Trial Outcomes & Findings for Blood-Stage Plasmodium Vivax Cell Bank (NCT NCT05095272)
NCT ID: NCT05095272
Last Updated: 2023-07-11
Results Overview
Collection of blood for the production of a P. vivax blood-stage parasite bank from study participants following experimental infection with P. vivax isolate HMPBS02-Pv.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
2 participants
Primary outcome timeframe
Time of enrollment until blood collection for blood-stage parasite bank (10-11 days post-infection)
Results posted on
2023-07-11
Participant Flow
Participant milestones
| Measure |
Healthy Malaria-naive US Adults Between 18 and 50 Years of Age
A single dose of cryopreserved inoculum containing blood-stage P. vivax will be administered IV
HMPBS02-Pv: The blood-stage P. vivax master cell bank HMPBS02-Pv was also produced using blood collected from a consenting patient with naturally acquired malaria infection. The malaria infection was confirmed to be P. vivax by species-specific PCR at Pathology Queensland (accredited by the Australian National Association of Testing Authorities) and further confirmed by deep sequencing at the Sanger Institute. The clinical response to antimalarial chemotherapy was also demonstrated with this donor, who was successfully cured with artemether/lumefantrine.
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Blood-Stage Plasmodium Vivax Cell Bank
Baseline characteristics by cohort
| Measure |
Healthy Malaria-naive US Adults Between 18 and 50 Years of Age
n=2 Participants
A single dose of cryopreserved inoculum containing blood-stage P. vivax will be administered IV
HMPBS02-Pv: The blood-stage P. vivax master cell bank HMPBS02-Pv was also produced using blood collected from a consenting patient with naturally acquired malaria infection. The malaria infection was confirmed to be P. vivax by species-specific PCR at Pathology Queensland (accredited by the Australian National Association of Testing Authorities) and further confirmed by deep sequencing at the Sanger Institute. The clinical response to antimalarial chemotherapy was also demonstrated with this donor, who was successfully cured with artemether/lumefantrine.
|
|---|---|
|
Age, Customized
23 years old
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Time of enrollment until blood collection for blood-stage parasite bank (10-11 days post-infection)Collection of blood for the production of a P. vivax blood-stage parasite bank from study participants following experimental infection with P. vivax isolate HMPBS02-Pv.
Outcome measures
| Measure |
Healthy Malaria-naive US Adults Between 18 and 50 Years of Age
n=2 Participants
A single dose of cryopreserved inoculum containing blood-stage P. vivax will be administered IV
HMPBS02-Pv: The blood-stage P. vivax master cell bank HMPBS02-Pv was also produced using blood collected from a consenting patient with naturally acquired malaria infection. The malaria infection was confirmed to be P. vivax by species-specific PCR at Pathology Queensland (accredited by the Australian National Association of Testing Authorities) and further confirmed by deep sequencing at the Sanger Institute. The clinical response to antimalarial chemotherapy was also demonstrated with this donor, who was successfully cured with artemether/lumefantrine.
|
|---|---|
|
P. Vivax Blood Collection
|
2 Participants
|
Adverse Events
Healthy Malaria-naive US Adults Between 18 and 50 Years of Age
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Healthy Malaria-naive US Adults Between 18 and 50 Years of Age
n=2 participants at risk
A single dose of cryopreserved inoculum containing blood-stage P. vivax will be administered IV
HMPBS02-Pv: The blood-stage P. vivax master cell bank HMPBS02-Pv was also produced using blood collected from a consenting patient with naturally acquired malaria infection. The malaria infection was confirmed to be P. vivax by species-specific PCR at Pathology Queensland (accredited by the Australian National Association of Testing Authorities) and further confirmed by deep sequencing at the Sanger Institute. The clinical response to antimalarial chemotherapy was also demonstrated with this donor, who was successfully cured with artemether/lumefantrine.
|
|---|---|
|
Investigations
Alanine aminotransferase increased
|
100.0%
2/2 • Number of events 2 • Time of enrollment until initiation of antimalarial treatment (10-11 days).
|
|
Investigations
Aspartate aminotransferase increased
|
100.0%
2/2 • Number of events 3 • Time of enrollment until initiation of antimalarial treatment (10-11 days).
|
|
General disorders
Chest discomfort
|
50.0%
1/2 • Number of events 1 • Time of enrollment until initiation of antimalarial treatment (10-11 days).
|
|
General disorders
Chills
|
50.0%
1/2 • Number of events 2 • Time of enrollment until initiation of antimalarial treatment (10-11 days).
|
|
General disorders
Fatigue
|
100.0%
2/2 • Number of events 4 • Time of enrollment until initiation of antimalarial treatment (10-11 days).
|
|
Investigations
Haemoglobin decreased
|
50.0%
1/2 • Number of events 1 • Time of enrollment until initiation of antimalarial treatment (10-11 days).
|
|
Nervous system disorders
Headache
|
100.0%
2/2 • Number of events 3 • Time of enrollment until initiation of antimalarial treatment (10-11 days).
|
|
Blood and lymphatic system disorders
Leukopenia
|
50.0%
1/2 • Number of events 1 • Time of enrollment until initiation of antimalarial treatment (10-11 days).
|
|
Investigations
Lymphocyte count decreased
|
100.0%
2/2 • Number of events 6 • Time of enrollment until initiation of antimalarial treatment (10-11 days).
|
|
General disorders
Malaise
|
100.0%
2/2 • Number of events 3 • Time of enrollment until initiation of antimalarial treatment (10-11 days).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
100.0%
2/2 • Number of events 3 • Time of enrollment until initiation of antimalarial treatment (10-11 days).
|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2 • Number of events 1 • Time of enrollment until initiation of antimalarial treatment (10-11 days).
|
|
Investigations
Neutrophil count decreased
|
50.0%
1/2 • Number of events 1 • Time of enrollment until initiation of antimalarial treatment (10-11 days).
|
|
Investigations
Platelet count decreased
|
100.0%
2/2 • Number of events 3 • Time of enrollment until initiation of antimalarial treatment (10-11 days).
|
|
Renal and urinary disorders
Proteinuria
|
50.0%
1/2 • Number of events 2 • Time of enrollment until initiation of antimalarial treatment (10-11 days).
|
|
General disorders
Pyrexia
|
50.0%
1/2 • Number of events 2 • Time of enrollment until initiation of antimalarial treatment (10-11 days).
|
|
Cardiac disorders
Tachycardia
|
50.0%
1/2 • Number of events 1 • Time of enrollment until initiation of antimalarial treatment (10-11 days).
|
|
Investigations
White blood cell count decreased
|
50.0%
1/2 • Number of events 2 • Time of enrollment until initiation of antimalarial treatment (10-11 days).
|
Additional Information
Dr. Patrick E. Duffy; Lab Chief
Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health
Phone: 240.381.1317
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place