Clinical trial NCT01557699: A Clinical Trial to Assess the Safety of a Measles Vaccine (Dry Powder) Administered by Two Different Devices
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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prophylaxis for the Measles Infection
Lead sponsor: Serum Institute of India Pvt. Ltd.
Sponsor class: INDUSTRY
Collaborators: name: University of Colorado, Boulder
name: Centers for Disease Control and Prevention
First posted: 2012-03-19
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Incidence of Solicited Reactions
timeFrame: Day 14
measure: Incidence of Unsolicited Adverse Events Within 84 Days
timeFrame: Day 84
measure: Incidence of Serious Adverse Events (SAEs) and New Onset Chronic Medical Conditions
timeFrame: Day 180
Secondary outcomes:
measure: The Proportion of Subjects in Each Group With Seropositive Anti-Measles IgG Antibodies
timeFrame: Day -7, Day 28 and Day 84
measure: The Proportion of Subjects in Each Group With Seroprotective Plaque-reduction Neutralization Test (PRNT) Titre
timeFrame: Day -7, Day 28 and Day 84
measure: The Proportion of Subjects in Each Group With Seroconversion for Serum Anti-Measles IgG
timeFrame: Day 28 and Day 84
measure: The Proportion of Subjects in Each Group With Seroconversion for PRNT
timeFrame: Day 28 and Day 84
measure: Geometric Mean Concentration (GMC) for Anti-Measles IgG Antibodies
timeFrame: Day -7, Day 28 and Day 84
measure: Geometric Mean Titre (GMT) by PRNT on Day -7, 28 and 84
timeFrame: Day -7, Day 28 and Day 84
Other outcomes:
Locations:
city: Pune
country: India
facility: Department of Pediatrics, Padmashree Dr. D. Y. Patil Medical College
state: Maharashtra
Study officials:
affiliation: Department of Pediatrics, Padmashree Dr. D. Y. Patil Medical College Hospital & Research Centre, Sant Tukaram Nagar, Pimpri Pune-411018
name: Sharad Agarkhedkar, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.