Condition category
Infections and Infestations
Date applied
25/06/2007
Date assigned
25/06/2007
Last edited
21/03/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 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 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

http://www.jhsph.edu/

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

  1. 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.

Additional files

Editorial Notes