AzTrials
AzTrials

MalariaPhase 2NCT03917654

Pfs230D1M-EPA/AS01 Vaccine, a Transmission Blocking Vaccine Against Plasmodium Falciparum, in an Age De-Escalation Trial of Children and a Family Compound Trial in Mali

A Phase 2 study testing Pfs230D1M-EPA/AS01, HAVRIX and TYPHIM Vi (Salmonella typhi vaccine) in people with Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Mali.

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

Background: Malaria affects many people in Mali and other parts of Africa. It is spread by mosquito bites. Malaria can make people sick or can lead to death. Scientists want to learn if a vaccine can stop it from spreading to other people. Read more about this study

Who is it for?
Ages 1 year and older
Conditions the study is for
Malaria
What is being tested?
Pfs230D1M-EPA/AS01, HAVRIX and TYPHIM Vi (Salmonella typhi vaccine)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,301 participants
Where
1 siteMali
Study dates
24 Apr 2019to 31 Oct 2022
Phase
Phase 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 1 year and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • All of the following criteria must be fulfilled for a volunteer to participate in this trial:
  • Meets age requirements for Arm currently being enrolled.
  • Available for the duration of the trial.
  • Family compound known resident or long-term resident (more than 1 year) of Doneguebougou, 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 42Show 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
  • Unmarried AND not sexually active AND menstruating OR not menstruating females 12-17 years of age
  • NOTE: if a female of childbearing potential s status changes during the course of vaccination through 1 month post vaccination (e.g. they become >=18 years of age, married, or sexually active), the female will be required to start reliable contraception
  • 7. Willing to have blood samples stored for future research.
  • All of the following criteria must be fulfilled for a volunteer to participate in this trial:
  • Meets age requirements for Arm currently being enrolled.
  • Available for the duration of the trial.
  • Family compound known resident or long-term resident (more than 1 year) of Doneguebougou, 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.
  • Willing to have blood samples stored for future research.
  • All of the following criteria must be fulfilled for a volunteer to continue to participate in this trial:
  • 1. Previously enrolled in the study and has received at least 1 vaccination. 2. Available for the duration of the trial.
  • 3. In good general health and without clinically significant medical history in the opinion of the investigator.
  • 4. Females of childbearing potential must be willing to use reliable contraception from 21 days prior to scheduled vaccine dose #4 and until 1 month after the 4th 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
  • Unmarried AND not sexually active AND menstruatingOR not menstruating females 12-17 years of age
  • NOTE: if a female of childbearing potential s status changes during the course of vaccination through 1 month post vaccination (e.g. they become greater than or equal to 18 years of age, married, or sexually active), the female will be required to start reliable contraception
  • Willing to have blood samples stored for future research.
  • All of the following criteria must be fulfilled for a volunteer to continue to participate in this trial:
  • Previously enrolled in the study
  • Available for the duration of the trial.
  • In good general health and without clinically significant medical history in the opinion of the investigator.
  • 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 (beta-hCG) test (if female).
  • NOTE: Pregnancy is also a criterion for discontinuation of any further vaccine dosing
  • Menstruating females 11 years of age and younger. (In order to avoid cultural implications of further assessing pregnancy potential i.e. sexual activity in this age group.)
  • 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.)
Show all 75Show fewer
  • 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
  • Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, hematological, oncologic, or renal disease by history, physical examination, and/or laboratory studies including urinalysis.
  • Clinically significant prolonged QTc (>450 milliseconds) on screening EKG
  • History of receiving any investigational product within the past 30 days.
  • Current or planned participation in an investigational vaccine study until the last required protocol visit.
  • 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, Sj(SqrRoot)(Delta)gren 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
  • Adverse reaction to hepatitis A and/or typhoid and/or meningococcal vaccine in the past
  • Adverse reaction to artemether/lumefantrine in the past
  • Receipt of:
  • -Live vaccine within the past 4 weeks or a killed vaccine within the past 2 weeks 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.
  • Co-enrollment guidelines: Co-enrollment in other trials is restricted, other than enrollment on observational studies. Consideration for co-enrollment in trials evaluating the use of a licensed medication will require the approval of the PI. Study staff should be notified of co-enrollment on any other protocol as it may require the approval of the investigator.
  • An individual will be excluded from participating in this trial if any one of the following criteria is fulfilled:
  • 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.
  • Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, hematological, oncologic, or renal disease by history, physical examination, and/or laboratory studies including urinalysis.
  • Clinically significant prolonged QTc (by sex/age) on screening EKG
  • History of adverse reactions to artemether/lumefantrine in the past
  • History of receiving any investigational product within the past 30 days.
  • Current or planned participation in an investigational vaccine study until the last required protocol visit.
  • Receipt of:
  • -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.
  • 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 (beta-hCG) test (if female).
  • NOTE: Pregnancy is also a criterion for discontinuation of any further vaccine dosing
  • Menstruating females 11 years of age and younger. (In order to avoid cultural implications of further assessing pregnancy potential i.e. sexual activity in this age group.)
  • 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 less than or equal to 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 less than or equal to Grade 2.)
  • Infected with HIV
  • Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, hematological, oncologic, or renal disease by history, physical examination, and/or laboratory studies including urinalysis.
  • History of receiving any investigational product within the past 30 days.
  • 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, Sjogren s syndrome, or autoimmune thrombocytopenia.
  • Immunodeficiency syndrome.
  • Seizure disorder (exception: history of simple febrile seizures)
  • Asplenia or functional asplenia.
  • Use of chronic (greater than or equal to 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
  • Adverse reaction to hepatitis A and/or typhoid and/or meningococcal vaccine in the past
  • Adverse reaction to artemether/lumefantrine in the past
  • Receipt of:
  • Live vaccine within the past 4 weeks or a killed vaccine within the past 2 weeks to enrollment.
  • Immunoglobulins and/or blood products within the past 6 months.
  • 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.
  • An individual will be excluded from participating in this trial if any one of the following criteria is fulfilled:
  • 1. 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.
  • 2. Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, hematological, oncologic, or renal disease by history, physical examination, and/or laboratory studies including urinalysis.
  • 3. History of adverse reactions to artemether/lumefantrine in the past
  • 4. History of receiving any investigational product within the past 30 days.
  • 5. Current or planned participation in an investigational vaccine study until the last required protocol visit.
  • 6. Receipt of:
  • Investigational malaria vaccine in the last 2 years.
  • 7. 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.

