Trial Outcomes & Findings for Evaluation of Reproducibility of a Sporozoite Challenge Model for Plasmodium Vivax in Human Volunteers (NCT NCT00367380)

Last Updated: 2021-03-22

Results Overview

Thick blood smear was performed to patients daily on days 7 to 23, and every other day until day 29. Any prove of P. vivax infection was considered positive and confirmed later by real time polymerase chain reaction (rPCR).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

18 participants

Primary outcome timeframe

Twenty eight days

Results posted on

2021-03-22

Participant Flow

Participant milestones

Participant milestones
Measure	Group 1 6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 413ABM 413ABM: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 413ABM	Group 2 6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 414WRR 414WRR: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 414WRR	Group 3 6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 418JAL 418JAL: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 418JAL
Overall Study STARTED	6	6	6
Overall Study COMPLETED	6	6	6
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Reproducibility of a Sporozoite Challenge Model for Plasmodium Vivax in Human Volunteers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 n=6 Participants 6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 413ABM 413ABM: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 413ABM	Group 2 n=6 Participants 6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 414WRR 414WRR: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 414WRR	Group 3 n=6 Participants 6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 418JAL 418JAL: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 418JAL	Total n=18 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	18 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	9 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	9 Participants n=4 Participants
Region of Enrollment Colombia	6 participants n=5 Participants	6 participants n=7 Participants	6 participants n=5 Participants	18 participants n=4 Participants
Age, Continuous	31 years STANDARD_DEVIATION 11 • n=5 Participants	23 years STANDARD_DEVIATION 2 • n=7 Participants	27 years STANDARD_DEVIATION 5 • n=5 Participants	27 years STANDARD_DEVIATION 7 • n=4 Participants

PRIMARY outcome

Timeframe: Twenty eight days

Population: Values in the data table represent time to occurrence of P.Vivax infection (prepatent period).

Outcome measures

Outcome measures
Measure	Group 1 n=6 Participants 6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 413ABM 413ABM: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 413ABM	Group 2 n=6 Participants 6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 414WRR 414WRR: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 414WRR	Group 3 n=6 Participants 6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 418JAL 418JAL: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 418JAL
Infection for P. Vivax	11 days Standard Deviation 2	11 days Standard Deviation 1	9 days Standard Deviation 4

Adverse Events

Group 1

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Group 2

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Group 3

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Group 1 n=6 participants at risk 6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 413ABM 413ABM: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 413ABM	Group 2 n=6 participants at risk 6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 414WRR 414WRR: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 414WRR	Group 3 n=6 participants at risk 6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 418JAL 418JAL: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 418JAL
Skin and subcutaneous tissue disorders Local pruritus	16.7% 1/6 • Number of events 1 • 3 months Volunteers were directly observed by a study physician for one hour post-challenge, they were phone called approximately eight hours after challenge to control her/his evolution and then were followed by by the physician at day 1 after challenge.	66.7% 4/6 • Number of events 4 • 3 months Volunteers were directly observed by a study physician for one hour post-challenge, they were phone called approximately eight hours after challenge to control her/his evolution and then were followed by by the physician at day 1 after challenge.	16.7% 1/6 • Number of events 1 • 3 months Volunteers were directly observed by a study physician for one hour post-challenge, they were phone called approximately eight hours after challenge to control her/his evolution and then were followed by by the physician at day 1 after challenge.
Skin and subcutaneous tissue disorders Local edema	16.7% 1/6 • Number of events 1 • 3 months Volunteers were directly observed by a study physician for one hour post-challenge, they were phone called approximately eight hours after challenge to control her/his evolution and then were followed by by the physician at day 1 after challenge.	16.7% 1/6 • Number of events 1 • 3 months Volunteers were directly observed by a study physician for one hour post-challenge, they were phone called approximately eight hours after challenge to control her/his evolution and then were followed by by the physician at day 1 after challenge.	0.00% 0/6 • 3 months Volunteers were directly observed by a study physician for one hour post-challenge, they were phone called approximately eight hours after challenge to control her/his evolution and then were followed by by the physician at day 1 after challenge.
Skin and subcutaneous tissue disorders Local erythema	16.7% 1/6 • Number of events 1 • 3 months Volunteers were directly observed by a study physician for one hour post-challenge, they were phone called approximately eight hours after challenge to control her/his evolution and then were followed by by the physician at day 1 after challenge.	33.3% 2/6 • Number of events 2 • 3 months Volunteers were directly observed by a study physician for one hour post-challenge, they were phone called approximately eight hours after challenge to control her/his evolution and then were followed by by the physician at day 1 after challenge.	0.00% 0/6 • 3 months Volunteers were directly observed by a study physician for one hour post-challenge, they were phone called approximately eight hours after challenge to control her/his evolution and then were followed by by the physician at day 1 after challenge.
Skin and subcutaneous tissue disorders Arm pain	16.7% 1/6 • Number of events 1 • 3 months Volunteers were directly observed by a study physician for one hour post-challenge, they were phone called approximately eight hours after challenge to control her/his evolution and then were followed by by the physician at day 1 after challenge.	0.00% 0/6 • 3 months Volunteers were directly observed by a study physician for one hour post-challenge, they were phone called approximately eight hours after challenge to control her/his evolution and then were followed by by the physician at day 1 after challenge.	16.7% 1/6 • Number of events 1 • 3 months Volunteers were directly observed by a study physician for one hour post-challenge, they were phone called approximately eight hours after challenge to control her/his evolution and then were followed by by the physician at day 1 after challenge.

Additional Information

Sócrates Herrera MD, principal investigator

Malaria Vaccine and Drug Development

Phone: (572) 5216232 - 5574929

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60