Evidence map›Paper›PMID 25173484›Full record

Trial reportVaccine2014

PedVacc 002: a phase I/II randomized clinical trial of MVA.HIVA vaccine administered to infants born to human immunodeficiency virus type 1-positive mothers in Nairobi.

Irene N Njuguna, Gwen Ambler, Marie Reilly, Beatrice Ondondo, Mercy Kanyugo, Barbara Lohman-Payne, Christine Gichuhi, Nicola Borthwick, Antony Black, Shams-Rony Mehedi and 6 more

Open access · hybridAbstract readClinical Trial, Phase IClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Vaccine, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
1.4field-weighted citation impact, top 19% 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

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 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

16 authors at 6 institutions in 5 countries.

Irene N NjugunaDepartment of Pediatrics and Child Health, University of Nairobi, PO Box 19676, 00202 Nairobi, Kenya.
Gwen AmblerDepartment of Global Health, University of Washington, Seattle, WA 98104, USA.
Marie ReillyDepartment of Medical Epidemiology and Biostatistics, Karolinska Institute, SE-17177 Stockholm, Sweden.
Beatrice OndondoThe Jenner Institute, University of Oxford, Oxford OX3 7DQ, UK.
Mercy KanyugoDepartment of Pediatrics and Child Health, University of Nairobi, PO Box 19676, 00202 Nairobi, Kenya.
Barbara Lohman-PayneDepartment of Pediatrics and Child Health, University of Nairobi, PO Box 19676, 00202 Nairobi, Kenya.
Christine GichuhiDepartment of Clinical Medicine and Therapeutics, University of Nairobi, PO Box 19676, 00202 Nairobi, Kenya.
Nicola BorthwickThe Jenner Institute, University of Oxford, Oxford OX3 7DQ, UK.
Antony BlackThe Jenner Institute, University of Oxford, Oxford OX3 7DQ, UK.
Shams-Rony MehediStatistics and Data Management Department, Medical Research Council Unit, Fajara, The Gambia.
Jiyu SunDepartment of Medical Epidemiology and Biostatistics, Karolinska Institute, SE-17177 Stockholm, Sweden.
Elizabeth Maleche-ObimboDepartment of Pediatrics and Child Health, University of Nairobi, PO Box 19676, 00202 Nairobi, Kenya.
Bhavna ChohanDepartment of Pediatrics and Child Health, University of Nairobi, PO Box 19676, 00202 Nairobi, Kenya.
Grace C John-StewartDepartments of Pediatrics, Medicine, Epidemiology, and Global Health, University of Washington, Seattle, WA 98104, USA.
Walter JaokoKAVI-Institute of Clinical Research, University of Nairobi, PO Box 19676, 00202 Nairobi, Kenya.
Tomáš HankeThe Jenner Institute, University of Oxford, Oxford OX3 7DQ, UK; The Weatherall Institute of Molecular Medicine, University of Oxford, Oxford OX3 9DS, UK. Electronic address: tomas.hanke@ndm.ox.ac.uk.
University of Nairobi · KEUniversity of Oxford · GBKarolinska Institutet · SEUniversity of Washington · USJenner Institute · GBMRC Unit the Gambia · GM

Funding

University of Washington/Fred Hutch Center for AIDS ResearchP30AI027757 · NIAID · UNIVERSITY OF WASHINGTON · PI EDWIN ROBERTO ORELLANA · 1988 to 2026
$104.9M
Pediatric HIV-1 in Africa: Pathogenesis and ManagementK24HD054314 · NICHD · UNIVERSITY OF WASHINGTON · PI JOHN-STEWART, GRACE C. · 2006 to 2016
$1.2M
Medical Research Council G1000800DNIAID NIH HHS P30 AI027757NICHD NIH HHS K24 HD054314PHS HHS P30A1027757
6 · The paper itself

Abstract

backgroundA safe, effective vaccine for breastfeeding infants born to HIV-1-positive mothers could complement antiretroviral therapy (ART) for prevention of mother-to-child transmission of HIV-1. To date, only a few HIV-1 vaccine candidates have been tested in infants. TRIAL

designA phase I/II randomized controlled trial PedVacc 002 was conducted to determine the safety and immunogenicity of a single, low dose of MVA.HIVA vaccine delivered intramuscularly to healthy 20-week-old infants born to HIV-1-positive mothers in Nairobi, Kenya.

methodsPregnant HIV-1-positive women in the 2nd/3rd trimester of gestation were enrolled, provided with ART and self-selected their infant-feeding modality. Infants received nevirapine and cotrimoxazole prophylaxis. At 20 weeks of age, eligible HIV-1-negative infants were randomized to vaccine versus no-treatment arms and followed to 48 weeks of age for assessments of vaccine safety, HIV-1-specific T-cell responses and antibodies to routine childhood vaccines.

resultsBetween February and November 2010, 182 mothers were screened, 104 were eligible and followed on ART during pregnancy/postpartum, of whom 73 had eligible infants at 20 weeks postpartum. Thirty-six infants were randomized to vaccine and 37 to no treatment. Eighty-four percent of infants breastfed, and retention at 48 weeks was 99%. Adverse events were rare and similar between the two arms. HIV-1-specific T-cell frequencies in interferon-γ ELISPOT assay were transiently higher in the MVA.HIVA arm (p=0.002), but not above the threshold for a positive assay. Protective antibody levels were adequate and similar between arms for all routine childhood vaccines except HBV, where 71% of MVA.HIVA subjects compared to 92% of control subjects were protected (p=0.05).

conclusionsThis trial tested for the first time an MVA-vectored candidate HIV-1 vaccine in HIV-1-exposed infants in Africa, demonstrating trial feasibility and vaccine safety, low immunogenicity, and compatibility with routine childhood vaccinations. These results are reassuring for use of the MVA vector in more potent prime-boost regimens.

Indexed as

AdultAIDS VaccinesAnti-HIV AgentsFemaleHIV-1HIV AntibodiesHIV InfectionsHumansInfantInfectious Disease Transmission, VerticalInterferon-gammaKenyaMaleMothersPregnancyPregnancy Complications, InfectiousAIDS VaccinesAnti-HIV AgentsHIV AntibodiesIFNG protein, humanInterferon-gammaMVA-HIVA vaccineVaccines, DNAEPI vaccinesExposed-uninfected infantsHIV-1Infant vaccine trial in AfricaKEPI vaccinesModified vaccinia virus Ankara (MVA)Pediatric HIV-1 vaccines

Identifiers

PMID25173484
PMCPMC4414927
OpenAlexW2081939945

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Registered trials

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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.