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

Purpose

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.

Condition	Intervention	Phase
Prophylaxis for the Measles Infection	Biological: Dry Powdered Measles Vaccine Biological: Licensed Subcutaneous Measles Vaccine	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
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

Resource links provided by NLM:

MedlinePlus related topics: Measles

U.S. FDA Resources

Further study details as provided by Serum Institute of India Limited:

Primary Outcome Measures:

Incidence of solicited reactions [ Time Frame: Day 14 ] [ Designated as safety issue: Yes ]
Incidence of solicited local and systemic reactions within 14 days of vaccine administration in each group will be assessed.
Incidence of unsolicited adverse events within 84 days [ Time Frame: Day 84 ] [ Designated as safety issue: Yes ]
Incidence of unsolicited adverse events for a period of 84 days in each group will be assessed.
Incidence of serious adverse events (SAEs) and new onset chronic medical conditions [ Time Frame: Day 180 ] [ Designated as safety issue: Yes ]
Incidence of serious adverse events (SAEs) and new onset chronic medical conditions throughout the entire study period of 180 days in each group will be assessed.

Secondary Outcome Measures:

The proportion of subjects in each group with seropositive anti-Measles IgG antibodies [ Time Frame: Day -7, Day 28 and Day 84 ] [ Designated as safety issue: No ]
The proportion of subjects in each group with seropositive anti-Measles IgG antibodies on Day -7, Day 28 and Day 84 will be assessed.
The proportion of subjects in each group with seroprotective plaque-reduction neutralization test (PRNT) titre [ Time Frame: Day -7, Day 28 and Day 84 ] [ Designated as safety issue: No ]
The proportion of subjects in each group with seroprotective plaque-reduction neutralization test (PRNT) titre on Day -7, Day 28 and Day 84 will be assessed.
The proportion of subjects in each group with seroconversion for serum anti-Measles IgG [ Time Frame: Day 28 and Day 84 ] [ Designated as safety issue: No ]
The proportion of subjects in each group who show a seroconversion for serum anti-Measles IgG on Day 28 and Day 84 will be assessed.
The proportion of subjects in each group with seroconversion for PRNT [ Time Frame: Day 28 and Day 84 ] [ Designated as safety issue: No ]
The proportion of subjects in each group who show a seroconversion for PRNT on Day 28 and Day 84 will be assessed.
Geometric Mean Concentration (GMC) for anti-Measles IgG antibodies [ Time Frame: Day -7, Day 28 and Day 84 ] [ Designated as safety issue: No ]
GMCs for anti-Measles IgG antibodies will be measured on Day -7, Day 28 and Day 84.
Geometric Mean Titre (GMT) for PRNT on Day -7, 28 and 84 [ Time Frame: Day -7, Day 28 and Day 84 ] [ Designated as safety issue: No ]
GMT for PRNT will be assessed on Day -7, 28 and 84.

Estimated Enrollment:	60
Study Start Date:	March 2012
Estimated Study Completion Date:	March 2013
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Dry Powdered Measles Vaccine via a Puffhaler® Device	Biological: Dry Powdered Measles Vaccine The vaccine will be administered via a Puffhaler® device. A single dose of 10 mg will be used. Other Name: PMV via Puffhaler® device.
Experimental: Dry Powdered Measles Vaccine via SoloventTM device	Biological: Dry Powdered Measles Vaccine The vaccine will be administered via SoloventTM device. A single dose of 10 mg will be used. Other Name: PMV via SoloventTM device
Active Comparator: Licensed Subcutaneous Measles Vaccine	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 Name: SMV

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.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01557699

Contacts

Contact: Prasad S Kulkarni, MD		drpsk@seruminstitute.com
Contact: Somnath A Mangrule, MD		somnath.mangrule@seruminstitute.com

Locations

India
Department of Pediatrics, Padmashree Dr. D. Y. Patil Medical College	Recruiting
Pune, Maharashtra, India, 411018
Contact: Sharad Agarkhedkar, MD ashalaka@gmail.com
Principal Investigator: Sharad Agarkhedkar, MD

Sponsors and Collaborators

Serum Institute of India Limited

Aktiv-Dry LLC, USA

Centers for Disease Control and Prevention

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

More Information

No publications provided

Responsible Party:	Serum Institute of India Limited
ClinicalTrials.gov Identifier:	NCT01557699 History of Changes
Other Study ID Numbers:	PMV-001, CTRI/2012/02/002447
Study First Received:	March 16, 2012
Last Updated:	March 28, 2012
Health Authority:	India: Drugs Controller General of India

Additional relevant MeSH terms:

Measles
Morbillivirus Infections
Paramyxoviridae Infections

Mononegavirales Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on May 19, 2013

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