Early Versus Delayed Pneumococcal Vaccination in HIV

CIHR Canadian HIV Trials Network

Status and phase: Completed; Phase 2; Phase 1

Conditions: Pneumococcal Infections

Treatments: Biological: Pneumovax; Biological: Prevnar

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT00137605

CTN 147

File # 9427-C1574-34C

Control # 078760

Details and patient eligibility

About

The purpose of this study is to determine whether people who are HIV-positive respond better to a vaccine for pneumonia-related disease when they are immunized immediately, or when immunization is delayed until the immune system has improved to a certain level. The study will also compare the effectiveness of polysaccharide and heptavalent vaccines.

Full description

A multicentre, randomized controlled trial using a two factorial design. Eighty patients will be randomly assigned to receive either Pneumovax (or Pneumo23 according to standard use at site) or heptavalent pneumococcal conjugate vaccine (Prevnar) prior to reconstitution of the immune system or will have immunization delayed until their CD4 count is greater than 200 cells/mm3 after the introduction of antiretroviral therapy. Randomization will be stratified by study centre. Variable block sizes will be used to try to prevent study personnel from guessing the next allocation. Random allocation lists will be generated by computer.

Enrollment: 79 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• HIV-positive
• Between 18 and 65 years of age
• Have a CD4 cell count below 200 cells/mm3
• Willing to begin/change antiretroviral therapy
• Willing and able to provide informed consent

Exclusion criteria

• Pregnant or breastfeeding
• Have had previous pneumococcal vaccination
• Have had occurrence of pneumococcal infection (brain, blood or lung infections) in past 5 years
• Have hypersensitivity to components of either vaccine
• Have acute feverish illness at the time of vaccination
• Have had splenectomy (removal of the spleen)
• Have received treatment with IVIG within the last 6 months

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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79 participants in 4 patient groups

Pneumovax/immediate

Experimental group

Treatment:

Biological: Pneumovax

Pneumovax/delayed

Experimental group

Treatment:

Biological: Pneumovax

Prevnar/immediate

Experimental group

Treatment:

Biological: Prevnar

Prevnar/delayed

Experimental group

Treatment:

Biological: Prevnar