTN 027): the first pediatric HIV vaccine trial in Africa.

Pontiano Kaleebu, Harr Freeya Njai, Lei Wang, Norman Jones, Isaac Ssewanyana, Paul Richardson, Kenneth Kintu, Lynda Emel, Philippa Musoke, Mary Glenn Fowler and 7 more

Open access · greenAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Journal of acquired immune deficiency syndromes (1999), 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
1.1field-weighted citation impact, top 26% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 17 citations in OpenAlex.

  1. Review
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  7. Virus-based nanoparticles as platform technologies for modern vaccines.Wiley interdisciplinary reviews. Nanomedicine and nanobiotechnology · 2016
    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

17 authors at 7 institutions in 3 countries.

Pontiano Kaleebu*Medical Research Council/Uganda Virus Research Institute, Entebbe, Uganda; †SCHARP, Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA; ‡Viral and Rickettsial Disease Laboratory, Richmond, CA; §Joint Clinical Research Center, Kampala, Uganda; ‖Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD; ¶Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda; #Department of Paediatrics and Child Health, College of Health Sciences, Makerere University, Kampala, Uganda; **George Washington University School of Public Health and Health Services, Washington, DC; ††FHI 360, Durham, NC; and ‡‡Sanofi Pasteur, Discovery Drive, Swiftwater, PA.
Harr Freeya Njai
Lei Wang
Norman Jones
Isaac Ssewanyana
Paul Richardson
Kenneth Kintu
Lynda Emel
Philippa Musoke
Mary Glenn Fowler
San-San Ou
J Brooks Jackson
Laura Guay
Philip Andrew
Lynn Baglyos
Huyen Cao
HPTN 027 protocol team
Johns Hopkins University · USFred Hutch Cancer Center · USCalifornia Health and Human Services Agency · USUganda Virus Research Institute · UGFamily Health International 360 · USGeorge Washington University · USSanofi (Mexico) · MX

Funding

International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) GroupU01AI068632 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI JACKSON, J BROOKS · 2006 to 2010
$109.7M
HIV PREVENTION TRIALS NETWORK LEADERSHIP GROUPU01AI046749 · NIAID · FAMILY HEALTH INTERNATIONAL · PI CATES, WILLARD · 1999 to 2005
$73.5M
Medical Research Council MC_U950097145NIAID NIH HHS U01 AI046749NIAID NIH HHS U01 AI068632NIAID NIH HHS U01AI068632NIAID NIH HHS U01AI46749
6 · The paper itself

Abstract

objectiveMaternal-to-child-transmission of HIV-1 infection remains a significant cause of HIV-1 infection despite successful prevention strategies. Testing protective HIV-1 vaccines remains a critical priority. The immunogenicity of ALVAC-HIV vCP1521 (ALVAC) in infants born to HIV-1-infected women in Uganda was evaluated in the first pediatric HIV-1 vaccine study in Africa.

designHIV Prevention Trials Network 027 was a randomized, double-blind, placebo-controlled phase I trial to evaluate the safety and immunogenicity of ALVAC in 60 infants born to HIV-1-infected mothers with CD4 counts of >500 cells per microliter, which were randomized to the ALVAC vaccine or placebo. ALVAC-HIV vCP1521 is an attenuated recombinant canarypox virus expressing HIV-1 clade E env, clade B gag, and protease gene products.

methodsInfants were vaccinated at birth and 4, 8, and 12 weeks of age with ALVAC or placebo. Cellular and humoral immune responses were evaluated using interferon-γ enzyme-linked immunosorbent spot, carboxyfluorescein diacetate succinimidyl ester proliferation, intracellular cytokine staining, and binding and neutralizing antibody assays. Fisher exact test was used to compare positive responses between the study arms.

resultsLow levels of antigen-specific CD4 and CD8 T-cell responses (intracellular cytokine assay) were detected at 24 months (CD4-6/36 vaccine vs. 1/9 placebo; CD8-5/36 vaccine vs. 0/9 placebo) of age. There was a nonsignificant trend toward higher cellular immune response rates in vaccine recipients compared with placebo. There were minimal binding antibody responses and no neutralizing antibodies detected.

conclusionsHIV-1-exposed infants are capable of generating low levels of cellular immune responses to ALVAC vaccine, similar to responses seen in adults.

Indexed as

AIDS VaccinesAntibodies, NeutralizingCell ProliferationChild, PreschoolDouble-Blind MethodEnzyme-Linked Immunospot AssayFemaleHIV-1HIV AntibodiesHIV InfectionsHumansInfantInfant, NewbornInfectious Disease Transmission, VerticalInterferon-gammaLeukocytes, MononuclearAIDS VaccinesAIDSVAXAntibodies, NeutralizingHIV AntibodiesInterferon-gammaPlacebos

Identifiers

PMID24091694
PMCPMC4171956
OpenAlexW1972386321

What OpenQuestion holds

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Registered trials

None linked

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.