Malaria,FalciparumPhase 1/2PbVacNCT03138096

Safety and Protective Efficacy of Pb(PfCS@UIS4)

A Phase 1/2 study testing Pb(PfCS@UIS4)-infected mosquitoes and Challenge infection P. falciparum in people with Malaria,Falciparum and Plasmodium Falciparum, run by Radboud University Medical Center at 2 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for: Malaria,Falciparum, Plasmodium Falciparum, Plasmodium Berghei
What is being tested?: Pb(PfCS@UIS4)-infected mosquitoes and Challenge infection P. falciparum
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 2 sitesNetherlands
Study dates: 29 May 2017to 3 Oct 2018
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 35 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Subject is aged ≥ 18 and ≤ 35 years and in good health.
Subject has adequate understanding of the procedures of the study and is able and willing (in the investigator's opinion) to comply with all study requirements.
Subject is willing to complete an informed consent questionnaire and is able to answer all questions correctly.
Subject is able to communicate well with the investigator and is available to attend all study visits, lives in Rotterdam or in proximity to the trial centre (can be on site within 1 hour) or is willing to stay in a hotel close to the trial centre during part of the study (phase 1: from day of immunization to day 12 post-immunization; phase 2: from day of immunization to day 8 post-immunization.
The subject will remain within the Netherlands from day -1 until day +28 after immunization during phase 1; from day -1 until day 12 after each immunization during phase 2, and during the challenge period, will not travel to a malaria-endemic area during the study period, and is reachable (24/7) by mobile telephone throughout the entire study period.
Subject agrees to their general practitioner being informed and contacted about their participation in the study and agrees to sign a form to request the release by their General Practitioner (GP), and medical specialist when necessary, to the investigator(s), of any relevant medical information concerning possible contra-indications for participation in the study.

Show all 11Show fewer

The subject agrees to refrain from blood donation to Sanquin or for other purposes throughout the study period and for a defined period thereafter according to current Sanquin guidelines (3 years minimum, depending on serology).
For female subjects: subject agrees to use continuous adequate contraception** and not to breastfeed for the duration of study.
Subject agrees to refrain from intensive physical exercise (disproportionate to the subject's usual daily activity or exercise routine) during the malaria challenge period.
Subject agrees to avoid additional triggers that may cause elevations in liver enzymes including alcohol from baseline up to 1 week post treatment.
Subject has signed written informed consent to participate in the trial.

Who cannot join

A potential subject who meets any of the following criteria will be excluded from participation in this study:
Any history, or evidence at screening, of clinically significant symptoms, physical signs or abnormal laboratory values suggestive of systemic conditions, such as cardiovascular, pulmonary, renal, hepatic, neurological, dermatological, endocrine, malignant, haematological, infectious, immunodeficient, psychiatric and other disorders, which could compromise the health of the volunteer during the study or interfere with the interpretation of the study results. These include, but are not limited to, any of the following.
1.1. Body weight <50 kg or Body Mass Index (BMI) <18 or >30 kg/m2 at screening. 1.2. A heightened risk of cardiovascular disease, as determined by: an estimated ten year risk of fatal cardiovascular disease of ≥5% at screening, as determined by the Systematic Coronary Risk Evaluation (SCORE); history, or evidence at screening, of clinically significant arrhythmia's, prolonged QT-interval or other clinically relevant ECG abnormalities; or a positive family history of cardiac events in 1st or 2nd degree relatives <50 years old.
1.3. A medical history of functional asplenia, sickle cell trait/disease, thalassaemia trait/disease or G6PD-deficiency.
1.4. History of epilepsy in the period of five years prior to study onset, even if no longer on medication.
1.5. Screening tests positive for Human Immunodeficiency Virus (HIV), active Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) 1.6. Chronic use of i) immunosuppressive drugs, ii) antibiotics, iii) or other immune modifying drugs within three months prior to study onset (inhaled and topical corticosteroids and oral anti-histamines exempted) or expected use of such during the study period.

