Pneumococcal InfectionNCT01307449
Systems Biology of PNEUMOVAX®23 and PREVNAR 13®
A study testing PNEUMOVAX and Prevnar in people with Pneumococcal Infection, run by Emory University at 2 sites in United States.
Trial summary
Vaccination is the most effective way of preventing infectious diseases. Despite the success of vaccines in general, vaccines induce diminished antibody responses and lower protection in the elderly in particular. This could be explained by a defect in the early responses of an ageing immune system. Read more about this study
- Who is it for?
- Ages 25 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Infection
- What is being tested?
- PNEUMOVAX and Prevnar
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2014to Jul 2017
- Phase
- Interventional
- 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 25 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to understand and give informed consent.
- Immunocompetent community dwelling subjects between the ages of ages of 25-40 and 60-89 years.
Who cannot join
- Prior vaccination with pneumococcal vaccine.
- Receipt of any of the following products:
- Blood products within 3 months prior to study entry or expected receipt at any time after study entry*.
- Any live virus vaccines within 4 weeks prior to study entry or expected receipt within 4 weeks after study entry*.
- Any inactivated vaccine within 2 weeks or expected receipt within 2 weeks after study entry*.
- Presence of co-morbidities or immunosuppressive states such as:
Show all 20Show fewer
- Chronic medical problems including (but not limited to) insulin dependent diabetes, severe heart disease, severe lung disease, severe liver disease, cerebrospinal fluid leaks, severe kidney disease, autoimmune diseases, severe gastrointestinal diseases and grade 4 hypertension per CTCAE criteria** .
- Alcohol, drug abuse or psychiatric conditions that in the opinion of the investigator would preclude compliance with the trial or interpretation of safety or endpoint data.
- Impaired immune function or known chronic infections including, but not limited, to known HIV, hepatitis B or C; organ transplant; immunosuppression due to cancer; current and/or expected receipt of chemotherapy, radiation therapy, steroids* (i.e., more than 20 mg of prednisone given daily or on alternative days for 2 weeks or more in the past 90 days , or high dose inhaled corticosteroids** or any other immunosuppressive therapies (including anti-TNF therapy), functional or anatomic asplenia and congenital immunodeficiency.
- Conditions that could affect the safety of the volunteers such as:
- o Severe reactions to prior vaccinations.
- o An allergy to any component of the study vaccines (phenol, aluminum, CRM197 protein, succinic acid, Polysorbate 80).
- History of Guillain-Barré syndrome.
- History of bleeding disorders.
- Volunteers with any acute illness* including, but not limited to, - fever (> 100.4 F [> 38 C], regardless of the route) within 3 days prior to study entry.
- Volunteers with social conditions or occupational conditions or any condition that in the opinion of the investigator might interfere with compliance with the study and vaccine evaluation.
- Pregnant or breast feeding or women expected to conceive within 30 days after vaccination *
- An individual who initially is excluded from study participation based on one or more of the time-limited exclusion criteria (e.g., acute illness, receipt or expected receipt of live or inactivated vaccines ) may be reconsidered for enrollment once the condition has resolved as long as the subject continues to meet all other entry criteria.
- Grade 4 hypertension per CTCAE criteria is defined as Life threatening consequences(e.g., malignant hypertension, transient or permanent neurologic deficit, hypertensive crisis) urgent intervention indicated. ***Subjects receiving > 20 mg/day of prednisone or its equivalent daily or on alternate days for more than 2 weeks may enter the study after therapy has been discontinued for more than 3 months.
- High dose ICS is defined as: > 960 mcg/day of beclomethasone dipropionate or equivalent * Women of child-bearing potential (not surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who are not postmenopausal for ≥1 year) must agree to practice adequate contraception that may include, but is not limited to, abstinence, monogamous relationship with vasectomized partner, barrier methods such as condoms, diaphragms, spermicides, intrauterine devices, and licensed hormonal methods for 30 days before and 30 days after receiving PPV23 or PCV13.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hope Clinic of the Emory Vaccine Center
Decatur, Georgia, 30030
Atlanta VA Medical Center
Decatur, Georgia, 30033
About this study
Official title: Systems Biology of 23 Valent Pneumococcal Polysaccharide Vaccine (PNEUMOVAX®23) and 13-valent Pneumococcal Conjugate Vaccine (PREVNAR 13®)
Vaccination is the most effective way of preventing infectious diseases. Despite the success of vaccines in general, vaccines induce diminished antibody responses and lower protection in the elderly in particular. This could be explained by a defect in the early responses of an ageing immune system. A better understanding of the basic immunological mechanisms that mediate vaccine efficacy is incomplete. Such information is critical and could greatly decrease both the cost and the time to new vaccine development particularly for the geriatric population.
