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New treatment option for Sickle Cell Disease
Official title Study of a Single Dose of a 21-valent Pneumococcal Conjugate Vaccine in Children and Adolescents With Sickle Cell Disease
ClinicalTrials.gov ID: NCT07247188
What this study is testing
What is PCV21?
PCV21 is an investigational medicine, being studied as a potential treatment for sickle cell disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to measure whether PCV21 vaccine (investigational pneumococcal vaccine) is safe and can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) compared with 20vPCV (licensed pneumococcal vaccine) when given as a single dose to children aged 2 to 17 years with sickle cell disease who had received or not a previous vaccination with pneumococcal conjugate or pneumococcal polysaccharide vaccine.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 17
You may be able to join if
- Aged 2 to 17 years on the day of inclusion. TYPE OF PARTICIPANT AND DISEASE CHARACTERISTICS
- Participants who have a documented diagnosis of sickle cell disease (SCD) in their medical record. SEX, CONTRACEPTIVE/BARRIER METHOD AND PREGNANCY...
- A participant is eligible to participate if the participant is not pregnant or breastfeeding and one of the following conditions applies:
- Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be pre-menarchal or surgically sterile. OR
- Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention...
You likely can't join if
- MEDICAL CONDITIONS
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation...
- History of microbiologically confirmed S. pneumoniae infection or disease.
- History of seizure or significant stable or progressive neurological disorders such as inflammatory nervous system diseases, encephalopathy, and...
- Known systemic hypersensitivity to any of the study interventions components, or history of a life-threatening reaction to the study interventions...
- Laboratory-confirmed thrombocytopenia, or known thrombocytopenia, as reported by the parent/LAR, contraindicating intramuscular (IM) injection.
See the full eligibility criteria
- Aged 2 to 17 years on the day of inclusion. TYPE OF PARTICIPANT AND DISEASE CHARACTERISTICS
- Participants who have a documented diagnosis of sickle cell disease (SCD) in their medical record. SEX, CONTRACEPTIVE/BARRIER METHOD AND PREGNANCY TESTING REQUIREMENTS
- A participant is eligible to participate if the participant is not pregnant or breastfeeding and one of the following conditions applies:
- Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be pre-menarchal or surgically sterile. OR
- Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 4 weeks after study intervention...
- Assent form has been signed and dated by the participant (based on local regulations), and, if applicable, informed consent form has been signed and dated by the parent(s) or another legally acceptable representative...
- Participant and parent(s)/LAR are able to attend all scheduled visits and to comply with all study procedures.
- MEDICAL CONDITIONS
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic...
- History of microbiologically confirmed S. pneumoniae infection or disease.
- History of seizure or significant stable or progressive neurological disorders such as inflammatory nervous system diseases, encephalopathy, and cerebral palsy.
- Known systemic hypersensitivity to any of the study interventions components, or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances.
- Laboratory-confirmed thrombocytopenia, or known thrombocytopenia, as reported by the parent/LAR, contraindicating intramuscular (IM) injection.
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM injection.
- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion.
- Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]) on the day of study intervention administration. A prospective participant should not...
- Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion. PRIOR/CONCOMITANT THERAPY
- Receipt of at least one dose of 20vPCV.
- For children aged \< 6 years: receipt of \< 3 doses of pneumococcal conjugate vaccine or any dose of 23-valent pneumococcal polysaccharide vaccine (PPSV23).
- For children and adolescents aged ≥ 6 years: receipt of PPSV23 \< 5 years before study vaccination or last PCV dose \< 8 weeks before study vaccination.
- Receipt of any vaccine in the 4 weeks preceding the study intervention administration or planned receipt of any vaccine in the 4 weeks following the study intervention administration, except for US licensed influenza...
- Receipt of immune globulins, blood or blood-derived products in the past 3 months.
- Receipt of an oral or injectable antibiotic therapy for any acute illness within 72 hours prior to the first blood draw. PRIOR/CONCURRENT CLINICAL STUDY EXPERIENCE
- Participation at the time of study enrollment (or in the 6 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a...
- Being in an emergency setting.
- Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study. For children/adolescents (6 to 17 YoA) only
- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
- Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of...
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
- Omaha, Nebraska, United States
- New Brunswick, New Jersey, United States
- Houston, Texas, United States
- Santo Domingo, Dominican Republic
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States; Omaha, Nebraska, United States; New Brunswick, New Jersey, United States; Houston, Texas, United States; Santo Domingo, Dominican Republic. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.