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

Primary Purpose

Prophylaxis for the Measles Infection

Status
Completed
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
PMV via Puffhaler® device
PMV via SoloventTM device
Licensed Subcutaneous Measles Vaccine
Sponsored by
Serum Institute of India Pvt. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prophylaxis for the Measles Infection

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

PMV via Puffhaler® Device

PMV via SoloventTM device

Licensed Subcutaneous Measles Vaccine

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
March 16, 2012
Last Updated
March 13, 2018
Sponsor
Serum Institute of India Pvt. Ltd.
Collaborators
University of Colorado, Boulder, Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT01557699
Brief Title
A Clinical Trial to Assess the Safety of a Measles Vaccine (Dry Powder) Administered by Two Different Devices
Acronym
PMV-001
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Serum Institute of India Pvt. Ltd.
Collaborators
University of Colorado, Boulder, Centers for Disease Control and Prevention

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prophylaxis for the Measles Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PMV via Puffhaler® Device
Arm Type
Experimental
Arm Description
The dry powder measles vaccine will be administered via a Puffhaler® device. A single dose of 10 mg will be used.
Arm Title
PMV via SoloventTM device
Arm Type
Experimental
Arm Description
The dry powder measles vaccine will be administered via a SoloventTM device. A single dose of 10 mg will be used.
Arm Title
Licensed Subcutaneous Measles Vaccine
Arm Type
Active Comparator
Arm Description
Licensed measles vaccine will be administered subcutaneously as single dose of 0.5 ml.
Intervention Type
Biological
Intervention Name(s)
PMV via Puffhaler® device
Intervention Description
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
Intervention Name(s)
PMV via SoloventTM device
Intervention Description
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
Intervention Name(s)
Licensed Subcutaneous Measles Vaccine
Other Intervention Name(s)
SMV
Intervention Description
This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml will be given subcutaneously.
Primary Outcome Measure Information:
Title
Incidence of Solicited Reactions
Description
Incidence of solicited local and systemic reactions within 14 days of vaccine administration in each group was assessed.
Time Frame
Day 14
Title
Incidence of Unsolicited Adverse Events Within 84 Days
Description
Incidence of unsolicited adverse events for a period of 84 days in each group was assessed.
Time Frame
Day 84
Title
Incidence of Serious Adverse Events (SAEs) and New Onset Chronic Medical Conditions
Description
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.
Time Frame
Day 180
Secondary Outcome Measure Information:
Title
The Proportion of Subjects in Each Group With Seropositive Anti-Measles IgG Antibodies
Description
The proportion of subjects in each group with seropositive anti-Measles IgG antibodies on Day -7, Day 28 and Day 84 was assessed.
Time Frame
Day -7, Day 28 and Day 84
Title
The Proportion of Subjects in Each Group With Seroprotective Plaque-reduction Neutralization Test (PRNT) Titre
Description
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.
Time Frame
Day -7, Day 28 and Day 84
Title
The Proportion of Subjects in Each Group With Seroconversion for Serum Anti-Measles IgG
Description
The proportion of subjects in each group who show a seroconversion for serum anti-Measles IgG on Day 28 and Day 84 was assessed.
Time Frame
Day 28 and Day 84
Title
The Proportion of Subjects in Each Group With Seroconversion for PRNT
Description
The proportion of subjects in each group who show a seroconversion for PRNT on Day 28 and Day 84 was assessed.
Time Frame
Day 28 and Day 84
Title
Geometric Mean Concentration (GMC) for Anti-Measles IgG Antibodies
Description
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.
Time Frame
Day -7, Day 28 and Day 84
Title
Geometric Mean Titre (GMT) by PRNT on Day -7, 28 and 84
Description
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.
Time Frame
Day -7, Day 28 and Day 84

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharad Agarkhedkar, MD
Organizational Affiliation
Department of Pediatrics, Padmashree Dr. D. Y. Patil Medical College Hospital & Research Centre, Sant Tukaram Nagar, Pimpri Pune-411018
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pediatrics, Padmashree Dr. D. Y. Patil Medical College
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411018
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
25446830
Citation
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.
Results Reference
result

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

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