In this trial, the investigators will study the immunologic differences of two FDA approved licensed pneumococcal vaccines between a younger and an older group. Twenty two healthy volunteers between the age of 25-40 and sixty six healthy volunteers between the ages of 60-89 will be enrolled in the study. Each participant in the study will be given one pneumococcal shot. Blood work will be obtained prior to vaccination, one day, three days, seven days, fourteen days, as well as one month and six months after vaccination. Throughout the duration of the study, the participants will be monitored for safety.
Read the detailed description
RATIONALE: PCV13 [13-valent pneumococcal conjugate vaccine (Prevnar®13)] induces better functional immune responses when compared to PPV23 [23-valent pneumococcal polysaccharide vaccine (Pneumovax®23)] in older naïve adults. We hypothesize that this is due to intrinsic defects in innate responses that could explain the poor immunogenicity of PPV23 when compared to PCV13. Therefore, we propose to extensively study innate and adaptive immune responses generated after administration of either pneumococcal polysaccharide or conjugate vaccines in older adults.
STUDY DESIGN: Single center, open label study in which adult healthy volunteers will be vaccinated with either PPV23 or PCV13. Blood samples will be collected on Days D0 (at enrollment) and D1, D3, D7, D14, D30 and D180 post vaccination to study innate and adaptive immune responses.
Even though PPV23 and PCV13 are considered safe, volunteers will be asked to report any local or systemic AEs from Day 0 (vaccination) to Day 7 . Reactogenicity events will also be evaluated by injection site examination on visits at D0, D1, D3 and D7. Also volunteers are asked to report any local or systemic AEs for 30 days post vaccination and any SAEs for 180 days post vaccination. Volunteers are also asked to report local and systemic AEs developing the day of a blood draw.
- Conditions
- Pneumococcal Infection
- Being tested
- PNEUMOVAX, Prevnar
- Keywords
- pneumococcal vaccine, immune responses
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNEUMOVAXBiological
Also called 23-valent polysaccharide pneumococcal vaccine
1 dose of PNEUMOVAX
PrevnarBiological
Also called 13-valent pneumococcal conjugate vaccine
1 dose of Prevnar
| Study group | Role | What they receive |
|---|---|---|
| Older Group on PREVNAR | Experimental | Participants between the ages of 60-89 received PREVNAR Receives: Biological: Prevnar |
| Younger Group on PREVNAR | Experimental | Participants between the ages of 25-40 years received PREVNAR Receives: Biological: Prevnar |
| Older Group on PNEUMOVAX | Experimental | Participants between the ages of 60-89 received PNEUMOVAX Receives: Biological: PNEUMOVAX |
| Younger Group on PNEUMOVAX | Experimental | Participants between the ages of 25-40 years received PNEUMOVAX Receives: Biological: PNEUMOVAX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Innate Immunity Signatures That Correlate With the Quality of Antibodies After PNEUMOVAX and PREVNAR - Monocyte Module M4.15
Expression of select gene modules reporting on innate and adaptive responses in young and elderly vaccine recipients. Gene expression was compared between pre-vaccination baseline and post-vaccination day 7 for each subject. The number of subjects with significant (by FDR < 0.05) positive enrichment of Monocyte Module M4.15 is reported.
Measured: Day 7
Number of Participants With Innate Immunity Signatures That Correlate With the Quality of Antibodies After PNEUMOVAX and PREVNAR - Monocyte Module M11
Expression of select gene modules reporting on innate and adaptive responses in young and elderly vaccine recipients. Gene expression was compared between pre-vaccination baseline and post-vaccination day 7 for each subject. The number of subjects with significant (by FDR < 0.05) positive enrichment of Monocyte Module M11 is reported.
Measured: Day 7
Number of Participants With Innate Immunity Signatures That Correlate With the Quality of Antibodies After PNEUMOVAX and PREVNAR - Monocyte Module M73
Expression of select gene modules reporting on innate and adaptive responses in young and elderly vaccine recipients. Gene expression was compared between pre-vaccination baseline and post-vaccination day 7 for each subject. The number of subjects with significant (by FDR < 0.05) positive enrichment of Monocyte Module M73 is reported.
