Trial Outcomes & Findings for Optimisation of Controlled Human Malaria Infection Using Sporozoites Administered by Needle and Syringe (NCT NCT01465048)

Results Overview

To determine the infectivity rates of PfSPZ Challenge administered in various regimens by thick film microscopy and highly sensitive PCR for Plasmodium falciparum DNA.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

18 participants

Primary outcome timeframe

21 days post administration of PfSPZ Challenge

Results posted on

2013-06-24

Participant Flow

Participant milestones

Participant milestones
Measure	PfSPZ Challenge 2,500 ID	PfSPZ Challenge 2,500 IM	PfSPZ Challenge 25,000 IM
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

Optimisation of Controlled Human Malaria Infection Using Sporozoites Administered by Needle and Syringe

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PfSPZ Challenge 2,500 ID n=6 Participants	PfSPZ Challenge 2,500 IM n=6 Participants	PfSPZ Challenge 25,000 IM n=6 Participants	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	3 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	8 Participants n=4 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	10 Participants n=4 Participants
Region of Enrollment United Kingdom	6 participants n=5 Participants	6 participants n=7 Participants	6 participants n=5 Participants	18 participants n=4 Participants

PRIMARY outcome

Timeframe: 21 days post administration of PfSPZ Challenge

To determine the infectivity rates of PfSPZ Challenge administered in various regimens by thick film microscopy and highly sensitive PCR for Plasmodium falciparum DNA.

Outcome measures

Outcome measures
Measure	PfSPZ Challenge 2,500 ID n=6 Participants	PfSPZ Challenge 2,500 IM n=6 Participants	PfSPZ Challenge 25,000 IM n=6 Participants
Number of Participants Infected	5 Participants	3 Participants	6 Participants

SECONDARY outcome

Timeframe: Participants will be followed for the duration of the study, an expected average of 3 months

To assess the safety of PfSPZ Challenge administered in various regimens by analysing actively and passively collected data from clinical review of volunteers and laboratory measurements, including lab reports and adverse events.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 21 days post administration of PfSPZ Challenge

To determine the parasite growth dynamics of PfSPZ Challenge administered in various regimens using highly sensitive PCR for Plasmodium falciparum DNA.

Outcome measures

Outcome data not reported

Adverse Events

PfSPZ Challenge 2,500 ID

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

PfSPZ Challenge 2,500 IM

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

PfSPZ Challenge 25,000 IM

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	PfSPZ Challenge 2,500 ID n=6 participants at risk	PfSPZ Challenge 2,500 IM n=6 participants at risk	PfSPZ Challenge 25,000 IM n=6 participants at risk
General disorders Headache	33.3% 2/6 • Number of events 2 • 07/11/11 to 13/02/12	0.00% 0/6 • 07/11/11 to 13/02/12	16.7% 1/6 • Number of events 1 • 07/11/11 to 13/02/12
General disorders Fever	0.00% 0/6 • 07/11/11 to 13/02/12	16.7% 1/6 • Number of events 1 • 07/11/11 to 13/02/12	0.00% 0/6 • 07/11/11 to 13/02/12
General disorders Nausea	0.00% 0/6 • 07/11/11 to 13/02/12	16.7% 1/6 • Number of events 1 • 07/11/11 to 13/02/12	0.00% 0/6 • 07/11/11 to 13/02/12
General disorders Pain	0.00% 0/6 • 07/11/11 to 13/02/12	0.00% 0/6 • 07/11/11 to 13/02/12	33.3% 2/6 • Number of events 2 • 07/11/11 to 13/02/12
General disorders Malasie	0.00% 0/6 • 07/11/11 to 13/02/12	0.00% 0/6 • 07/11/11 to 13/02/12	16.7% 1/6 • Number of events 1 • 07/11/11 to 13/02/12
General disorders Gum Bleeding	0.00% 0/6 • 07/11/11 to 13/02/12	0.00% 0/6 • 07/11/11 to 13/02/12	16.7% 1/6 • Number of events 1 • 07/11/11 to 13/02/12

Additional Information

Dr Susanne Sheehy

University of Oxford

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place