ISRCTN ISRCTN07638533
DOI https://doi.org/10.1186/ISRCTN07638533
ClinicalTrials.gov number NCT00247091
Secondary identifying numbers 059114
Submission date
25/06/2007
Registration date
25/06/2007
Last edited
21/03/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr William J Moss
Scientific

Johns Hopkins University Bloomberg School of Public Health
615 N. Wolfe Street
Baltimore, Maryland
21205
United States of America

Phone +1 410 502 1165
Email wmoss@jhsph.edu

Study information

Study designObservational, natural history, longitudinal, defined population, prospective study
Primary study designObservational
Secondary study designCross-section survey
Study setting(s)Other
Study typeScreening
Scientific titleImpact of human immunodeficiency virus on measles and measles immunisation: an observational cohort study
Study objectivesWe 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(s)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)
Health condition(s) or problem(s) studiedHIV infection, measles, children
InterventionWe 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 child’s 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Standard-titre measles vaccine
Primary outcome measurePrimary neutralising antibody responses and persistence of neutralising antibodies following measles vaccination of HIV-1-infected and uninfected children.
Secondary outcome measuresSeroconversion after measles vaccination of HIV-1-infected and uninfected children.
Overall study start date05/01/2000
Completion date09/01/2004

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit2 Months
Upper age limit8 Months
SexBoth
Target number of participants700
Key inclusion criteria1. 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
Key exclusion criteriaChildren with severe illness.
Date of first enrolment05/01/2000
Date of final enrolment09/01/2004

Locations

Countries of recruitment

  • United States of America
  • Zambia

Study participating centre

Johns Hopkins University Bloomberg School of Public Health
Baltimore, Maryland
21205
United States of America

Sponsor information

Johns Hopkins University Bloomberg School of Public Health (USA)
University/education

615 N. Wolfe Street
Baltimore, Maryland
21205
United States of America

Email wmoss@jhsph.edu
Website http://www.jhsph.edu/
ROR logo "ROR" https://ror.org/00za53h95

Funders

Funder type

Charity

The Wellcome Trust (UK) (grant ref: 059114)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results: 01/08/2007 Yes No