MalariaPhase 1NCT02334462

Study of the Safety and Immunogenicity of Pfs230D1M-EPA/Alhydrogel and Pfs25M-EPA/Alhydrogel , a Transmission Blocking Vaccine Against Plasmodium Falciparum Malaria, in Adults in the U.S. and Mali

A Phase 1 study testing Pfs230D1M-EPA/Alhydrogel, Pfs25M-EPA/Alhydrogel and TWINRIX in people with Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in 2 countries.

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 is a severe infection caused by a parasite. People can get malaria if a mosquito that carries the parasite bites them. Malaria infection does not happen in the United States, but many people in Africa, Asia, and South America are at risk for it. Read more about this study

Who is it for?: Ages 18 to 50 years
Conditions the study is for: Malaria
What is being tested?: Pfs230D1M-EPA/Alhydrogel, Pfs25M-EPA/Alhydrogel and TWINRIX
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 538 participants
Where: 2 sitesin 2 countries
Study dates: 7 Jan 2015to 22 Oct 2018
Phase: Phase 1
Are there results?: None posted in the registry

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
No healthy volunteers
Adult

Who may be able to join

All of the following criteria must be fulfilled for a volunteer to participate in this trial:
Age greater than or equal to18 and less than or equal to 50 years.
Available for the duration of the trial.
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.
Females of childbearing potential must be willing to use reliable contraception (as defined below) from 21 days prior to Study Day 0 to 3 months after the last vaccination.

Show all 16Show fewer

Reliable methods of birth control include one of the following: confirmed pharmacologic contraceptives (parenteral) delivery; intrauterine or implantable device.
Reliable methods of birth control include concurrent use of a pharmacologic and a barrier method, i.e. two of the following: confirmed pharmacologic contraceptives (oral, transdermal) delivery or vaginal ring AND condoms with spermicide or diaphragm with spermicide.
Abstinence of potentially reproductive sexual activity.
Non-childbearing women will also be required to report date of last menstrual period, history of surgical sterility (i.e. tubal ligation, hysterectomy) or premature ovarian insufficiency (POI), and will have a baseline urine or serum pregnancy test performed.
Willingness to have blood samples stored for future research.
Willingness to undergo direct skin feeds (Mali only).
Known resident of Bancoumana or surrounding area (Mali only).
Individuals previously enrolled in Arms A2, B2, or C2 may be asked to return to the clinic for a single additional visit. This visit would be to collect a single large volume blood sample for additional serological analysis and characterization of B cell receptor usage.
-The following criteria must be fulfilled for a volunteer to participate in the large volume blood draw addendum:
-- Previously enrolled in 15-I-0044 in Arms A2, B2, or C2

Who cannot join

A subject will be excluded from participating in this trial if any one of the following criteria is
fulfilled:
Pregnancy as determined by a positive urine or serum human choriogonadotropin ( <=- hCG) test (if female).
NOTE: Pregnancy is also a criteria for discontinuation of any further dosing or nonsafety related interventions for that subject.
Currently breast-feeding (if female).
Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and comply with the study protocol.

Show all 32Show fewer

Hemoglobin, WBC, absolute neutrophils, and platelets outside the local laboratorydefined limits of normal (subjects may be included at the investigator s discretion for not clinically significant values outside of normal range).
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).
Infected with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or
hepatitis B (HBV).
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.
Participation or planned participation in a clinical trial with an investigational product prior to completion of the follow up visit 28 days following last vaccination OR planned participation in an investigational vaccine study until the last required protocol visit
Subject has had 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.
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.
Pre-existing autoimmune or antibody-mediated diseases including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sj(SqrRoot)(Delta)gren s syndrome, or autoimmune thrombocytopenia.
Known immunodeficiency syndrome.
Known asplenia or functional asplenia.
Use of chronic (greater than or equal to 14 days) oral or intravenous corticosteroids (excluding topical or nasal) at immunosuppressive doses (i.e., prednisone >10 mg/day) or immunosuppressive drugs within 30 days of Study Day 0.
Prior to Study Day 0 and every subsequent vaccination day, receipt of a live vaccine within the past 4 weeks or a killed vaccine within the past 2 weeks.
Receipt of immunoglobulins and/or blood products within the past 6 months.
Previous receipt of an investigational malaria vaccine in the last 5 years.
Other condition that in the opinion of the investigator would jeopardize the safety or rights of a participant participating in the trial, interfere with the evaluation of the study objectives, or would render the subject unable to comply with the protocol.
Prior malaria infection by history in the last 10 years (US only).
Prior travel to a malaria transmission area in the last 5 years or planned travel during the course of the study (US only).
History of severe reaction to mosquito bites (Mali only).
History of allergy to any component of the comparator vaccine (e.g. neomycin) (Mali only).
A subject will be excluded from participating in the large volume blood draw addendum if any one of the following criteria is fulfilled:
Pregnancy as determined by self report (if female).
Within the past 30 days has received a research drug or vaccine or been enrolled in another research drug or vaccine trial.
Condition or on a medication that in the opinion of the investigator would jeopardize the safety or rights of a participant 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

