Evidence map›Paper›PMID 22622049›Full record

Trial reportThe Journal of pediatrics2012

Immunogenicity and safety of 1 vs 2 doses of quadrivalent meningococcal conjugate vaccine in youth infected with human immunodeficiency virus.

Jorge Lujan-Zilbermann, Meredith G Warshaw, Paige L Williams, Stephen A Spector, Michael D Decker, Mark J Abzug, Barb Heckman, Adam Manzella, Bill Kabat, Patrick Jean-Philippe and 3 more

3 registry-linked trialsAbstract readClinical Trial, Phase IClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in The Journal of pediatrics, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 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.

NCT00459316 phase1 / phase2completednot on this map

Phase I/II Study of Safety and Immunogenicity of Quadrivalent Meningococcal Conjugate Vaccine (MCV4) in HIV-Infected Children and Youth And Open Label Immunogenicity Study of a Booster Dose of MCV4 in Previously Immunized HIV-Infected Children and Youth

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2007 to 2013Enrolled384ConditionsHIV Infections, MeningitisArmsQuadrivalent meningococcal conjugate vaccine
NCT03682939 phase4unknown statusnot on this mapstarted 2019, after this paper: background citation

Evaluation of Safety and Immunogenicity of Meningococcal B and Meningococcal ACWY Vaccine in at Risk Population (ProPositive Study)

TypeinterventionalSponsorSt George's, University of LondonRan2019 to 2021Enrolled55ConditionsHiv, Meningitis, Meningococcal, HIV InfectionsArmsBexsero® (meningitis B vaccine), Menveo® (meningitis ACWY vaccine)
NCT04875819 phase4recruitingnot on this mapstarted 2021, after this paper: background citation

Safety and Immunogenicity Following Meningococcal and Pneumococcal Immunization Among Adult People Living With HIV: A Single Center, Non-blinded, Randomized Clinical Trial

TypeinterventionalSponsorThomas BenfieldRan2021 to 2026Enrolled55ConditionsHiv, Meningococcal Infections, Pneumococcal InfectionsArmsNeisseria meningitidis oligosaccharide conjugate vaccine and recombinant protein-based vaccine, 13 valent pneumococcal conjugate vaccine and 23 valent pneumococcal polysaccharide vaccine
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Meningococcal Vaccination: Recommendations of the Advisory Committee on Immunization Practices, United States, 2020.MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2020
    Guideline
  2. Trial
  3. Review
  4. Article
  5. Article
  6. Review
  7. Review
  8. Article
  9. Article
  10. Article
  11. Review
  12. Review
  13. Meningococcal Vaccinations.Infectious diseases and therapy · 2016
    Review
  14. Article
  15. Article
  16. Immunization of children with secondary immunodeficiency.Human vaccines & immunotherapeutics · 2015
    Review
  17. Vaccination in HIV-infected adults.AIDS patient care and STDs · 2014
    Review
  18. Article
  19. 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

13 authors.

Jorge Lujan-ZilbermannUniversity of South Florida College of Medicine, Tampa, FL, USA.
Meredith G Warshaw
Paige L Williams
Stephen A Spector
Michael D Decker
Mark J Abzug
Barb Heckman
Adam Manzella
Bill Kabat
Patrick Jean-Philippe
Sharon Nachman
George K Siberry
International Maternal Pediatric Adolescent AIDS Clinical Trials Group P1065 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 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
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
University of Puerto Rico Clinical Trials UnitUM1AI069415 · NIAID · UNIVERSITY OF PUERTO RICO MED SCIENCES · PI FEBO, IRMA LUZ, SANTANA-BAGUR, JORGE L. · 2012 to 2021
$15.2M
Miami Treatment and Prevention Clinical Trials Unit (CTU)UM1AI069477 · NIAID · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI JAYAWEERA, DUSHYANTHA, SCOTT, GWENDOLYN BARBARA · 2012 to 2020
$9.2M
INTRACELLULAR PH PHYSIOLOGY IN MESANGIAL CELL GROWTHF32DK009001 · NIDDK · YALE UNIVERSITY · PI SINGH, SATISH K · 1993 to 1995
–
NIAID NIH HHS AI068632NIAID NIH HHS L40 AI071436NIAID NIH HHS U01 AI068616NIAID NIH HHS U01 AI068632NIAID NIH HHS U01 AI41110NIAID NIH HHS UM1 AI069415NIAID NIH HHS UM1 AI069477NIDDK NIH HHS N01-DK-9-001
6 · The paper itself

Abstract

objectiveTo compare the immunogenicity of 1 vs 2 doses of meningococcal polysaccharide conjugate vaccine (MCV4) in youth infected with human immunodeficiency virus (HIV). STUDY

designP1065 was a phase I/II immunogenicity and safety trial of MCV4 in 324 youth infected with HIV performed at 27 sites of the International Maternal Pediatric Adolescent AIDS Clinical Trials Group network in the US. At entry subjects received 1 dose of MCV4. At 24 weeks, those with screening cluster of differentiation 4 (CD4)% ≥ 15 were randomized to receive a second dose or not, and all with screening CD4% <15 received a second dose. Immunogenicity was evaluated as the proportion of subjects with a ≥ 4-fold rise from entry in serum bactericidal antibody against each meningococcal serogroup (SG) at weeks 28 and 72. Logistic regression models adjusting for HIV disease severity were used to evaluate the effect of 1 vs 2 MCV4 doses among those with screening CD4% ≥ 15.

resultsSubjects randomized to receive 2 vs 1 MCV4 dose had significantly higher response rates to all SGs at week 28 and to all except Neisseria meningitidis SG Y at week 72, with adjusted ORs of 2.5-5.6. In 31 subjects with screening CD4% <15 who received 2 MCV4 doses, response rates ranged from 22%-55% at week 28 and 6%-28% at week 72.

conclusionIn youth infected with HIV with a CD4% ≥ 15, a second dose of MCV4 given 6 months after the initial dose significantly improves response rates at 28 and 72 weeks. Subjects with CD4% <15 at entry had lower response rates despite 2 doses of MCV4.

Indexed as

AdolescentAdultAntibodies, BacterialChildFemaleHIV InfectionsHumansMaleMeningococcal InfectionsMeningococcal VaccinesMicrobial ViabilityNeisseria meningitidisVaccines, ConjugateYoung AdultAntibodies, BacterialMeningococcal VaccinesVaccines, Conjugate

Identifiers

PMID22622049
PMCPMC3434315

What OpenQuestion holds

Textmetadata
LicenceTDM
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.