MalariaPhase 1/2NCT05441410
Comparing Safety and Protective Efficacy of Vaccine Candidate PfSPZ-CVac and MVA ME-TRAP/ ChAd63 ME-TRAP in Adults
A Phase 1/2 study testing Pyronaridine Tetraphosphate, Artesunate Drug Combination, PfSPZ Challenge (NF54) and MVA ME-TRAP in people with Malaria, run by University Hospital Tuebingen.
Trial summary
This is a single centre, randomized, placebo-controlled phase 1/2 study comparing two malaria vaccine candidates. The first vaccine candidate PfSPZ-CVac (Plasmodium falciparum sporozoites (PfSPZ) challenge administered with a chemoprophylactic antimalarial) will be chemoattenuated in vivo with the antimalarial… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Pyronaridine Tetraphosphate, Artesunate Drug Combination, PfSPZ Challenge (NF54) and MVA ME-TRAP
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 30 Jun 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able and willing (in the Investigator's opinion) to comply with all study requirements.
- Willing to allow the investigators to discuss the volunteer's medical history with their general practitioner if required.
- Residence in Tübingen or surroundings for the period of the trial.
- Women only: Must agree to practice continuous highly effective contraception for the duration of the study and until the end of relevant systemic exposure (a method which results in a low failure rate; i.e. less than 1% per year). Additionally, women will only be exposed to the PfSPZ-CVac/ME-TRAP products following a negative highly sensitive pregnancy test the day before immunization/CHMI.
- Agreement to refrain from blood donation during the course of the study and after the end of their involvement in the study according to the local and national blood banking eligibility criteria (which is a permanent refrain from blood donations after a malaria parasite infection).
- Provision of written informed consent to receive PfSPZ Challenge products or ME-TRAP products for immunization and subsequently for CHMI.
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- Accept to be contacted (24/7) by mobile phone during the immunization and CHMI period.
- Willingness to take Pyramax during immunization (PfSPZ-CVac group) and a curative antimalarial regimen following CHMI.
- Agreement to stay overnight for observation during the period of intensive follow-up post-challenge if required.
- Answer all questions on the informed consent quiz correctly.
- A body mass index <35
Who cannot join
- History of P. falciparum malaria within the last 5 years.
- Prior receipt of malaria vaccine.
- Planned travel to malaria endemic areas during the study period.
- Use of drugs with known antimalarial activity within 30 days of study enrollment (e.g. trimethoprim-sulfamethoxazole, doxycycline, tetracycline, clindamycin, erythromycin, fluoroquinolones, or azithromycin).
- Participation in other clinical trials or the intake of an investigational medicinal product within the last 90 days or planned receipt during the duration of this study
- Human Immunodeficiency Virus (HIV) infection.
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- Any confirmed or suspected immunosuppressive or immunodeficient state (e.g. repeated and/or unusual infections), history of infection caused by opportunistic organisms any infection or combination of infections that suggest underlying immunodeficiency, history of meningitis, encephalitis, septic shock, life-threatening soft tissue infection, more than one pneumonia, asplenia and/or chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed)).
- Use of immunoglobulins or blood products within 3 months prior to enrollment.
- Known (or signs consistent with) sickle cell anaemia, sickle cell trait, thalassemia or thalassemia trait, glucose-6-phosphate dehydrogenase deficiency.
- Pregnancy, lactation or intention to become pregnant during the study.
- Contraindications to the use of the following antimalarial medications: Atovaquone-proguanil, artemether-lumefantrine, artesunate, pyronaridine-artesunate, i.e.:
- Known hypersensitivity to any of these drugs
- intake of the following drugs: rifampicine, rifabutin, metoclopramide, warfarin, cumarine-derivatives, etoposide, antiretroviral drugs, imipramine, amytriptilin, clomipramin, carbamazepine, phenytoin, St. Johns wort, metoprolol, flecainide, propafenone, digoxin, dabigatran; drugs inducing QTc prolongation, drugs metabolized by CYP2D6, drugs inducing CAP3A4.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine (e.g. egg products, Kathon).
- History of clinically significant contact dermatitis.
- History of cancer within the last 5 years (except basal cell carcinoma of the skin and cervical carcinoma in situ).
- History of serious psychiatric condition that may affect participation in the study.
- Alcohol consumption should not exceed 24 g (men) or 12 g (women)/per day
- Haemoglobin <14 g/dl (men) or <12 g/dl (women)
- Suspected or known injected drug abuse in the 5 years preceding enrollment.
- Positive for hepatitis B surface antigen (HBs-antigen).
- Seropositivity for hepatitis C virus (antibodies to HCV)
- Clinical signs or symptoms of hepatic injury (such as nausea and/or abdominal pain associated with jaundice) or known liver disease (i.e. decompensated cirrhosis, Child-Pugh stage B or C).
- Renal abnormalities
- GFR <30ml/min (glomerular filtration rate)
- Presence or past history of cardiac arrhythmia or an abnormal electrocardiogram or suspected coronary heart disease or family history for sudden cardiac death.
- Known or suspected porphyria.
- Volunteers unable to be closely followed for social, geographic or psychological reasons.
- History of seizure (except uncomplicated febrile convulsion at childhood)
- Immunization with more than 3 other vaccines within four weeks.
- Electrolyte disturbance.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparing Safety and Protective Efficacy of the Whole Plasmodium Falciparum Sporozoite Chemoprophylaxis Vaccine Candidate PfSPZ-CVac and Prime- Target Vaccination with Viral Vectored Vaccine Candidate Regime MVA ME-TRAP/ ChAd63 ME-TRAP in Malaria-naïve, Healthy Adult Volunteers in Germany
This is a single centre, randomized, placebo-controlled phase 1/2 study comparing two malaria vaccine candidates. The first vaccine candidate PfSPZ-CVac (Plasmodium falciparum sporozoites (PfSPZ) challenge administered with a chemoprophylactic antimalarial) will be chemoattenuated in vivo with the antimalarial Pyramax. The second vaccine candidate is prime- target vaccination with viral vectored vaccine candidate regime MVA ME-TRAP (Modified Vaccinia Ankara (MVA) multiple epitope thrombosponin-related adhesion protein (ME-TRAP)) and ChAd63 ME-TRAP (Chimpanzee adenovirus 63 (ChAd63). The safety and protective efficacy of both vaccine candidates will be to assessed by controlled human malaria infection with PfSPZ Challenge strain NF54 administered intravenously by syringe.
- Conditions
- Malaria
- Being tested
- Pyronaridine Tetraphosphate, Artesunate Drug Combination, PfSPZ Challenge (NF54), MVA ME-TRAP, ChAd63 ME-TRAP, Sodium chloride (NaCl) 0.9%
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pyronaridine Tetraphosphate, Artesunate Drug CombinationDrug
Also called Pyramax
Combination drug for treatment of uncomplicated malaria
PfSPZ Challenge (NF54)Biological
cryopreserved Plasmodium falciparum sporozoites injected by intravenous inoculation
MVA ME-TRAPBiological
virally vectored subunit vaccine candidates where ME-TRAP is expressed by the non-replicating viral vector Modified Vaccinia Ankara (MVA)
ChAd63 ME-TRAPBiological
virally vectored subunit vaccine candidates where ME-TRAP is expressed by the non-replicating viral vector Chimpanzee Adenovirus 63 (ChAd63)
Sodium chloride (NaCl) 0.9%Biological
Also called Placebo: Saline
0.9% NaCl solution for injection
| Study group | Role | What they receive |
|---|---|---|
| PfSPZ-CVac/Pyramax | Experimental | 200.000 PfSPZ of PfSPZ Challenge NF54 will be administered by DVI along with one weight-adjusted oral dose of Pyramax each on day 1, day 6, and day 29 Receives: Drug: Pyronaridine Tetraphosphate, Artesunate Drug Combination; Biological: PfSPZ Challenge (NF54) |
| MVA ME-TRAP/ChAd63 ME-TRAP | Experimental | MVA ME-TRAP 1.5 x 10^8 pfu will be administered intramuscularly on day 1 for priming. ChAd63 ME-TRAP 5 x 10^10 vp will subsequently administered by DVI on day 29. Receives: Biological: MVA ME-TRAP; Biological: ChAd63 ME-TRAP |
| Saline/placebo pill | Placebo comparator | As placebo comparator to PfSPZ-CVac/Pyramax, saline will be administered intravenously along with an oral placebo pill on day 1, day 6, and day 29.
As placebo comparator to MVA ME-TRAP/ChAd63 ME-TRAP, saline will be administered intramuscularly on day 1 and intravenously on day 29. No placebo pill will be used to compare to the arm MVA ME-TRAP/ChAd63 ME-TRAP. Receives: Biological: Sodium chloride (NaCl) 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of safety and tolerability of PfSPZ-CVac/Pyramax and MVA ME-TRAP/ChAd63 ME-TRAP
Assessment of all adverse events and serious adverse events that might be related to the administration of PfSPZ-CVac/Pyramax and MVA ME-TRAP/ChAd63 ME-TRAP
Measured: From the first administration until the last follow-up visit (Group 1: day 136, Group 2: day 82)
Secondary outcomes (1)
Assessment of protective efficacy of PfSPZ-CVac/Pyramax and of MVA ME-TRAP /ChAd63 ME-TRAP in healthy, malaria-naïve adults against homologous CHMI with PfSPZ Challenge (NF54) by DVI
Assessment of the development of parasitemias following the controlled human malaria infection (CHMI)
Measured: From administration of CHMI (Group 1:day 113, Group 2: 59) until the last follow-up visit (Group 1: day 136, Group 2: day 82)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start1 Jun 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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
- Randomised
- Intervention model
- Factorial
- Model description
- There will be two groups: Group 1 ("PfSPZ-CVac") and Group 2 ("ME-TRAP"). Within Group 1, Arm 1 (N=12) participants will receive PfSPZ Challenge (NF54) via direct venous inoculation (DVI) along with one weight-adjusted oral dose of Pyramax on day 1, day 6, and day 29. The placebo group of Arm 2 (N=3) will receive an oral placebo pill and saline DVI on day 1, day 6, and day 29. In Group 2, participants of Arm 1 (N=12) will receive MVA ME-TRAP intramuscularly on day 1 and ChAd63 ME-TRAP intravenously by DVI on day 29. The placebo group of Arm 2 (N=3) will receive saline intramuscularly on day 1 and intravenously on day 29.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Sanaria Inc., University of Oxford
- Responsible party
- Sponsor
- Investigators
- Sabine Bélard, Dr., Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05441410
- Sponsor's protocol ID
- SPICY
- Status last verified
- Dec 2024
- First submitted
- 21 Jun 2022
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sulyok Z, Fendel R, Eder B, Lorenz FR, Kc N, Karnahl M, Lalremruata A, Nguyen TT, Held J, Adjadi FAC, Klockenbring T, Flugge J, Woldearegai TG, Lamsfus Calle C, Ibanez J, Rodi M, Egger-Adam D, Kreidenweiss A, Kohler C, Esen M, Sulyok M, Manoj A, Richie TL, Sim BKL, Hoffman SL, Mordmuller B, Kremsner PG. Heterologous protection against malaria by a simple chemoattenuated PfSPZ vaccine regimen in a randomized trial. Nat Commun. 2021 May 4;12(1):2518. doi: 10.1038/s41467-021-22740-w.
PubMed 33947856
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Safety and Protective Efficacy of the Whole Plasmodium Falciparum Sporozoite Chemoprophylaxis Vaccine Candidate PfSPZ-CVac and Prime- Target Vaccination with Viral Vectored Vaccine Candidate Regime MVA ME-TRAP/ ChAd63 ME-TRAP in Malaria-naïve, Healthy Adult Volunteers in Germany
- ClinicalTrials.gov ID
- NCT05441410
- Acronym / sponsor ID
- SPICY
- Conditions
- Malaria
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Sanaria Inc., University of Oxford
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 1 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single centre, randomized, placebo-controlled phase 1/2 study comparing two malaria vaccine candidates. The first vaccine candidate PfSPZ-CVac (Plasmodium falciparum sporozoites (PfSPZ) challenge administered with a chemoprophylactic antimalarial) will be chemoattenuated in vivo with the antimalarial Pyramax. The second vaccine candidate is prime- target vaccination with viral vectored vaccine candidate regime MVA ME-TRAP (Modified Vaccinia Ankara (MVA) multiple epitope thrombosponin-related adhesion protein (ME-TRAP)) and ChAd63 ME-TRAP (Chimpanzee adenovirus 63 (ChAd63). The safety and protective efficacy of both vaccine candidates will be to assessed by controlled human malaria infection with PfSPZ Challenge strain NF54 administered intravenously by syringe.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- There will be two groups: Group 1 ("PfSPZ-CVac") and Group 2 ("ME-TRAP"). Within Group 1, Arm 1 (N=12) participants will receive PfSPZ Challenge (NF54) via direct venous inoculation (DVI) along with one weight-adjusted oral dose of Pyramax on day 1, day 6, and day 29. The placebo group of Arm 2 (N=3) will receive an oral placebo pill and saline DVI on day 1, day 6, and day 29. In Group 2, participants of Arm 1 (N=12) will receive MVA ME-TRAP intramuscularly on day 1 and ChAd63 ME-TRAP intravenously by DVI on day 29. The placebo group of Arm 2 (N=3) will receive saline intramuscularly on day 1 and intravenously on day 29.
| Arm | Type | Receives |
|---|---|---|
| PfSPZ-CVac/Pyramax | Experimental | Drug: Pyronaridine Tetraphosphate, Artesunate Drug Combination, Biological: PfSPZ Challenge (NF54)200.000 PfSPZ of PfSPZ Challenge NF54 will be administered by DVI along with one weight-adjusted oral dose of Pyramax each on day 1, day 6, and day 29 |
| MVA ME-TRAP/ChAd63 ME-TRAP | Experimental | Biological: MVA ME-TRAP, Biological: ChAd63 ME-TRAPMVA ME-TRAP 1.5 x 10^8 pfu will be administered intramuscularly on day 1 for priming. ChAd63 ME-TRAP 5 x 10^10 vp will subsequently administered by DVI on day 29. |
| Saline/placebo pill | Placebo comparator | Biological: Sodium chloride (NaCl) 0.9%As placebo comparator to PfSPZ-CVac/Pyramax, saline will be administered intravenously along with an oral placebo pill on day 1, day 6, and day 29. As placebo comparator to MVA ME-TRAP/ChAd63 ME-TRAP, saline will be administered intramuscularly on day 1 and intravenously on day 29. No placebo pill will be used to compare to the arm MVA ME-TRAP/ChAd63 ME-TRAP. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Able and willing (in the Investigator's opinion) to comply with all study requirements.
- Willing to allow the investigators to discuss the volunteer's medical history with their general practitioner if required.
- Residence in Tübingen or surroundings for the period of the trial.
- Women only: Must agree to practice continuous highly effective contraception for the duration of the study and until the end of relevant systemic exposure (a method which results in a low failure rate; i.e. less than 1% per year). Additionally, women will only be exposed to the PfSPZ-CVac/ME-TRAP products following a negative highly sensitive pregnancy test the day before immunization/CHMI.
- Agreement to refrain from blood donation during the course of the study and after the end of their involvement in the study according to the local and national blood banking eligibility criteria (which is a permanent refrain from blood donations after a malaria parasite infection).