Measured: Day 7
Secondary outcomes (3)
Number of Participants With Specific B Cell Responses at Day 7 That Correlate With the Innate Immune Signatures After PNEUMOVAX and PREVNAR - B Cell Module S3
Expression of select B cell modules was compared between pre-vaccination baseline and 7 days post-vaccination for each subject individually. The number of subjects with significant (by FDR < 0.05) positive enrichment of B cell module S3 is reported.
Measured: Day 7
Number of Participants With Specific B Cell Responses at Day 7 That Correlate With the Innate Immune Signatures After PNEUMOVAX and PREVNAR - B Cell Module M156.0
Expression of select B cell modules was compared between pre-vaccination baseline and 7 days post-vaccination for each subject individually. The number of subjects with significant (by FDR < 0.05) positive enrichment of B cell module M156.0 is reported.
Measured: Day 7
Number of Participants With Specific B Cell Responses at Day 7 That Correlate With the Innate Immune Signatures After PNEUMOVAX and PREVNAR - B Cell Module M156.1
Expression of select B cell modules was compared between pre-vaccination baseline and 7 days post-vaccination for each subject individually. The number of subjects with significant (by FDR < 0.05) positive enrichment of B cell module M156.1 is reported.
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2011 (estimated)
- Study startApr 2014
- Primary completionJul 2017
- Study completionJul 2017
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 Pneumococcal InfectionStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadine Rouphael, Emory University
- Investigators
- Nadine Rouphael, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01307449
- Sponsor's protocol ID
- IRB00047973
- Other IDs
- U19AI090023, IRB00078300
- Status last verified
- Sep 2018
- First submitted
- 1 Mar 2011
- Last updated
- 2 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systems Biology of 23 Valent Pneumococcal Polysaccharide Vaccine (PNEUMOVAX®23) and 13-valent Pneumococcal Conjugate Vaccine (PREVNAR 13®)
- ClinicalTrials.gov ID
- NCT01307449
- Acronym / sponsor ID
- IRB00047973
- Conditions
- Pneumococcal Infection
- Keywords
- pneumococcal vaccine, immune responses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Apr 2014 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 3 Mar 2011 (estimated)
- Results
- Posted 2 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vaccination is the most effective way of preventing infectious diseases. Despite the success of vaccines in general, vaccines induce diminished antibody responses and lower protection in the elderly in particular. This could be explained by a defect in the early responses of an ageing immune system. A better understanding of the basic immunological mechanisms that mediate vaccine efficacy is incomplete. Such information is critical and could greatly decrease both the cost and the time to new vaccine development particularly for the geriatric population.
In this trial, the investigators will study the immunologic differences of two FDA approved licensed pneumococcal vaccines between a younger and an older group. Twenty two healthy volunteers between the age of 25-40 and sixty six healthy volunteers between the ages of 60-89 will be enrolled in the study. Each participant in the study will be given one pneumococcal shot. Blood work will be obtained prior to vaccination, one day, three days, seven days, fourteen days, as well as one month and six months after vaccination. Throughout the duration of the study, the participants will be monitored for safety.
Detailed description
RATIONALE: PCV13 [13-valent pneumococcal conjugate vaccine (Prevnar®13)] induces better functional immune responses when compared to PPV23 [23-valent pneumococcal polysaccharide vaccine (Pneumovax®23)] in older naïve adults. We hypothesize that this is due to intrinsic defects in innate responses that could explain the poor immunogenicity of PPV23 when compared to PCV13. Therefore, we propose to extensively study innate and adaptive immune responses generated after administration of either pneumococcal polysaccharide or conjugate vaccines in older adults.
STUDY DESIGN: Single center, open label study in which adult healthy volunteers will be vaccinated with either PPV23 or PCV13. Blood samples will be collected on Days D0 (at enrollment) and D1, D3, D7, D14, D30 and D180 post vaccination to study innate and adaptive immune responses.