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

United States1 site

National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892

Other trials in United States

Mali1 site

Malaria Research and Training Center
Bamako

Other trials in Mali

About this study

Official title: Phase 1 Study of the Safety and Immunogenicity of Pfs230D1M-EPA/Alhydrogel and Pfs25M-EPA/Alhydrogel, a Transmission Blocking Vaccine Against Plasmodium Falciparum Malaria in Adults in the US and Mali

Background:

Malaria is a severe infection caused by a parasite. People can get malaria if a mosquito that carries the parasite bites them. Malaria infection does not happen in the United States, but many people in Africa, Asia, and South America are at risk for it. Researchers want to test two vaccines that may help decrease malaria infection.

Objective:

To see if two vaccines (Pfs25M-EPA/Alhydrogel and Pfs230DIM-EPA/Alhydrogel ) are safe in humans and cause an immune response that will prevent malaria parasites from correctly growing in the mosquito.

Eligibility:

Healthy adults ages 18 50.

Design:

There are several groups in this study. Each group will receive a different dose of the vaccine and some groups will received both vaccines.
Vaccinations will be given on two days about 4 weeks apart.
Participants will receive each vaccine as an injection into the arm. Blood will be drawn on the day of vaccination.
In the 4 weeks after receiving a vaccination, participants will have at least 3 clinic visits and 1 phone contact. They will have at least 3 more visits and 3 phone contacts over the next 6 months.
At each visit, participants will be evaluated for side effects to the vaccine and any new health changes or problems. They will be asked how they are feeling and if they have taken any medicine. Blood and urine samples may be taken at the visit. More follow-up visits may be needed to follow up on changes or problems.

Read the detailed description

A vaccine to interrupt malaria transmission would be a valuable tool for local elimination or

eradication of this disease. Pfs25 and Pfs230, surface antigens of zygotes and ookinetes in the mosquito stage of Plasmodium falciparum, are the lead candidates for a malaria transmission blocking vaccine. Recombinant Pfs25M and recombinant Pfs230D1M have each been conjugated to Pseudomonas aeruginosa ExoProtein A (EPA) and adjuvanted with Alhydrogel . This dose-escalating phase 1 study will determine safety and immunogenicity of these vaccines in US adults and subsequently in Malian adults.

A total of 260 subjects will be enrolled at sites in the US and Mali to receive escalating doses of Pfs25M- EPA/Alhydrogel , Pfs230D1M-EPA/Alhydrogel , or simultaneous Pfs25MEPA/Alhydrogel and Pfs230D1M-EPA/Alhydrogel . Enrollment within each group will be staggered for additional safety, and subjects will only be enrolled into the simultaneous administration group once each individual dose has been administered and reviewed for safety. Subjects will be followed for at least 6 months after the last vaccination. Safety outcomes will be local and systemic adverse events (AEs) and serious adverse events (SAEs). Immunogenicity outcomes will be antibody responses as measured by ELISA against recombinant Pfs25, Pfs230, and EPA, and B cell responses. Functional activity of the induced antibodies will be assessed by membrane feeding assays conducted at the National Institute of Allergy and Infectious Diseases in the US.

