Pneumococcal InfectionsPhase 4NCT04875858
Immunogenicity After Revaccination With 23-valent Pneumococcal Polysaccharide Vaccine: Healthy Elderly People Versus Diabetic Patients
A Phase 4 study testing ProDiax-23 (PPSV23) in people with Pneumococcal Infections, run by Korea University Guro Hospital at 1 site in South Korea.
Trial summary
Pneumococcal disease causes thousands of infections, such as meningitis, bloodstream infections, pneumonia, and ear infections in US annually. As pneumococcal vaccines provide serotype-specific protection, it is important to induce sufficient immune responses for the most clinically relevant serotypes. Read more about this study
- Who is it for?
- Ages 70 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Infections
- What is being tested?
- ProDiax-23 (PPSV23)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 May 2021to 30 Apr 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 70 to 75 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Elderly people aged 70-75 years
- Had received PPSV23 in the previous 5-7 years
Who cannot join
- Immunocompromised patients
- Subjects receiving immunosuppressive agents
- Subjects with a history of vaccination with pneumococcal conjugate vaccine
- Subjects with a history of pneumococcal disease (positive culture from blood or other sterile fluid)
- Fever (defined as an oral temperature >37.5℃) within 24 h before PPSV23 vaccination
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Koera University Guro Hospital
Seoul, 08308
Hye Seong, MD.PhD, +82-10-4840-5965, msmjoonhoo@gmail.com
Joon Young Song, MD.PhD
About this study
Official title: Non-randomized Clinical Trial to Compare the Immunogenicity of Revaccination With 23-valent Pneumococcal Polysaccharide Vaccine Between Healthy Elderly and Those With Diabetes in Korea
Pneumococcal disease causes thousands of infections, such as meningitis, bloodstream infections, pneumonia, and ear infections in US annually. As pneumococcal vaccines provide serotype-specific protection, it is important to induce sufficient immune responses for the most clinically relevant serotypes. All adults aged 65 years or older are recommended to receive PPSV23 vaccination irrespective of underlying medical conditions. Thus, since May 2013, South Korea introduced PPSV23 in the national immunization program for elderly individuals aged ≥65 years. Following PPSV23 vaccination, serotype-specific IgG concentrations and OPA titers increase and then decline over time thereby decreasing protective efficacy, although these might remain above pre-vaccination levels until 5 years from PPSV23 administration. The decline of pneumococcal immunity may be more prominent among chronically ill patients, including those with diabetes. Currently however, revaccination is not recommended. In this study, we aimed to evaluate the serotype specific immunogenicity between healthy elderly people and old adults with diabetes after revaccination with PPSV23 at the age of 70-75 years. Serotype-specific IgG concentrations and opsonophagocytic killing activity (OPA) titers will be assessed.
- Conditions
- Pneumococcal Infections
- Being tested
- ProDiax-23 (PPSV23)
- Keywords
- Streptococcus pneumoniae, Diabetes Mellitus, Immunogenicity, Vaccine, Pneumococcal Vaccines
- Medical subject headings
- Pneumococcal Infections, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProDiax-23 (PPSV23)Drug
diabetic old adults aged 70-75 years who received PPSV23 in previous 5-7 years (Persons 65-70 years old who have been inoculated with PPSV23 and 5-7 years have passed) and healthy old adults aged 70-75 years who received PPSV23 in previous 5-7 years (Persons 65-70 years old who have been inoculated with PPSV23 and 5-7 years have passed)
| Study group | Role | What they receive |
|---|---|---|
| healthy old adults aged 70-75 years who received PPSV23 | Active comparator | Recruitment of 254 healthy 70-75-year healthy old adults who meet the selection and exclusion criteria and voluntarily agree to participate in this study. Vaccination -Based on guidelines for vaccination. Injecting muscles on the triceps Visit 4 weeks after vaccination ․ Blood sample collection for evaluation of immunogenicity (10 mL) ․ Comparison of GMT and seroconversion rates of IgG antibody titers against 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F and 23F) -Comparison of GMT and seroconversion rates of opsonophagocytic killing assay (OPA) for four pneumococcal serotypes (serotypes 5, 6B, 18C, 19A) Receives: Drug: ProDiax-23 (PPSV23) |
| old adults who have diabetes mellitus aged 70-75 years who rec | Experimental | Recruitment of 254 healthy 70-75-year diabetic old adults who meet the selection and exclusion criteria and voluntarily agree to participate in this study. Vaccination -Based on guidelines for vaccination. Injecting muscles on the triceps Visit 4 weeks after vaccination ․ Blood sample collection for evaluation of immunogenicity (10 mL) ․ Comparison of GMT and seroconversion rates of IgG antibody titers against 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F and 23F) -Comparison of GMT and seroconversion rates of opsonophagocytic killing assay (OPA) for four pneumococcal serotypes (serotypes 5, 6B, 18C, 19A) Receives: Drug: ProDiax-23 (PPSV23) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serotype-specific immunogenicity assessed by opsonophagocytic killing assay.
