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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Hospital Universitari Son Dureta.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Hospital Son Llatzer
Fondo de Investigacion Sanitaria
Information provided by:
Hospital Universitari Son Dureta
ClinicalTrials.gov Identifier:
NCT00999739
First received: October 21, 2009
Last updated: November 6, 2009
Last verified: October 2009

October 21, 2009
November 6, 2009
December 2007
April 2008   (final data collection date for primary outcome measure)
Antibody response in terms of antibody concentration at 4,8,48 and 69 weeks of vaccination [ Time Frame: 4, 8, 48 and 96 weeks of vaccination ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00999739 on ClinicalTrials.gov Archive Site
  • Avidity of the antibodies induced in the two vaccination groups before and at 4 ,8 , 48 and 96 weeks of vaccination [ Time Frame: 4 , 8 ,48 and 96 weeks after vaccintation ] [ Designated as safety issue: No ]
  • safety of both vaccines [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
  • risk factors associated to a good vaccine response [ Time Frame: 8 weeks, 48 weeks, 96 weeks ] [ Designated as safety issue: No ]
  • opsonophagocytic activity against the seven polysaccharides before, and after 4,8,48 and 96 weeks of vaccination [ Time Frame: 4,8,48 and 96 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Conjugate And Polysaccharide Vaccines Compared With Polysaccharide Vaccine In Hiv-Infected Adults
A Sequential Vaccination Strategy With Conjugated and Polysaccharide Pneumococcal Vaccines Compared With Polysaccharide Vaccine in HIV- Infected Adults.

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.

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. A sample of 220 HIV-infected adults will be randomised to receive twe strategy one(110 patients) one dose of heptavalent conjugated vaccine at day 0 and one dose of polysaccharide vaccine at week 4 (in deltoid muscle); or strategy two (110 patients) one dose of polysaccharide vaccine at day 0. Secondary effects to the vaccines will be evaluated by phone interview 3 days after vaccinations.

Blood samples will be taken at day 0(before the first vaccine), at week 4 before the polysaccharide in the group one, and 4 weeks after the polysaccharide in the group two) and at week 8 in the group one, and at weeks 48 and 96 in both groups Antibody concentration , avidity, and opsonophagocytic killing activity will be measured in all the samples for serotypes 4,14,19F,23F,6B,18C,9V.

Antibody concentration , avidity, and opsonophagocytic killing activity will be compared between both vaccine groups, and between prevaccination and at 4,8, 48 and 96 weeks of vaccination. Risk factors associated to good antibody response (antibody duplication and antibody duplication plus achieve a level above 1ug/ml)will be measured at 8, 48 and96 weeks.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Pneumococcal Vaccines
  • HIV
  • HIV Infections
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.
Other Names:
  • Prevenar (heptavalent conjugated pneumococcal vaccine)
  • Pneumo23 (23valent polysaccharide pneumococcal vaccine)
  • Experimental: two vaccines
    people allocated to arm two vaccines will receive one dose of heptavalent pneumococcal conjugate vaccine at day 0 and 23-valent polysaccharide vaccine at week4 , 110 HIV-infected people will be included Intervention: administration of two vaccines
    Intervention: Biological: Prevenar and Pneumo23
  • Experimental: One vaccine
    people allocated to arm one will receive only one doses of pneumococcal polysaccharide 23-valent vaccine. 110 HIV-infected adults will be included in this arm Intervention: administration of one vaccine
    Intervention: Biological: Prevenar and Pneumo23
Peñaranda M, Payeras A, Cambra A, Mila J, Riera M; Majorcan Pneumococcal Study Group. Conjugate and polysaccharide pneumococcal vaccines do not improve initial response of the polysaccharide vaccine in HIV-infected adults. AIDS. 2010 May 15;24(8):1226-8. doi: 10.1097/QAD.0b013e3283389de5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
220
April 2010
April 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV-infected adults with CD4 between 200 and 500 cels/ul and viral load under 5 logarithm

Exclusion Criteria:

  • previous pneumococcal vaccine, pregnancy, advanced renal or liver disease, other vaccine or antibiotics 6 weeks before, other immunosuppression, immunoglobulins or investigation drugs
Both
18 Years and older
No
Contact: maria penaranda, physician 0034971175371 maria.penaranda@ssib.es
Contact: antonio payeras, physician 0034971175371 a.payeras@hsll.es
Spain
 
NCT00999739
Maria Penaranda
No
Maria Penaranda, Hospital Son Dureta
Hospital Universitari Son Dureta
  • Hospital Son Llatzer
  • Fondo de Investigacion Sanitaria
Principal Investigator: maria penaranda, physician Hospital Son Dureta
Principal Investigator: antonio payeras, physician Hospital Son Llatzer
Hospital Universitari Son Dureta
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP