Contact information
Type
Scientific
Primary contact
Dr William J Moss
ORCID ID
Contact details
Johns Hopkins University Bloomberg School of Public Health
615 N. Wolfe Street
Baltimore
Maryland
21205
United States of America
+1 410 502 1165
wmoss@jhsph.edu
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00247091
Protocol/serial number
059114
Study information
Scientific title
Impact of human immunodeficiency virus on measles and measles immunisation: an observational cohort study
Acronym
Study hypothesis
We conducted an observational study to assess the immunogenicity of standard-titre measles vaccine in Human Immunodeficiency Virus (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.
Ethics approval
1. Johns Hopkins University Ethics Committee on Human Research, London School of Hygiene and Tropical Medicine (UK)
2. University of Zambia Research Ethics Committee (Zambia)
Study design
Observational, natural history, longitudinal, defined population, prospective study
Primary study design
Observational
Secondary study design
Cross-section survey
Trial setting
Other
Trial type
Screening
Patient information sheet
Condition
HIV infection, measles, children
Intervention
We conducted a longitudinal study to compare the primary vaccine failure rate and rate of antibody decline following administration of standard-titre measles vaccine at nine months of age to HIV-infected and HIV-uninfected Zambian children. The Edmonston-Zagreb measles vaccine strain was administered subcutaneously in the upper arm by a trained health worker. At the time of vaccination, and at each follow-up visit, a study clinical officer or nurse interviewed the mother or guardian about the childs medical history, examined the child for signs of illness, and recorded data on immunisations received as well as the child's length and weight on standard case-report forms. We randomly assigned children to follow-up at one or three months post-vaccination, and asked mothers of all children to return at 15 and 27 months post-vaccination and to seek care from the study team any time the child was ill. Venous blood samples were obtained on the day of vaccination and at one or three, and 15 and 27 months post-vaccination. Antibodies to HIV-1 were measured again by Enzyme Immunoassay (EIA) and antibody-positive samples were assayed for HIV-1 RNA by reverse transcriptase polymerase chain reaction. A modified plaque reduction neutralisation assay was used to measure measles antibodies. Plasma samples were tested in parallel with the Second International World Health Organisation (WHO) Serum Standard, 66/202. Logarithms of antibody levels were calculated, and geometric mean measles antibody concentrations and their 95% Confidence Intervals (CI) estimated.
Intervention type
Drug
Phase
Not Applicable
Drug names
Standard-titre measles vaccine
Primary outcome measures
Primary neutralising antibody responses and persistence of neutralising antibodies following measles vaccination of HIV-1-infected and uninfected children.
Secondary outcome measures
Seroconversion after measles vaccination of HIV-1-infected and uninfected children.
Overall trial start date
05/01/2000
Overall trial end date
09/01/2004
Reason abandoned
Eligibility
Participant inclusion criteria
1. Children aged two to eight months (either sex) presenting for well-child care
2. Reside within 10 miles of the study clinic
3. Parents or caretakers provide signed informed consent
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
700
Participant exclusion criteria
Children with severe illness.
Recruitment start date
05/01/2000
Recruitment end date
09/01/2004
Locations
Countries of recruitment
Zambia
Trial participating centre
Johns Hopkins University Bloomberg School of Public Health
Baltimore, Maryland
21205
United States of America
Sponsor information
Organisation
Johns Hopkins University Bloomberg School of Public Health (USA)
Sponsor details
615 N. Wolfe Street
Baltimore
Maryland
21205
United States of America
wmoss@jhsph.edu
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
The Wellcome Trust (UK) (grant ref: 059114)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2007 results: http://www.ncbi.nlm.nih.gov/pubmed/17597448
Publication citations
-
Results
Moss WJ, Scott S, Mugala N, Ndhlovu Z, Beeler JA, Audet SA, Ngala M, Mwangala S, Nkonga-Mwangilwa C, Ryon JJ, Monze M, Kasolo F, Quinn TC, Cousens S, Griffin DE, Cutts FT, Immunogenicity of standard-titer measles vaccine in HIV-1-infected and uninfected Zambian children: an observational study., J. Infect. Dis., 2007, 196, 3, 347-355, doi: 10.1086/519169.