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Tests treatment safety and results for Malaria
Official title A Study to Assess the Safety and Immunogenicity of a Vaccine Against Malaria in Healthy Children Aged 5-60 Months
ClinicalTrials.gov ID: NCT07036159
What this study is testing
What is RTS,S/AS01E vaccine?
RTS,S/AS01E vaccine is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for malaria.
Also referred to as Mosquirix.
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 evaluate the safety and immunogenicity of reduced antigen doses and alternative vaccination regimes for RTS,S/AS01E in healthy children aged 5-60 months in a malaria-endemic area.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 60. Healthy volunteers may be eligible.
You may be able to join if
- Healthy male or female participants aged 5 to 60 months at the time of the first vaccination, who have previously completed the World Health...
- Participants' parent(s)/Legally Acceptable Representative(s) (LAR), in the opinion of the investigator, can and will comply with the requirements of...
- Written or witnessed/thumb-printed informed consent obtained from the participant's parent(s)/LAR prior to performance of any study-specific...
- Healthy, as established by medical history and clinical examination.
- Negative for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV).
You likely can't join if
- Progressive, unstable, or uncontrolled clinical conditions.
- History (known or suspected) of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccine.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing...
- Clinical conditions representing a contraindication to IM vaccination or blood draws.
- Any behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the participant's ability...
- Recurrent history of or uncontrolled neurological disorders or seizures.
See the full eligibility criteria
- Healthy male or female participants aged 5 to 60 months at the time of the first vaccination, who have previously completed the World Health Organization (WHO) Expanded Programme on Immunization (EPI) vaccinations or...
- Participants' parent(s)/Legally Acceptable Representative(s) (LAR), in the opinion of the investigator, can and will comply with the requirements of the protocol (eg, completion of the diaries, returning for follow-up...
- Written or witnessed/thumb-printed informed consent obtained from the participant's parent(s)/LAR prior to performance of any study-specific procedure.
- Healthy, as established by medical history and clinical examination.
- Negative for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV).
- With hemoglobin levels \>8 g/dL.
- Born after a gestation period of ≥37 weeks.
- Progressive, unstable, or uncontrolled clinical conditions.
- History (known or suspected) of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccine.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- Clinical conditions representing a contraindication to IM vaccination or blood draws.
- Any behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the participant's ability to participate in the study.
- Recurrent history of or uncontrolled neurological disorders or seizures.
- Undernutrition, defined as WHO Z-score less than -2 standard deviation.
- Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant as a result of participation in the study, for example, any major congenital defects.
- Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination and medical history.
- Administration of long-acting immune-modifying drugs (eg, infliximab) during the study period starting 3 months before the first dose of study vaccine or planned administration during the study period.
- Prior receipt of a malaria vaccine (registered or experimental).
- Use of any investigational or non-registered product (drug, vaccine, or medical device)\ other than the study vaccine during the period starting 30 days before the first dose of study vaccine (Day -30 to Day 1), or...
- Planned administration of a vaccine not foreseen by the study protocol or the country EPI in the period starting 14 days before each dose and ending 28 days after the last dose of study vaccine administration\ , with...
- Administration of immunoglobulins and/or any blood products or plasma derivatives, or bone marrow transplantation, during the period starting 3 months before the first dose of study vaccine or planned administration...
- Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first vaccine dose or planned administration during...
- Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug or...
- Any study personnel's immediate dependents, family, or household members.
- Child in care.
The study team makes the final eligibility decision.
Where it's taking place
- Kigali, Rwanda
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, 5 months to 60 months. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kigali, Rwanda. 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.