Show all 17Show fewer

1.7. Any recent or current systemic therapy with an antibiotic or drug with potential anti-malarial activity (chloroquine, atovaquone-proguanil, arthemether-lumefantrine, sulfadoxine-pyrimethamine, doxycycline, tetracycline, piperaquine, benzodiazepine, flunarizine, fluoxetine, tetracycline, azithromycin, clindamycin, erythromycin, hydroxychloroquine, etc.) (allowable timeframe for use at the Investigator's discretion).
1.8. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years.
1.9. Any history of treatment for severe psychiatric disease by a psychiatrist in the past year.
1.10. History of drug or alcohol abuse interfering with normal social function in the period of one year prior to study onset, positive urine toxicology test for cocaine or amphetamines at screening or at inclusion, or positive urine toxicology test for cannabis at inclusion.
For female subjects: positive urine pregnancy test at screening and/or at the baseline visits, including baseline of immunizations (I-1) and or baseline before CHMI (C-1).
Any history of malaria, positive serology for P. falciparum, or previous participation in any malaria (vaccine) study.
Known hypersensitivity to or contra-indications (including co-medication) for use of sulfadoxine-pyrimethamine, piperaquine, chloroquine, Malarone®, artemether-lumefantrine, primaquine or history of severe (allergic) reactions to mosquito bites.
Receipt of any vaccinations in the 3 months prior to the start of the study or plans to receive any other vaccinations during the study period or up to 8 weeks thereafter.
Participation in any other clinical study in the 30 days prior to the start of the study or during the study period.
Being an employee or student of the department of Medical Microbiology and Infectious Diseases of the Erasmus MC or Radboudumc, or the department of Internal Medicine of the Radboudumc or Havenziekenhuis.
Any other condition or situation that would, in the opinion of the investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.

Trial locations and contacts

2 sites in 1 country.

Netherlands2 sites

Radboud university medical center
Nijmegen, Gelderland, 6525 GA
Havenziekenhuis
Rotterdam

Other trials in Netherlands

About this study

Official title: Safety and Protective Efficacy of Genetically Modified Plasmodium Berghei (Pb(PfCS@UIS4)) Malaria Parasites in Healthy Volunteers

In the underlying study, a genetically modified P. berghei parasite is used. P. berghei is one of the four Plasmodium species that causes malaria in rodents. The hypothesis is that immunization of humans with P. berghei will induce a cross-species immune response without the risk of a breakthrough infection. To further increase the potential for protective efficacy, the P. falciparum circumsporozoite (CS)- protein gene has been integrated in the P. berghei parasite, generating a genetically modified P. berghei parasite, abbreviated as Pb(PfCS@UIS4).

Conditions: Malaria,Falciparum, Plasmodium Falciparum, Plasmodium Berghei, Controlled Human Malaria Infection (CHMI)
Being tested: Pb(PfCS@UIS4)-infected mosquitoes, Challenge infection P. falciparum
Medical subject headings: Malaria, Falciparum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pb(PfCS@UIS4)-infected mosquitoesBiological
Pb(PfCS@UIS4)-infected mosquitoes
Challenge infection P. falciparumOther
Challenge infection with bites of five infected Pf mosquitoes

Study groups in NCT03138096
Study group	Role	What they receive
Group 1 - five Pb(PfCS@UIS4)-infected mosquitoes	Experimental	(Group 1) will be exposed to bites of five Pb(PfCS@UIS4)-infected mosquitoes Receives: Biological: Pb(PfCS@UIS4)-infected mosquitoes
Group 2 - 25 Pb(PfCS@UIS4)-infected mosquito bites	Experimental	(group 2) will be exposed to 25 Pb(PfCS@UIS4)-infected mosquito bites Receives: Biological: Pb(PfCS@UIS4)-infected mosquitoes
Group 3 - 75 Pb(PfCS@UIS4)-infected mosquito bites	Experimental	(group 3) will be exposed to 75 Pb(PfCS@UIS4)-infected mosquito bites Receives: Biological: Pb(PfCS@UIS4)-infected mosquitoes; Other: Challenge infection P. falciparum
Group 4 - Infectivity control group of Phase 1	Other	Infectivity control group of Phase 1 Receives: Other: Challenge infection P. falciparum
Group 5 - Infectivity control group of Phase 2	Other	Infectivity control group of Phase 2 Receives: Other: Challenge infection P. falciparum

What is being measured

The primary outcome is the main question the study is designed to answer.

Adverse Events in Study Groups Following Exposure to Pb(PfCS@UIS4)-Infected Mosquitoes [Safety]
Frequency and magnitude of adverse events in study groups following one or more exposures to Pb(PfCS@UIS4)-infected mosquitoes.
Measured: Groups 1&2: from exposure to Pb(PfCS@UIS4)-infected mosquitoes until 28 days thereafter. Group 3: from first exposure until 21 days after fourth/final exposure (=until day immediately prior to CHMI, i.e. approximately 15 weeks after first exposure).
Presence of Breakthrough Parasitemia Following Exposure to Pb(PfCS@UIS4)-Infected Mosquito Bites
Presence of breakthrough parasitemia following (first) exposure to Pb(PfCS@UIS4)-infected mosquito bites, as determined by thick blood smear microscopy
Measured: Groups 1-3: from (first) exposure until 28 days thereafter.
Time to Parasitemia After CHMI [Efficacy]
Time to parasitemia after CHMI with the wild-type NF54 P. falciparum strain, as detected by qPCR [Efficacy]
Measured: Groups 3&4: from day of CHMI until 28 days thereafter

Secondary outcomes (1)

Immunogenicity of Pb(PfCS@UIS4) as Assessed by ELISA
Immunogenicity of repeated Pb(PfCS@UIS4) immunization as assessed by fold change in anti-P. falciparum IgG from baseline to post-immunization (day prior to CHMI), as measured by ELISA.
Measured: Group 3: from baseline until day prior to CHMI (approximately 15 weeks after first Pb(PfCS@UIS4) immunization)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 May 20173 Oct 2018

First posted3 May 2017
Study start29 May 2017
Primary completion28 Mar 2018
Study completion3 Oct 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Malaria,FalciparumStudies of the same condition, open and under way.
More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03138096
Sponsor's protocol ID: PbVac
Acronym: PbVac
Status last verified: Mar 2017
First submitted: 19 Apr 2017
Last updated: 4 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Results will be published

Publications

Reuling IJ, Mendes AM, de Jong GM, Fabra-Garcia A, Nunes-Cabaco H, van Gemert GJ, Graumans W, Coffeng LE, de Vlas SJ, Yang ASP, Lee C, Wu Y, Birkett AJ, Ockenhouse CF, Koelewijn R, van Hellemond JJ, van Genderen PJJ, Sauerwein RW, Prudencio M. An open-label phase 1/2a trial of a genetically modified rodent malaria parasite for immunization against Plasmodium falciparum malaria. Sci Transl Med. 2020 May 20;12(544):eaay2578. doi: 10.1126/scitranslmed.aay2578.
PubMed 32434846

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
Safety, Tolerability and Efficacy of PfSPZ-LARC2 Vaccine Against CHMI in Malaria-Naïve Adults
Malaria Falciparum
Not yet recruiting
Three-arm Cluster Randomised Control Trial Evaluation of Guardian Spatial Emanator as a Complimentary Vector Control Tool in Papua New Guinea
Malaria
Active, not recruitingPhase 4
Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity Diagnostics
Malaria,Falciparum, Malaria in Pregnancy
Not yet recruiting
Permethrin-Treated Baby Wraps for Malaria Prevention in Refugee Settings
Malaria (Plasmodium Falciparum), Malaria Incidence
RecruitingPhase 1/2
DON in Pediatric Cerebral Malaria
Malaria, Cerebral

All Malaria,Falciparum trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Protective Efficacy of Genetically Modified Plasmodium Berghei (Pb(PfCS@UIS4)) Malaria Parasites in Healthy Volunteers
ClinicalTrials.gov ID: NCT03138096
Acronym / sponsor ID: PbVac / PbVac
Conditions: Malaria,Falciparum, Plasmodium Falciparum, Plasmodium Berghei, Controlled Human Malaria Infection (CHMI)
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Radboud University Medical CenterUniversity, hospital or other
Collaborators: Havenziekenhuis, Erasmus Medical Center, The PATH Malaria Vaccine Initiative (MVI)
Study start: 29 May 2017 (actual)
Primary completion: 28 Mar 2018 (actual)
Study completion: 3 Oct 2018 (actual)
First posted: 3 May 2017 (actual)
Results: Posted 15 Dec 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Group 1 - five Pb(PfCS@UIS4)-infected mosquitoes	Experimental	Biological: Pb(PfCS@UIS4)-infected mosquitoes(Group 1) will be exposed to bites of five Pb(PfCS@UIS4)-infected mosquitoes
Group 2 - 25 Pb(PfCS@UIS4)-infected mosquito bites	Experimental	Biological: Pb(PfCS@UIS4)-infected mosquitoes(group 2) will be exposed to 25 Pb(PfCS@UIS4)-infected mosquito bites
Group 3 - 75 Pb(PfCS@UIS4)-infected mosquito bites	Experimental	Biological: Pb(PfCS@UIS4)-infected mosquitoes, Other: Challenge infection P. falciparum(group 3) will be exposed to 75 Pb(PfCS@UIS4)-infected mosquito bites
Group 4 - Infectivity control group of Phase 1	Other	Other: Challenge infection P. falciparumInfectivity control group of Phase 1
Group 5 - Infectivity control group of Phase 2	Other	Other: Challenge infection P. falciparumInfectivity control group of Phase 2

Who may qualify

Ages: 18 to 35 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (11 listed)

Subject is aged ≥ 18 and ≤ 35 years and in good health.
Subject has adequate understanding of the procedures of the study and is able and willing (in the investigator's opinion) to comply with all study requirements.
Subject is willing to complete an informed consent questionnaire and is able to answer all questions correctly.
Subject is able to communicate well with the investigator and is available to attend all study visits, lives in Rotterdam or in proximity to the trial centre (can be on site within 1 hour) or is willing to stay in a hotel close to the trial centre during part of the study (phase 1: from day of immunization to day 12 post-immunization; phase 2: from day of immunization to day 8 post-immunization.
The subject will remain within the Netherlands from day -1 until day +28 after immunization during phase 1; from day -1 until day 12 after each immunization during phase 2, and during the challenge period, will not travel to a malaria-endemic area during the study period, and is reachable (24/7) by mobile telephone throughout the entire study period.

Key exclusion criteria (17 listed)

A potential subject who meets any of the following criteria will be excluded from participation in this study:
Any history, or evidence at screening, of clinically significant symptoms, physical signs or abnormal laboratory values suggestive of systemic conditions, such as cardiovascular, pulmonary, renal, hepatic, neurological, dermatological, endocrine, malignant, haematological, infectious, immunodeficient, psychiatric and other disorders, which could compromise the health of the volunteer during the study or interfere with the interpretation of the study results. These include, but are not limited to, any of the following.
1.1. Body weight <50 kg or Body Mass Index (BMI) <18 or >30 kg/m2 at screening. 1.2. A heightened risk of cardiovascular disease, as determined by: an estimated ten year risk of fatal cardiovascular disease of ≥5% at screening, as determined by the Systematic Coronary Risk Evaluation (SCORE); history, or evidence at screening, of clinically significant arrhythmia's, prolonged QT-interval or other clinically relevant ECG abnormalities; or a positive family history of cardiac events in 1st or 2nd degree relatives <50 years old.
1.3. A medical history of functional asplenia, sickle cell trait/disease, thalassaemia trait/disease or G6PD-deficiency.
1.4. History of epilepsy in the period of five years prior to study onset, even if no longer on medication.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pb(PfCS@UIS4)-infected mosquitoesPb(PfCS@UIS4)-infected mosquitoes	Biological	Group 1 - five Pb(PfCS@UIS4)-infected mosquitoes, Group 2 - 25 Pb(PfCS@UIS4)-infected mosquito bites, Group 3 - 75 Pb(PfCS@UIS4)-infected mosquito bites
Challenge infection P. falciparumChallenge infection with bites of five infected Pf mosquitoes	Other	Group 3 - 75 Pb(PfCS@UIS4)-infected mosquito bites, Group 4 - Infectivity control group of Phase 1, Group 5 - Infectivity control group of Phase 2

