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Adjuvant
rCSP for Malaria
Phase 1
Waitlist Available
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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 118 to day 141
Awards & highlights
Study Summary
rCSP/AP10-602 [GLA-LSQ] Vaccine Trial
Eligible Conditions
- Malaria
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 118 to day 141
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 118 to day 141
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of subjects reporting Adverse Events of Special Interest (AESIs)
Number of subjects reporting serious adverse events (SAEs)
Number of subjects reporting serious adverse events (SAEs) considered related to vaccination
+4 moreSecondary outcome measures
Antibody titer against the malaria circumsporozoite antigen
Presence of P. falciparum asexual parasitemia following experimental malaria challenge
Time to P. falciparum asexual parasitemia following experimental malaria challenge
Trial Design
7Treatment groups
Experimental Treatment
Group I: Group 6Experimental Treatment1 Intervention
6 subjects receive CHMI challenge with P. falciparum parasites of the NF54/3D7 strain.
Group II: Group 5Experimental Treatment3 Interventions
10 subjects receive 10 mcg or 30 mcg rCSP + AP 10-602 [GLA-LSQ] (5 mcg GLA - 2 mcg LSQ) intramuscularly (IM) on days 1, 29 and 85 if immunogenicity analysis conducted 28 days post-2nd dose in Groups 1, 2, and 3 show promise (at least fourfold increase in geometric mean anti-CSP antibody or geometric mean anti-CSP titer of 20). Otherwise, subjects will receive 60 mcg rCSP + AP 10-602 [GLA-LSQ] (5 mcg GLA - 2 mcg LSQ). Subjects will then receive CHMI challenge with P. falciparum parasites of the NF54/3D7 strain on day 113.
Group III: Group 4BExperimental Treatment3 Interventions
10 subjects receive 60 mcg rCSP + AP 10-602 [GLA-LSQ] (5 mcg GLA - 2 mcg LSQ) intramuscularly (IM) on days 1, 29 and 85. Subjects will then receive CHMI challenge with P. falciparum parasites of the NF54/3D7 strain on day 113.
Group IV: Group 4Experimental Treatment3 Interventions
9 subjects receive 60 mcg rCSP + AP 10-602 [GLA-LSQ] (5 mcg GLA - 2 mcg LSQ) intramuscularly (IM) on days 1 and 85. Subjects will then receive CHMI challenge with P. falciparum parasites of the NF54/3D7 strain on day 113.
Group V: Group 3Experimental Treatment1 Intervention
10 subjects receive 30 mcg rCSP intramuscularly (IM) on days 1, 29 and 85.
Group VI: Group 2Experimental Treatment2 Interventions
10 subjects receive 30 mcg rCSP + AP 10-602 [GLA-LSQ] (5 mcg GLA - 2 mcg LSQ) intramuscularly (IM) on days 1, 29 and 85.
Group VII: Group 1Experimental Treatment2 Interventions
10 subjects receive 10 mcg rCSP + AP 10-602 [GLA-LSQ] (5 mcg GLA - 2 mcg LSQ) intramuscularly (IM) on days 1, 29 and 85.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
rCSP
2018
Completed Phase 1
~70
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,268 Previous Clinical Trials
5,480,635 Total Patients Enrolled
149 Trials studying Malaria
612,591 Patients Enrolled for Malaria
Frequently Asked Questions
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