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

NCT ID: NCT01557699

Last Updated: 2018-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2013-09-30

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.

Conditions

Prophylaxis for the Measles Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

PMV via Puffhaler® device

Intervention Type: BIOLOGICAL

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

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.

Group Type: EXPERIMENTAL

PMV via SoloventTM device

Intervention Type: BIOLOGICAL

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

Licensed Subcutaneous Measles Vaccine

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

Group Type: ACTIVE_COMPARATOR

Licensed Subcutaneous Measles Vaccine

Intervention Type: BIOLOGICAL

This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml will be given subcutaneously.

Interventions

PMV via Puffhaler® device

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

Intervention Type: BIOLOGICAL

PMV via SoloventTM device

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

Intervention Type: BIOLOGICAL

Licensed Subcutaneous Measles Vaccine

This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml will be given subcutaneously.

Intervention Type: BIOLOGICAL

Other Intervention Names

SMV

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Colorado, Boulder

OTHER

Sponsor Role: collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

Serum Institute of India Pvt. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sharad Agarkhedkar, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Pediatrics, Padmashree Dr. D. Y. Patil Medical College Hospital & Research Centre, Sant Tukaram Nagar, Pimpri Pune-411018

Locations

Department of Pediatrics, Padmashree Dr. D. Y. Patil Medical College

Pune, Maharashtra, India

Countries

India

References

MVDP author group; Cape S, Chaudhari A, Vaidya V, Mulay R, Agarkhedkar S, Shermer C, Collins M, Anderson R, Agarkhedkar S, Kulkarni PS, Winston S, Sievers R, Dhere RM, Gunale B, Powell K, Rota PA, Papania M. Safety and immunogenicity of dry powder measles vaccine administered by inhalation: a randomized controlled Phase I clinical trial. Vaccine. 2014 Nov 28;32(50):6791-7. doi: 10.1016/j.vaccine.2014.09.071. Epub 2014 Oct 22.

Reference Type: RESULT

PMID: 25446830 (View on PubMed)

Other Identifiers

CTRI/2012/02/002447

Identifier Type: REGISTRY

Identifier Source: secondary_id

PMV-001

Identifier Type: -

Identifier Source: org_study_id