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

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

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.

Study Overview

• Status: Completed
• Conditions: Prophylaxis for the Measles Infection
• Intervention / Treatment: Biological: PMV via Puffhaler® device; Biological: PMV via SoloventTM device; Biological: Licensed Subcutaneous Measles Vaccine

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• India
  • Maharashtra
    • Pune, Maharashtra, India, 411018
      • Department of Pediatrics, Padmashree Dr. D. Y. Patil Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Biological: 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.
EXPERIMENTAL: 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.	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.
ACTIVE_COMPARATOR: Licensed Subcutaneous Measles Vaccine; Licensed measles vaccine will be administered subcutaneously as single dose of 0.5 ml.	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.; Other Names: SMV

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Serum Institute of India Pvt. Ltd.
• Collaborators: Centers for Disease Control and Prevention; University of Colorado, Boulder
• Investigators: Principal Investigator: Sharad Agarkhedkar, MD, Department of Pediatrics, Padmashree Dr. D. Y. Patil Medical College Hospital & Research Centre, Sant Tukaram Nagar, Pimpri Pune-411018

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (ACTUAL): February 1, 2013
• Study Completion (ACTUAL): September 1, 2013

Study Registration Dates

• First Submitted: March 16, 2012
• First Submitted That Met QC Criteria: March 16, 2012
• First Posted (ESTIMATE): March 19, 2012

Study Record Updates

• Last Update Posted (ACTUAL): March 14, 2018
• Last Update Submitted That Met QC Criteria: March 13, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; Measles
• Other Study ID Numbers: PMV-001; CTRI/2012/02/002447 (REGISTRY: CLINICAL TRIAL REGISTRY OF INDIA (CTRI))