PneumoniaPhase 4NCT03104075

Genomics and Epigenomics of the Elderly Response to Pneumococcal Vaccines

A Phase 4 study testing Pneumococcal 13valent Conj Vaccine Diphtheria CRM197 Protein and Pneumococcal Vaccine Polyvalent in people with Pneumonia and Aging, run by The Jackson Laboratory at 1 site in United States.

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 prospective, single-site, randomized, then open-label study designed to develop a detailed transcriptional and epigenetic profile of the immune response to pneumococcal vaccination with conjugated and non-conjugated polysaccharide vaccines in the senescent immune system of older adults. Read more about this study

Who is it for?: Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for: Pneumonia, Aging
What is being tested?: Pneumococcal 13valent Conj Vaccine Diphtheria CRM197 Protein and Pneumococcal Vaccine Polyvalent
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited States
Study dates: 17 Apr 2017to 29 Aug 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 60 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Able and willing to provide written informed consent
Male or Female, 60 years of age or older
Willing to receive pneumococcal vaccination with Prevnar 13 (Wyeth/ Pfizer) or Pneumovax 23 (Merck), as randomly assigned.
Available to attend 6 study visits over 67 days (Visit 7 is optional at Day 365-720).

Who cannot join

Previous pneumococcal vaccination with Prevnar 13 or Pneumovax 23.
History of anaphylactic/anaphylactoid or severe allergic reaction to any component of Pneumovax 23, Prevnar 13 or any diphtheria toxoid-containing vaccine.
Established diagnosis of diabetes
History of receiving Zostavax (shingles vaccine) within previous 4 weeks. (Study entry may be delayed to satisfy a 28-day interval between vaccinations)
Known history of any of the following co-morbid conditions:
Malignancy (participants without a recurrence in the last 5 years will be allowed)

Show all 16Show fewer

Congestive Heart Failure
Cardiovascular Disease (unstable ≤ 6 months*)
Kidney disease
Renal failure
Impaired hepatic function
Autoimmune disease such as: Rheumatoid Arthritis, systemic lupus erythematosus (SLE), Inflammatory Bowel Disease, etc.
Use of medicines during past 6 months known to alter immune response such as high-dose corticosteroids
HIV, AIDS or other Immunodeficiency
Recent (≤ 3 months) trauma or surgery
Current substance and/or alcohol abuse * Unstable disease is defined as a change in therapy or hospitalization for worsening disease.

Trial locations and contacts

1 site in 1 country.

United States1 site

UConn Center On Aging
Farmington, Connecticut, 06030

Other trials in United States

About this study

In this study, 40 healthy adults ages 60 and older that have never received pneumococcal vaccination, will be randomized in a 1:1 ratio to receive Prevnar-13 (Pfizer), a conjugated 13-valent vaccine or Pneumovax 23 (Merck), a non-conjugated 23-valent vaccine. Following randomized assignment of vaccine, the study will be open-label.

Six (6) study visits will occur over about 70 days, with an optional 7th visit for participants to receive a second vaccination with the other pneumococcal vaccine one to two years after randomization. Participants will provide blood samples for transcriptional, epigenetic and biological analyses pre- and post-vaccination.

Read the detailed description

This prospective, single-site, randomized, then open-label study is designed to develop a detailed transcriptional and epigenetic profile of the immune response to pneumococcal vaccination with conjugated and non-conjugated polysaccharide vaccines in the senescent immune system of older adults. This knowledge may lead to development of more effective vaccines through increased understanding of the effects of immunosenescence on mechanisms of immune response to pneumococcal vaccination in older adults elderly.

Forty (40) healthy adults ages 60 and older that have never received pneumococcal vaccination, will be randomized in a 1:1 ratio to receive Prevnar-13 (Pfizer), a conjugated 13-valent vaccine or Pneumovax 23 (Merck), a non-conjugated 23-valent vaccine. Following randomized assignment of vaccine, the study will be open-label. The study sample will be drawn from the population of healthy older participants in the catchment area of UConn Health in Farmington, CT.

The first six (6) study visits are planned to occur over 67 days at Days -7, 0, 1, 10, 28 (±3 d) and 60 (± 5d). Participants will provide blood samples for transcriptional, epigenetic and biological analyses pre- and post-vaccination.

One to two years after receiving the randomly-assigned vaccination, participants may opt to receive administration of a second pneumococcal vaccine with the vaccine that they did not receive by random assignment at Visit 2 (Day 0). This second vaccine will be provided at no charge to the participant. Administration of this vaccine will occur at an optional Visit 7 for participants who choose to receive the second vaccine and will be scheduled at the participant's convenience one-two years after receiving the first pneumococcal vaccine.

