Evidence map›Paper›PMID 24103895›Full record

Trial reportVaccine2013

Safety and infectivity of two doses of live-attenuated recombinant cold-passaged human parainfluenza type 3 virus vaccine rHPIV3cp45 in HPIV3-seronegative young children.

Janet A Englund, Ruth A Karron, Coleen K Cunningham, Philip Larussa, Ann Melvin, Ram Yogev, Ed Handelsman, George K Siberry, Bhavanji Thumar, Elizabeth Schappell and 7 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Vaccine, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 1 pooled it
3.5field-weighted citation impact, top 7% 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

26 citing papers in PubMed, 1 synthesis or guideline pooled it, 46 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Evaluation of a Live Attenuated Human Metapneumovirus Vaccine in Adults and Children.Journal of the Pediatric Infectious Diseases Society · 2018
    Trial
  4. Trial
  5. Evaluation of a Live-Attenuated Human Parainfluenza Type 1 Vaccine in Adults and Children.Journal of the Pediatric Infectious Diseases Society · 2015
    Trial
  6. Article
  7. Review
  8. Article
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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 8 institutions in 1 country.

Janet A EnglundSeattle Children's Hospital, University of Washington, 4800 Sand Point Way NE, Seattle, WA 98105, United States. Electronic address: janet.englund@seattlechildrens.org.
Ruth A Karron
Coleen K Cunningham
Philip Larussa
Ann Melvin
Ram Yogev
Ed Handelsman
George K Siberry
Bhavanji Thumar
Elizabeth Schappell
Catherine V Bull
Helen Y Chu
Anne Schaap-Nutt
Ursula Buchholz
Peter L Collins
Alexander C Schmidt
International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) P1096 Study Group
National Institutes of Health · USSeattle Children's Hospital · USJohns Hopkins University · USColumbia University · USDuke Medical Center · USEunice Kennedy Shriver National Institute of Child Health and Human Development · USNational Institute of Allergy and Infectious Diseases · USNorthwestern 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
International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) GroupU01AI068632 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI JACKSON, J BROOKS · 2006 to 2010
$109.7M
INSTITUTE FOR TRANSLATIONAL HEALTH SCIENCE (UL1): BPCAUL1RR025014 · NCRR · UNIVERSITY OF WASHINGTON · PI DISIS, MARY L. · 2007 to 2011
$51.5M
Institute of Translational Health SciencesUL1TR000423 · NCATS · UNIVERSITY OF WASHINGTON · PI DISIS, MARY L. · 2012 to 2016
$49.4M
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
Prospective Community-Based Study of RSV Risk Factors in Nepalese ChildrenK23AI103105 · NIAID · UNIVERSITY OF WASHINGTON · PI CHU, HELEN YING-HUI · 2013 to 2017
$897k
INTRACELLULAR PH PHYSIOLOGY IN MESANGIAL CELL GROWTHF32DK009001 · NIDDK · YALE UNIVERSITY · PI SINGH, SATISH K · 1993 to 1995
–
Intramural NIH HHSNCRR NIH HHS UL1 RR025014NCRR NIH HHS UL1RR025014NIAID NIH HHS 1U01 AI068616NIAID NIH HHS AI068632NIAID NIH HHS HHSN272200900010CNIAID NIH HHS K23 AI103105NIAID NIH HHS U01 AI068616NIAID NIH HHS U01 AI068632NIAID NIH HHS UM1 AI068632NICHD NIH HHS HHSN267200800001CNIDDK NIH HHS HHSN267200800001GNIDDK NIH HHS N01-DK-9-001/HHSN267200800001CPHS HHS HSN272200900010C
6 · The paper itself

Abstract

backgroundHuman parainfluenza virus type 3 (HPIV3) is a common cause of upper and lower respiratory tract illness in infants and young children. Live-attenuated cold-adapted HPIV3 vaccines have been evaluated in infants but a suitable interval for administration of a second dose of vaccine has not been defined.

methodsHPIV3-seronegative children between the ages of 6 and 36 months were randomized 2:1 in a blinded study to receive two doses of 10⁵ TCID₅₀ (50% tissue culture infectious dose) of live-attenuated, recombinant cold-passaged human PIV3 vaccine (rHPIV3cp45) or placebo 6 months apart. Serum antibody levels were assessed prior to and approximately 4-6 weeks after each dose. Vaccine virus infectivity, defined as detection of vaccine-HPIV3 in nasal wash and/or a≥4-fold rise in serum antibody titer, and reactogenicity were assessed on days 3, 7, and 14 following immunization.

resultsForty HPIV3-seronegative children (median age 13 months; range 6-35 months) were enrolled; 27 (68%) received vaccine and 13 (32%) received placebo. Infectivity was detected in 25 (96%) of 26 evaluable vaccinees following doses 1 and 9 of 26 subject (35%) following dose 2. Among those who shed virus, the median duration of viral shedding was 12 days (range 6-15 days) after dose 1 and 6 days (range 3-8 days) after dose 2, with a mean peak log₁₀ viral titer of 3.4 PFU/mL (SD: 1.0) after dose 1 compared to 1.5 PFU/mL (SD: 0.92) after dose 2. Overall, reactogenicity was mild, with no difference in rates of fever and upper respiratory infection symptoms between vaccine and placebo groups.

conclusionrHPIV3cp45 was immunogenic and well-tolerated in seronegative young children. A second dose administered 6 months after the initial dose was restricted in those previously infected with vaccine virus; however, the second dose boosted antibody responses and induced antibody responses in two previously uninfected children.

Indexed as

Antibodies, ViralChild, PreschoolDouble-Blind MethodDrug-Related Side Effects and Adverse ReactionsFemaleHumansInfantMaleNasal CavityParainfluenza VaccinesParainfluenza Virus 3, HumanPlacebosRespirovirus InfectionsVaccinationVaccines, AttenuatedVaccines, SyntheticAntibodies, ViralParainfluenza VaccinesPlacebosVaccines, AttenuatedVaccines, SyntheticLive-attenuated vaccineParainfluenzaPediatric vaccineRecombinant virus vaccine

Identifiers

PMID24103895
PMCPMC3889708
OpenAlexW2091538916

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.