Condition category
Infections and Infestations
Date applied
08/05/2006
Date assigned
12/05/2006
Last edited
10/09/2007
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 Ana-Maria Henao Restrepo

ORCID ID

Contact details

Initiative for Vaccine Research
World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

WHO/MAP/IN/001

Study information

Scientific title

Acronym

Study hypothesis

Respiratory administration of live measles vaccine closely mimics the natural route of measles infection. It is already established that current measles vaccines are more effective or equivalent in inducing antibody production when delivered by nebulisation compared to when delivered parenterally. Maternal antibody interference might be avoided or mucosal immunity might be enhanced. No increase in adverse side effects of respiratory administration has been noted compared to current injection practice. Aerosol delivery devices are available or being developed and could be used by lay people with limited training. Administration of the current measles vaccine via the respiratory route should now be comprehensively studied to achieve licensure for international use.

Ethics approval

Approved by the:
1. Research Ethics Review Committee (ERC) of the World Health Organization on the 4th April 2006
2. Health Ministry Screening Committee (HMSC) of the Ministry of Health (India) on the 17th January 2006

Study design

Multicentre, open, non-controlled, sequential by age group, parallel trial.

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

Measles infection

Intervention

Attenuated measles aerosol vaccine administrated via the following devices:
1. Omron's nebuliser
2. Aerogen's clinical nebuliser
3. Trudell's nebuliser

Intervention type

Drug

Phase

Not Specified

Drug names

Measles vaccine

Primary outcome measures

Evaluation of the safety of aerosol administration of live Edmonston Zagreb attenuated measles vaccine given to healthy volunteers.

Secondary outcome measures

Evaluation of the serum plaque reduction neutralisation titres before and after aerosol administration of live attenuated measles vaccine given to healthy volunteers.

Overall trial start date

10/05/2006

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male subject, 18 to 35 years old for first group
2. Male or female at the age of 1 to 17 years for second and third group
3. Residence in the study area
4. Measles immune, as determined by Plaque Reduction Neutralisation (PRN) titre greater than 120 mIU/ml
5. Healthy on the day of the visit as supported by physical examination and laboratory evaluation on preset parameters
6. Signed informed consent (subject and/or parent/guardian/legal representative)
7. Expressed interest and availability to fulfil the study requirements
8. Non pregnant as certified by pregnancy test and agreement to avoid pregnancy for at least 30 days after vaccination (women of childbearing age)
9. Willing not to receive any experimental drug or vaccine within 90 days after study vaccination

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

60 subjects for 3 sequential age groups; 20 participants in each

Participant exclusion criteria

1. Human Immunodeficiency Virus (HIV) positive (serology test)
2. Pregnant (based on positive pregnancy test)
3. Immunodeficiency or suppression (disease or iatrogenic induced), seizure disorder and progressive neurological disorder
4. Enrolled in any experimental drug or vaccine study within 30 days prior to vaccination
5. Known hypersensitivity to any component of the study vaccine
6. History of thrombocytopenia or immune thrombocytopenia purpura
7. Significant psychiatric or medical illness, including pulmonary disease (such as asthma requiring medication)
8. Severe malnutrition, as indicated by current guidelines by Indian Academic of Paediatrics
9. Axillary temperature greater than 38.3°C or other acute illness on the day of scheduled vaccination
10. Household contact who has a medical history suggestive of disease or drug induced immunodeficiency or suppression (e.g. ongoing treatment with an immunosuppressive agent, chronic diarrhoea for greater than one month, fever for greater than one month, chronic cough for greater than one month, generalised dermatitis or lymphadenopathy, gastrointestinal candidiasis)
11. Receipt of any licensed vaccine within 30 days prior to vaccination

Recruitment start date

10/05/2006

Recruitment end date

31/12/2007

Locations

Countries of recruitment

India

Trial participating centre

Initiative for Vaccine Research
Geneva-27
CH-1211
Switzerland

Sponsor information

Organisation

World Health Organization (WHO) (Switzerland)

Sponsor details

Initiative for Vaccine Research
20 Avenue Appia
Geneva-27
CH-1211
Switzerland

Sponsor type

Research organisation

Website

http://www.who.int/vaccine_research/en/

Funders

Funder type

Research organisation

Funder name

World Health Organization (WHO) (Switzerland)

Alternative name(s)

WHO

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

Switzerland

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

Publication citations

Additional files

Editorial Notes