Conditions: Malaria
Being tested: Pfs230D1M-EPA/Alhydrogel, Pfs25M-EPA/Alhydrogel, TWINRIX, Menactra
Keywords: Assays, Antibody, Reactogenicity, Mosquito, Responses
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/AlhydrogelBiological
Pfs25M-EPA/AlhydrogelBiological
TWINRIXDrug
MenactraDrug

Study groups in NCT02334462
Study group	Role	What they receive
Group 1- Mali	Experimental	Arm A1 (N=5) to receive 16 micrograms Pfs25M on D0, D28 Arm A2 (N=50) to receive 47 micrograms Pfs25M and Normal Saline on D0, D28, D168, D530 Receives: Biological: Pfs25M-EPA/Alhydrogel
Group 1-U.S	Experimental	Arm 1a (N=5) to receive 16 micrograms Pfs25M on D0, D28. Arm 1b (N=5) to receive 47 micrograms Pfs25M on D0, D28. Receives: Biological: Pfs25M-EPA/Alhydrogel
Group 2- Mali	Experimental	Arm B1 (N=5) to receive 15 micrograms Pfs230D1M on D0, D28 Pfs230D1M-EPA/Alhydrogel Arm B2 (N=50) to receive 40 micrograms Pfs230D1M and Normal Saline on D0, D28, D168, D530 Receives: Biological: Pfs230D1M-EPA/Alhydrogel
Group 2-U.S	Experimental	Arm 2a (N=5) to receive 5 micrograms Pfs230D1M on D0, D28.Arm 2b (N=5) to receive 15 micrograms Pgs230D1M on D0, D28. Arm 2c (N=5) to receive 40 micrograms Pfs230D1M on D0, D28. Receives: Biological: Pfs230D1M-EPA/Alhydrogel
Group 3- Mali	Experimental	Arm C1 (N=5) to receive 16 micrograms Pfs25M and 15 micrograms Pfs230D1M on D0, D28Arm C2 (N=50) to receive 47 micrograms Pfs25M and 40 microgramsPfs230D1M on D0, D28, D168, D530 Receives: Biological: Pfs230D1M-EPA/Alhydrogel; Biological: Pfs25M-EPA/Alhydrogel
Group 3- U.S.	Experimental	Arm 3a (N=5) to receive 16 micrograms Pfs25M and 15 micrograms Pfs230D1M on D0, D28. Arm 3b (N=5) to receive 47 micrograms Pfs25M and 40 micrograms Pfs230D1M on D0, D28. Receives: Biological: Pfs230D1M-EPA/Alhydrogel; Biological: Pfs25M-EPA/Alhydrogel
Group 4- Mali	Active comparator	Arm D1 (N=5) to receive TWINRIX on D0, D28Arm D2 (N=5) to receive TWINRIX and NormalSaline on D0, D28Arm D3 (N=50) to receive TWINRIX and NormalSaline on D0, D28, D168; to receive Menactra andNormal Saline on D530 Receives: Drug: TWINRIX; Drug: Menactra

What is being measured

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

Incidence of local and systemic adverse events and serious advents in U.S. adults and in exposed Malian adults.
Measured: U.S. Study: Days 1,3,7,14,28,29,31,35,42,56,84,112,140,168 and 196. Same as U.S. plus Days 169,171,175,182,189,196,203,210,217,240,2 70,300,330,360,390,420,450,480,510,540,541,543,547,554,561,568,575,582,589,610,640,670,700,730

Secondary outcomes (1)

Anti -Pfs25 and Anti-Pfs230 antibody levels elicited by as measured by ELISA in U.S. adults and in exposed Malian adults
Measured: U.S. Study: D. 14,28,42,84,140,196 Mali (Safety Arm: Same as the U.S. Mali (Functional Arm): D. 14,28,42,84,140,168,182,196,210,240,300,360,420,480,540,554,568,582,610,670,730

Timeline

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

7 Jan 201522 Oct 2018

First posted8 Jan 2015 (estimated)
Study start7 Jan 2015
Primary completion31 Mar 2016
Study completion22 Oct 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for MalariaStudies 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: 538 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02334462
Sponsor's protocol ID: 150044
Other IDs: 15-I-0044
Status last verified: 22 Oct 2018
First submitted: 7 Jan 2015
Last updated: 11 Apr 2019
Results posted: No
FDA-regulated drug: Yes

