Malaria,FalciparumPhase 1NCT05135273
Study of the Transmission-Blocking Vaccine Pfs230D1-EPA/Matrix-M Against Malaria in Adults in Mali
A Phase 1 study testing Pfs230D1-EPA/Matrix-M Vaccine and Verorab Rabies Vaccine in people with Malaria,Falciparum, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Mali.
Trial summary
Background: Researchers are trying to develop a vaccine that will safely reduce the spread of malaria in the community by preventing mosquitos from carrying malaria from person to person. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria,Falciparum
- What is being tested?
- Pfs230D1-EPA/Matrix-M Vaccine and Verorab Rabies Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteMali
- Study dates
- 22 Oct 2021to 21 Jun 2023
- Phase
- Phase 1
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All of the following criteria must be fulfilled for a volunteer to participate in this trial:
- Age: > 18 years old and < 50 years old.
- Available for the duration of the trial.
- Known resident or long-term resident (more than 1 year) of Sotuba, Mali or surrounding villages.
- Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
- In good general health and without clinically significant medical history in the opinion of the investigator.
Show all 14Show fewer
- Females of childbearing potential must be willing to use reliable contraception from 21 days prior to Study Day 0 and until 1 month after the last vaccination.
- A reliable method of birth control includes one of the following:
- Confirmed pharmacologic contraceptives (parenteral) delivery.
- Intrauterine or implantable device.
- EXCEPTIONS to required pregnancy prevention includes the following:
- Postmenopausal state: defined as no menses for 12 months without an alternative medical cause.
- Surgical sterilization.
- Willing to have blood samples stored for future research.
Who cannot join
- An individual will be excluded from participating in this trial if any one of the following criteria is fulfilled:
- Pregnant, as determined by a positive urine or serum beta human choriogonadotropin (β hCG) test (if female). NOTE: Pregnancy is also a criterion for discontinuation of any further vaccine dosing.
- Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the subject to understand and comply with the study protocol at a level appropriate for the subject's age.
- Hemoglobin, white blood cell (WBC), absolute neutrophil count, or platelet levels outside the local laboratory-defined limits of normal. (Subjects may be included at the investigator's discretion for "not clinically significant" values outside of normal range and ≤ Grade 2.)
- Alanine transaminase (ALT) or creatinine (Cr) level above the local laboratory-defined upper limit of normal. (Subjects may be included at the investigator's discretion for "not clinically significant" values outside of normal range and ≤ Grade 2.)
- Infected with HIV.
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- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, hematological, oncologic, or renal disease by history, physical examination, and/or laboratory studies.
- History of receiving any investigational product within the past 30 days.
- Current or planned participation in an investigational vaccine study until the time period of the last required study visit under this protocol.
- Medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months.
- History of a severe allergic reaction or anaphylaxis.
- Known:
- Severe asthma, defined as asthma that is unstable or required emergent care, urgent care, hospitalization, or intubation during the past 2 years, or that has required the use of oral or parenteral corticosteroids at any time during the past 2 years.
- Autoimmune or antibody-mediated disease including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjögren's syndrome, or autoimmune thrombocytopenia.
- Immunodeficiency syndrome.
- Seizure disorder (exception: history of simple febrile seizures).
- Asplenia or functional asplenia.
- Use of chronic (≥14 days) oral or intravenous (IV) corticosteroids (excluding topical or nasal) at immunosuppressive doses (i.e., prednisone >10 mg/day) or immunosuppressive drugs within 30 days of Study Day 0.
- Allergy to latex or neomycin.
- Receipt of:
- Live vaccine within 4 weeks prior to enrollment or a killed vaccine within 2 weeks prior to enrollment.
- Immunoglobulins and/or blood products within the past 6 months.
- Investigational malaria vaccine in the last 2 years.
- Any other condition that in the opinion of the investigator would jeopardize the safety or rights of a subject participating in the trial, interfere with the evaluation of the study objectives, or would render the subject unable to comply with the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1, Dose-Escalating, Double-Blind, Randomized, Comparator-Controlled Trial of the Safety, Tolerability, and Immunogenicity of the Transmission-Blocking Vaccine Pfs230D1-EPA/Matrix-M™ Against Plasmodium Falciparum in Adults in Mali
Background:
Researchers are trying to develop a vaccine that will safely reduce the spread of malaria in the community by preventing mosquitos from carrying malaria from person to person.
Read more
Objective:
To assess in African adults the safety of and immune response to the administration of Pfs230D1-EPA/Matrix-M vaccine as compared to the rabies vaccine control.
Eligibility:
Healthy adults (18 to 50 years of age) who reside in Sotuba and surrounding villages in Mali
Design:
Participants will be screened with:
- Medical history
- Physical exam
- Blood, urine, and heart tests
- Malaria comprehension exam
Participants will be randomly assigned to get either the experimental vaccine or the approved rabies vaccine. They will not know which they are getting.
Participants will get 3 doses of the study or comparator vaccine via injection in the upper arm. This occurs at the first visit, 1 month, and 2 months later.
Participants will have up to 23 scheduled visits over 14 to 16 months. Each visit includes a physical exam, and blood will be collected at most visits.
Participants will be followed up to 1 year after the final vaccination.
If participants develop an injection site rash or reaction, photographs may be taken of the site.
Read the detailed description
A vaccine to interrupt malaria transmission (VIMT), targeting disruption of parasite transmission through both human and mosquito, would be a valuable additional resource in the fight to eliminate this disease. Transmission-blocking vaccines (TBVs) induce anti-sporogonic antibodies that disrupt parasite transmission to the mosquito, thereby halting transmission to another human host. Malaria-exposed populations acquire antibody against Pfs230, a parasite protein expressed by gametocytes in the human stage of P. falciparum and a surface antigen of gametes and zygotes in the mosquito stage, which suggests that a Pfs230-based vaccine may be boosted by natural malaria infection. Pfs230D1 has become one of the leading transmission-blocking antigens for consideration as a licensed TBV to be used either alone or in combination with other transmission-blocking antigens. Clinical trials with this antigen adjuvanted with either Alhydrogel or AS01 have provided very encouraging results.
This is a Phase 1, dose-escalating, randomized, double-blind, comparator-controlled study to assess the safety, tolerability, immunogenicity and transmission-blocking activity (TBA) of a 3 dose regimen of Pfs230D1-EPA/Matrix-M versus rabies vaccine in healthy adults. This will be a first-in-human assessment of Pfs230D1-EPA/Matrix-M and will be conducted as a dose-escalation trial. Participants will be randomized to 1 of the study arms to receive 1 of 3 dose levels of Pfs230D1-EPA/Matrix-M or a standard dose of comparator rabies vaccine administered as an intramuscular injection at 3 timepoints. For the 3 Pfs230D1-EPA/Matrix-M antigen dosages, we will start with a Pilot Group of 5 subjects in each Pfs230D1-EPA/Matrix-M arm and the rabies vaccine control arm. For the Pilot Group, the different dosage administrations are separated by approximately 2 weeks.
Safety outcomes will include the frequency of systemic and local adverse events and serious adverse events. Immunogenicity outcomes will be antibody responses measured by ELISA against Pfs230D1. Functional activity will be assessed by standard membrane feeding assays.
- Conditions
- Malaria,Falciparum
- Being tested
- Pfs230D1-EPA/Matrix-M Vaccine, Verorab Rabies Vaccine
- Keywords
- Malaria, Reactogenicity, Antibody, Mosquito, Vaccine
- Medical subject headings
- Malaria, Falciparum, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pfs230D1-EPA/Matrix-M VaccineBiological
Each single-use vial of Pfs230D1M-EPA contains 160 µg/mL of conjugated Pfs230D1M and 124 µg/mL or 143 µg/mL of conjugated EPA in 4 mM phosphate-buffered saline (PBS), in a volume of 0.5 mL. Each vial of Matrix-M1 contains saponin content of 0.375 mg/mL in PBS, at a pH of 7.2, in a final volume of 0.75 mL. Components will be combined in volumes defined in the protocol at point of use.
