Evidence map›Paper›PMID 29509929›Full record

Trial reportThe Journal of infectious diseases2018

Live Respiratory Syncytial Virus (RSV) Vaccine Candidate Containing Stabilized Temperature-Sensitivity Mutations Is Highly Attenuated in RSV-Seronegative Infants and Children.

Ursula J Buchholz, Coleen K Cunningham, Petronella Muresan, Devasena Gnanashanmugam, Paul Sato, George K Siberry, Vivian Rexroad, Megan Valentine, Charlotte Perlowski, Elizabeth Schappell and 10 more

2 registry-linked trialsOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 44 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 3 pooled it
4.9field-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.

NCT01852266 phase1completednot on this map

A Phase I Study of the Safety and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine RSV cps2, Lot RSV#005A, Delivered as Nose Drops to RSV-Seronegative Infants and Children 6 to 24 Months of Age

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2013Enrolled50ConditionsRespiratory Syncytial Virus InfectionsArmsRSV cps2 Vaccine, Placebo Vaccine
NCT01968083 phase1completednot on this map

A Phase I Study of the Safety and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine RSV cps2, Lot RSV#005A, Delivered as Nose Drops to RSV-Seronegative Infants and Children 6 to 24 Months of Age

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2013 to 2015Enrolled51ConditionsRespiratory Syncytial Virus InfectionsArmsRSV cps2 Vaccine, Placebo Vaccine
3 · Its place in the literature

Who cites it

44 citing papers in PubMed, 3 syntheses or guidelines pooled it, 59 citations in OpenAlex.

  1. Efficacy and safety of respiratory syncytial virus vaccines.The Cochrane database of systematic reviews · 2025
    Pooled it
  2. Vaccines for the common cold.The Cochrane database of systematic reviews · 2022
    Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Article
  11. Article
  12. Review
  13. Review
  14. Article
  15. Article
  16. Review
  17. Review
  18. Article
  19. Article
  20. Review
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

20 authors at 11 institutions in 1 country.

Ursula J BuchholzRNA Viruses Section, Laboratory of Infectious Diseases, Bethesda.
Coleen K CunninghamDepartment of Pediatrics, Duke University School of Medicine, Durham, North Carolina.
Petronella MuresanHarvard T. H. Chan School of Public Health, Boston, Massachusetts.
Devasena GnanashanmugamDivision of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda.
Paul SatoDivision of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda.
George K SiberryMaternal Pediatric Infectious Disease Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda.
Vivian RexroadJohns Hopkins Hospital.
Megan ValentineFHI 360, Durham, North Carolina.
Charlotte PerlowskiFHI 360, Durham, North Carolina.
Elizabeth SchappellCenter for Immunization Research, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
Bhagvinji ThumarCenter for Immunization Research, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
Cindy LuongoRNA Viruses Section, Laboratory of Infectious Diseases, Bethesda.
Emily BarrDepartment of Pediatric Infectious Diseases, Aurora, Colorado.
Mariam AzizRush University Medical Center, Chicago, Illinois.
Ram YogevLurie Children's Hospital of Chicago, Northwestern University Feinberg School of Medicine, Chicago, Illinois.
Stephen A SpectorClinical Trials Unit, International Maternal Pediatric Adolescent AIDS Clinical Trials Group, University of California, San Diego, California.
Peter L CollinsRNA Viruses Section, Laboratory of Infectious Diseases, Bethesda.
Elizabeth J McFarlandDepartment of Pediatric Infectious Diseases, Aurora, Colorado.
Ruth A KarronCenter for Immunization Research, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) P1114 Study Team
Johns Hopkins University · USFamily Health International 360 · USNational Institute of Allergy and Infectious Diseases · USUniversity of Colorado Anschutz Medical Campus · USAIDS Clinical Trials Group · USDuke University · USEunice Kennedy Shriver National Institute of Child Health and Human Development · USHarvard University · USJohns Hopkins Hospital · USNorthwestern University · USRush University Medical Center · 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 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
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
Clinical Trials of Vaccines for Respiratory Syncytial Virus and Related VirusesZIAAI000326 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI BUCHHOLZ, URSULA · 2009 to 2025
$33.1M
NIAID NIH HHS U01 AI068616NIAID NIH HHS UM1 AI068616NIAID NIH HHS UM1 AI068632NIAID NIH HHS UM1 AI106716
6 · The paper itself

Abstract

Background: Respiratory syncytial virus (RSV) is the most important viral cause of severe respiratory illness in young children and lacks a vaccine. RSV cold-passage/stabilized 2 (RSVcps2) is a modification of a previously evaluated vaccine candidate in which 2 major attenuating mutations have been stabilized against deattenuation. Methods: RSV-seronegative 6-24-month-old children received an intranasal dose of 105.3 plaque-forming units (PFU) of RSVcps2 (n = 34) or placebo (n = 16) (International Maternal Pediatric Adolescent AIDS Clinical Trials protocol P1114 and companion protocol CIR285). RSV serum neutralizing antibody titers before and 56 days after vaccination, vaccine virus infectivity (defined as vaccine virus shedding detectable in nasal wash and/or a ≥4-fold rise in serum antibodies), reactogenicity, and genetic stability were assessed. During the following RSV transmission season, participants were monitored for respiratory illness, with serum antibody titers measured before and after the season. Results: A total of 85% of vaccinees were infected with RSVcps2 (median peak titer, 0.5 log10 PFU/mL by culture and 2.9 log10 copies/mL by polymerase chain reaction analysis); 77% shed vaccine virus, and 59% developed a ≥4-fold rise in RSV-serum neutralizing antibody titers. Respiratory tract and/or febrile illness occurred at the same rate (50%) in the vaccine and placebo groups. Deattenuation was not detected at either of 2 stabilized mutation sites. Conclusions: RSVcps2 was well tolerated and moderately immunogenic and had increased genetic stability in 6-24-month-old RSV-seronegative children. Clinical Trials Registration: NCT01852266 and NCT01968083.

Indexed as

Antibodies, NeutralizingAntibodies, ViralFemaleHumansImmunogenicity, VaccineInfantMaleMutationRespiratory Syncytial Virus, HumanRespiratory Syncytial Virus InfectionsRespiratory Syncytial Virus VaccinesVaccines, AttenuatedVirus ReplicationAntibodies, NeutralizingAntibodies, ViralRespiratory Syncytial Virus VaccinesVaccines, Attenuated

Identifiers

PMID29509929
PMCPMC5894088
OpenAlexW2789501639

What OpenQuestion holds

Textmetadata
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.