If the participant opts to receive the second vaccine within the study and attends optional Visit 7, blood samples for genomic and biologic analysis will be collected at the visit.

Conditions: Pneumonia, Aging
Being tested: Pneumococcal 13valent Conj Vaccine Diphtheria CRM197 Protein, Pneumococcal Vaccine Polyvalent
Keywords: Genomics, Epigenomics, Pneumococcal vaccine, Elderly
Medical subject headings: Pneumonia

What participants receive

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

Pneumococcal 13valent Conj Vaccine Diphtheria CRM197 ProteinBiological
Also called Prevnar 13
One to two years after receiving the randomly-assigned vaccination, participants may opt to receive administration of a second pneumococcal vaccine with Pneumovax 23
Pneumococcal Vaccine PolyvalentBiological
Also called Pneumovax 23
One to two years after receiving the randomly-assigned vaccination, participants may opt to receive administration of a second pneumococcal vaccine with Prevnar-13

Study groups in NCT03104075
Study group	Role	What they receive
Prevnar 13	Active comparator	Prevnar 13 (Pneumococcal 13valent Conj Vaccine Diphtheria CRM197 Protein) will be administered at the single 0.5 ml dose, by intramuscular injection with routine clinical care. Receives: Biological: Pneumococcal 13valent Conj Vaccine Diphtheria CRM197 Protein
Pneumovax 23	Active comparator	Pneumovax 23 (Pneumococcal Vaccine Polyvalent) will be administered at the single 0.5ml dose, by intramuscular injection with routine clinical care. Receives: Biological: Pneumococcal Vaccine Polyvalent

What is being measured

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

Pneumococcal-specific Antibody Responses
To vaccinate healthy older participants with pneumococcal vaccines, collect longitudinal blood samples and assess pneumococcal-specific antibody responses. The unit of measurement used is log2 titer defined as a measure to quantify the overall strength of responses using the sum of all serotype responses. Data shown below is from longitudinal study timepoints (pre and post) first pneumococcal vaccine. At study endpoint, Visit 7, a second pneumococcal vaccine was administered and no further sample collection visits were conducted as proposed in the study design.
Measured: 70 days
Pneumococcal-specific Antibody Responses - Fold Change Post First Vaccination
Fold change between the baseline and post first vaccination titers was calculated for each pneumococcal vaccine cohort.
Data shown below is from longitudinal study timepoints (pre and post) first pneumococcal vaccine. At study endpoint, Visit 7, a second pneumococcal vaccine was administered and no further sample collection visits were conducted as proposed in the study design.
Measured: 70 days

Secondary outcomes (2)

Number of Genes Upregulated Following Vaccination With PCV13 or PPSV23
RNA-seq and ATAC-seq to enable quantitative assessment of both coding RNA's and ncsRNA's as well as to resolve the epigenetic landscape of immune cells in the context of vaccine responses. We assessed the number of genes upregulated post first vaccination [PCV13 or PPSV23].
Data shown below is from longitudinal study timepoints (pre and post) first pneumococcal vaccine. At study endpoint, Visit 7, a second pneumococcal vaccine was administered and no further sample collection visits were conducted as proposed in the study design.
Measured: 10 days post first vaccination
Alterations to APCs, Tfh Cells or B Cells in Response to PCV13 and PPSV23
Measure of functional status of immune cells in older participants following administration of a single pneumococcal vaccine, Prevnar13 or Pneumovax23, at baseline and 10 days post first vaccination.
Data shown below is from longitudinal study timepoints (pre and post) first pneumococcal vaccine. At study endpoint, Visit 7, a second pneumococcal vaccine was administered and no further sample collection visits were conducted as proposed in the study design.
Measured: baseline and 10 days post first vaccination

Timeline

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

17 Apr 201729 Aug 2020

First posted7 Apr 2017
Study start17 Apr 2017
Primary completion5 Dec 2019
Study completion29 Aug 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.
Publications (2)Papers the sponsor has linked to this study.
Other trials for PneumoniaStudies 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 4
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomized assignment to group will be in a 1:1 ratio utilizing block randomization in blocks of 10 to receive Prevnar-13 or Pneumovax 23. Following randomized assignment of vaccine, the study will be open-label.
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03104075
Sponsor's protocol ID: 16-071J-1
Status last verified: Aug 2025
First submitted: 21 Mar 2017
Last updated: 22 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Participants will provide or decline consent within the ICF for sharing of their randomly recoded (new code that is different than the study code) genomic data in public and/or controlled access scientific databases. The study database will include a field for whether consent for genomic data sharing was provided or declined by the participant and if consent provided was for public and/or limited access databases. This information will be included in the dataset so that it can be provided to dbGAP (NIH database of Genotypes and Phenotypes) at the conclusion of the study to ensure that the wishes of the participant regarding use of their data and samples are respected. Raw IPD data is available through dbGAP (phs002361) due to patient privacy concerns. Genomic summary results and gene expression data are shared on GEO; accession numbers GSE247276 (Bulk) and GSE247277 (scRANSeq).

