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Conjugate And Polysaccharide Vaccines Compared With Polysaccharide Vaccine In Hiv-Infected Adults

NCT00999739 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2009-11-09

No results posted yet for this study

Summary

Randomised study comparing two pneumococcal vaccination strategies in HIV-infected adults with moderate immunossupression (CD4 between 200 and 500 cells/uL and viral load under 5logs), one with conjugated heptavalent vaccine(Prevenar, Wyeth-Lederle) followed by polysaccharide vaccine 4 weeks after (Aventis-Pasteur), and two with one dose of polysaccharide vaccine. Determination of secondary effects related to both vaccines and determination of antibody concentration (ELISA) and avidity (ELISA with thiocyanate) and opsonophagocytosis killing activity against the seven serotypes included in the heptavalent vaccine before vaccination, at 4 weeks, at 8 weeks, at48 weeks and 96 weeks. A sample of 220 HIV-infected adults (110 in each group) will be needed to detect differences of 10% for a type I error o 5% for a limited population of 2500 HIV-infected adults. The main hypothesis are :the immunogenicity of pneumococcal vaccination with conjugate and polysaccharide vaccines is superior to immunogenicity induced by polysaccharide vaccination alone(antibody concentration), the avidity and opsonophagocytosis induced by two vaccines is better than the one after polysaccharide vaccine alone, both vaccinations are safe.

Conditions

  • Pneumococcal Vaccines
  • HIV
  • HIV Infections

Interventions

BIOLOGICAL

Prevenar and Pneumo23

Two vaccines: participants will receive via intramuscular in deltoid one dose of conjugated heptavalent vaccine at day 0 (Prevenar, Wyeth-lederle)and one dose of 23valent polysaccharide vaccine (Pneumo23, AventisPasteur)at week4 One vaccine:participants will receive only one dose of 23valent polysaccharide vaccine at day 0.

Sponsors & Collaborators

  • Hospital Son Llatzer

    collaborator OTHER

  • Fondo de Investigacion Sanitaria

    collaborator OTHER

  • Hospital Universitari Son Dureta

    lead OTHER

Principal Investigators

  • maria penaranda, physician · Hospital Son Dureta

  • antonio payeras, physician · Hospital Son Llatzer

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2008-04-30
Completion
2010-04-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00999739 on ClinicalTrials.gov