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

Phase 1

Completed

Interventions: Biological: PMV via Puffhaler® device
Biological: Licensed Subcutaneous Measles Vaccine
Biological: PMV via SoloventTM device

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
PMV via Puffhaler® Device	PMV via Puffhaler® device	The dry powder measles vaccine will be administered via a Puffhaler® device. A single dose of 10 mg will be used.
Licensed Subcutaneous Measles Vaccine	Licensed Subcutaneous Measles Vaccine	Licensed measles vaccine will be administered subcutaneously as single dose of 0.5 ml.
PMV via SoloventTM device	PMV via SoloventTM device	The dry powder measles vaccine will be administered via a SoloventTM device. A single dose of 10 mg will be used.

Primary Outcome Measures

Name	Time	Method
Incidence of Unsolicited Adverse Events Within 84 Days	Day 84	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	Day 180	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.
Incidence of Solicited Reactions	Day 14	Incidence of solicited local and systemic reactions within 14 days of vaccine administration in each group was assessed.

Secondary Outcome Measures

Name	Time	Method
The Proportion of Subjects in Each Group With Seropositive Anti-Measles IgG Antibodies	Day -7, Day 28 and Day 84	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	Day -7, Day 28 and Day 84	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 With Seroconversion for PRNT	Day 28 and Day 84	The proportion of subjects in each group who show a seroconversion for PRNT on Day 28 and Day 84 was assessed.
Geometric Mean Titre (GMT) by PRNT on Day -7, 28 and 84	Day -7, Day 28 and Day 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.
Geometric Mean Concentration (GMC) for Anti-Measles IgG Antibodies	Day -7, Day 28 and Day 84	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.
The Proportion of Subjects in Each Group With Seroconversion for Serum Anti-Measles IgG	Day 28 and Day 84	The proportion of subjects in each group who show a seroconversion for serum anti-Measles IgG on Day 28 and Day 84 was assessed.