Mali1 site

  • Mrtc/Usttb

    Bamako

Other trials in Mali

About this study

Official title: Safety, Immunogenicity and Efficacy of Pfs230D1M-EPA/AS01 Vaccine, a Transmission Blocking Vaccine Against Plasmodium Falciparum, in an Age De-Escalation Trial of Children and a Family Compound Trial in Mali

Background:

Malaria affects many people in Mali and other parts of Africa. It is spread by mosquito bites. Malaria can make people sick or can lead to death. Scientists want to learn if a vaccine can stop it from spreading to other people.

Read more

Objective:

To test how well an experimental malaria vaccine works to decrease malaria infections.

Eligibility:

Healthy people ages 5 and older who live in Doneguebougou, Mali, and surrounding areas

Design:

Participants will be screened with:

Medical history

Physical exam

Blood, urine, and heart tests

EKG

Participants will be randomly assigned to get either the experimental vaccine or an approved vaccine. They will not know which they are getting.

Participants will have a visit about a week before their first vaccine. They will take a medicine that kills malaria. They will take it at the clinic the next 2 days. Participants ages 5-8 will take the drug again 2 weeks before their third vaccine.

Participants get the vaccine through a needle in the arm. They will have visits 1, 3, 7, and 14 days after. They will have blood tests or finger pricks.

Participants will get another vaccine 1 and 6 months later.