Publications

Thibodeau A, Eroglu A, McGinnis CS, Lawlor N, Nehar-Belaid D, Kursawe R, Marches R, Conrad DN, Kuchel GA, Gartner ZJ, Banchereau J, Stitzel ML, Cicek AE, Ucar D. AMULET: a novel read count-based method for effective multiplet detection from single nucleus ATAC-seq data. Genome Biol. 2021 Sep 1;22(1):252. doi: 10.1186/s13059-021-02469-x.
PubMed 34465366
Ravichandran S, Erra-Diaz F, Karakaslar OE, Marches R, Kenyon-Pesce L, Rossi R, Chaussabel D, Pascual V, Palucka K, Paust S, Nahm MH, Kuchel GA, Banchereau J, Ucar D. Distinct baseline immune characteristics associated with responses to conjugated and unconjugated pneumococcal polysaccharide vaccines in older adults. medRxiv [Preprint]. 2023 Apr 19:2023.04.16.23288531. doi: 10.1101/2023.04.16.23288531.
PubMed 37131707

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?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Genomics and Epigenomics of the Elderly Response to Pneumococcal Vaccines
ClinicalTrials.gov ID: NCT03104075
Acronym / sponsor ID: 16-071J-1
Conditions: Pneumonia, Aging
Keywords: Genomics, Epigenomics, Pneumococcal vaccine, Elderly
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: The Jackson LaboratoryUniversity, hospital or other
Collaborators: UConn Health, University of Alabama at Birmingham
Study start: 17 Apr 2017 (actual)
Primary completion: 5 Dec 2019 (actual)
Study completion: 29 Aug 2020 (actual)
First posted: 7 Apr 2017 (actual)
Results: Posted 7 Dec 2021

Clinical summary

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

Detailed description

If the participant opts to receive the second vaccine within the study and attends optional Visit 7, blood samples for genomic and biologic analysis will be collected at the visit.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Randomized assignment to group will be in a 1:1 ratio utilizing block randomization in blocks of 10 to receive Prevnar-13 or Pneumovax 23. Following randomized assignment of vaccine, the study will be open-label.

Arm	Type	Receives
Prevnar 13	Active comparator	Biological: Pneumococcal 13valent Conj Vaccine Diphtheria CRM197 ProteinPrevnar 13 (Pneumococcal 13valent Conj Vaccine Diphtheria CRM197 Protein) will be administered at the single 0.5 ml dose, by intramuscular injection with routine clinical care.
Pneumovax 23	Active comparator	Biological: Pneumococcal Vaccine PolyvalentPneumovax 23 (Pneumococcal Vaccine Polyvalent) will be administered at the single 0.5ml dose, by intramuscular injection with routine clinical care.

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Able and willing to provide written informed consent
Male or Female, 60 years of age or older
Willing to receive pneumococcal vaccination with Prevnar 13 (Wyeth/ Pfizer) or Pneumovax 23 (Merck), as randomly assigned.
Available to attend 6 study visits over 67 days (Visit 7 is optional at Day 365-720).

Key exclusion criteria (16 listed)

Previous pneumococcal vaccination with Prevnar 13 or Pneumovax 23.
History of anaphylactic/anaphylactoid or severe allergic reaction to any component of Pneumovax 23, Prevnar 13 or any diphtheria toxoid-containing vaccine.
Established diagnosis of diabetes
History of receiving Zostavax (shingles vaccine) within previous 4 weeks. (Study entry may be delayed to satisfy a 28-day interval between vaccinations)
Known history of any of the following co-morbid conditions:

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
Pneumococcal 13valent Conj Vaccine Diphtheria CRM197 ProteinAlso: Prevnar 13One to two years after receiving the randomly-assigned vaccination, participants may opt to receive administration of a second pneumococcal vaccine with Pneumovax 23	Biological	Prevnar 13
Pneumococcal Vaccine PolyvalentAlso: Pneumovax 23One to two years after receiving the randomly-assigned vaccination, participants may opt to receive administration of a second pneumococcal vaccine with Prevnar-13	Biological	Pneumovax 23

