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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00247091
Other study ID # GR059114MA
Secondary ID
Status Completed
Phase N/A
First received October 28, 2005
Last updated October 28, 2005
Start date May 2000
Est. completion date September 2004

Study information

Verified date October 2005
Source Johns Hopkins Bloomberg School of Public Health
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 700
Est. completion date September 2004
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 2 Months to 15 Months
Eligibility 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 Design

Observational Model: Defined Population, Time Perspective: Longitudinal


Related Conditions & MeSH terms


Intervention

Biological:
standard-titer measles vaccine


Locations

Country Name City State
Zambia Chawama Clinic Lusaka

Sponsors (4)

Lead Sponsor Collaborator
Johns Hopkins Bloomberg School of Public Health Burroughs Wellcome, London School of Hygiene and Tropical Medicine, University of Zambia

Country where clinical trial is conducted

Zambia, 

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