After PPSV23 vaccination, blood samples (10 mL) will be collected before vaccination and at 4 weeks post-vaccination. Serotype-specific opsonophagocytic activity (OPA) will be evaluated from those blood samples by opsonophagocytic killing assay for 4 serotypes (5, 6B, 18C, 19A).
Measured: up to one month after vaccination
Secondary outcomes (2)
Serotype-specific IgG antibody concentrations assessed by ELISA.
After PPSV23 vaccination, blood samples (10 mL) will be collected before vaccination and at 4 weeks post-vaccination. Serotype-specific IgG antibody concentrations for 13 serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F and 23F) will be measured.
Measured: up to one month after vaccination
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Solicited local or systemic reactions to the vaccines will be monitored using diary cards during the14 days post-vaccination. Participants will be asked to record pain, tenderness and redness diameter at both injection sites and systemic symptoms such as headache, malaise, chills, muscle aches, and arthralgia. Severity will be recorded according to the Food and Drug Administration Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Subjects will be also asked to record any unsolicited adverse event during the 14 days after vaccination.
Measured: up to one month after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start1 May 2021 (estimated)
- Primary completion30 Apr 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pneumococcal InfectionsStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 254 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Guro Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Joon Young Song, Korea University Guro Hospital
- Investigators
- Joon Young Song, MD, PhD., Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04875858
- Sponsor's protocol ID
- 2020GR0143
- Status last verified
- May 2021
- First submitted
- 24 Nov 2020
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Song JY, Cheong HJ, Tsai TF, Chang HA, Choi MJ, Jeon JH, Kang SH, Jeong EJ, Noh JY, Kim WJ. Immunogenicity and safety of concomitant MF59-adjuvanted influenza vaccine and 23-valent pneumococcal polysaccharide vaccine administration in older adults. Vaccine. 2015 Aug 26;33(36):4647-52. doi: 10.1016/j.vaccine.2015.05.003. Epub 2015 May 14.
PubMed 25980426Kawakami K, Kishino H, Kanazu S, Toshimizu N, Takahashi K, Sterling T, Wang M, Musey L. Revaccination with 23-valent pneumococcal polysaccharide vaccine in the Japanese elderly is well tolerated and elicits immune responses. Vaccine. 2016 Jul 19;34(33):3875-81. doi: 10.1016/j.vaccine.2016.05.052. Epub 2016 Jun 10.
PubMed 27265450Choi WS, Choi JH, Kwon KT, Seo K, Kim MA, Lee SO, Hong YJ, Lee JS, Song JY, Bang JH, Choi HJ, Choi YH, Lee DG, Cheong HJ; Committee of Adult Immunization; Korean Society of Infectious Diseases. Revised adult immunization guideline recommended by the korean society of infectious diseases, 2014. Infect Chemother. 2015 Mar;47(1):68-79. doi: 10.3947/ic.2015.47.1.68. Epub 2015 Mar 30. No abstract available.
PubMed 25844267
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-randomized Clinical Trial to Compare the Immunogenicity of Revaccination With 23-valent Pneumococcal Polysaccharide Vaccine Between Healthy Elderly and Those With Diabetes in Korea
- ClinicalTrials.gov ID
- NCT04875858
- Acronym / sponsor ID
- 2020GR0143
- Conditions
- Pneumococcal Infections
- Keywords
- Streptococcus pneumoniae, Diabetes Mellitus, Immunogenicity, Vaccine, Pneumococcal Vaccines
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 254 participants (estimated)
- Lead sponsor
- Korea University Guro HospitalUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 6 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pneumococcal disease causes thousands of infections, such as meningitis, bloodstream infections, pneumonia, and ear infections in US annually. As pneumococcal vaccines provide serotype-specific protection, it is important to induce sufficient immune responses for the most clinically relevant serotypes. All adults aged 65 years or older are recommended to receive PPSV23 vaccination irrespective of underlying medical conditions. Thus, since May 2013, South Korea introduced PPSV23 in the national immunization program for elderly individuals aged ≥65 years. Following PPSV23 vaccination, serotype-specific IgG concentrations and OPA titers increase and then decline over time thereby decreasing protective efficacy, although these might remain above pre-vaccination levels until 5 years from PPSV23 administration. The decline of pneumococcal immunity may be more prominent among chronically ill patients, including those with diabetes. Currently however, revaccination is not recommended. In this study, we aimed to evaluate the serotype specific immunogenicity between healthy elderly people and old adults with diabetes after revaccination with PPSV23 at the age of 70-75 years. Serotype-specific IgG concentrations and opsonophagocytic killing activity (OPA) titers will be assessed.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy old adults aged 70-75 years who received PPSV23 | Active comparator | Drug: ProDiax-23 (PPSV23)Recruitment of 254 healthy 70-75-year healthy old adults who meet the selection and exclusion criteria and voluntarily agree to participate in this study. Vaccination -Based on guidelines for vaccination. Injecting muscles on the triceps Visit 4 weeks after vaccination ․ Blood sample collection for evaluation of immunogenicity (10 mL) ․ Comparison of GMT and seroconversion rates of IgG antibody titers against 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F and 23F) -Comparison of GMT and seroconversion rates of opsonophagocytic killing assay (OPA) for four pneumococcal serotypes (serotypes 5, 6B, 18C, 19A) |
