- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00247091
Impact of HIV on Measles and Measles Immunisation
October 28, 2005 updated by: Johns Hopkins Bloomberg School of Public Health
We conducted a longitudinal study to assess the immunogenicity of standard-titer measles vaccine in HIV-infected and uninfected Zambian children.
The study hypothesis was that HIV-infected children would have higher rates of primary and secondary measles vaccine failure compared to uninfected children, contributing to decreased levels of population immunity to measles and facilitating measles virus transmission in regions of high HIV prevalence.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Despite great progress in measles control in sub-Saharan Africa, measles remains a significant cause of morbidity and mortality in young children.
In regions of high HIV prevalence, measles virus transmission may be sustained despite high immunization coverage rates if HIV-infected children are important transmitters of measles virus.
Factors potentially contributing to enhanced measles virus transmission by HIV-infected children include an early decline in protective maternal antibody titers resulting in susceptibility to measles at a younger age, and high rates of primary and secondary measles vaccine failure.
To evaluate the potential impact of the HIV-1 epidemic on immunity following measles vaccination, we conducted a longitudinal study to compare the primary vaccine failure rate and rate of antibody decline following administration of standard-titer measles vaccine at nine months of age to HIV-infected and HIV-uninfected Zambian children.
Our results show that children born to HIV-infected women have lower levels of passively-acquired maternal antibodies to measles virus prior to the age of routine vaccination at 9 months, and HIV-infected children are particularly susceptible to measles in infancy.
This finding supports the WHO recommendation to provide the first dose of measles vaccine to HIV-infected children at 6 months.
Furthermore, HIV-infected children develop adequate primary antibody responses to measles vaccine in the months following vaccination but lose protective antibody titers by two to three years of age.
Mitigating the potential impact of this decreased immunogenicity on the level of population immunity to measles virus was the high mortality rate observed among HIV-infected children.
Improved access to antiretroviral therapy will likely improve the survival of HIV-infected children without enhancing protective immunity to measles virus, although this has yet to be investigated.
We are working to incorporate our findings into a mathematical model to better understand the impact of the HIV-1 epidemic on measles control strategies and to investigate the immunologic mechanisms for impaired memory B cell responses in HIV-infected children.
Study Type
Observational
Enrollment
700
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Lusaka, Zambia
- Chawama Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 months to 1 year (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- children aged 2 to 8 months presenting for well-child care
- reside within 10 miles of the study clinic
- parents or caretakers provide signed informed consent
Exclusion Criteria:
-children with severe illness
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Defined Population
- Time Perspectives: Prospective
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: William J. Moss, MD, Johns Hopkins University Bloomberg School of Public Health
- Principal Investigator: Felicity Cutts, MD, London School of Hygiene and Tropical Medicine
- Principal Investigator: Francis Kasolo, MD, PhD, University of Zambia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2000
Primary Completion
December 7, 2022
Study Completion
September 1, 2004
Study Registration Dates
First Submitted
October 28, 2005
First Submitted That Met QC Criteria
October 28, 2005
First Posted (Estimate)
November 1, 2005
Study Record Updates
Last Update Posted (Estimate)
November 1, 2005
Last Update Submitted That Met QC Criteria
October 28, 2005
Last Verified
October 1, 2005
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GR059114MA
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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