Phase 1
N=60
A Clinical Trial to Assess the Safety of a Measles Vaccine (Dry Powder) Administered by Two Different Devices
Prophylaxis for the Measles Infection
Bottom Line
View on ClinicalTrials.gov: NCT01557699 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcome: Primary: Incidence of Solicited Reactions — 0; 0; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- PMV via Puffhaler® device (Biological); PMV via SoloventTM device (Biological); Licensed Subcutaneous Measles Vaccine (Biological)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Serum Institute of India Pvt. Ltd.
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Solicited Reactions |
0; 0; 0 | — |
| PRIMARY Incidence of Unsolicited Adverse Events Within 84 Days |
0; 0; 0 | — |
| PRIMARY Incidence of Serious Adverse Events (SAEs) and New Onset Chronic Medical Conditions |
0; 0; 0 | — |
| SECONDARY The Proportion of Subjects in Each Group With Seropositive Anti-Measles IgG Antibodies |
100; 100; 100 | — |
| SECONDARY The Proportion of Subjects in Each Group With Seroprotective Plaque-reduction Neutralization Test (PRNT) Titre |
100; 100; 95 | — |
| SECONDARY The Proportion of Subjects in Each Group With Seroconversion for Serum Anti-Measles IgG |
45; 20; 25; 55; 45; 35 | — |
| SECONDARY The Proportion of Subjects in Each Group With Seroconversion for PRNT |
45; 25; 30; 30; 30; 25 | — |
| SECONDARY Geometric Mean Concentration (GMC) for Anti-Measles IgG Antibodies |
0.91; 1.31; 0.86; 1.46; 1.49; 1.03 | — |
| SECONDARY Geometric Mean Titre (GMT) by PRNT on Day -7, 28 and 84 |
1914.3; 1479.5; 2010.4; 2626.5; 1569.1; 1789.7 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01557699). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.