Title
A Clinical Trial to Assess the Safety of a Measles Vaccine (Dry Powder) Administered by Two Different Devices
An Open-Label, Randomized, Phase I Study in Healthy Male Adults to Evaluate the Safety of a Measles Vaccine (Dry Powder)Administered by Two Devices
Phase
Phase 1Lead Sponsor
Serum Institute of India Pvt. Ltd.Study Type
InterventionalStatus
Completed Results PostedIndication/Condition
Prophylaxis for the Measles InfectionIntervention/Treatment
attenuated measles vaccine - Edmonston strain ...Study Participants
60This is a phase I, open-label, randomized study in healthy adults. Eligible subjects will be given single dose of either Dry Powdered Measles Vaccine (PMV) by Puffhaler® device, Dry PMV by SoloventTM device or licensed measles vaccine by subcutaneous route (SMV). Subjects will be followed for 180 days for safety.
This is a phase I, open-label, randomized study in healthy adults. Eligible subjects will be given single dose of either Dry Powdered Measles Vaccine (PMV) by Puffhaler® device, Dry PMV by SoloventTM device or licensed measles vaccine by subcutaneous route (SMV). Solicited reactions will be assessed for first 14 days after vaccination and unsolicited adverse events will be assessed till 84 days after vaccination. Subjects will be followed for 180 days for any SAEs.
The vaccine will be administered via a Puffhaler® device. A single dose of 10 mg of PMV (dry powder measles vaccine) will be used.
The vaccine will be administered via SoloventTM device. A single dose of 10 mg of PMV (dry powder measles vaccine) will be used.
This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml will be given subcutaneously.
The dry powder measles vaccine will be administered via a Puffhaler® device. A single dose of 10 mg will be used.
The dry powder measles vaccine will be administered via a SoloventTM device. A single dose of 10 mg will be used.
Licensed measles vaccine will be administered subcutaneously as single dose of 0.5 ml.
Inclusion Criteria: Male adults of age of 18-45 years. Measles immune, as determined by IgG antibody levels. Healthy as supported by medical history, physical examination and laboratory evaluation on preset parameters. Signed informed consent for participation in trial and for HIV screening. Exclusion Criteria: Medical history of immunodeficiency/suppression or subject with history of close contact with immunocompromised/ immunosuppressed person. Chronic administration of immunosuppressants or other immune modifying agents Acute febrile illness or suspected measles illness or acute infectious disease Acute or chronic, clinically significant pulmonary, endocrine, autoimmune, psychiatric, cardiovascular, neurological, hepatic or renal functional abnormality which in the opinion of the investigator, might interfere with the study objectives History of seizure disorders Major congenital defects Thrombocytopenia or known bleeding disorders 8. History of a previous severe allergic reaction Positive serology for HIV antibody, HCV antibody or Hepatitis B surface antigen Known hypersensitivity to any component of the study vaccine
| Event Type | Organ System | Event Term |
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Incidence of solicited local and systemic reactions within 14 days of vaccine administration in each group was assessed.
Incidence of unsolicited adverse events for a period of 84 days in each group was assessed.
Incidence of serious adverse events (SAEs) and new onset chronic medical conditions throughout the entire study period of 180 days in each group was assessed.
The proportion of subjects in each group with seropositive anti-Measles IgG antibodies on Day -7, Day 28 and Day 84 was assessed.
The proportion of subjects in each group with seroprotective plaque-reduction neutralization test (PRNT) titre on Day -7, Day 28 and Day 84 was assessed.
The proportion of subjects in each group who show a seroconversion for serum anti-Measles IgG on Day 28 and Day 84 was assessed.
The proportion of subjects in each group who show a seroconversion for PRNT on Day 28 and Day 84 was assessed.
Geometric Mean Concentration (GMC) for anti-Measles IgG antibodies were measured on Day -7, Day 28 and Day 84 by ELISA using Trinity ELISA Kits for Measles.
Geometric Mean Titre by Plaque Reduction Neutralization Test were assessed on Day -7, 28 and 84 at CDC, Atlanta. Titers are expressed as IU/ml.