Primary outcome

Adverse Events in Study Groups Following Exposure to Pb(PfCS@UIS4)-Infected Mosquitoes [Safety]
Time frame: Groups 1&2: from exposure to Pb(PfCS@UIS4)-infected mosquitoes until 28 days thereafter. Group 3: from first exposure until 21 days after fourth/final exposure (=until day immediately prior to CHMI, i.e. approximately 15 weeks after first exposure).
Frequency and magnitude of adverse events in study groups following one or more exposures to Pb(PfCS@UIS4)-infected mosquitoes.
Presence of Breakthrough Parasitemia Following Exposure to Pb(PfCS@UIS4)-Infected Mosquito Bites
Time frame: Groups 1-3: from (first) exposure until 28 days thereafter.
Presence of breakthrough parasitemia following (first) exposure to Pb(PfCS@UIS4)-infected mosquito bites, as determined by thick blood smear microscopy
Time to Parasitemia After CHMI [Efficacy]
Time frame: Groups 3&4: from day of CHMI until 28 days thereafter
Time to parasitemia after CHMI with the wild-type NF54 P. falciparum strain, as detected by qPCR [Efficacy]

1 secondary outcome

Immunogenicity of Pb(PfCS@UIS4) as Assessed by ELISA
Time frame: Group 3: from baseline until day prior to CHMI (approximately 15 weeks after first Pb(PfCS@UIS4) immunization)

Results and safety

Results posted to the registry on 15 Dec 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1 - Five Pb(PfCS@UIS4)-Infected Mosquitoes	3	3
Group 2 - 25 Pb(PfCS@UIS4)-Infected Mosquito Bites	3	3
Group 3 -25 Pb(PfCS@UIS4)-Infected Mosquito Bites	12	12
Group 4 - Infectivity Control Group (Phase 1)	6	6
Group 5 - Infectivity Control Group (Phase 2)	0	0

Primary outcome: Adverse Events in Study Groups Following Exposure to Pb(PfCS@UIS4)-Infected Mosquitoes [Safety]

Time frame: Groups 1&2: from exposure to Pb(PfCS@UIS4)-infected mosquitoes until 28 days thereafter. Group 3: from first exposure until 21 days after fourth/final exposure (=until day immediately prior to CHMI, i.e. approximately 15 weeks after first exposure).. Number. Unit: numbers of adverse events

Measure	Group 1 n = 3	Group 2 n = 3	Group 3 n = 12	Group 4 n = 0
Immunization 1: Numbers of local adverse events (grade 1/2)	0	3	10	–
Immunization 2: Numbers of local adverse events (grade 1/2)	–	–	9	–
Immunization 3: Numbers of local adverse events (grade 1/2)	–	–	12	–
Immunization 4: Numbers of local adverse events (grade 1/2)	–	–	11	–
Immunization 1: Numbers of systemic adverse events (grade 1/2)	7	5	9	–
Immunization 2: Numbers of systemic adverse events (grade 1/2)	–	–	2	–
Immunization 3: Numbers of systemic adverse events (grade 1/2)	–	–	4	–
Immunization 4: Numbers of systemic adverse events (grade 1/2)	–	–	4	–

Population analysed: Groups 1-3, immunization phase only (groups 1\&2 underwent only a single immunization; group 3 underwent 4 sequential immunizations). Note: group 4 did NOT undergo immunization. AEs following CHMI with WT-infected mosquitoes (i.e. in group 3\&4) were not a protocol-defined endpoint and are NOT included here. Group 5 was not enrolled, as protective efficacy in group 3 following first CHMI was insufficient (per protocol) to warrant a second CHMI and hence a second infectivity control group.