Publications

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
Kaslow DC, Quakyi IA, Syin C, Raum MG, Keister DB, Coligan JE, McCutchan TF, Miller LH. A vaccine candidate from the sexual stage of human malaria that contains EGF-like domains. Nature. 1988 May 5;333(6168):74-6. doi: 10.1038/333074a0.
PubMed 3283563
Shimp RL Jr, Rowe C, Reiter K, Chen B, Nguyen V, Aebig J, Rausch KM, Kumar K, Wu Y, Jin AJ, Jones DS, Narum DL. Development of a Pfs25-EPA malaria transmission blocking vaccine as a chemically conjugated nanoparticle. Vaccine. 2013 Jun 19;31(28):2954-62. doi: 10.1016/j.vaccine.2013.04.034. Epub 2013 Apr 24.
PubMed 23623858
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
Sagara I, Healy SA, Assadou MH, Kone M, Swihart BJ, Kwan JL, Fintzi J, Sissoko K, Kamate B, Samake Y, Guindo MA, Doucoure M, Niare K, Dolo A, Diarra B, Rausch KM, Narum DL, Jones DS, MacDonald NJ, Zhu D, Gorres JP, Imeru A, Mohan R, Thera I, Zaidi I, Salazar-Miralles F, Duan J, Neal J, Morrison RD, Muratova O, Sylla D, O'Connell EM, Wu Y, Hume JCC, Coulibaly MB, Anderson CF, Traore SF, Doumbo OK, Duffy PE. Malaria transmission-blocking vaccines Pfs230D1-EPA and Pfs25-EPA in Alhydrogel in healthy Malian adults; a phase 1, randomised, controlled trial. Lancet Infect Dis. 2023 Nov;23(11):1266-1279. doi: 10.1016/S1473-3099(23)00276-1. Epub 2023 Jul 24.
PubMed 37499679
Fantin RF, Coelho CH, Berhe AD, Magalhaes LMD, Pereira DB, Salinas ND, Tolia NH, Amaratunga C, Suon S, Sagara I, Narum DL, Fujiwara RT, Abejon C, Campos-Neto A, Duffy PE, Bueno LL. Immunological characterization of a VIR protein family member (VIR-14) in Plasmodium vivax-infected subjects from different epidemiological regions in Africa and South America. PLoS Negl Trop Dis. 2023 Apr 7;17(4):e0011229. doi: 10.1371/journal.pntd.0011229. eCollection 2023 Apr.
PubMed 37027391
Healy 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 33561016
Guindo A, Sagara I, Ouedraogo B, Sallah K, Assadou MH, Healy S, Duffy P, Doumbo OK, Dicko A, Giorgi R, Gaudart J. "Spatial heterogeneity of environmental risk in randomized prevention trials: consequences and modeling". BMC Med Res Methodol. 2019 Jul 15;19(1):149. doi: 10.1186/s12874-019-0759-z.
PubMed 31307393

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?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1 Study of the Safety and Immunogenicity of Pfs230D1M-EPA/Alhydrogel and Pfs25M-EPA/Alhydrogel, a Transmission Blocking Vaccine Against Plasmodium Falciparum Malaria in Adults in the US and Mali
ClinicalTrials.gov ID: NCT02334462
Acronym / sponsor ID: 150044
Conditions: Malaria
Keywords: Assays, Antibody, Reactogenicity, Mosquito, Responses
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 538 participants (actual)
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
Collaborators: Rodolphe Merieux Laboratory@@@Bamako, Mali
Study start: 7 Jan 2015
Primary completion: 31 Mar 2016 (actual)
Study completion: 22 Oct 2018 (actual)
First posted: 8 Jan 2015 (estimated)
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.

Background:

Malaria is a severe infection caused by a parasite. People can get malaria if a mosquito that carries the parasite bites them. Malaria infection does not happen in the United States, but many people in Africa, Asia, and South America are at risk for it. Researchers want to test two vaccines that may help decrease malaria infection.

Objective:

To see if two vaccines (Pfs25M-EPA/Alhydrogel and Pfs230DIM-EPA/Alhydrogel ) are safe in humans and cause an immune response that will prevent malaria parasites from correctly growing in the mosquito.

Eligibility:

Healthy adults ages 18 50.