Primary outcome

Pneumococcal-specific Antibody Responses
Time frame: 70 days
To vaccinate healthy older participants with pneumococcal vaccines, collect longitudinal blood samples and assess pneumococcal-specific antibody responses. The unit of measurement used is log2 titer defined as a measure to quantify the overall strength of responses using the sum of all serotype responses. Data shown below is from longitudinal study timepoints (pre and post) first pneumococcal vaccine. At study endpoint, Visit 7, a second pneumococcal vaccine was administered and no further sample collection visits were conducted as proposed in the study design.
Pneumococcal-specific Antibody Responses - Fold Change Post First Vaccination
Time frame: 70 days
Fold change between the baseline and post first vaccination titers was calculated for each pneumococcal vaccine cohort. Data shown below is from longitudinal study timepoints (pre and post) first pneumococcal vaccine. At study endpoint, Visit 7, a second pneumococcal vaccine was administered and no further sample collection visits were conducted as proposed in the study design.

2 secondary outcomes

Number of Genes Upregulated Following Vaccination With PCV13 or PPSV23
Time frame: 10 days post first vaccination
Alterations to APCs, Tfh Cells or B Cells in Response to PCV13 and PPSV23
Time frame: baseline and 10 days post first vaccination

Results and safety

Results posted to the registry on 7 Dec 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
Prevnar 13	20	19
Pneumovax 23	20	20

Primary outcome: Pneumococcal-specific Antibody Responses

Time frame: 70 days. Mean (Standard Deviation). Unit: log2 titer

Measure	Prevnar 13 n = 19	Pneumovax 23 n = 20
Baseline	72.1 (19.4)	79.4 (18.6)
Post first vaccination	128.9 (19.5)	120.9 (15.0)

Population analysed: 39 healthy volunteers

Primary outcome: Pneumococcal-specific Antibody Responses - Fold Change Post First Vaccination

Time frame: 70 days. Mean (Standard Deviation). Unit: Fold Change

Measure	Prevnar 13 n = 19	Pneumovax 23 n = 20
Value	55.6 (25.5)	41.6 (18.8)

Population analysed: 39 healthy volunteers

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Data were collected on participants during the 2017-2018 vaccination seasons. Blood samples obtained 7 days prior to vaccination and Day 1, 10, 28, 60 post-vaccination.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Prevnar 13	0 of 19 (0%)	1 of 19 (5.3%)	0 of 19
Pneumovax 23	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 34465366Thibodeau A, Eroglu A, McGinnis CS, Lawlor N, Nehar-Belaid D, Kursawe R, Marches R, Conrad DN, Kuchel GA, Gartner ZJ, Banchereau J, Stitzel ML, Cicek AE, Ucar D. AMULET: a novel read count-based method for effective multiplet detection from single nucleus ATAC-seq data. Genome Biol. 2021 Sep 1;22(1):252. doi: 10.1186/s13059-021-02469-x.
Results publication: PubMed 37131707Ravichandran S, Erra-Diaz F, Karakaslar OE, Marches R, Kenyon-Pesce L, Rossi R, Chaussabel D, Pascual V, Palucka K, Paust S, Nahm MH, Kuchel GA, Banchereau J, Ucar D. Distinct baseline immune characteristics associated with responses to conjugated and unconjugated pneumococcal polysaccharide vaccines in older adults. medRxiv [Preprint]. 2023 Apr 19:2023.04.16.23288531. doi: 10.1101/2023.04.16.23288531.
Individual participant dataSharing planned: Yes. Participants will provide or decline consent within the ICF for sharing of their randomly recoded (new code that is different than the study code) genomic data in public and/or controlled access scientific databases. The study database will include a field for whether consent for genomic data sharing was provided or declined by the participant and if consent provided was for public and/or limited access databases. This information will be included in the dataset so that it can be provided to dbGAP (NIH database of Genotypes and Phenotypes) at the conclusion of the study to ensure that the wishes of the participant regarding use of their data and samples are respected. Raw IPD data is available through dbGAP (phs002361) due to patient privacy concerns. Genomic summary results and gene expression data are shared on GEO; accession numbers GSE247276 (Bulk) and GSE247277 (scRANSeq).

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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.

George Kuchel, M.D. F.R.C.P principal investigator

UConn Center on Aging

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 16 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 22 Aug 2025. 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 7 Dec 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?

Pneumococcal-specific Antibody Responses (time frame: 70 days). The study lists 2 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 NCT03104075, which also lists 2 linked publications.

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 22 Aug 2025.