AsthmaPhase 4NCT03260790

Pneumococcal Vaccines in Patients With Asthma

A Phase 4 study testing PCV13 and PPSV23 in people with Asthma, run by Mayo Clinic at 1 site in United States.

Completed

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

Trial summary

Investigators are assessing if patients with asthma respond better to the Pneumovax vaccine if they are given Prevnar initially. Read more about this study

Who is it for?: Ages 19 to 64 years
Conditions the study is for: Asthma
What is being tested?: PCV13 and PPSV23
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 17 participants
Where: 1 siteUnited States
Study dates: 1 Oct 2017to 25 Dec 2020
Phase: Phase 4
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 19 to 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Diagnosis of asthma

Who cannot join

Research exemption requested
History of PCV-13 vaccination
History of cochlear implant
Cerebrospinal Fluid (CSF) leak
Congestive Heart Failure (CHF)
Diabetes Mellitus (DM)

Show all 11Show fewer

Chronic Kidney Disease (CKD)
Human Immunodeficiency Virus (HIV)
Common Variable Immune Deficiency (CVID)
Patients who have received the PPSV23 vaccine in the last 5 years
Women who are pregnant will also be excluded from the study by performing 2 point of care urine pregnancy tests ( prior to vaccinations)

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic in Rochester
Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Immunogenicity of PPSV-23 After PCV-13 Vaccination in Adult Asthmatic Patients

Investigators are assessing if patients with asthma respond better to the Pneumovax vaccine if they are given Prevnar initially.

Read the detailed description

Patients will be randomized into either PCV13 and PPSV23 (Experimental) or PPSV23 alone (Active comparator). At the Week 0 time point, the patients will receive either PCV13 (Experimental) or PPSV23 (Active comparator) and undergo a blood draw of 5ml for assessment of pre-vacation serotype titers. The Active Comparator group will undergo a 5ml draw of blood for assessment of titers at week 8, 16, and 24 following vaccination. The Experimental group will undergo vaccination with PPSV23 at week 8 with 5 ml blood draw for pneumococcal serotype titers as well as a blood draw at week 16 and week 24.

Conditions: Asthma
Being tested: PCV13, PPSV23
Keywords: Vaccine, Pneumococcal, Pneumonia
Medical subject headings: Asthma, Pneumonia

What participants receive

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

PCV13Biological
Also called Prevnar
Single 0.5 ml dose of PCV13 administered via intramuscular injection
PPSV23Biological
Also called Pneumovax
Single 0.5 ml dose of PPSV23 administered via intramuscularly or subcutaneously

Study groups in NCT03260790
Study group	Role	What they receive
PCV13 and PPSV23	Experimental	Participants randomized to receive PPSV23 primed with PCV13. Participants will receive PCV13 8 weeks prior to receiving PPSV23 Receives: Biological: PCV13; Biological: PPSV23
PPSV23	Active comparator	Participants randomized to receive PPSV23 alone Receives: Biological: PPSV23

What is being measured

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

Total Anti-pneumococcal IgG Levels at Baseline, Week 0, Week 8 and Week 16
5 ml blood draw for assessment of pneumococcal specific titer IgG. Measured as mcg/dL.
Measured: Baseline, week 0, week 8, week 16
Sum of Anti-pneumococcal IgG to All Serotypes at Baseline, Week 0, Week 8 and Week 16
5 ml blood draw for assessment of IgG specific Antibody titers to all 23 serotypes. Measured as mcg/mL.
Measured: Baseline, week 0, week 8, week 16
Sum of Anti-pneumococcal IgG to Serotypes Common to PCV13 and PPSV23 at Baseline, Week 0, Week 8, Week 16
5 ml blood draw for assessment of IgG specific Antibody titers for serotypes common PCV13 \& PPSV23. Measured as mcg/mL.
Measured: Baseline, week 0, week 8, week 16
Sum of Anti-pneumococcal IgG to Serotypes Unique to PPSV23 at Baseline, Week 0, Week 8 and Week 16.
5 ml blood draw for assessment of IgG specific Antibody titers for serotypes unique to PPSV23. Measured as mcg/mL.
Measured: Baseline, week 0, week 8, week 16

Timeline

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

1 Oct 201725 Dec 2020

First posted24 Aug 2017
Study start1 Oct 2017
Primary completion21 Dec 2020
Study completion25 Dec 2020

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.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
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 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03260790
Sponsor's protocol ID: 16-007731
Status last verified: Oct 2021
First submitted: 31 Jul 2017
Last updated: 5 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immunogenicity of PPSV-23 After PCV-13 Vaccination in Adult Asthmatic Patients
ClinicalTrials.gov ID: NCT03260790
Acronym / sponsor ID: 16-007731
Conditions: Asthma
Keywords: Vaccine, Pneumococcal, Pneumonia
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Study start: 1 Oct 2017 (actual)
Primary completion: 21 Dec 2020 (actual)
Study completion: 25 Dec 2020 (actual)
First posted: 24 Aug 2017 (actual)
Results: Posted 5 Nov 2021

Clinical summary

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

Investigators are assessing if patients with asthma respond better to the Pneumovax vaccine if they are given Prevnar initially.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
PCV13 and PPSV23	Experimental	Biological: PCV13, Biological: PPSV23Participants randomized to receive PPSV23 primed with PCV13. Participants will receive PCV13 8 weeks prior to receiving PPSV23
PPSV23	Active comparator	Biological: PPSV23Participants randomized to receive PPSV23 alone

Who may qualify

Ages: 19 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Diagnosis of asthma

Key exclusion criteria (11 listed)

Research exemption requested
History of PCV-13 vaccination
History of cochlear implant
Cerebrospinal Fluid (CSF) leak
Congestive Heart Failure (CHF)