Verorab Rabies VaccineBiological
Verorab Rabies Vaccine is a purified inactivated rabies vaccine (Wistar rabies PM/WI 38 1503-3M strain) prepared on Vero cells. It is supplied as a powder and solvent for suspension for injection in a prefilled syringe. Before reconstitution, the powder is a white and homogeneous pellet. The solvent is a limpid solution.
| Study group | Role | What they receive |
|---|---|---|
| 1a (Pilot Group) | Experimental | (n=5) to receive 12.5 µg Pfs230D1-EPA/25 µg Matrix-M on D1, D29, D57 Receives: Biological: Pfs230D1-EPA/Matrix-M Vaccine |
| 1b (Pilot Group) | Experimental | (n=5) to receive 20 µg Pfs230D1-EPA/50 µg Matrix-M on D1, D29, D57 Receives: Biological: Pfs230D1-EPA/Matrix-M Vaccine |
| 1c (Pilot Group) | Experimental | (n=5) to receive 40 µg Pfs230D1-EPA/50 µg Matrix-M on D1, D29, D57 Receives: Biological: Pfs230D1-EPA/Matrix-M Vaccine |
| 1d (Pilot Group) | Active comparator | (n=4) to receive rabies vaccine (standard dose) on D1, D29, D57 Receives: Biological: Verorab Rabies Vaccine |
| 2a (Main Group) | Experimental | (n=15) to receive 12.5 µg Pfs230D1-EPA/25 µg Matrix-M on D1, D29, D57 Receives: Biological: Pfs230D1-EPA/Matrix-M Vaccine |
| 2b (Main Group) | Experimental | (n=15) to receive 20 µg Pfs230D1-EPA/50 µg Matrix-M on D1, D29, D57 Receives: Biological: Pfs230D1-EPA/Matrix-M Vaccine |
| 2c (Main Group) | Experimental | (n=15) to receive 40 µg Pfs230D1-EPA/50 µg Matrix-M on D1, D29, D57 Receives: Biological: Pfs230D1-EPA/Matrix-M Vaccine |
| 2d (Main Group) | Active comparator | (n=16) to receive rabies vaccine (standard dose) on D1, D29, D57 Receives: Biological: Verorab Rabies Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Local and Systemic Adverse Events (AEs) to Assess the Safety of the Study Drug
The analyses included only subjects who received at least one vaccination
Measured: Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
Number of Local and Systemic Serious Adverse Events (SAEs) to Assess the Safety of the Study Drug
Measured: Serious Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start22 Oct 2021
- Primary completion17 Feb 2023
- Study completion21 Jun 2023
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 (4)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 National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Novavax, Malaria Research and Training Center, Bamako, Mali
- Responsible party
- Sponsor
- Investigators
- Patrick Duffy, MD, Study chair, National Institute of Allergy and Infectious Diseases (NIAID)Issaka Sagara, MD, Principal investigator, Malaria Research and Training Center, Bamako, Mali
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05135273
- Sponsor's protocol ID
- N°2021/210/CE/USTTB
- Other IDs
- 000576
- Status last verified
- May 2024
- First submitted
- 17 Nov 2021
- Last updated
- 6 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Coelho CH, Tang WK, Burkhardt M, Galson JD, Muratova O, Salinas ND, Alves E Silva TL, Reiter K, MacDonald NJ, Nguyen V, Herrera R, Shimp R, Narum DL, Byrne-Steele M, Pan W, Hou X, Brown B, Eisenhower M, Han J, Jenkins BJ, Doritchamou JYA, Smelkinson MG, Vega-Rodriguez J, Truck J, Taylor JJ, Sagara I, Healy SA, Renn JP, Tolia NH, Duffy PE. A human monoclonal antibody blocks malaria transmission and defines a highly conserved neutralizing epitope on gametes. Nat Commun. 2021 Mar 19;12(1):1750. doi: 10.1038/s41467-021-21955-1.
PubMed 33741942Datoo MS, Natama MH, Some A, Traore O, Rouamba T, Bellamy D, Yameogo P, Valia D, Tegneri M, Ouedraogo F, Soma R, Sawadogo S, Sorgho F, Derra K, Rouamba E, Orindi B, Ramos Lopez F, Flaxman A, Cappuccini F, Kailath R, Elias S, Mukhopadhyay E, Noe A, Cairns M, Lawrie A, Roberts R, Valea I, Sorgho H, Williams N, Glenn G, Fries L, Reimer J, Ewer KJ, Shaligram U, Hill AVS, Tinto H. Efficacy of a low-dose candidate malaria vaccine, R21 in adjuvant Matrix-M, with seasonal administration to children in Burkina Faso: a randomised controlled trial. Lancet. 2021 May 15;397(10287):1809-1818. doi: 10.1016/S0140-6736(21)00943-0. Epub 2021 May 5.
