Preventive Immunization; MeningitisPhase 4PLATNCT04224311
Immunogenicity of Quadrivalent Meningococcal Conjugate Vaccine in Frequent Platelets Donors
A Phase 4 study testing Menactra in people with Preventive Immunization; Meningitis, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
In this study, the investigators will evaluate the immunogenicity of a quadrivalent conjugate meningococcal vaccine in healthy, plateletpheresis donors. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Preventive Immunization; Meningitis
- What is being tested?
- Menactra
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2020to 15 Apr 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female aged 18 years old or older
- Meet the standard requirements to donate platelets
- Have had at least one plateletpheresis in the prior 365 days (including the day of enrollment)
Who cannot join
- Participants who donated platelets in any other medical center in the previous 365 days
- Severe allergic reaction to a previous meningococcal vaccine or to any component of MenACYW-D
- History of Guillain-Barré syndrome
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
In this study, the investigators will evaluate the immunogenicity of a quadrivalent conjugate meningococcal vaccine in healthy, plateletpheresis donors.
Read the detailed description
This will be an open-label prospective vaccine response study evaluating one dose of MenACWY-D in plateletpheresis donors at the Brigham and Women's Hospital (BWH). Potential participants will be divided into three groups according to the number of plateletpheresis within 365 days of enrollment (including the day of enrollment): 1-2 sessions group (considered as the control group), 3-19 sessions group, 20-24 sessions group and randomly sampled from in allocation proportions of 0.45, 0.10, and 0.45, respectively; justification for this approach is provided in the Statistical Analysis section. MenACWY-D vaccine will be administered to each patient. Pre- and post-vaccination blood will be collected to assess immunogenicity, likely using serum bactericidal antibody (SBA) against Neisseria meningitidis for each serogroup. Immunogenicity will be primarily evaluated by seroresponse such as a fourfold increase of SBA titers between pre- and post-vaccination.
- Conditions
- Preventive Immunization; Meningitis
- Being tested
- Menactra
- Medical subject headings
- Meningitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MenactraBiological
0.5 mL dosage of Menactra will be administered by intramuscular injection in the deltoid muscle on day 0.
| Study group | Role | What they receive |
|---|---|---|
| Low number plateletpheresis donations | Active comparator | Participants that have had 1-2 plateletpheresis donations in the last 365 days. Menactra will be administered as a 0.5 mL dose. Receives: Biological: Menactra |
| Medium number plateletpheresis donations | Active comparator | Participants that have had 3-19 plateletpheresis donations in the last 365 days. Menactra will be administered as a 0.5 mL dose. Receives: Biological: Menactra |
| High number plateletpheresis donations | Active comparator | Participants that have had 20-24 plateletpheresis donations in the last 365 days. Menactra will be administered as a 0.5 mL dose. Receives: Biological: Menactra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroresponse of vaccine
The primary outcome will be the seroresponse of MenACYW-D vaccination, such as a fourfold change of SBA titers between pre- and post-vaccination for each of the 4 antigens.
Measured: Months 1 and 6.
Secondary outcomes (1)
Seroprotection
The pre- and post-vaccination seroprotection, such as SBA titer greater than or equal to 1:8.
Measured: Months 1 and 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start12 Mar 2020
- Primary completion1 Oct 2023 (estimated)
- Study completion15 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preventive Immunization; MeningitisStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lindsey R. Baden, MD, Brigham and Women's Hospital
- Investigators
- Lindsey Baden, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04224311
- Sponsor's protocol ID
- 2019P003638
- Acronym
- PLAT
- Status last verified
- Nov 2022
- First submitted
- 8 Jan 2020
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data will be made available upon request to the principal investigator following the publication of the primary manuscript.
Publications
Desjardins M, Cunningham P, Mitre X, Pierre D, Montesano C, Woods T, Oganezova K, Krauss JH, Von SS, Kupelian JA, Li X, Gothing JA, Kleinjan JA, Zhou G, Piantadosi S, Sherman AC, Walsh SR, Issa NC, Kaufman RM, Baden LR. Immunogenicity of quadrivalent meningococcal conjugate vaccine in frequent platelet donors. Blood. 2023 Jul 13;142(2):202-209. doi: 10.1182/blood.2022019482.