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
PCV13Also: PrevnarSingle 0.5 ml dose of PCV13 administered via intramuscular injection	Biological	PCV13 and PPSV23
PPSV23Also: PneumovaxSingle 0.5 ml dose of PPSV23 administered via intramuscularly or subcutaneously	Biological	PCV13 and PPSV23, PPSV23

Primary outcome

Total Anti-pneumococcal IgG Levels at Baseline, Week 0, Week 8 and Week 16
Time frame: Baseline, week 0, week 8, week 16
5 ml blood draw for assessment of pneumococcal specific titer IgG. Measured as mcg/dL.
Sum of Anti-pneumococcal IgG to All Serotypes at Baseline, Week 0, Week 8 and Week 16
Time frame: Baseline, week 0, week 8, week 16
5 ml blood draw for assessment of IgG specific Antibody titers to all 23 serotypes. Measured as mcg/mL.
Sum of Anti-pneumococcal IgG to Serotypes Common to PCV13 and PPSV23 at Baseline, Week 0, Week 8, Week 16
Time frame: Baseline, week 0, week 8, week 16
5 ml blood draw for assessment of IgG specific Antibody titers for serotypes common PCV13 \& PPSV23. Measured as mcg/mL.
Sum of Anti-pneumococcal IgG to Serotypes Unique to PPSV23 at Baseline, Week 0, Week 8 and Week 16.
Time frame: Baseline, week 0, week 8, week 16
5 ml blood draw for assessment of IgG specific Antibody titers for serotypes unique to PPSV23. Measured as mcg/mL.

Results and safety

Results posted to the registry on 5 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PCV13 and PPSV23	8	8
PPSV23	9	9

Primary outcome: Total Anti-pneumococcal IgG Levels at Baseline, Week 0, Week 8 and Week 16

Time frame: Baseline, week 0, week 8, week 16. Median (Inter-Quartile Range). Unit: mcg/dL

Measure	PCV13 and PPSV23 n = 8	PPSV23 n = 9
baseline	109.8 (74.3 to 141.8)	53.9 (34.8 to 185.3)
week 0	142.3 (111.7 to 194.6)	53.9 (34.8 to 185.3)
week 8	211.7 (184.6 to 271.0)	243.3 (173.4 to 271.0)
week 16	212.0 (171.1 to 257.7)	224.8 (196.6 to 271.0)

Population analysed: Baseline = For arm PPSV23 baseline is 8 weeks prior to receiving PPSV-23. For arm PCV13 and PPSV23 baseline is day of receiving PCV-13. Week 0 = day of receiving PPSV-23 for both arms. Week 8 = eight weeks after receiving PPSV-23 for both arms. Week 16 = sixteen weeks after receiving PPSV-23 for both arms.

Primary outcome: Sum of Anti-pneumococcal IgG to All Serotypes at Baseline, Week 0, Week 8 and Week 16

Time frame: Baseline, week 0, week 8, week 16. Median (Inter-Quartile Range). Unit: mcg/mL.

Measure	PCV13 and PPSV23 n = 8	PPSV23 n = 9
baseline	228.0 (174.2 to 362.3)	206.8 (130.1 to 323.8)
week 0	506.3 (349.6 to 670.9)	206.8 (130.1 to 323.8)
week 8	502.9 (369.9 to 790.5)	449.4 (338.7 to 583.4)
week 16	534.8 (325.4 to 688.4)	485.7 (321.2 to 588.6)

Primary outcome: Sum of Anti-pneumococcal IgG to Serotypes Common to PCV13 and PPSV23 at Baseline, Week 0, Week 8, Week 16

Time frame: Baseline, week 0, week 8, week 16. Median (Inter-Quartile Range). Unit: mcg/mL

Measure	PCV13 and PPSV23 n = 8	PPSV23 n = 9
baseline	142.4 (110.7 to 246.8)	107.4 (92.9 to 161.8)
week 0	418.9 (303.2 to 525.1)	107.4 (92.9 to 161.8)
week 8	362.8 (258.9 to 498.6)	229.4 (162.6 to 302.2)
week 16	343.7 (221.5 to 447.1)	230.5 (149.5 to 302.1)

Primary outcome: Sum of Anti-pneumococcal IgG to Serotypes Unique to PPSV23 at Baseline, Week 0, Week 8 and Week 16.

Time frame: Baseline, week 0, week 8, week 16. Median (Inter-Quartile Range). Unit: mcg/mL

Measure	PCV13 and PPSV23 n = 8	PPSV23 n = 9
baseline	89.2 (64.1 to 120.9)	74.7 (41.0 to 160.2)
week 0	82.4 (56.2 to 152.4)	74.7 (41.0 to 160.2)
week 8	174.2 (92.3 to 283.4)	220.0 (164.7 to 246.8)
week 16	179.1 (96.9 to 277.0)	184.1 (171.0 to 255.2)

Adverse events

Time frame: Adverse Events were collected from baseline to end of study, approximately 16 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PCV13 and PPSV23	0 of 8 (0%)	0 of 8 (0%)	0 of 8
PPSV23	0 of 9 (0%)	0 of 9 (0%)	0 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Mayo Clinic Clinical TrialsLink provided by the sponsor.
Individual participant dataSharing planned: No

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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.

Avni Y Joshi principal investigator

Mayo Clinic

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing PCV13 and PPSV23 in people with Asthma, run by Mayo Clinic at 1 site in United States.

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 1 inclusion and 11 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 5 Nov 2021. 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 5 Nov 2021). 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?

Total Anti-pneumococcal IgG Levels at Baseline, Week 0, Week 8 and Week 16 (time frame: Baseline, week 0, week 8, week 16). The study lists 4 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 NCT03260790.

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 5 Nov 2021.