Participants will have blood tests once a month. At these visits they may also have urines tests or mosquito feeds. For the feeds a cup full of mosquitoes will be placed on arms or legs for 15-20 minutes.

Participants will have visits twice a month for 4 months after their last vaccine.

Read the detailed description

A vaccine to interrupt malaria transmission (VIMT), targeting disruption of both human and mosquito transmission, would be a valuable tool for local elimination or eradication of this disease. One strategy to design a VIMT is using components that block transmission of malaria to mosquitoes, such as Pfs230. Pfs230, a surface antigen of intracellular gametocytes, as well as extracellular gametes and zygotes in the mosquito stage of Plasmodium falciparum, is currently the leading candidate in clinical trials for a malaria transmission-blocking vaccine (TBV). Recombinant Pfs230D1M has been conjugated to a recombinant Pseudomonas aeruginosa ExoProtein A (EPA) and adjuvanted with AS01. When formulated in AS01, results from a recent first-in-human trial demonstrated that Pfs230-EPA induces functional transmission-reducing, and in a significant proportion of vaccinees, transmission-blocking serum activity that can be measured for months, the vaccine is well-tolerated and safe in adults, and our recent natural history data clearly indicate that children play a disproportionate role in malaria transmission. The next step in the development of Pfs230D1M-EPA as a TBV is therefore to conduct an age de-escalation trial to ensure that the vaccine is safe to administer to children and then to conduct a community clinical trial to assess efficacy in family groups.

This Phase 2 study will first determine safety and tolerability of Pfs230D1M-EPA/AS01 in healthy Malian children of decreasing ages: 9-18 years old, followed by 5-8 years old. A total of 60 subjects will be enrolled in Doneguebougou, Mali, West Africa. Children will be recruited from compounds/family that have agreed to participate in the main phase of the study and will enroll in a staggered manner to receive either Pfs230D1M-EPA/AS01 vaccine or comparator as assigned by their compound block randomization. Prior to receipt of vaccination #1, all subjects will receive a full treatment course of artemether/lumefantrine (AL). Safety and tolerability will be monitored and reported as local and systemic adverse events (AEs) and serious adverse events (SAEs) and reviewed by DSMB, sponsor, medical monitors, and study team prior to proceeding with enrollment of the main phase.

If there are no safety concerns, in a staggered manner, the main phase will begin enrollment of approximately 137 compounds/vaccine units (about 1500 vaccinees + about 400 under 5 years of age for parasite surveillance). Children enrolled during the pilot safety phase will join their main phase compounds/family for vaccination #3. Prior to receipt of first vaccination, all subjects will receive a full treatment course of AL. All vaccinated subjects will be monitored for safety and tolerability. Immunogenicity outcomes will be antibody responses as measured by enzyme-linked immunosorbent assay (ELISA) against recombinant Pfs230D1M. Functional activity of the induced antibodies will be assessed by standard membrane feeding assays in select samples. Vaccine activity will be measured in children 9-18 years of age who will undergo direct skin feeds (DSF) starting 2 weeks post vaccination #3 for a total of 8 DSFs.

Prior to scheduled last vaccination in members of the compound/family, children 1-4 years of age and vaccinated children 5-8 years of age will receive a full treatment course of AL prior to the expected start of the transmission season and will then be followed every 2 weeks by blood smear (BS) along with all vaccinated children. Children 9-18 years of age will also be assessed for vaccine efficacy, but as a separate analysis from those 1-8 years of age.

In Year 2, those who received vaccination during Year 1 (5 years of age and older at enrollment), if eligible and still on study, will receive a single fourth vaccination per their vaccine unit (VU) blinded arm assignment. No new individuals will be enrolled. Again, children 1-4 years of age and vaccinated children 5-8 years of age will receive a full treatment course of AL prior to the expected start of the transmission season and will then be followed every 2 weeks by BS along with all vaccinated children. Children 9-18 years of age will also be assessed for vaccine efficacy against parasitemia, but as a separate analysis from those 1-8 years of age. Immunogenicity outcomes will be antibody responses as measured by ELISA against recombinant Pfs230D1M. Functional activity of the induced antibodies will be assessed by standard membrane feeding assays in select samples. Vaccine activity will be measured in children 9-18 years of age who will undergo DSF starting 2 weeks post vaccination #4 for a total of 10 DSFs.