Key exclusion criteria (31 listed)
- History of P. falciparum malaria within the last 5 years.
- Prior receipt of malaria vaccine.
- Planned travel to malaria endemic areas during the study period.
- Use of drugs with known antimalarial activity within 30 days of study enrollment (e.g. trimethoprim-sulfamethoxazole, doxycycline, tetracycline, clindamycin, erythromycin, fluoroquinolones, or azithromycin).
- Participation in other clinical trials or the intake of an investigational medicinal product within the last 90 days or planned receipt during the duration of this study
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 |
|---|---|---|
| Pyronaridine Tetraphosphate, Artesunate Drug CombinationAlso: PyramaxCombination drug for treatment of uncomplicated malaria | Drug | PfSPZ-CVac/Pyramax |
| PfSPZ Challenge (NF54)cryopreserved Plasmodium falciparum sporozoites injected by intravenous inoculation | Biological | PfSPZ-CVac/Pyramax |
| MVA ME-TRAPvirally vectored subunit vaccine candidates where ME-TRAP is expressed by the non-replicating viral vector Modified Vaccinia Ankara (MVA) | Biological | MVA ME-TRAP/ChAd63 ME-TRAP |
| ChAd63 ME-TRAPvirally vectored subunit vaccine candidates where ME-TRAP is expressed by the non-replicating viral vector Chimpanzee Adenovirus 63 (ChAd63) | Biological | MVA ME-TRAP/ChAd63 ME-TRAP |
| Sodium chloride (NaCl) 0.9%Also: Placebo: Saline0.9% NaCl solution for injection | Biological | Saline/placebo pill |
Primary outcome
Assessment of safety and tolerability of PfSPZ-CVac/Pyramax and MVA ME-TRAP/ChAd63 ME-TRAP
Time frame: From the first administration until the last follow-up visit (Group 1: day 136, Group 2: day 82)
Assessment of all adverse events and serious adverse events that might be related to the administration of PfSPZ-CVac/Pyramax and MVA ME-TRAP/ChAd63 ME-TRAP
1 secondary outcome
Assessment of protective efficacy of PfSPZ-CVac/Pyramax and of MVA ME-TRAP /ChAd63 ME-TRAP in healthy, malaria-naïve adults against homologous CHMI with PfSPZ Challenge (NF54) by DVI
Time frame: From administration of CHMI (Group 1:day 113, Group 2: 59) until the last follow-up visit (Group 1: day 136, Group 2: day 82)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Background: PubMed 33947856Sulyok Z, Fendel R, Eder B, Lorenz FR, Kc N, Karnahl M, Lalremruata A, Nguyen TT, Held J, Adjadi FAC, Klockenbring T, Flugge J, Woldearegai TG, Lamsfus Calle C, Ibanez J, Rodi M, Egger-Adam D, Kreidenweiss A, Kohler C, Esen M, Sulyok M, Manoj A, Richie TL, Sim BKL, Hoffman SL, Mordmuller B, Kremsner PG. Heterologous protection against malaria by a simple chemoattenuated PfSPZ vaccine regimen in a randomized trial. Nat Commun. 2021 May 4;12(1):2518. doi: 10.1038/s41467-021-22740-w.
- Individual participant dataSharing planned: Undecided
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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.
Sabine Bélard, Dr. principal investigator
University Hospital Tuebingen
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pyronaridine Tetraphosphate, Artesunate Drug Combination, PfSPZ Challenge (NF54) and MVA ME-TRAP in people with Malaria, run by University Hospital Tuebingen.
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 31 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: opening soon, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jaana Heinze, Dr. (+49070712982191, jaana.heinze@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of safety and tolerability of PfSPZ-CVac/Pyramax and MVA ME-TRAP/ChAd63 ME-TRAP (time frame: From the first administration until the last follow-up visit (Group 1: day 136, Group 2: day 82)). 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 NCT05441410, 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 6 Dec 2024.