A Clinical Trial to Assess the Safety of a Measles Vaccine (Dry Powder) Administered by Two Different Devices

Study Overview
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Brief Summary
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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). Subjects will be followed for 180 days for safety.

Detailed Description
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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.

Official Title
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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

Conditions
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Prophylaxis for the Measles Infection

Intervention / Treatment
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* Biological: PMV via Puffhaler® device
* Biological: PMV via SoloventTM device
* Biological: Licensed Subcutaneous Measles Vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PMV via Puffhaler® Device<br>The dry powder measles vaccine will be administered via a Puffhaler® device. A single dose of 10 mg will be used. | Biological: PMV via Puffhaler® device<br>* The vaccine will be administered via a Puffhaler® device. A single dose of 10 mg of PMV (dry powder measles vaccine) will be used.<br>|
| Experimental: PMV via SoloventTM device<br>The dry powder measles vaccine will be administered via a SoloventTM device. A single dose of 10 mg will be used. | Biological: PMV via SoloventTM device<br>* The vaccine will be administered via SoloventTM device. A single dose of 10 mg of PMV (dry powder measles vaccine) will be used.<br>|
| Active Comparator: Licensed Subcutaneous Measles Vaccine<br>Licensed measles vaccine will be administered subcutaneously as single dose of 0.5 ml. | Biological: Licensed Subcutaneous Measles Vaccine<br>* This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml will be given subcutaneously.<br>* Other names: SMV;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Solicited Reactions | Incidence of solicited local and systemic reactions within 14 days of vaccine administration in each group was assessed. | Day 14 | 
| Incidence of Unsolicited Adverse Events Within 84 Days | Incidence of unsolicited adverse events for a period of 84 days in each group was assessed. | Day 84 | 
| Incidence of Serious Adverse Events (SAEs) and New Onset Chronic Medical Conditions | 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. | Day 180 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Proportion of Subjects in Each Group With Seropositive Anti-Measles IgG Antibodies | The proportion of subjects in each group with seropositive anti-Measles IgG antibodies on Day -7, Day 28 and Day 84 was assessed. | Day -7, Day 28 and Day 84 | 
| The Proportion of Subjects in Each Group With Seroprotective Plaque-reduction Neutralization Test (PRNT) Titre | 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. | Day -7, Day 28 and Day 84 | 
| The Proportion of Subjects in Each Group With Seroconversion for Serum Anti-Measles IgG | The proportion of subjects in each group who show a seroconversion for serum anti-Measles IgG on Day 28 and Day 84 was assessed. | Day 28 and Day 84 | 
| The Proportion of Subjects in Each Group With Seroconversion for PRNT | The proportion of subjects in each group who show a seroconversion for PRNT on Day 28 and Day 84 was assessed. | Day 28 and Day 84 | 
| Geometric Mean Concentration (GMC) for Anti-Measles IgG Antibodies | 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. | Day -7, Day 28 and Day 84 | 
| Geometric Mean Titre (GMT) by PRNT on Day -7, 28 and 84 | 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. | Day -7, Day 28 and Day 84 |