Conditions
Malaria
Being tested
Pfs230D1M-EPA/AS01, HAVRIX, TYPHIM Vi (Salmonella typhi vaccine), Menactra, AVAXIM
Keywords
Randomized, Assays, Blood Smear, Antibody, Parasites
Medical subject headings
Malaria

What participants receive

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

  • Pfs230D1M-EPA/AS01Biological

    The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM phosphate-buffered saline (PBS) to a 2X dilution of the high dose (160 (Micro)g/mL in 0.5 mL volume) in cGMP compliance at Walter Reed Bioproduction facility in April 2016 and will be provided as a single use vial. AS01B adjuvant was manufactured for use in the SHINGRIX vaccine by GSK

  • HAVRIXBiological

    HAVRIX (Hepatitis A Vaccine; HAV) is produced by GSK and is a sterile suspension of inactivated virus for IM administration. The virus (strain HM175) is propagated in MRC-5 human diploid cells. HAVRIX is FDA approved for active immunization against disease caused by HAV for persons 12 months of age and older.

  • TYPHIM Vi (Salmonella typhi vaccine)Biological

    TYPHIM Vi (Typhoid Vi Polysaccharide Vaccine), produced by Sanofi Pasteur SA, for IM use, is a sterile solution containing the cell surface Vi polysaccharide extracted from Salmonella enterica serovar Typhi, S typhi Ty2 strain (inactivated, subunit vaccine). TYPHIM Vi vaccine is indicated for active immunization for the prevention of typhoid fever caused by S typhi and is FDA approved for use in persons 2 years of age or older

  • MenactraBiological

    Menactra (Sanofi Pasteur) is a sterile, intramuscularly administered vaccine that contains Neisseria meningitidis serogroup A, C, Y, and W-135 capsular polysaccharide antigens individually conjugated to diphtheria toxoid protein. No preservative or adjuvant is added during the manufacturing process. Menactra is FDA approved for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 (but does not protect against serotype B) for use in individuals 9 months through 55 years of age.

  • AVAXIMBiological

    AVAXIM - Pediatric [Hepatitis A Vaccine Inactivated] is a sterile, whitish, cloudy suspension. The active ingredient is a purified and formaldehyde-inactivated hepatitis A virus (HAV) obtained from the GBM strain, cultured on MRC-5 human diploid cells. HAV is adsorbed onto aluminum.

Study groups in NCT03917654
Study groupRoleWhat they receive
Arm 1a/3cExperimentalArm 1a (pilot) + Arm 3c (main) to receive 40ug of Pfs230D1M-EPA/AS01 on days 0, 28, 168; receipt of artemether/lumefantrine (AL) on day -7
Receives: Biological: Pfs230D1M-EPA/AS01; Biological: AVAXIM
Arm 1b/3dActive comparatorArm 1b (pilot) + Arm 3d (main) to receive HAVRIX (day 0), TYPHIM Vi (day 28), HAVRIX (day 168); receipt of AL on day -7
Receives: Biological: HAVRIX; Biological: Menactra
Arm 2a/3aExperimentalArm 2a (pilot) + Arm 3a (main) to receive 40ug of Pfs230D1M-EPA/AS01 on days 0, 28, 168; receipt of AL on day -7 and 154
Receives: Biological: Pfs230D1M-EPA/AS01
Arm 2b/3bActive comparatorArm 2b (pilot) + Arm 3b (main) to receive HAVRIX (day 0), TYPHIM Vi (day 28), HAVRIX (day 168); receipt of AL on day -7 and 154
Receives: Biological: HAVRIX; Biological: Menactra
Arm 3eExperimentalArm 3e (main) to receive 40microg of Pfs230D1M-EPA/AS01 on days 0, 28, 168; receipt of AL on day -7
Receives: Biological: Pfs230D1M-EPA/AS01
Arm 3fActive comparatorArm 3f (main) to receive HAVRIX (day 0), TYPHIM Vi (day 28), HAVRIX (day 168); receipt of AL on day -7
Receives: Biological: HAVRIX; Biological: TYPHIM Vi (Salmonella typhi vaccine); Biological: Menactra
Arm 4aNo interventionReceipt of AL on day 154
Arm 4bNo interventionReceipt of AL on day 154