Primary outcome: Presence of Breakthrough Parasitemia Following Exposure to Pb(PfCS@UIS4)-Infected Mosquito Bites

Time frame: Groups 1-3: from (first) exposure until 28 days thereafter.. Count of participants. Unit: Participants

Measure	Group 1 -Five Pb(PfCS@UIS4)-Infected Mosquitoes n = 3	Group 2 - 25 Pb(PfCS@UIS4)-Infected Mosquito Bites n = 3	Group 3 - 75 Pb(PfCS@UIS4)-Infected Mosquito Bites n = 12	Group 4 - Infectivity Control Group n = 0
Value	0	0	0	–

Population analysed: Groups 1-3 only. Note: For group 3, only immunisation (exposure) #1 is included here, as immunisations #2-4 fell in phase 2 of the trial, during which this outcome was no longer classified as an endpoint. Group 4 was not exposed to Pb(PfCS@UIS4)-infected mosquitoes (only to CHMI with WT-infected mosquitoes) and group 5 was not enrolled, as protective efficacy in group 3 following first CHMI was insufficient (per protocol) to warrant a second CHMI and hence a second infectivity control group.

Primary outcome: Time to Parasitemia After CHMI [Efficacy]

Time frame: Groups 3&4: from day of CHMI until 28 days thereafter. Mean (Full Range). Unit: days to P. falciparum parasitemia

Measure	Group 1 -Five Pb(PfCS@UIS4)-Infected Mosquitoes n = 0	Group 2 - 25 Pb(PfCS@UIS4)-Infected Mosquito Bites n = 0	Group 3 - 75 Pb(PfCS@UIS4)-Infected Mosquito Bites n = 12	Group 4 - Infectivity Control Group n = 6
Value	–	–	9.9 (7 to 14)	7.7 (7 to 11)

Population analysed: Groups 3\&4 only. Note: Groups 1 \& 2 did not undergo CHMI and group 5 was not enrolled, as protective efficacy in group 3 following first CHMI was insufficient (per protocol) to warrant a second CHMI and hence a second infectivity control group

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 79 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Group 2	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Group 3	0 of 12 (0%)	11 of 12 (91.7%)	0 of 12
Group 4	0 of 6 (0%)	6 of 6 (100%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 32434846Reuling IJ, Mendes AM, de Jong GM, Fabra-Garcia A, Nunes-Cabaco H, van Gemert GJ, Graumans W, Coffeng LE, de Vlas SJ, Yang ASP, Lee C, Wu Y, Birkett AJ, Ockenhouse CF, Koelewijn R, van Hellemond JJ, van Genderen PJJ, Sauerwein RW, Prudencio M. An open-label phase 1/2a trial of a genetically modified rodent malaria parasite for immunization against Plasmodium falciparum malaria. Sci Transl Med. 2020 May 20;12(544):eaay2578. doi: 10.1126/scitranslmed.aay2578.
Individual participant dataSharing planned: Yes. Results will be published

Related trials for Malaria,Falciparum

RecruitingPhase 1
Safety, Tolerability and Efficacy of PfSPZ-LARC2 Vaccine Against CHMI in Malaria-Naïve Adults
Malaria Falciparum
Not yet recruiting
Three-arm Cluster Randomised Control Trial Evaluation of Guardian Spatial Emanator as a Complimentary Vector Control Tool in Papua New Guinea
Malaria
Active, not recruitingPhase 4
Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity Diagnostics
Malaria,Falciparum, Malaria in Pregnancy
Not yet recruiting
Permethrin-Treated Baby Wraps for Malaria Prevention in Refugee Settings
Malaria (Plasmodium Falciparum), Malaria Incidence
RecruitingPhase 1/2
DON in Pediatric Cerebral Malaria
Malaria, Cerebral

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Robert Sauerwein, MD PhD principal investigator

Radboud University Medical Center

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events in Study Groups Following Exposure to Pb(PfCS@UIS4)-Infected Mosquitoes [Safety] (time frame: Groups 1&2: from exposure to Pb(PfCS@UIS4)-infected mosquitoes until 28 days thereafter. Group 3: from first exposure until 21 days after fourth/final exposure (=until day immediately prior to CHMI, i.e. approximately 15 weeks after first exposure).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03138096, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2022.