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OpenTrials
Completed

NCT Number: NCT00137605

Early Versus Delayed Pneumococcal Vaccination in HIV

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.

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Key information

Conditions

Pneumococcal Infections Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Communicable Diseases Genital Diseases Gram-Positive Bacterial Infections HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Streptococcal Infections Urogenital Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Medical Arts Health Research Group, Kelowna, British Columbia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pneumovax

Biological

Prevnar

Biological

Primary outcomes

  1. Number of serotypes to which a response is found

  2. A response is defined as a doubling in antibody titer at 1 month compared to baseline.

Secondary outcomes

  1. Antibody response at 6 months and one year

  2. Changes in viral load 3 months post immunization

  3. Adverse events

  4. Overall incidence of invasive pneumococcal disease

  5. Incidence of invasive pneumococcal disease between vaccines

Sponsors and collaborators

Lead sponsor

CIHR Canadian HIV Trials Network

Network

Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

Registry information

Official study title

A Pilot Study Assessing the Efficacy of Pneumococcal Vaccine in HIV Patients: Delayed Versus Immediate Immunization

Important dates

Study start
2004
Study completion
2007
First posted
Aug 30, 2005
Registry last updated
Feb 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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