PubMed 33964223Healy SA, Anderson C, Swihart BJ, Mwakingwe A, Gabriel EE, Decederfelt H, Hobbs CV, Rausch KM, Zhu D, Muratova O, Herrera R, Scaria PV, MacDonald NJ, Lambert LE, Zaidi I, Coelho CH, Renn JP, Wu Y, Narum DL, Duffy PE. Pfs230 yields higher malaria transmission-blocking vaccine activity than Pfs25 in humans but not mice. J Clin Invest. 2021 Apr 1;131(7):e146221. doi: 10.1172/JCI146221.
PubMed 33561016Cao Y, da Silva Araujo M, Lorang CG, Dos Santos NAC, Tripathi A, Vinetz J, Kumar N. Distinct immunogenicity outcomes of DNA vaccines encoding malaria transmission-blocking vaccine target antigens Pfs230D1M and Pvs230D1. Vaccine. 2025 Feb 15;47:126696. doi: 10.1016/j.vaccine.2024.126696. Epub 2025 Jan 8.
PubMed 39787798
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Dose-Escalating, Double-Blind, Randomized, Comparator-Controlled Trial of the Safety, Tolerability, and Immunogenicity of the Transmission-Blocking Vaccine Pfs230D1-EPA/Matrix-M™ Against Plasmodium Falciparum in Adults in Mali
- ClinicalTrials.gov ID
- NCT05135273
- Acronym / sponsor ID
- N°2021/210/CE/USTTB
- Conditions
- Malaria,Falciparum
- Keywords
- Malaria, Reactogenicity, Antibody, Mosquito, Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Novavax, Malaria Research and Training Center, Bamako, Mali
- Study start
- 22 Oct 2021 (actual)
- Primary completion
- 17 Feb 2023 (actual)
- Study completion
- 21 Jun 2023 (actual)
- First posted
- 26 Nov 2021 (actual)
- Results
- Posted 6 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Researchers are trying to develop a vaccine that will safely reduce the spread of malaria in the community by preventing mosquitos from carrying malaria from person to person.
Objective:
To assess in African adults the safety of and immune response to the administration of Pfs230D1-EPA/Matrix-M vaccine as compared to the rabies vaccine control.
Eligibility:
Healthy adults (18 to 50 years of age) who reside in Sotuba and surrounding villages in Mali
Design:
Participants will be screened with:
- Medical history
- Physical exam
- Blood, urine, and heart tests
- Malaria comprehension exam
Participants will be randomly assigned to get either the experimental vaccine or the approved rabies vaccine. They will not know which they are getting.
Participants will get 3 doses of the study or comparator vaccine via injection in the upper arm. This occurs at the first visit, 1 month, and 2 months later.
Participants will have up to 23 scheduled visits over 14 to 16 months. Each visit includes a physical exam, and blood will be collected at most visits.
Participants will be followed up to 1 year after the final vaccination.
If participants develop an injection site rash or reaction, photographs may be taken of the site.
Detailed description
A vaccine to interrupt malaria transmission (VIMT), targeting disruption of parasite transmission through both human and mosquito, would be a valuable additional resource in the fight to eliminate this disease. Transmission-blocking vaccines (TBVs) induce anti-sporogonic antibodies that disrupt parasite transmission to the mosquito, thereby halting transmission to another human host. Malaria-exposed populations acquire antibody against Pfs230, a parasite protein expressed by gametocytes in the human stage of P. falciparum and a surface antigen of gametes and zygotes in the mosquito stage, which suggests that a Pfs230-based vaccine may be boosted by natural malaria infection. Pfs230D1 has become one of the leading transmission-blocking antigens for consideration as a licensed TBV to be used either alone or in combination with other transmission-blocking antigens. Clinical trials with this antigen adjuvanted with either Alhydrogel or AS01 have provided very encouraging results.
