Safety of an aerosol attenuated measles vaccine in healthy subjects with Omron's nebuliser, Aerogen's clinical nebuliser and Trudell's nebuliser
| ISRCTN | ISRCTN03256458 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN03256458 |
| Secondary identifying numbers | WHO/MAP/IN/001 |
- Submission date
- 08/05/2006
- Registration date
- 12/05/2006
- Last edited
- 10/09/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Ana-Maria Henao Restrepo
Scientific
Scientific
Initiative for Vaccine Research
World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
Study information
| Study design | Multicentre, open, non-controlled, sequential by age group, parallel trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| Scientific title | |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Measles vaccine |
| Primary outcome measure | 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 study start date | 10/05/2006 |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 60 subjects for 3 sequential age groups; 20 participants in each |
| Key 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 |
| Key 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 |
| Date of first enrolment | 10/05/2006 |
| Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- India
- Switzerland
Study participating centre
Initiative for Vaccine Research
Geneva-27
CH-1211
Switzerland
CH-1211
Switzerland
Sponsor information
World Health Organization (WHO) (Switzerland)
Research organisation
Research organisation
Initiative for Vaccine Research
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
| Website | http://www.who.int/vaccine_research/en/ |
|---|---|
"ROR" |
https://ror.org/01f80g185 |
Funders
Funder type
Research organisation
World Health Organization (WHO) (Switzerland)
Private sector organisation / International organizations
Private sector organisation / International organizations
- Alternative name(s)
- منظمة الصحة العالمية, 世界卫生组织, Всемирная организация здравоохранения, Organisation mondiale de la Santé, Organización Mundial de la Salud, WHO, 世卫组织, ВОЗ, OMS
- Location
- Switzerland
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