| old adults who have diabetes mellitus aged 70-75 years who rec | Experimental | Drug: ProDiax-23 (PPSV23)Recruitment of 254 healthy 70-75-year diabetic old adults who meet the selection and exclusion criteria and voluntarily agree to participate in this study. Vaccination -Based on guidelines for vaccination. Injecting muscles on the triceps Visit 4 weeks after vaccination ․ Blood sample collection for evaluation of immunogenicity (10 mL) ․ Comparison of GMT and seroconversion rates of IgG antibody titers against 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F and 23F) -Comparison of GMT and seroconversion rates of opsonophagocytic killing assay (OPA) for four pneumococcal serotypes (serotypes 5, 6B, 18C, 19A) |
Who may qualify
- Ages
- 70 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Elderly people aged 70-75 years
- Had received PPSV23 in the previous 5-7 years
Key exclusion criteria (5 listed)
- Immunocompromised patients
- Subjects receiving immunosuppressive agents
- Subjects with a history of vaccination with pneumococcal conjugate vaccine
- Subjects with a history of pneumococcal disease (positive culture from blood or other sterile fluid)
- Fever (defined as an oral temperature >37.5℃) within 24 h before PPSV23 vaccination
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 |
|---|---|---|
| ProDiax-23 (PPSV23)diabetic old adults aged 70-75 years who received PPSV23 in previous 5-7 years (Persons 65-70 years old who have been inoculated with PPSV23 and 5-7 years have passed) and healthy old adults aged 70-75 years who received PPSV23 in previous 5-7 years (Persons 65-70 years old who have been inoculated with PPSV23 and 5-7 years have passed) | Drug | healthy old adults aged 70-75 years who received PPSV23, old adults who have diabetes mellitus aged 70-75 years who rec |
Primary outcome
Serotype-specific immunogenicity assessed by opsonophagocytic killing assay.
Time frame: up to one month after vaccination
After PPSV23 vaccination, blood samples (10 mL) will be collected before vaccination and at 4 weeks post-vaccination. Serotype-specific opsonophagocytic activity (OPA) will be evaluated from those blood samples by opsonophagocytic killing assay for 4 serotypes (5, 6B, 18C, 19A).
2 secondary outcomes
Serotype-specific IgG antibody concentrations assessed by ELISA.
Time frame: up to one month after vaccination
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: up to one month after vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- Background: PubMed 25980426Song JY, Cheong HJ, Tsai TF, Chang HA, Choi MJ, Jeon JH, Kang SH, Jeong EJ, Noh JY, Kim WJ. Immunogenicity and safety of concomitant MF59-adjuvanted influenza vaccine and 23-valent pneumococcal polysaccharide vaccine administration in older adults. Vaccine. 2015 Aug 26;33(36):4647-52. doi: 10.1016/j.vaccine.2015.05.003. Epub 2015 May 14.
- Background: PubMed 27265450Kawakami K, Kishino H, Kanazu S, Toshimizu N, Takahashi K, Sterling T, Wang M, Musey L. Revaccination with 23-valent pneumococcal polysaccharide vaccine in the Japanese elderly is well tolerated and elicits immune responses. Vaccine. 2016 Jul 19;34(33):3875-81. doi: 10.1016/j.vaccine.2016.05.052. Epub 2016 Jun 10.
- Background: PubMed 25844267Choi WS, Choi JH, Kwon KT, Seo K, Kim MA, Lee SO, Hong YJ, Lee JS, Song JY, Bang JH, Choi HJ, Choi YH, Lee DG, Cheong HJ; Committee of Adult Immunization; Korean Society of Infectious Diseases. Revised adult immunization guideline recommended by the korean society of infectious diseases, 2014. Infect Chemother. 2015 Mar;47(1):68-79. doi: 10.3947/ic.2015.47.1.68. Epub 2015 Mar 30. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
Joon Young Song, MD, PhD. principal investigator
Professor
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 ProDiax-23 (PPSV23) in people with Pneumococcal Infections, run by Korea University Guro Hospital at 1 site in South Korea.
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 5 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: status not confirmed, as of the sponsor's last update on 6 May 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hye Seong, MD, PhD. (+82-10-4840-5965, msmjoonhoo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serotype-specific immunogenicity assessed by opsonophagocytic killing assay. (time frame: up to one month after vaccination). 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 NCT04875858, which also lists 3 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 6 May 2021.