Antibody Responses to Pneumococcal Vaccines Among HIV-Infected Adults.

F

French National Agency for Research on AIDS and Viral Hepatitis

Status and phase

Completed
Phase 2

Conditions

HIV Infections

Treatments

Biological: 23-valent pneumococcal conjugate vaccine (vaccine)
Biological: 7-valent pneumococcal conjugate vaccine (vaccine)

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00148824
ANRS 114 PNEUMOVAC

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems