Vaccine ReactionPhase 1NCT04268420
A Trial For The Study of Falciparum Malaria Protein 013 Administered Via Intramuscular Injection in Healthy Adults
A Phase 1 study testing FMP013 and ALFQ in people with Vaccine Reaction, run by U.S. Army Medical Research and Development Command at 1 site in United States.
Trial summary
A Phase 1, open label clinical study to evaluate the safety, immunogenicity, tolerability and efficacy of Plasmodium falciparum Malaria Protein 013 (FMP013) combined with (ALF with QS-21), saponin molecule derived from the bark of Quillaja species (ALFQ)) in healthy adult volunteers at different doses and dosing… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaccine Reaction
- What is being tested?
- FMP013 and ALFQ
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2020to Dec 2023
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults between the ages 18-55 (inclusive);
- Able and willing to provide written, informed consent;
- Able and willing to comply with all research requirements, in the opinion of the Investigator;
- Agreement to refrain from blood donation during the course of the study. Volunteers who have undergone CHMI can donate to other research once the study is complete but cannot donate to the American Red Cross for at least 3 years after the CHMI event;
- Laboratory Criteria within 90 days before enrollment:
- Hemoglobin ≥ 11.7 g/dL for women; ≥ 12.0 g/dL for men;
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- White Blood Cell count = 3,800-10,800 cells/mm3;
- Platelets = 140,000-400,000/mm3;
- Alanine aminotransferase (ALT; SGPT) 9-46 U/L male and 6-29 U/L female;
- Serum creatinine ≤ 1.5 mg/dL;
- Negative HIV testing (HIV Ab / antigen 4th generation screen with reflex confirmatory RNA testing);
- Negative hepatitis B surface antigen (HBsAg) and hepatitis C antibody testing; Note: As above, Grade 1 lab abnormalities detected on screening may be repeated at PI discretion. Persistent Grade 1 abnormalities that are felt to represent the non-pathologic baseline for the subject will be discussed with the research monitor and documented before a subject is enrolled in the trial, and are allowable per discretion and agreement of the PI and Research Monitor
- Birth control requirements:
- Female subjects must meet one of the following 2 criteria:
- No reproductive potential due to post-menopausal status (12 months of natural [spontaneous] amenorrhea) or hysterectomy, bilateral oophorectomy or tubal ligation;
- Women of childbearing potential should agree to practice highly effective contraception at least 30 days before enrollment and through 3 months post-CHMI or post-last vaccination (whichever is latest), using one of the following methods: condoms (male or female) with spermicide; diaphragm, or cervical cap with spermicide; intrauterine device; contraceptive pills, patch, injection, intravaginal ring or other FDA-approved contraceptive method; male partner has previously undergone a vasectomy; abstinence.
- Male subjects are encouraged but not required to practice highly effective contraception to avoid pregnancy in their partner from 30 days prior to enrollment through 60 days post-CHMI. This is due to the potential impact of malaria and antimalarial medications on spermatogenesis.
- For all female subjects except those with a history of hysterectomy or bilateral oophorectomy, a negative β-HCG pregnancy test (urine) on day of enrollment, each day of vaccination, and the day of CHMI (tubal ligations have a not insignificant failure rate, 12 months of spontaneous amenorrhea does not completely preclude pregnancy and can be a result of polycystic ovarian syndrome);
- Reachable (24/7) by mobile phone or other method of communication (email, landline, etc) during the period between CHMI and 28 days post-CHMI, per volunteer report;
- No plans to travel outside the Washington DC metro area (DC, Maryland, and Virginia) between the day of challenge and 28 days post-challenge; For Travel outside the US occurring 28 days post-challenge to a malaria endemic area inclusion will be at the discretion of the PI.
- If a subject is active duty military, he or she must obtain approval from his or her supervisor per WRAIR Policy 11-45;
- Must have low (< 10%) cardiac risk factors according to clinical Gaziano (NHANES I) criteria assessed at screening, and a normal or normal variant ECG;
- Completion of Study Comprehension Quiz (minimum passing score of 80% with 2 attempts permitted).
- Subject must be willing to take anti-malarial treatment after CHMI;
- Subject must provide 2 emergency contacts who will be made aware of the subject's participation in this trial and the vital importance of being reached during the challenge phase of the study. Both contacts must be verified by pone prior to subject enrollment.
- Verification will be define as either speaking to the emergency contact over the phone, hearing their name included in the voicemail response, or confirming the emergency contact uses the number if a third party answers the phone.
Who cannot join
- History of malaria infection (any species) or residence in a malaria-endemic area for more than 5 years (includes previous participation in CHMI studies).
- Previous travel to malaria endemic regions within the past 6 months before study enrollment defined as first vaccination or day of challenge (for infectivity controls) or planned travel to malaria endemic regions during the vaccination, CHMI and 28-day CHMI follow-up period; For Travel outside the US occurring 28 days post-challenge to a malaria endemic area exclusion will be at the discretion of the PI.
- Any history of receiving a malaria vaccine.
- Received an investigational product in the 30 days before enrollment, or planned to receive during the study period.
- Concurrent participation in another clinical research study.
- Any use of medications that prevent or treat malaria during the 1 month prior to challenge or planned use during the study (outside of the drugs provided by the study team).
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- Any serious medical illness or condition involving the heart, liver, lungs, or kidneys.
- Any significant risk for developing heart disease in the next 5 years, assessed according to clinical Gaziano (NHANES I) criteria assessed at screening, and an ECG.
- Receipt of immunoglobulins or blood products within 3 months before enrollment.
- Any history of anaphylaxis.
- History of sickle cell trait or disease, or any condition that could affect susceptibility to malaria infection, per subject verbal report.
- Pregnancy, lactation, or intention to become pregnant during the study, and 3 months after malaria challenge, if applicable.
- Contraindications or allergies to the use of all 3 proposed anti-malarial medications; Malarone (atovaquone/proguanil), Coartem (artemether/lumefantrine) and chloroquine; contraindication to 1 or 2 is not exclusionary.
- History of active/recent cancer still within treatment or active surveillance follow-up (except basal cell carcinoma of the skin and cervical carcinoma in situ). Treated/resolved cancers with no likelihood of recurrence may be deemed acceptable at Principal investigator discretion
- History of autoimmune disease.
- Significant (eg systemic anaphylaxis) hypersensitivity reactions to mosquito bites (local reactions at the site of mosquito bites are not an exclusion criterion) requiring hospitalization.
- Suspected or known current alcohol or drug abuse as defined by an alcohol intake of greater than 3 drinks a day on average for a man, and greater than 2 drinks a day on average for a woman.
- Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to give informed consent, participate in the study, or impair interpretation of the study data, in the opinion of the Investigator.
- Current anti-tuberculosis prophylaxis or treatment.
- History of splenectomy.
- History of confirmed or suspected immunodeficiency.
- History of Hereditary angioedema (HAE), acquired angioedema (AAE), or idiopathic forms of angioedema.
- History of Asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past 2 years.
- History of Diabetes mellitus (type I or II), with the exception of gestational diabetes.
- History of Thyroid disease (except for well controlled hypothyroidism).
- History of Idiopathic urticaria within the past year.
- History of hypertension that is not well controlled by medication or that is persistently greater than 150/95 at screening...
- History of bleeding disorder diagnosed by a doctor (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws.
- History of chronic or active neurologic disease to include seizure disorder and chronic migraine headaches. Exceptions are: i) childhood febrile seizures, or ii) seizures secondary to alcohol withdrawal more than 3 years ago.
- Subjects receiving any of the following substances:
- Systemic immunosuppressive medications or cytotoxic medications within 12 weeks before enrollment [with the exception of a short course of corticosteroids (≤ 14 days duration or a single injection) for a self-limited condition at least 2 weeks before enrollment; inhaled, intranasal or topical steroids are not considered exclusionary]
- Treatment with known immunomodulators (other than nonsteroidal anti-inflammatory drugs [NSAIDs]) for any reason.
- History of receipt of medication that prevent or treat malaria within 1 month of CHMI
- Live attenuated vaccines within 30 days before initial study vaccine administration
- Medically indicated subunit or killed vaccines, eg, influenza, pneumococcal, or allergy treatment with antigen injections, planned for administration 14 days before or after study vaccine administration
- History of arthritis diagnosis other than osteoarthritis.
- History of other diagnosed rheumatoid disorders.
- Any history of psoriasis (itchy skin rash) or porphyria (rare disturbance of metabolism), since these conditions could get worse after treatment with chloroquine (a medication for treating malaria).
- Subject must not have a fever in order to receive the study vaccine or participate in the malaria challenge.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
WRAIR, Clinical Trials Center
Silver Spring, Maryland, 20910-7500
Jack N Hutter, MD, MPH&TM, MAJ, MC, USA, 301-319-3095, jack.n.hutter.mil@mail.mil
About this study
Official title: Phase 1 Clinical Trial With Controlled Human Malaria Infection (CHMI) for Safety, Protective Efficacy, and Immunogenicity of Plasmodium Falciparum Malaria Protein (FMP013) Administered Intramuscularly With ALFQ Healthy Malaria-Naïve Adults
A Phase 1, open label clinical study to evaluate the safety, immunogenicity, tolerability and efficacy of Plasmodium falciparum Malaria Protein 013 (FMP013) combined with (ALF with QS-21), saponin molecule derived from the bark of Quillaja species (ALFQ)) in healthy adult volunteers at different doses and dosing schedules.
Read the detailed description
This is an open-label immunization with Controlled Human Malaria Infection (CHMI) study. Healthy, malaria-naïve adults, aged 18-55 years old will be recruited into one of 5 experimental cohorts in 2 parts.
In Part A, 2 experimental cohorts of 5 subjects each will receive a series of 3 vaccinations at 0, 1, and 2 months at 2 doses (the "low dose" arm and the "high dose" arm).
In Part B, 3 experimental cohorts of 10 subjects will receive a series of 3 vaccinations at 0, 1, 6 months (called the "delayed dose" arm), the "delayed fractional dose" arm is vaccinated at 0, 1, and 6 months with the 6 month dose being 1/5 the other doses, and the "standard" arm" at the 4th, 5th, and 6th month (after the first 2 vaccinations of the other 2 arms in Part B).
- Conditions
- Vaccine Reaction
- Being tested
- FMP013, ALFQ
- Keywords
- Plasmodium falciparum
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMP013Drug
Falciparum Malaria Protein-13
ALFQDrug
ALF with QS-21, saponin molecule derived from the tree bark of Quillaja species
| Study group | Role | What they receive |
|---|---|---|
| Part A - "Low" Dose | Active comparator | Part A vaccinees in the "low dose" arm will receive the lower dosing (20 μg FMP013 per 0.5 mL ALFQ) approximately 2 weeks prior to each vaccination. Vaccination to be delivered on 0,1,2 month. Receives: Drug: FMP013; Drug: ALFQ |
| Part A - "High" Dose | Active comparator | Part A vaccinees in the "high dose" arm will receive the lower dosing (40 μg FMP013 per 1.0 mL ALFQ) approximately 2 weeks prior to each vaccination.
Vaccination to be delivered on 0,1,2 month. Receives: Drug: FMP013; Drug: ALFQ |
| Part B - "Standard" Dose | Active comparator | Part B vaccinees in the "high dose" arm will receive the lower dosing (40 μg FMP013 per 1.0 mL ALFQ) approximately 2 weeks prior to each vaccination.
Vaccination to be delivered on 4,5,6 month. Receives: Drug: FMP013; Drug: ALFQ |
| Part B - "Delayed" Dose | Active comparator | Part B vaccinees in the "high dose" arm will receive the lower dosing (40 μg FMP013 per 1.0 mL ALFQ) approximately 2 weeks prior to each vaccination.
Vaccination to be delivered on 0,1,6 month. Receives: Drug: FMP013; Drug: ALFQ |
| Part B - "Delayed Fractional" Dose | Active comparator | Part B vaccinees in the "high dose" arm will receive the lower dosing (40 μg FMP013 per 1.0 mL ALFQ) approximately 2 weeks prior to each vaccination.
Vaccination to be delivered on 0,1,6 month. Receives: Drug: FMP013; Drug: ALFQ |
| Control | No intervention | Up to 6 subjects will be enrolled (defined as receiving malaria challenge) later in the trial to serve as challenge controls. Additional subjects may be recruited as alternates to ensure that 6 control subjects undergo the challenge. Any alternates not challenged will be released from the study at day of challenge. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Dosage of Candidate Malaria Vaccine FMP013/ALFQ
To assess the safety of candidate malaria vaccine FMP013/ALFQ. Safety dosage as indicated by incidence of solicited adverse events and serious adverse events through the end of the study.
Measured: 393 Days (+/-14)
Assess Reactogenicity of Candidate Malaria Vaccine FMP013/ALFQ
To assess reactogenicity of candidate malaria vaccine. Occurrence of solicited local and systemic reactogenicity to FMP013/ALFQ
Measured: 393 Days (+/-14)
Secondary outcomes (3)
Determine the Protective Efficacy of FMP013/ALFQ against a Plasmodium falciparum controlled human malaria infection.
Proportion of vaccinated subjects without P.falciparum parasitemia (defined as one positive qRT-PCR test. Time to onset of P. falciparum parasitemia (defined as one positive qRT-PCR test) following CHMI.
Measured: 505 Days (+/-14)
Measure Immune Responses to CSP, induced by FMP013/ALFQ using various immunoassays.
The Quantitative Anti-CSP IgG antibody titers, isotypes, and avidity measured by ELISA, ELISpot, and multiplex-based detection systems. Assess cellular immune responses to CSP by multicolor flow cytometry, ELISpot, and stimulation assays.
Measured: 505 Days (+/-14)
Measure Immune Responses to CSP, induced by FMP013/ALFQ using various immunoassays.
The Qualitative Anti-CSP IgG antibody titers, isotypes, and avidity measured by ELISA, ELISpot, and multiplex-based detection systems. Assess cellular immune responses to CSP by multicolor flow cytometry, ELISpot, and stimulation assays.
Measured: 505 Days (+/-14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start20 Mar 2020
- Primary completionJul 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vaccine ReactionStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Collaborators
- Walter Reed Army Institute of Research (WRAIR)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04268420
- Sponsor's protocol ID
- S-19-04
- Status last verified
- Jan 2023
- First submitted
- 4 Feb 2020
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hutter JN, Robben PM, Lee C, Hamer M, Moon JE, Merino K, Zhu L, Galli H, Quinn X, Brown DR, Duncan E, Bolton J, Zou X, Angov E, Lanar DE, Rao M, Matyas GR, Beck Z, Bergmann-Leitner E, Soisson LA, Waters NC, Ngauy V, Regules J, Dutta S. First-in-human assessment of safety and immunogenicity of low and high doses of Plasmodium falciparum malaria protein 013 (FMP013) administered intramuscularly with ALFQ adjuvant in healthy malaria-naive adults. Vaccine. 2022 Sep 22;40(40):5781-5790. doi: 10.1016/j.vaccine.2022.08.048. Epub 2022 Aug 31.
PubMed 36055874
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Clinical Trial With Controlled Human Malaria Infection (CHMI) for Safety, Protective Efficacy, and Immunogenicity of Plasmodium Falciparum Malaria Protein (FMP013) Administered Intramuscularly With ALFQ Healthy Malaria-Naïve Adults
- ClinicalTrials.gov ID
- NCT04268420
- Acronym / sponsor ID
- S-19-04
- Conditions
- Vaccine Reaction
- Keywords
- Plasmodium falciparum
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Collaborators
- Walter Reed Army Institute of Research (WRAIR)
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 13 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 1, open label clinical study to evaluate the safety, immunogenicity, tolerability and efficacy of Plasmodium falciparum Malaria Protein 013 (FMP013) combined with (ALF with QS-21), saponin molecule derived from the bark of Quillaja species (ALFQ)) in healthy adult volunteers at different doses and dosing schedules.
Detailed description
This is an open-label immunization with Controlled Human Malaria Infection (CHMI) study. Healthy, malaria-naïve adults, aged 18-55 years old will be recruited into one of 5 experimental cohorts in 2 parts.
In Part A, 2 experimental cohorts of 5 subjects each will receive a series of 3 vaccinations at 0, 1, and 2 months at 2 doses (the "low dose" arm and the "high dose" arm).
In Part B, 3 experimental cohorts of 10 subjects will receive a series of 3 vaccinations at 0, 1, 6 months (called the "delayed dose" arm), the "delayed fractional dose" arm is vaccinated at 0, 1, and 6 months with the 6 month dose being 1/5 the other doses, and the "standard" arm" at the 4th, 5th, and 6th month (after the first 2 vaccinations of the other 2 arms in Part B).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part A - "Low" Dose | Active comparator | Drug: FMP013, Drug: ALFQPart A vaccinees in the "low dose" arm will receive the lower dosing (20 μg FMP013 per 0.5 mL ALFQ) approximately 2 weeks prior to each vaccination. Vaccination to be delivered on 0,1,2 month. |
| Part A - "High" Dose | Active comparator | Drug: FMP013, Drug: ALFQPart A vaccinees in the "high dose" arm will receive the lower dosing (40 μg FMP013 per 1.0 mL ALFQ) approximately 2 weeks prior to each vaccination. Vaccination to be delivered on 0,1,2 month. |
| Part B - "Standard" Dose | Active comparator | Drug: FMP013, Drug: ALFQPart B vaccinees in the "high dose" arm will receive the lower dosing (40 μg FMP013 per 1.0 mL ALFQ) approximately 2 weeks prior to each vaccination. Vaccination to be delivered on 4,5,6 month. |
| Part B - "Delayed" Dose | Active comparator | Drug: FMP013, Drug: ALFQPart B vaccinees in the "high dose" arm will receive the lower dosing (40 μg FMP013 per 1.0 mL ALFQ) approximately 2 weeks prior to each vaccination. Vaccination to be delivered on 0,1,6 month. |
| Part B - "Delayed Fractional" Dose | Active comparator | Drug: FMP013, Drug: ALFQPart B vaccinees in the "high dose" arm will receive the lower dosing (40 μg FMP013 per 1.0 mL ALFQ) approximately 2 weeks prior to each vaccination. Vaccination to be delivered on 0,1,6 month. |
| Control | No intervention | –Up to 6 subjects will be enrolled (defined as receiving malaria challenge) later in the trial to serve as challenge controls. Additional subjects may be recruited as alternates to ensure that 6 control subjects undergo the challenge. Any alternates not challenged will be released from the study at day of challenge. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (26 listed)
- Healthy adults between the ages 18-55 (inclusive);
- Able and willing to provide written, informed consent;
- Able and willing to comply with all research requirements, in the opinion of the Investigator;
- Agreement to refrain from blood donation during the course of the study. Volunteers who have undergone CHMI can donate to other research once the study is complete but cannot donate to the American Red Cross for at least 3 years after the CHMI event;
- Laboratory Criteria within 90 days before enrollment:
Key exclusion criteria (39 listed)
- History of malaria infection (any species) or residence in a malaria-endemic area for more than 5 years (includes previous participation in CHMI studies).