This is a Phase 1, dose-escalating, randomized, double-blind, comparator-controlled study to assess the safety, tolerability, immunogenicity and transmission-blocking activity (TBA) of a 3 dose regimen of Pfs230D1-EPA/Matrix-M versus rabies vaccine in healthy adults. This will be a first-in-human assessment of Pfs230D1-EPA/Matrix-M and will be conducted as a dose-escalation trial. Participants will be randomized to 1 of the study arms to receive 1 of 3 dose levels of Pfs230D1-EPA/Matrix-M or a standard dose of comparator rabies vaccine administered as an intramuscular injection at 3 timepoints. For the 3 Pfs230D1-EPA/Matrix-M antigen dosages, we will start with a Pilot Group of 5 subjects in each Pfs230D1-EPA/Matrix-M arm and the rabies vaccine control arm. For the Pilot Group, the different dosage administrations are separated by approximately 2 weeks.
Safety outcomes will include the frequency of systemic and local adverse events and serious adverse events. Immunogenicity outcomes will be antibody responses measured by ELISA against Pfs230D1. Functional activity will be assessed by standard membrane feeding assays.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 1a (Pilot Group) | Experimental | Biological: Pfs230D1-EPA/Matrix-M Vaccine(n=5) to receive 12.5 µg Pfs230D1-EPA/25 µg Matrix-M on D1, D29, D57 |
| 1b (Pilot Group) | Experimental | Biological: Pfs230D1-EPA/Matrix-M Vaccine(n=5) to receive 20 µg Pfs230D1-EPA/50 µg Matrix-M on D1, D29, D57 |
| 1c (Pilot Group) | Experimental | Biological: Pfs230D1-EPA/Matrix-M Vaccine(n=5) to receive 40 µg Pfs230D1-EPA/50 µg Matrix-M on D1, D29, D57 |
| 1d (Pilot Group) | Active comparator | Biological: Verorab Rabies Vaccine(n=4) to receive rabies vaccine (standard dose) on D1, D29, D57 |
| 2a (Main Group) | Experimental | Biological: Pfs230D1-EPA/Matrix-M Vaccine(n=15) to receive 12.5 µg Pfs230D1-EPA/25 µg Matrix-M on D1, D29, D57 |
| 2b (Main Group) | Experimental | Biological: Pfs230D1-EPA/Matrix-M Vaccine(n=15) to receive 20 µg Pfs230D1-EPA/50 µg Matrix-M on D1, D29, D57 |
| 2c (Main Group) | Experimental | Biological: Pfs230D1-EPA/Matrix-M Vaccine(n=15) to receive 40 µg Pfs230D1-EPA/50 µg Matrix-M on D1, D29, D57 |
| 2d (Main Group) | Active comparator | Biological: Verorab Rabies Vaccine(n=16) to receive rabies vaccine (standard dose) on D1, D29, D57 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- All of the following criteria must be fulfilled for a volunteer to participate in this trial:
- Age: > 18 years old and < 50 years old.
- Available for the duration of the trial.
- Known resident or long-term resident (more than 1 year) of Sotuba, Mali or surrounding villages.
- Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
Key exclusion criteria (24 listed)
- An individual will be excluded from participating in this trial if any one of the following criteria is fulfilled:
- Pregnant, as determined by a positive urine or serum beta human choriogonadotropin (β hCG) test (if female). NOTE: Pregnancy is also a criterion for discontinuation of any further vaccine dosing.
- Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the subject to understand and comply with the study protocol at a level appropriate for the subject's age.
- Hemoglobin, white blood cell (WBC), absolute neutrophil count, or platelet levels outside the local laboratory-defined limits of normal. (Subjects may be included at the investigator's discretion for "not clinically significant" values outside of normal range and ≤ Grade 2.)
- Alanine transaminase (ALT) or creatinine (Cr) level above the local laboratory-defined upper limit of normal. (Subjects may be included at the investigator's discretion for "not clinically significant" values outside of normal range and ≤ Grade 2.)
