Study of measles immunisation
| ISRCTN | ISRCTN07638533 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN07638533 |
| ClinicalTrials.gov (NCT) | NCT00247091 |
| Protocol serial number | 059114 |
| Sponsor | Johns Hopkins University Bloomberg School of Public Health (USA) |
| Funder | The Wellcome Trust (UK) (grant ref: 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
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 |
|---|---|
| wmoss@jhsph.edu |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational, natural history, longitudinal, defined population, prospective study |
| Secondary study design | Cross-section survey |
| Scientific title | Impact of human immunodeficiency virus on measles and measles immunisation: an observational cohort study |
| Study objectives | 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(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) studied | 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 / device / biological / vaccine name(s) | Standard-titre measles vaccine |
| Primary outcome measure(s) |
Primary neutralising antibody responses and persistence of neutralising antibodies following measles vaccination of HIV-1-infected and uninfected children. |
| Key secondary outcome measure(s) |
Seroconversion after measles vaccination of HIV-1-infected and uninfected children. |
| Completion date | 09/01/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 2 Months |
| Upper age limit | 8 Months |
| Sex | All |
| Target sample size at registration | 700 |
| Key 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 |
| Key exclusion criteria | Children with severe illness. |
| Date of first enrolment | 05/01/2000 |
| Date of final enrolment | 09/01/2004 |
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
21205
United States of America
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
