Prophylaxis for the Measles InfectionPhase 1PMV-001NCT01557699

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

A Phase 1 study testing PMV via Puffhaler® device, PMV via SoloventTM device and Licensed Subcutaneous Measles Vaccine in people with Prophylaxis for the Measles Infection, run by Serum Institute of India Pvt. Ltd. at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Prophylaxis for the Measles Infection
What is being tested?: PMV via Puffhaler® device, PMV via SoloventTM device and Licensed Subcutaneous Measles Vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteIndia
Study dates: Mar 2012to Sep 2013
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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

Show all 9Show fewer

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

Trial locations and contacts

1 site in 1 country.

India1 site

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

Other trials in India

About this study

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

Read the 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.

Conditions: Prophylaxis for the Measles Infection
Being tested: PMV via Puffhaler® device, PMV via SoloventTM device, Licensed Subcutaneous Measles Vaccine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PMV via Puffhaler® deviceBiological
The vaccine will be administered via a Puffhaler® device. A single dose of 10 mg of PMV (dry powder measles vaccine) will be used.
PMV via SoloventTM deviceBiological
The vaccine will be administered via SoloventTM device. A single dose of 10 mg of PMV (dry powder measles vaccine) will be used.
Licensed Subcutaneous Measles VaccineBiological
Also called SMV
This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml will be given subcutaneously.

Study groups in NCT01557699
Study group	Role	What they receive
PMV via Puffhaler® Device	Experimental	The dry powder measles vaccine will be administered via a Puffhaler® device. A single dose of 10 mg will be used. Receives: Biological: PMV via Puffhaler® device
PMV via SoloventTM device	Experimental	The dry powder measles vaccine will be administered via a SoloventTM device. A single dose of 10 mg will be used. Receives: Biological: PMV via SoloventTM device
Licensed Subcutaneous Measles Vaccine	Active comparator	Licensed measles vaccine will be administered subcutaneously as single dose of 0.5 ml. Receives: Biological: Licensed Subcutaneous Measles Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Solicited Reactions
Incidence of solicited local and systemic reactions within 14 days of vaccine administration in each group was assessed.
Measured: 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.
Measured: 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.
Measured: Day 180

Secondary outcomes (6)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day -7, Day 28 and Day 84

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2012Sep 2013

First posted19 Mar 2012 (estimated)
Study startMar 2012
Primary completionFeb 2013
Study completionSep 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Prophylaxis for the Measles InfectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01557699
Sponsor's protocol ID: PMV-001
Other IDs: CTRI/2012/02/002447
Acronym: PMV-001
Status last verified: Mar 2018
First submitted: 16 Mar 2012
Last updated: 14 Mar 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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.
PubMed 25446830

Study at a glance

From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01557699
Acronym / sponsor ID: PMV-001 / PMV-001
Conditions: Prophylaxis for the Measles Infection
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Serum Institute of India Pvt. Ltd.Industry (pharma, biotech, devices)
Collaborators: University of Colorado, Boulder, Centers for Disease Control and Prevention
Study start: Mar 2012
Primary completion: Feb 2013 (actual)
Study completion: Sep 2013 (actual)
First posted: 19 Mar 2012 (estimated)
Results: Posted 1 Dec 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
PMV via Puffhaler® Device	Experimental	Biological: PMV via Puffhaler® deviceThe dry powder measles vaccine will be administered via a Puffhaler® device. A single dose of 10 mg will be used.
PMV via SoloventTM device	Experimental	Biological: PMV via SoloventTM deviceThe dry powder measles vaccine will be administered via a SoloventTM device. A single dose of 10 mg will be used.
Licensed Subcutaneous Measles Vaccine	Active comparator	Biological: Licensed Subcutaneous Measles VaccineLicensed measles vaccine will be administered subcutaneously as single dose of 0.5 ml.

