Evidence map›Paper›PMID 23378284›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2013

Safety and immunogenicity of 2009 pH1N1 vaccination in HIV-infected pregnant women.

Mark J Abzug, Sharon A Nachman, Petronella Muresan, Edward Handelsman, D Heather Watts, Terence Fenton, Barbara Heckman, Elizabeth Petzold, Adriana Weinberg, Myron J Levin and 1 more

Registry-linked trialAbstract readClinical Trial
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00992017 (A Phase II Study to Assess the Safety and Immunogenicity of an Inactivated Monovalent Influenza A), which is not on this map. Cited by 18 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.

NCT00992017 phase2completednot on this map

A Phase II Study to Assess the Safety and Immunogenicity of an Inactivated Monovalent Influenza A (H1N1) Vaccine in HIV-1 Infected Pregnant Women

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2009 to 2010Enrolled130ConditionsHIV Infections, H1N1 Influenza VirusArmsInfluenza A (H1N1) monovalent vaccine
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Review
  6. Observational
  7. Article
  8. Review
  9. Article
  10. Review
  11. Review
  12. Review
  13. Review
  14. Article
  15. Article
  16. Article
  17. Review
  18. 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

11 authors.

Mark J AbzugDepartment of Pediatrics, Infectious Diseases, University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, CO, USA. mark.abzug@childrenscolorado.org
Sharon A Nachman
Petronella Muresan
Edward Handelsman
D Heather Watts
Terence Fenton
Barbara Heckman
Elizabeth Petzold
Adriana Weinberg
Myron J Levin
International Maternal Pediatric Adolescent AIDS Clinical Trials Group P1086 Protocol Team

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
UCSF CLINICAL AND TRANSLATIONAL SCIENCE INSTITUTEUL1RR024131 · NCRR · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI JOHNSTON, S. CLAIBORNE · 2006 to 2011
$111.2M
International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) GroupU01AI068632 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI JACKSON, J BROOKS · 2006 to 2010
$109.7M
Statistical and Data Management Center for the AIDS Clinical Trials GroupU01AI068634 · NIAID · HARVARD SCHOOL OF PUBLIC HEALTH · PI HUGHES, MICHAEL DAVID · 2006 to 2010
$71.9M
Colorado Clinical and Translational Sciences InstituteUL1TR001082 · NCATS · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2013 to 2017
$48.0M
Statistical/Data Management Center-Pediatric AIDS CTGU01AI041110 · NIAID · HARVARD UNIVERSITY (SCH OF PUBLIC HLTH) · PI FENTON, TERRENCE · 1997 to 2006
$38.6M
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
ZORVIRAX ORAL SUSPENSION FOR SEVERE CHILDHOOD HERPES VIRUS INFECTIONSM01RR000069 · NCRR · UNIVERSITY OF COLORADO DENVER · PI KRUGMAN, RICHARD D. · 1985 to 2008
$22.1M
Colorado Clinical and Translational Science Institute (UL1)UL1TR000154 · NCATS · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2012 to 2013
$20.4M
INTRACELLULAR PH PHYSIOLOGY IN MESANGIAL CELL GROWTHF32DK009001 · NIDDK · YALE UNIVERSITY · PI SINGH, SATISH K · 1993 to 1995
–
NCATS NIH HHS UL1 TR000154NCATS NIH HHS UL1 TR001082NCRR NIH HHS M01 RR000069NCRR NIH HHS RR00069NCRR NIH HHS UL1 RR024131NIAID NIH HHS 1 U01 AI068616NIAID NIH HHS 5 U01 AI41110NIAID NIH HHS AI068632NIAID NIH HHS U01 AI041110NIAID NIH HHS U01 AI068616NIAID NIH HHS U01 AI068632NIAID NIH HHS UM1 AI068616NIAID NIH HHS UM1 AI068632NICHD NIH HHS HHSN267200800001CNIDDK NIH HHS HHSN267200800001GNIDDK NIH HHS N01-DK-9-001
6 · The paper itself

Abstract

backgroundPregnant women infected with human immunodeficiency virus (HIV) may have particular vulnerability to 2009 pandemic H1N1 influenza (pH1N1) infection. The safety and immunogenicity of pH1N1 vaccination in HIV-infected pregnant women are unknown.

methodsHIV-infected women 18-39 years of age and 14-34 weeks' gestation on antiretroviral therapy received two 30-μg doses of unadjuvanted, inactivated pH1N1 vaccine 21 days apart. Hemagglutination inhibition titers were measured at entry, 21 days after dose 1, and 10 and 21 days after dose 2, and, in mothers and infants, at delivery and 3 and 6 months postdelivery.

resultsNo severe vaccine-related adverse events were observed among 127 subjects. At entry, 21% had seroprotective (≥1:40) titers. Seroprotection and seroresponse (≥4-fold rise) occurred in 73% and 66% after dose 1 and 80% and 72% after dose 2, respectively. Of women lacking seroprotection at entry, 66% attained seroprotection after dose 1 and 75% after dose 2. Seroprotective titers were present in 67% of mothers and 65% of infants at delivery (median 66 days after dose 2), 60% of mothers and 26% of infants at 3 months postdelivery, and 59% of mothers and 12% of infants at 6 months postdelivery.

conclusionsTwo 30-μg doses were moderately immunogenic in HIV-infected pregnant women. No concerning vaccine-related safety signals were observed. Seroprotection persisted in most women postpartum. Efficient transplacental antibody transfer occurred, but seroprotection in infants waned rapidly. Vaccination to protect HIV-infected pregnant women and their newborns from new influenza strains is feasible, but more immunogenic platforms should be evaluated. Clinical Trials Registration. NCT00992017.

Indexed as

AdolescentAdultAntibodies, ViralCD4 Lymphocyte CountChi-Square DistributionFemaleHemagglutination Inhibition TestsHIV InfectionsHumansInfant, NewbornInfluenza A Virus, H1N1 SubtypeInfluenza, HumanInfluenza VaccinesPregnancyPregnancy Complications, InfectiousAntibodies, ViralInfluenza Vaccines

Identifiers

PMID23378284
PMCPMC3634309

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.