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Cancer Vaccine
Pvs230D1-EPA/Matrix-M Vaccine for Malaria
Phase 1
Recruiting
Led By Joel A Goldberg, M.D.
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >=18 and <=50 years
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up receipt of first vaccine through subject study completion
Awards & highlights
Study Summary
This trial will test a new vaccine to stop the spread of malaria. Healthy adults aged 18-50 can volunteer for 3 vaccine visits & 12 clinic visits over 8 months, plus 7 follow-up phone calls over 12 months.
Who is the study for?
Healthy adults aged 18-50 who can consent to the study, understand it well, and have reliable access to NIHCC for visits. They must agree to use contraception and not donate blood during the trial. Excluded are pregnant or breastfeeding individuals, those with certain medical conditions or treatments that affect immune function, and anyone planning travel to malaria-endemic areas.Check my eligibility
What is being tested?
The trial is testing a new vaccine called Pvs230D1-EPA/Matrix-M designed to prevent the spread of malaria. Participants will receive three injections over several months and attend multiple clinic visits for health checks without being exposed to malaria.See study design
What are the potential side effects?
Potential side effects aren't specified in this summary but may include typical vaccine reactions such as soreness at injection site, fever, fatigue or allergic responses. Specific risks will be monitored throughout the study.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 50 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ receipt of first vaccine through subject study completion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~receipt of first vaccine through subject study completion
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To assess the safety and reactogenicity of Pvs230D1-EPA/MM in healthy malaria-naive adults
Trial Design
3Treatment groups
Experimental Treatment
Group I: Group 3Experimental Treatment1 Intervention
50 (micro)g Pvs230D1-EPA/50 (micro)g MM
Group II: Group 2Experimental Treatment1 Intervention
25 (micro)g Pvs230D1-EPA/50 (micro)g MM
Group III: Group 1Experimental Treatment1 Intervention
5 (micro)g Pvs230D1-EPA/50 (micro)g MM
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Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,270 Previous Clinical Trials
5,485,037 Total Patients Enrolled
149 Trials studying Malaria
612,456 Patients Enrolled for Malaria
Joel A Goldberg, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken strong immune system suppressing drugs for more than 2 weeks in the last 6 months.I am between 18 and 50 years old.I haven't used any experimental drugs or non-approved vaccines in the last 28 days.I have had P. vivax malaria or symptoms that suggest it.I can sign a consent form to participate in the study.I have not had a blood transfusion or IVIG in the last 6 months.I do not have HIV, hepatitis B, or hepatitis C.You have had a serious allergic reaction or other severe adverse reaction to a previous vaccine.I am in good health with no major medical issues.You are currently breastfeeding a baby.You have received an experimental malaria vaccine for P. vivax within the past 2 years.I do not have a spleen or my spleen does not work properly.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1
- Group 2: Group 2
- Group 3: Group 3
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who meets the criteria to participate in this research trial?
"This clinical trial requires participants to have a confirmed diagnosis of malaria and be between the ages of 18-50. Recruitment is open for 200 individuals in total."
Answered by AI
Has Group 1 obtained clearance from the FDA?
"Taking into consideration the limited evidence of efficacy and safety, Group 1 was attributed a score of 1."
Answered by AI
Is participation in this experiment permissible for those aged 35 and above?
"This investigation has specific criteria for participants; those between 18 and 50 years of age are eligible to apply. Separately, there are 67 trials that admit patients below the age-of-consent and 35 studies which accept seniors above 65."
Answered by AI
Are there still openings in this medical trial for potential participants?
"According to clinicaltrials.gov, this particular study has closed its recruitment process and is no longer actively seeking participants. Initially posted on July 4th 2023 and last updated June 28th, there are nevertheless 94 other medical trials that are currently enrolling patients."
Answered by AI
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