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PMV via Puffhaler® deviceThe vaccine will be administered via a Puffhaler® device. A single dose of 10 mg of PMV (dry powder measles vaccine) will be used.	Biological	PMV via Puffhaler® Device
PMV via SoloventTM deviceThe vaccine will be administered via SoloventTM device. A single dose of 10 mg of PMV (dry powder measles vaccine) will be used.	Biological	PMV via SoloventTM device
Licensed Subcutaneous Measles VaccineAlso: SMVThis is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml will be given subcutaneously.	Biological	Licensed Subcutaneous Measles Vaccine

Primary outcome

Incidence of Solicited Reactions
Time frame: Day 14
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
Time frame: Day 84
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
Time frame: Day 180
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.

6 secondary outcomes

The Proportion of Subjects in Each Group With Seropositive Anti-Measles IgG Antibodies
Time frame: Day -7, Day 28 and Day 84
The Proportion of Subjects in Each Group With Seroprotective Plaque-reduction Neutralization Test (PRNT) Titre
Time frame: Day -7, Day 28 and Day 84
The Proportion of Subjects in Each Group With Seroconversion for Serum Anti-Measles IgG
Time frame: Day 28 and Day 84
The Proportion of Subjects in Each Group With Seroconversion for PRNT
Time frame: Day 28 and Day 84
Geometric Mean Concentration (GMC) for Anti-Measles IgG Antibodies
Time frame: Day -7, Day 28 and Day 84
Geometric Mean Titre (GMT) by PRNT on Day -7, 28 and 84
Time frame: Day -7, Day 28 and Day 84

Results and safety

Results posted to the registry on 1 Dec 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dry Powdered Measles Vaccine Via a Puffhaler® Device	20	20
Dry Powdered Measles Vaccine Via SoloventTM Device	20	20
Licensed Subcutaneous Measles Vaccine	20	20

Primary outcome: Incidence of Solicited Reactions

Time frame: Day 14. Number. Unit: participants

Measure	PMV Puffhaler® n = 20	PMV SoloventTM n = 20	Subcutaneous Meales Vaccine n = 20
Value	0	0	0

Population analysed: Intention-To-Treat (ITT) Population included all subjects who received at least one dose of study vaccine and had at least one post-baseline assessment, regardless of whether they adhered to the study eligibility criteria or whether their study medication administration and study procedure visits are within the protocol-specified windows.

Primary outcome: Incidence of Unsolicited Adverse Events Within 84 Days

Time frame: Day 84. Number. Unit: participants

Measure	Dry Powdered Measles Vaccine Via a Puffhaler® Device n = 20	Dry Powdered Measles Vaccine Via SoloventTM Device n = 20	Licensed Subcutaneous Measles Vaccine n = 20
Value	0	0	0

Population analysed: Intention-To-Treat (ITT) Population was used for safety analysis.

Primary outcome: Incidence of Serious Adverse Events (SAEs) and New Onset Chronic Medical Conditions

Time frame: Day 180. Number. Unit: participants

Measure	Dry Powdered Measles Vaccine Via a Puffhaler® Device n = 20	Dry Powdered Measles Vaccine Via SoloventTM Device n = 20	Licensed Subcutaneous Measles Vaccine n = 20
Value	0	0	0

Population analysed: Intention-To-Treat (ITT) Population was used for safety and immunogenicity analysis. ITT population included subjects who had blood drawn to confirm a measles protective titer at Day -7 and met all inclusion/ exclusion criteria and did not receive a vaccine forbidden in the study protocol within the previous 30 days.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 84. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dry Powdered Measles Vaccine Via a Puffhaler® Device	0 of 20 (0%)	0 of 20 (0%)	Not reported
Dry Powdered Measles Vaccine Via SoloventTM Device	0 of 20 (0%)	0 of 20 (0%)	Not reported
Licensed Subcutaneous Measles Vaccine	0 of 20 (0%)	0 of 20 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 25446830MVDP 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sharad Agarkhedkar, MD principal investigator

Department of Pediatrics, Padmashree Dr. D. Y. Patil Medical College Hospital & Research Centre, Sant Tukaram Nagar, Pimpri Pune-411018

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Solicited Reactions (time frame: Day 14). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01557699, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2018.