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

NCT00999739 | Unknown Phase 3

• 1 other identifier: Maria Penaranda
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

pneumococcal vaccines; HIV; antibody response; antibody affinity; Antibody formation; Phagocytosis

Outcome Measures

Primary Outcomes (1)

• Antibody response in terms of antibody concentration at 4,8,48 and 69 weeks of vaccination

  4, 8, 48 and 96 weeks of vaccination

Secondary Outcomes (4)

• Avidity of the antibodies induced in the two vaccination groups before and at 4 ,8 , 48 and 96 weeks of vaccination

  4 , 8 ,48 and 96 weeks after vaccintation

• safety of both vaccines

  3 days

• risk factors associated to a good vaccine response

  8 weeks, 48 weeks, 96 weeks

• opsonophagocytic activity against the seven polysaccharides before, and after 4,8,48 and 96 weeks of vaccination

  4,8,48 and 96 weeks

Study Arms (2)

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

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

Interventions

Prevenar and Pneumo23 BIOLOGICAL

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.

Also known as: Prevenar (heptavalent conjugated pneumococcal vaccine), Pneumo23 (23valent polysaccharide pneumococcal vaccine)

One vaccine; two vaccines

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• previous pneumococcal vaccine, pregnancy, advanced renal or liver disease, other vaccine or antibiotics 6 weeks before, other immunosuppression, immunoglobulins or investigation drugs

Sponsors & Collaborators

• Hospital Universitari Son Dureta: lead
• Hospital Son Llatzer: collaborator
• Fondo de Investigacion Sanitaria: collaborator

Study Sites (2)

Hospital Son Dureta

Palma de Mallorca, Balearic Islands, 07014, Spain

RECRUITING

Hospital Son Llatzer

Palma de Mallorca, Balearic Islands, 07014, Spain

RECRUITING

Related Publications (1)

• Penaranda 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.

  PMID: 20299956 DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Heptavalent Pneumococcal Conjugate Vaccine; Pneumococcal Vaccines

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Vaccines, Combined

Study Officials

• maria penaranda, physician

  Hospital Son Dureta

  PRINCIPAL INVESTIGATOR

• antonio payeras, physician

  Hospital Son Llatzer

  PRINCIPAL INVESTIGATOR

Central Study Contacts

maria penaranda, physician

CONTACT

0034971175371; maria.penaranda@ssib.es

antonio payeras, physician

CONTACT

0034971175371; a.payeras@hsll.es

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 21, 2009
• First Posted: October 22, 2009
• Study Start: December 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2010
• Last Updated: November 9, 2009

Record last verified: 2009-10

Locations

ES (2)