HIV Infections
Conditions
Keywords
HIV infections, Pneumococcal vaccines, Treatment Experienced, Treatment Naive
Brief 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.
Detailed 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.
Interventions
BIOLOGICAL7-valent pneumococcal conjugate vaccine (vaccine)
BIOLOGICAL23-valent pneumococcal conjugate vaccine (vaccine)
Sponsors
ANRS, Emerging Infectious Diseases
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients responders to 7 pneumococcal polysaccharides at W8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Persistence of antibody responses at W24 and W96 | — |
| Clinical tolerance of pneumococcal vaccines at W8 | — |
| Evolution of the CD4 count and plasma HIV RNA load | — |
| Immunological substudy (predictive factors of the antibody responses) at W24 | — |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORPhilippe Lesprit, MD
Service d'Immunologie Clinique, Créteil, 94010, France
STUDY_DIRECTORGeneviève Chêne, MD, PhD
INSERM unité 593
Outcome results
None listed