Design:

There are several groups in this study. Each group will receive a different dose of the vaccine and some groups will received both vaccines.
Vaccinations will be given on two days about 4 weeks apart.
Participants will receive each vaccine as an injection into the arm. Blood will be drawn on the day of vaccination.
In the 4 weeks after receiving a vaccination, participants will have at least 3 clinic visits and 1 phone contact. They will have at least 3 more visits and 3 phone contacts over the next 6 months.
At each visit, participants will be evaluated for side effects to the vaccine and any new health changes or problems. They will be asked how they are feeling and if they have taken any medicine. Blood and urine samples may be taken at the visit. More follow-up visits may be needed to follow up on changes or problems.

Detailed description

A vaccine to interrupt malaria transmission would be a valuable tool for local elimination or

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 7

Arm	Type	Receives
Group 1- Mali	Experimental	Biological: Pfs25M-EPA/AlhydrogelArm A1 (N=5) to receive 16 micrograms Pfs25M on D0, D28 Arm A2 (N=50) to receive 47 micrograms Pfs25M and Normal Saline on D0, D28, D168, D530
Group 1-U.S	Experimental	Biological: Pfs25M-EPA/AlhydrogelArm 1a (N=5) to receive 16 micrograms Pfs25M on D0, D28. Arm 1b (N=5) to receive 47 micrograms Pfs25M on D0, D28.
Group 2- Mali	Experimental	Biological: Pfs230D1M-EPA/AlhydrogelArm B1 (N=5) to receive 15 micrograms Pfs230D1M on D0, D28 Pfs230D1M-EPA/Alhydrogel Arm B2 (N=50) to receive 40 micrograms Pfs230D1M and Normal Saline on D0, D28, D168, D530
Group 2-U.S	Experimental	Biological: Pfs230D1M-EPA/AlhydrogelArm 2a (N=5) to receive 5 micrograms Pfs230D1M on D0, D28.Arm 2b (N=5) to receive 15 micrograms Pgs230D1M on D0, D28. Arm 2c (N=5) to receive 40 micrograms Pfs230D1M on D0, D28.
Group 3- Mali	Experimental	Biological: Pfs230D1M-EPA/Alhydrogel, Biological: Pfs25M-EPA/AlhydrogelArm C1 (N=5) to receive 16 micrograms Pfs25M and 15 micrograms Pfs230D1M on D0, D28Arm C2 (N=50) to receive 47 micrograms Pfs25M and 40 microgramsPfs230D1M on D0, D28, D168, D530
Group 3- U.S.	Experimental	Biological: Pfs230D1M-EPA/Alhydrogel, Biological: Pfs25M-EPA/AlhydrogelArm 3a (N=5) to receive 16 micrograms Pfs25M and 15 micrograms Pfs230D1M on D0, D28. Arm 3b (N=5) to receive 47 micrograms Pfs25M and 40 micrograms Pfs230D1M on D0, D28.
Group 4- Mali	Active comparator	Drug: TWINRIX, Drug: MenactraArm D1 (N=5) to receive TWINRIX on D0, D28Arm D2 (N=5) to receive TWINRIX and NormalSaline on D0, D28Arm D3 (N=50) to receive TWINRIX and NormalSaline on D0, D28, D168; to receive Menactra andNormal Saline on D530

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (16 listed)

All of the following criteria must be fulfilled for a volunteer to participate in this trial:
Age greater than or equal to18 and less than or equal to 50 years.
Available for the duration of the trial.
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.

Key exclusion criteria (32 listed)

A subject will be excluded from participating in this trial if any one of the following criteria is
Pregnancy as determined by a positive urine or serum human choriogonadotropin ( <=- hCG) test (if female).
NOTE: Pregnancy is also a criteria for discontinuation of any further dosing or nonsafety related interventions for that subject.
Currently breast-feeding (if female).
Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and comply with the study protocol.

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
Pfs230D1M-EPA/Alhydrogel	Biological	Group 2- Mali, Group 2-U.S, Group 3- Mali, Group 3- U.S.
Pfs25M-EPA/Alhydrogel	Biological	Group 1- Mali, Group 1-U.S, Group 3- Mali, Group 3- U.S.
TWINRIX	Drug	Group 4- Mali
Menactra	Drug	Group 4- Mali

Primary outcome

Incidence of local and systemic adverse events and serious advents in U.S. adults and in exposed Malian adults.
Time frame: U.S. Study: Days 1,3,7,14,28,29,31,35,42,56,84,112,140,168 and 196. Same as U.S. plus Days 169,171,175,182,189,196,203,210,217,240,2 70,300,330,360,390,420,450,480,510,540,541,543,547,554,561,568,575,582,589,610,640,670,700,730

1 secondary outcome

Anti -Pfs25 and Anti-Pfs230 antibody levels elicited by as measured by ELISA in U.S. adults and in exposed Malian adults
Time frame: U.S. Study: D. 14,28,42,84,140,196 Mali (Safety Arm: Same as the U.S. Mali (Functional Arm): D. 14,28,42,84,140,168,182,196,210,240,300,360,420,480,540,554,568,582,610,670,730

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2019.
Background: PubMed 21715576Farrance 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.
Background: PubMed 3283563Kaslow DC, Quakyi IA, Syin C, Raum MG, Keister DB, Coligan JE, McCutchan TF, Miller LH. A vaccine candidate from the sexual stage of human malaria that contains EGF-like domains. Nature. 1988 May 5;333(6168):74-6. doi: 10.1038/333074a0.
Background: PubMed 23623858Shimp RL Jr, Rowe C, Reiter K, Chen B, Nguyen V, Aebig J, Rausch KM, Kumar K, Wu Y, Jin AJ, Jones DS, Narum DL. Development of a Pfs25-EPA malaria transmission blocking vaccine as a chemically conjugated nanoparticle. Vaccine. 2013 Jun 19;31(28):2954-62. doi: 10.1016/j.vaccine.2013.04.034. Epub 2013 Apr 24.
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.
Derived from this study: PubMed 37499679Sagara I, Healy SA, Assadou MH, Kone M, Swihart BJ, Kwan JL, Fintzi J, Sissoko K, Kamate B, Samake Y, Guindo MA, Doucoure M, Niare K, Dolo A, Diarra B, Rausch KM, Narum DL, Jones DS, MacDonald NJ, Zhu D, Gorres JP, Imeru A, Mohan R, Thera I, Zaidi I, Salazar-Miralles F, Duan J, Neal J, Morrison RD, Muratova O, Sylla D, O'Connell EM, Wu Y, Hume JCC, Coulibaly MB, Anderson CF, Traore SF, Doumbo OK, Duffy PE. Malaria transmission-blocking vaccines Pfs230D1-EPA and Pfs25-EPA in Alhydrogel in healthy Malian adults; a phase 1, randomised, controlled trial. Lancet Infect Dis. 2023 Nov;23(11):1266-1279. doi: 10.1016/S1473-3099(23)00276-1. Epub 2023 Jul 24.
Derived from this study: PubMed 37027391Fantin RF, Coelho CH, Berhe AD, Magalhaes LMD, Pereira DB, Salinas ND, Tolia NH, Amaratunga C, Suon S, Sagara I, Narum DL, Fujiwara RT, Abejon C, Campos-Neto A, Duffy PE, Bueno LL. Immunological characterization of a VIR protein family member (VIR-14) in Plasmodium vivax-infected subjects from different epidemiological regions in Africa and South America. PLoS Negl Trop Dis. 2023 Apr 7;17(4):e0011229. doi: 10.1371/journal.pntd.0011229. eCollection 2023 Apr.
Derived from this study: 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 31307393Guindo A, Sagara I, Ouedraogo B, Sallah K, Assadou MH, Healy S, Duffy P, Doumbo OK, Dicko A, Giorgi R, Gaudart J. "Spatial heterogeneity of environmental risk in randomized prevention trials: consequences and modeling". BMC Med Res Methodol. 2019 Jul 15;19(1):149. doi: 10.1186/s12874-019-0759-z.

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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 E Duffy, M.D. principal investigator

National Institute of Allergy and Infectious Diseases (NIAID)

2 sites in 2 countries: 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 16 inclusion and 32 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 11 Apr 2019. 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 United States, 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Incidence of local and systemic adverse events and serious advents in U.S. adults and in exposed Malian adults. (time frame: U.S. Study: Days 1,3,7,14,28,29,31,35,42,56,84,112,140,168 and 196. Same as U.S. plus Days 169,171,175,182,189,196,203,210,217,240,2 70,300,330,360,390,420,450,480,510,540,541,543,547,554,561,568,575,582,589,610,640,670,700,730). 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 NCT02334462, which also lists 8 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 11 Apr 2019.