- Previous travel to malaria endemic regions within the past 6 months before study enrollment defined as first vaccination or day of challenge (for infectivity controls) or planned travel to malaria endemic regions during the vaccination, CHMI and 28-day CHMI follow-up period; For Travel outside the US occurring 28 days post-challenge to a malaria endemic area exclusion will be at the discretion of the PI.
- Any history of receiving a malaria vaccine.
- Received an investigational product in the 30 days before enrollment, or planned to receive during the study period.
- Concurrent participation in another clinical research study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FMP013Falciparum Malaria Protein-13 | Drug | Part A - "High" Dose, Part A - "Low" Dose, Part B - "Delayed Fractional" Dose, Part B - "Delayed" Dose, Part B - "Standard" Dose |
| ALFQALF with QS-21, saponin molecule derived from the tree bark of Quillaja species | Drug | Part A - "High" Dose, Part A - "Low" Dose, Part B - "Delayed Fractional" Dose, Part B - "Delayed" Dose, Part B - "Standard" Dose |
Primary outcome
Safety Dosage of Candidate Malaria Vaccine FMP013/ALFQ
Time frame: 393 Days (+/-14)
To assess the safety of candidate malaria vaccine FMP013/ALFQ. Safety dosage as indicated by incidence of solicited adverse events and serious adverse events through the end of the study.
Assess Reactogenicity of Candidate Malaria Vaccine FMP013/ALFQ
Time frame: 393 Days (+/-14)
To assess reactogenicity of candidate malaria vaccine. Occurrence of solicited local and systemic reactogenicity to FMP013/ALFQ
3 secondary outcomes
Determine the Protective Efficacy of FMP013/ALFQ against a Plasmodium falciparum controlled human malaria infection.
Time frame: 505 Days (+/-14)
Measure Immune Responses to CSP, induced by FMP013/ALFQ using various immunoassays.
Time frame: 505 Days (+/-14)
Measure Immune Responses to CSP, induced by FMP013/ALFQ using various immunoassays.
Time frame: 505 Days (+/-14)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Derived from this study: PubMed 36055874Hutter JN, Robben PM, Lee C, Hamer M, Moon JE, Merino K, Zhu L, Galli H, Quinn X, Brown DR, Duncan E, Bolton J, Zou X, Angov E, Lanar DE, Rao M, Matyas GR, Beck Z, Bergmann-Leitner E, Soisson LA, Waters NC, Ngauy V, Regules J, Dutta S. First-in-human assessment of safety and immunogenicity of low and high doses of Plasmodium falciparum malaria protein 013 (FMP013) administered intramuscularly with ALFQ adjuvant in healthy malaria-naive adults. Vaccine. 2022 Sep 22;40(40):5781-5790. doi: 10.1016/j.vaccine.2022.08.048. Epub 2022 Aug 31.
- 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.
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 FMP013 and ALFQ in people with Vaccine Reaction, run by U.S. Army Medical Research and Development Command at 1 site in United States.
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 26 inclusion and 39 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: status not confirmed, as of the sponsor's last update on 10 Jan 2023. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jack N Hutter MD, MPH&TM, MAJ,MC,USA (301-319-3095, jack.n.hutter.mil@mail.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Dosage of Candidate Malaria Vaccine FMP013/ALFQ (time frame: 393 Days (+/-14)). 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 NCT04268420, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2023.