PubMed 37172200
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity of Quadrivalent Meningococcal Conjugate Vaccine in Frequent Platelets Donors
- ClinicalTrials.gov ID
- NCT04224311
- Acronym / sponsor ID
- PLAT / 2019P003638
- Conditions
- Preventive Immunization; Meningitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 12 Mar 2020 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 15 Apr 2024 (estimated)
- First posted
- 13 Jan 2020 (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.
In this study, the investigators will evaluate the immunogenicity of a quadrivalent conjugate meningococcal vaccine in healthy, plateletpheresis donors.
Detailed description
This will be an open-label prospective vaccine response study evaluating one dose of MenACWY-D in plateletpheresis donors at the Brigham and Women's Hospital (BWH). Potential participants will be divided into three groups according to the number of plateletpheresis within 365 days of enrollment (including the day of enrollment): 1-2 sessions group (considered as the control group), 3-19 sessions group, 20-24 sessions group and randomly sampled from in allocation proportions of 0.45, 0.10, and 0.45, respectively; justification for this approach is provided in the Statistical Analysis section. MenACWY-D vaccine will be administered to each patient. Pre- and post-vaccination blood will be collected to assess immunogenicity, likely using serum bactericidal antibody (SBA) against Neisseria meningitidis for each serogroup. Immunogenicity will be primarily evaluated by seroresponse such as a fourfold increase of SBA titers between pre- and post-vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low number plateletpheresis donations | Active comparator | Biological: MenactraParticipants that have had 1-2 plateletpheresis donations in the last 365 days. Menactra will be administered as a 0.5 mL dose. |
| Medium number plateletpheresis donations | Active comparator | Biological: MenactraParticipants that have had 3-19 plateletpheresis donations in the last 365 days. Menactra will be administered as a 0.5 mL dose. |
| High number plateletpheresis donations | Active comparator | Biological: MenactraParticipants that have had 20-24 plateletpheresis donations in the last 365 days. Menactra will be administered as a 0.5 mL dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female aged 18 years old or older
- Meet the standard requirements to donate platelets
- Have had at least one plateletpheresis in the prior 365 days (including the day of enrollment)
Key exclusion criteria (3 listed)
- Participants who donated platelets in any other medical center in the previous 365 days
- Severe allergic reaction to a previous meningococcal vaccine or to any component of MenACYW-D
- History of Guillain-Barré syndrome
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 |
|---|---|---|
| Menactra0.5 mL dosage of Menactra will be administered by intramuscular injection in the deltoid muscle on day 0. | Biological | High number plateletpheresis donations, Low number plateletpheresis donations, Medium number plateletpheresis donations |
Primary outcome
Seroresponse of vaccine
Time frame: Months 1 and 6.
The primary outcome will be the seroresponse of MenACYW-D vaccination, such as a fourfold change of SBA titers between pre- and post-vaccination for each of the 4 antigens.
1 secondary outcome
Seroprotection
Time frame: Months 1 and 6.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
- Derived from this study: PubMed 37172200Desjardins M, Cunningham P, Mitre X, Pierre D, Montesano C, Woods T, Oganezova K, Krauss JH, Von SS, Kupelian JA, Li X, Gothing JA, Kleinjan JA, Zhou G, Piantadosi S, Sherman AC, Walsh SR, Issa NC, Kaufman RM, Baden LR. Immunogenicity of quadrivalent meningococcal conjugate vaccine in frequent platelet donors. Blood. 2023 Jul 13;142(2):202-209. doi: 10.1182/blood.2022019482.
- Individual participant dataSharing planned: Yes. Deidentified data will be made available upon request to the principal investigator following the publication of the primary manuscript.
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.
Lindsey Baden, MD principal investigator
Brigham and Women's Hospital
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 Menactra in people with Preventive Immunization; Meningitis, run by Brigham and Women's Hospital 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 3 inclusion and 3 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 15 Nov 2022. 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?
Results are not available in the source record.
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?
Seroresponse of vaccine (time frame: Months 1 and 6.). 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 NCT04224311, 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 15 Nov 2022.