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 |
|---|---|---|
| Pfs230D1-EPA/Matrix-M VaccineEach single-use vial of Pfs230D1M-EPA contains 160 µg/mL of conjugated Pfs230D1M and 124 µg/mL or 143 µg/mL of conjugated EPA in 4 mM phosphate-buffered saline (PBS), in a volume of 0.5 mL. Each vial of Matrix-M1 contains saponin content of 0.375 mg/mL in PBS, at a pH of 7.2, in a final volume of 0.75 mL. Components will be combined in volumes defined in the protocol at point of use. | Biological | 1a (Pilot Group), 1b (Pilot Group), 1c (Pilot Group), 2a (Main Group), 2b (Main Group), 2c (Main Group) |
| Verorab Rabies VaccineVerorab Rabies Vaccine is a purified inactivated rabies vaccine (Wistar rabies PM/WI 38 1503-3M strain) prepared on Vero cells. It is supplied as a powder and solvent for suspension for injection in a prefilled syringe. Before reconstitution, the powder is a white and homogeneous pellet. The solvent is a limpid solution. | Biological | 1d (Pilot Group), 2d (Main Group) |
Primary outcome
Number of Local and Systemic Adverse Events (AEs) to Assess the Safety of the Study Drug
Time frame: Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
The analyses included only subjects who received at least one vaccination
Number of Local and Systemic Serious Adverse Events (SAEs) to Assess the Safety of the Study Drug
Time frame: Serious Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 33741942Coelho CH, Tang WK, Burkhardt M, Galson JD, Muratova O, Salinas ND, Alves E Silva TL, Reiter K, MacDonald NJ, Nguyen V, Herrera R, Shimp R, Narum DL, Byrne-Steele M, Pan W, Hou X, Brown B, Eisenhower M, Han J, Jenkins BJ, Doritchamou JYA, Smelkinson MG, Vega-Rodriguez J, Truck J, Taylor JJ, Sagara I, Healy SA, Renn JP, Tolia NH, Duffy PE. A human monoclonal antibody blocks malaria transmission and defines a highly conserved neutralizing epitope on gametes. Nat Commun. 2021 Mar 19;12(1):1750. doi: 10.1038/s41467-021-21955-1.
- Background: PubMed 33964223Datoo MS, Natama MH, Some A, Traore O, Rouamba T, Bellamy D, Yameogo P, Valia D, Tegneri M, Ouedraogo F, Soma R, Sawadogo S, Sorgho F, Derra K, Rouamba E, Orindi B, Ramos Lopez F, Flaxman A, Cappuccini F, Kailath R, Elias S, Mukhopadhyay E, Noe A, Cairns M, Lawrie A, Roberts R, Valea I, Sorgho H, Williams N, Glenn G, Fries L, Reimer J, Ewer KJ, Shaligram U, Hill AVS, Tinto H. Efficacy of a low-dose candidate malaria vaccine, R21 in adjuvant Matrix-M, with seasonal administration to children in Burkina Faso: a randomised controlled trial. Lancet. 2021 May 15;397(10287):1809-1818. doi: 10.1016/S0140-6736(21)00943-0. Epub 2021 May 5.
- Background: PubMed 33561016Healy SA, Anderson C, Swihart BJ, Mwakingwe A, Gabriel EE, Decederfelt H, Hobbs CV, Rausch KM, Zhu D, Muratova O, Herrera R, Scaria PV, MacDonald NJ, Lambert LE, Zaidi I, Coelho CH, Renn JP, Wu Y, Narum DL, Duffy PE. Pfs230 yields higher malaria transmission-blocking vaccine activity than Pfs25 in humans but not mice. J Clin Invest. 2021 Apr 1;131(7):e146221. doi: 10.1172/JCI146221.
- Derived from this study: PubMed 39787798Cao Y, da Silva Araujo M, Lorang CG, Dos Santos NAC, Tripathi A, Vinetz J, Kumar N. Distinct immunogenicity outcomes of DNA vaccines encoding malaria transmission-blocking vaccine target antigens Pfs230D1M and Pvs230D1. Vaccine. 2025 Feb 15;47:126696. doi: 10.1016/j.vaccine.2024.126696. Epub 2025 Jan 8.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Patrick Duffy, MD study chair
National Institute of Allergy and Infectious Diseases (NIAID)
Issaka Sagara, MD principal investigator
Malaria Research and Training Center, Bamako, Mali
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pfs230D1-EPA/Matrix-M Vaccine and Verorab Rabies Vaccine in people with Malaria,Falciparum, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Mali.
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 14 inclusion and 24 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 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mali. 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 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.
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 6 May 2024). 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?
Number of Local and Systemic Adverse Events (AEs) to Assess the Safety of the Study Drug (time frame: Adverse Events monitored/assessed for 7 days after each vaccination at days 1, 29, and 57; All-Cause Mortality monitored/assessed through 14 months). The study lists 2 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 NCT05135273, which also lists 4 linked publications.
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 May 2024.