Antibody Responses to Pneumococcal Vaccines Among HIV-Infected Adults.

HIV Infections Clinical Trial

Official title:

Immunological Efficacy of a Prime-Boost Strategy Combining a 7-Valent Pneumococcal Conjugate Vaccine (PCV) Followed by a 23-Valent Pneumococcal Polysaccharide Vaccine (PPV) Versus PPV Alone in HIV-Infected Adults. ANRS 114 PNEUMOVAC.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00148824
• Other study ID #: ANRS 114 PNEUMOVAC
• Status: Completed
• Phase: Phase 2
• First received: September 7, 2005
• Last updated: March 20, 2008
• Start date: February 2003
• Est. completion date: January 2006

Study information

• Verified date: March 2008
• Source: French National Agency for Research on AIDS and Viral Hepatitis
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

Streptococcus pneumoniae is the major cause of bacterial infection in HIV-infected patients. The current pneumococcal vaccine is poorly efficacious in patients with a CD4 cell count lower than 500/mm3. This study will test the efficacy and safety of a new pneumococcal vaccine strategy in patients with a CD4 cell count between 200 and 500/mm3.

Description:

Streptococcus pneumoniae (SP) is the major cause of bacterial infection in HIV-infected patients. The 23-valent pneumococcal polysaccharide (PPV) is poorly immunogenic in patients with CD4 below 500 cells/mm3. The purpose of this multicentric national study is to evaluate whether a prime with a 7-valent pneumococcal conjugate vaccine (PCV), able to induce immunological memory, would improve immunogenicity against SP polysaccharides. 212 HIV-1 infected patients, with a CD4 count between 200 and 500/mm3, will be randomly assigned to one of two vaccine groups: PCV at Week 0 followed by PPV at Week 4 or PPV alone at Week 4. Evaluation will be done at week 8. The primary endpoint is the proportion of patients who had antibody responses against 7 pneumococcal polysaccharides at Week 8. Secondary endpoints include the persistence of antibody responses at Weeks 24 and 96, vaccines safety and occurrence of pneumococcal disease over time.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients with proven HIV-1 infection

• Naïve or antiretroviral experienced

• CD4 cell count between 200 and 500/mm3

• Plasma HIV RNA load lower than 4 log10 copies/mL

• Signed written informed consent

Exclusion Criteria:

• Immunotherapy

• Immunization with the PPV within the past 5 years

• Splenectomy

• Use of intravenous immunoglobulin within the past 2 months

• Chemotherapy or radiation

• Any other vaccination within the past 2 months

• Severe renal failure

• End-stage liver disease

• Pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections

Intervention

Biological:
• 7-valent pneumococcal conjugate vaccine (vaccine)

• 23-valent pneumococcal conjugate vaccine (vaccine)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
French National Agency for Research on AIDS and Viral Hepatitis	Wyeth is now a wholly owned subsidiary of Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients responders to 7 pneumococcal polysaccharides at W8
Secondary	Persistence of antibody responses at W24 and W96
Secondary	Clinical tolerance of pneumococcal vaccines at W8
Secondary	Evolution of the CD4 count and plasma HIV RNA load
Secondary	Immunological substudy (predictive factors of the antibody responses) at W24