A Clinical Trial to Assess the Safety of a Measles Vaccine (Dry Powder) Administered by Two Different Devices (PMV-001)

Serum Institute of India

Status and phase: Completed; Phase 1

Conditions: Prophylaxis for the Measles Infection

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

Study type: Interventional

Funder types: Other; Industry; Other U.S. Federal agency

Identifiers

NCT01557699

PMV-001

CTRI/2012/02/002447 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

PMV via Puffhaler® Device

Experimental group

Description:

The dry powder measles vaccine will be administered via a Puffhaler® device. A single dose of 10 mg will be used.

Treatment:

Biological: PMV via Puffhaler® device

PMV via SoloventTM device

Experimental group

Description:

The dry powder measles vaccine will be administered via a SoloventTM device. A single dose of 10 mg will be used.

Treatment:

Biological: PMV via SoloventTM device

Licensed Subcutaneous Measles Vaccine

Active Comparator group

Description:

Licensed measles vaccine will be administered subcutaneously as single dose of 0.5 ml.

Treatment:

Biological: Licensed Subcutaneous Measles Vaccine