Even though PPV23 and PCV13 are considered safe, volunteers will be asked to report any local or systemic AEs from Day 0 (vaccination) to Day 7 . Reactogenicity events will also be evaluated by injection site examination on visits at D0, D1, D3 and D7. Also volunteers are asked to report any local or systemic AEs for 30 days post vaccination and any SAEs for 180 days post vaccination. Volunteers are also asked to report local and systemic AEs developing the day of a blood draw.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Older Group on PREVNAR | Experimental | Biological: PrevnarParticipants between the ages of 60-89 received PREVNAR |
| Younger Group on PREVNAR | Experimental | Biological: PrevnarParticipants between the ages of 25-40 years received PREVNAR |
| Older Group on PNEUMOVAX | Experimental | Biological: PNEUMOVAXParticipants between the ages of 60-89 received PNEUMOVAX |
| Younger Group on PNEUMOVAX | Experimental | Biological: PNEUMOVAXParticipants between the ages of 25-40 years received PNEUMOVAX |
Who may qualify
- Ages
- 25 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Able to understand and give informed consent.
- Immunocompetent community dwelling subjects between the ages of ages of 25-40 and 60-89 years.
Key exclusion criteria (20 listed)
- Prior vaccination with pneumococcal vaccine.
- Receipt of any of the following products:
- Presence of co-morbidities or immunosuppressive states such as:
- Conditions that could affect the safety of the volunteers such as:
- o Severe reactions to prior vaccinations.
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 |
|---|---|---|
| PNEUMOVAXAlso: 23-valent polysaccharide pneumococcal vaccine1 dose of PNEUMOVAX | Biological | Older Group on PNEUMOVAX, Younger Group on PNEUMOVAX |
| PrevnarAlso: 13-valent pneumococcal conjugate vaccine1 dose of Prevnar | Biological | Older Group on PREVNAR, Younger Group on PREVNAR |
Primary outcome
Number of Participants With Innate Immunity Signatures That Correlate With the Quality of Antibodies After PNEUMOVAX and PREVNAR - Monocyte Module M4.15
Time frame: Day 7
Expression of select gene modules reporting on innate and adaptive responses in young and elderly vaccine recipients. Gene expression was compared between pre-vaccination baseline and post-vaccination day 7 for each subject. The number of subjects with significant (by FDR < 0.05) positive enrichment of Monocyte Module M4.15 is reported.
Number of Participants With Innate Immunity Signatures That Correlate With the Quality of Antibodies After PNEUMOVAX and PREVNAR - Monocyte Module M11
Time frame: Day 7
Expression of select gene modules reporting on innate and adaptive responses in young and elderly vaccine recipients. Gene expression was compared between pre-vaccination baseline and post-vaccination day 7 for each subject. The number of subjects with significant (by FDR < 0.05) positive enrichment of Monocyte Module M11 is reported.
Number of Participants With Innate Immunity Signatures That Correlate With the Quality of Antibodies After PNEUMOVAX and PREVNAR - Monocyte Module M73
Time frame: Day 7
Expression of select gene modules reporting on innate and adaptive responses in young and elderly vaccine recipients. Gene expression was compared between pre-vaccination baseline and post-vaccination day 7 for each subject. The number of subjects with significant (by FDR < 0.05) positive enrichment of Monocyte Module M73 is reported.
3 secondary outcomes
Number of Participants With Specific B Cell Responses at Day 7 That Correlate With the Innate Immune Signatures After PNEUMOVAX and PREVNAR - B Cell Module S3
Time frame: Day 7
Number of Participants With Specific B Cell Responses at Day 7 That Correlate With the Innate Immune Signatures After PNEUMOVAX and PREVNAR - B Cell Module M156.0
Time frame: Day 7
Number of Participants With Specific B Cell Responses at Day 7 That Correlate With the Innate Immune Signatures After PNEUMOVAX and PREVNAR - B Cell Module M156.1
Time frame: Day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for Pneumococcal Infection
Active, not recruitingPhase 2
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
Pneumococcal Disease
RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
Active, not recruitingObservational study
A Study to Learn About the Safety of PREVENAR 20 Vaccine in Infants Aged Between Two to Six Months
Pneumococcal Disease
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
RecruitingObservational study
National, Non Interventional Study of Invasive Pneumococcal Disease in Children and Newborns
Pneumococcal Infections, Pneumococcal Conjugate Vaccine
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.
Nadine Rouphael, MD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PNEUMOVAX and Prevnar in people with Pneumococcal Infection, run by Emory University at 2 sites 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 2 inclusion and 20 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 2 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Oct 2018). 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?
Number of Participants With Innate Immunity Signatures That Correlate With the Quality of Antibodies After PNEUMOVAX and PREVNAR - Monocyte Module M4.15 (time frame: Day 7). 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?
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 2 Oct 2018.