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Completed

NCT Number: NCT01286493

Immune Response After Booster Vaccination in HIV - Infected Patients Who Received Rabies Primary Vaccination

Booster rabies vaccination in HIV - infected patients who have ever received rabies primary vaccination could improve their immune response to this kind of vaccine.

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Key information

Conditions

HIV Infections Mononegavirales Infections RNA Virus Infections Rabies Rhabdoviridae Infections Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Saovabha Memorial Institute

Bangkok, 10330, Thailand

About this study

The investigators have learned from the previous studies that some HIV-infected patients especially those with low CD4+ T-lymphocyte count had poor antibody response to rabies vaccination. Because of the role of the memory B cell, the investigators hypothesized that primary rabies immunization in HIV-infected patients could rise rapid anamnestic antibody response to ones after booster vaccination in case of re-exposure of rabies occur despite of their immunocompromised state.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • HIV infected patients 18-60 years of age
  • Ever received primary rabies immunization

Exclusion criteria

  • currently have any active opportunistic infections
  • have received blood or blood product within previous 3 months
  • history of allergy to vaccine or any vaccine components
  • currently received anti-malarial drugs

Treatment and study plan

rabies vaccines on day 0 and 3

Biological

All subjects would receive conventional intramuscular booster rabies vaccination on day 0 and 3. Their blood would be drawn for rabies neutralizing antibody on day 0,7,14,30,90,180,360

Primary outcomes

  1. Rabies Neutralizing Antibody Titers

    Time frame: Day 360

    Rabies Neutralizing Antibody titers(RNab)of HIV-infected patients who receive booster rabies vaccination would be measured by Rapid Fluorescent Focus Inhibition Test(RFFIT) method at day 0, 7, 14, 28, 90,180 and 360. RNab level above 0.5 IU/ml indicate acceptable protective antibody response.

    for 7 times in 1 year.

Sponsors and collaborators

Lead sponsor

Queen Saovabha Memorial Institute

Other

Registry information

Official study title

Immune Response After Booster Vaccination in HIV - Infected Patients Who Ever Received Rabies Primary Vaccination

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 31, 2011
Registry last updated
Nov 18, 2015

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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