What is being measured

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

  1. Number of Participants With Local and Systemic Adverse Events in Years 1 and 2

    Number of participants with local and systemic adverse events (AEs) graded by severity occurring within 7 days after each vaccine

    Measured: Within 7 days after each vaccination at days, 0, 28, 126, 448 (for arms 1a, 1b, 2a, 2b), days 0, 28, 56, 392 (for arms 3a, 3b, 3c, 3d, 3e, 3f), days -14 and 385 (for arms 4a, 4b) and year 2 (for all arms)

Timeline

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

  1. First posted17 Apr 2019
  2. Study start24 Apr 2019
  3. Primary completion30 Jul 2021
  4. Study completion31 Oct 2022

Resources

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,301 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03917654
Sponsor's protocol ID
999919086
Other IDs
19-I-N086
Status last verified
Dec 2021
First submitted
16 Apr 2019
Last updated
22 Oct 2024
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • MacDonald NJ, Nguyen V, Shimp R, Reiter K, Herrera R, Burkhardt M, Muratova O, Kumar K, Aebig J, Rausch K, Lambert L, Dawson N, Sattabongkot J, Ambroggio X, Duffy PE, Wu Y, Narum DL. Structural and Immunological Characterization of Recombinant 6-Cysteine Domains of the Plasmodium falciparum Sexual Stage Protein Pfs230. J Biol Chem. 2016 Sep 16;291(38):19913-22. doi: 10.1074/jbc.M116.732305. Epub 2016 Jul 18.

    PubMed 27432885

  • Tachibana M, Wu Y, Iriko H, Muratova O, MacDonald NJ, Sattabongkot J, Takeo S, Otsuki H, Torii M, Tsuboi T. N-terminal prodomain of Pfs230 synthesized using a cell-free system is sufficient to induce complement-dependent malaria transmission-blocking activity. Clin Vaccine Immunol. 2011 Aug;18(8):1343-50. doi: 10.1128/CVI.05104-11. Epub 2011 Jun 29.

    PubMed 21715579

  • Farrance CE, Rhee A, Jones RM, Musiychuk K, Shamloul M, Sharma S, Mett V, Chichester JA, Streatfield SJ, Roeffen W, van de Vegte-Bolmer M, Sauerwein RW, Tsuboi T, Muratova OV, Wu Y, Yusibov V. A plant-produced Pfs230 vaccine candidate blocks transmission of Plasmodium falciparum. Clin Vaccine Immunol. 2011 Aug;18(8):1351-7. doi: 10.1128/CVI.05105-11. Epub 2011 Jun 29.

    PubMed 21715576

  • Cao 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pfs230D1M-EPA/AS01, HAVRIX and TYPHIM Vi (Salmonella typhi vaccine) in people with Malaria, 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 42 inclusion and 75 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 22 Oct 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 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 23 Aug 2022). 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 Participants With Local and Systemic Adverse Events in Years 1 and 2 (time frame: Within 7 days after each vaccination at days, 0, 28, 126, 448 (for arms 1a, 1b, 2a, 2b), days 0, 28, 56, 392 (for arms 3a, 3b, 3c, 3d, 3e, 3f), days -14 and 385 (for arms 4a, 4b) and year 2 (for all arms)). 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 NCT03917654, 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 22 Oct 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in