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

Sponsor:	Hospital Universitari Son Dureta
Collaborators:	Hospital Son Llatzer Fondo de Investigacion Sanitaria
Information provided by:	Hospital Universitari Son Dureta
ClinicalTrials.gov Identifier:	NCT00999739

Purpose

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.

Condition	Intervention	Phase
Pneumococcal Vaccines HIV HIV Infections	Biological: Prevenar and Pneumo23	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Sequential Vaccination Strategy With Conjugated and Polysaccharide Pneumococcal Vaccines Compared With Polysaccharide Vaccine in HIV- Infected Adults.

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines

U.S. FDA Resources

Further study details as provided by Hospital Universitari Son Dureta:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	220
Study Start Date:	December 2007
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
two vaccines: Experimental 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	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.
One vaccine: Experimental 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	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.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00999739

Contacts

Contact: maria penaranda, physician	0034971175371	maria.penaranda@ssib.es
Contact: antonio payeras, physician	0034971175371	a.payeras@hsll.es

Locations

Spain, Illes Balears
Hospital Son Dureta	Recruiting
Palma de Mallorca, Illes Balears, Spain, 07014
Contact: Maria Penaranda, physician 0034971175371 maria.penaranda@ssib.es
Principal Investigator: maria penaranda, physician
Hospital Son Llatzer	Recruiting
Palma de Mallorca, Illes Balears, Spain, 07014
Contact: antonio payeras, physician 0037971175371 a.payeras@hsll.es
Principal Investigator: antonio payeras, physician

Sponsors and Collaborators

Hospital Universitari Son Dureta

Hospital Son Llatzer

Fondo de Investigacion Sanitaria

Investigators

Principal Investigator:	maria penaranda, physician	Hospital Son Dureta
Principal Investigator:	antonio payeras, physician	Hospital Son Llatzer

More Information

No publications provided

Responsible Party:	Hospital Son Dureta ( Maria Penaranda )
Study ID Numbers:	Maria Penaranda
Study First Received:	October 21, 2009
Last Updated:	November 6, 2009
ClinicalTrials.gov Identifier:	NCT00999739 History of Changes
Health Authority:	Spain: Comité Ético de Investigación Clínica; Spain: Ethics Committee

Keywords provided by Hospital Universitari Son Dureta:

pneumococcal vaccines
HIV
antibody response

antibody affinity
Antibody formation
Phagocytosis

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on November 30, 2009