Evidence map›Paper›PMID 25936724›Full record

Trial reportVaccine2015

A double-blind, randomised, placebo-controlled, dose-finding trial of the novel tuberculosis vaccine AERAS-402, an adenovirus-vectored fusion protein, in healthy, BCG-vaccinated infants.

M Tameris, D A Hokey, V Nduba, J Sacarlal, F Laher, G Kiringa, K Gondo, E M Lazarus, G E Gray, S Nachman and 20 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Vaccine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01198366 (A Phase II, Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Safety and Immunogenicity of AERAS-402 in BCG-vaccinated, HIV-uninfected Infants Without Evidence of Tuberculosis), which is not on this map. Cited by 36 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 1 pooled it
5.2field-weighted citation impact, top 4% 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.

NCT01198366 phase1 / phase2completednot on this map

A Phase II, Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Safety and Immunogenicity of AERAS-402 in BCG-vaccinated, HIV-uninfected Infants Without Evidence of Tuberculosis

TypeinterventionalSponsorAerasRan2010 to 2014Enrolled487ConditionsTuberculosisArmsAERAS-402 1.5 x 10^10 vp, AERAS-402 3.0 x 10^10 vp, AERAS-402 1.0 x 10^11 vp, Placebo
3 · Its place in the literature

Who cites it

36 citing papers in PubMed, 1 synthesis or guideline pooled it, 64 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Antigen 85B ofVaccines · 2026
    Review
  5. Article
  6. Developing the next-generation of adenoviral vector vaccines.Human vaccines & immunotherapeutics · 2025
    Review
  7. Article
  8. Review
  9. Review
  10. Article
  11. Article
  12. Review
  13. What's Old and New in Tuberculosis Vaccines for Children.Journal of the Pediatric Infectious Diseases Society · 2022
    Article
  14. Review
  15. Article
  16. An Update on Tuberculosis Vaccines.Methods in molecular biology (Clifton, N.J.) · 2022
    Article
  17. Article
  18. Article
  19. Review
  20. 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

30 authors at 7 institutions in 4 countries.

M TamerisSouth African Tuberculosis Vaccine Initiative (SATVI), Department of Paediatrics and Child Health and Institute of Infectious Disease & Molecular Medicine, University of Cape Town, Cape Town, South Africa. Electronic address: michele.tameris@uct.ac.za.
D A HokeyAeras, Rockville, MD, USA.
V NdubaKEMRI/CDC, Kisumu, Kenya.
J SacarlalCentro de Investigação em Saúde de Manhiça (CISM), Manhiça, Mozambique; Faculty of Medicine, Universidade Eduardo Mondlane, Maputo, Mozambique.
F LaherPerinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
G KiringaKEMRI/CDC, Kisumu, Kenya.
K GondoCentro de Investigação em Saúde de Manhiça (CISM), Manhiça, Mozambique.
E M LazarusPerinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
G E GrayPerinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
S NachmanState University of New York at Stony Brook, Stony Brook, NY, USA.
H MahomedSouth African Tuberculosis Vaccine Initiative (SATVI), Department of Paediatrics and Child Health and Institute of Infectious Disease & Molecular Medicine, University of Cape Town, Cape Town, South Africa.
K DowningSouth African Tuberculosis Vaccine Initiative (SATVI), Department of Paediatrics and Child Health and Institute of Infectious Disease & Molecular Medicine, University of Cape Town, Cape Town, South Africa.
B AbelSouth African Tuberculosis Vaccine Initiative (SATVI), Department of Paediatrics and Child Health and Institute of Infectious Disease & Molecular Medicine, University of Cape Town, Cape Town, South Africa.
T J ScribaSouth African Tuberculosis Vaccine Initiative (SATVI), Department of Paediatrics and Child Health and Institute of Infectious Disease & Molecular Medicine, University of Cape Town, Cape Town, South Africa.
J B McClainAeras, Rockville, MD, USA.
M G PauCrucell Holland BV, Archimedesweg 4-6, 2333 CN Leiden, The Netherlands.
J HendriksCrucell Holland BV, Archimedesweg 4-6, 2333 CN Leiden, The Netherlands.
V DheenadhayalanAeras, Rockville, MD, USA.
S IshmukhamedovAeras, Rockville, MD, USA.
A K K LuabeyaSouth African Tuberculosis Vaccine Initiative (SATVI), Department of Paediatrics and Child Health and Institute of Infectious Disease & Molecular Medicine, University of Cape Town, Cape Town, South Africa.
H GeldenhuysSouth African Tuberculosis Vaccine Initiative (SATVI), Department of Paediatrics and Child Health and Institute of Infectious Disease & Molecular Medicine, University of Cape Town, Cape Town, South Africa.
B ShepherdAeras, Rockville, MD, USA.
G BlatnerAeras, Rockville, MD, USA.
V CardenasAeras, Rockville, MD, USA.
R WalkerAeras, Rockville, MD, USA.
W A HanekomSouth African Tuberculosis Vaccine Initiative (SATVI), Department of Paediatrics and Child Health and Institute of Infectious Disease & Molecular Medicine, University of Cape Town, Cape Town, South Africa.
J SadoffCrucell Holland BV, Archimedesweg 4-6, 2333 CN Leiden, The Netherlands.
M DouoguihCrucell Holland BV, Archimedesweg 4-6, 2333 CN Leiden, The Netherlands.
L BarkerAeras, Rockville, MD, USA.
M HatherillSouth African Tuberculosis Vaccine Initiative (SATVI), Department of Paediatrics and Child Health and Institute of Infectious Disease & Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Aeras · USUniversity of Cape Town · ZASouth African Tuberculosis Vaccine Initiative · ZAPerinatal HIV Research Unit · ZAKenya Medical Research Institute · KEManhiça Health Research Centre · MZStony Brook University · US

Funding

LOC-IMPAACT Leadership GroupPharmacokinetics and Safety of Remdesivir for Treatment of COVID-19 in Pregnant Women in the USUM1AI068632 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI Jennifer Jao, Sharon A Nachman · 2011 to 2026
$278.1M
Statistical and Data Management Center-Pediatric,Adolescent, and Maternal CTGUM1AI068616 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Sean Scott Brummel, Marlene Ann Cooper · 2011 to 2026
$155.6M
International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) GroupU01AI068632 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI JACKSON, J BROOKS · 2006 to 2010
$109.7M
LC - IMPAACT Leadership GroupUM1AI106716 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$47.2M
Statistical and Data Management Center-Pediatric,Adolescent, and Maternal CTGU01AI068616 · NIAID · HARVARD SCHOOL OF PUBLIC HEALTH · PI SHAPIRO, DAVID ERIC · 2006 to 2010
$38.6M
NIAID NIH HHS UM1 AI068616NIAID NIH HHS UM1AI068616NIAID NIH HHS UM1 AI068632NIAID NIH HHS UM1AI068632NIAID NIH HHS UM1 AI106716NIAID NIH HHS UM1AI106716
6 · The paper itself

Abstract

backgroundSeveral novel tuberculosis vaccines are currently in clinical trials, including AERAS-402, an adenovector encoding a fusion protein of Mycobacterium tuberculosis antigens 85A, 85B, and TB10.4. A multicentred trial of AERAS-402 safety and immunogenicity in healthy infants was conducted in three countries in sub-Saharan Africa, using an adaptive design.

methodsIn a double-blind, randomised, placebo-controlled, dose-finding trial, we enrolled BCG-vaccinated, HIV-uninfected infants aged 16-26 weeks. Infants in the safety/dose-finding phase received two doses of AERAS-402 across three dose levels, or placebo, intramuscularly on days 0 and 28. Infants in the expanded safety phase received three doses of the highest dose level, with the 3rd dose at day 280. Follow up for safety and immunogenicity was for up to two years.

resultsWe enrolled 206 infants (52 placebo and 154 AERAS-402 recipients) into the dose-finding phase and 281 (141 placebo and 140 AERAS-402 recipients) into the expanded safety phase. Safety data were acceptable across all dose levels. No vaccine-related deaths were recorded. A single serious adverse event of tachypnoea was deemed related to study vaccine. Antibodies directed largely against Ag85A and Ag85B were detected. Low magnitude CD4+ and CD8+ polyfunctional T cell responses were observed at all dose levels. The addition of a third dose of AERAS-402 at the highest dose level did not increase frequency or magnitude of antibody or CD8+ T cell responses.

conclusionsAERAS-402 has an acceptable safety profile in infants and was well tolerated at all dose levels. Response rate was lower than previously seen in BCG vaccinated adults, and frequency and magnitude of antigen-specific T cells were not increased by a third dose of vaccine.

Indexed as

AcyltransferasesAdultAfrica South of the SaharaAntibodies, BacterialAntigens, BacterialBCG VaccineCD4-Positive T-LymphocytesCD8-Positive T-LymphocytesDose-Response Relationship, ImmunologicDouble-Blind MethodFemaleHealthy VolunteersHumansImmunity, HumoralInfantInterferon-gammaAcyltransferasesAERAS-402Antibodies, Bacterialantigen 85A, Mycobacterium tuberculosisAntigens, BacterialBCG VaccineInterferon-gammaTuberculosis VaccinesVaccines, DNAAdenovirus vectoredInfantNovel TB vaccine trialTuberculosis vaccine

Identifiers

PMID25936724
PMCPMC6698638
OpenAlexW2055129955

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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.