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RecruitingNCT07215858Updated Nov 10, 2026

BPL-1357 Against H1N1 Influenza Virus Challenge

A Phase 2 interventional study of BPL-1357 IM and BPL-1357 IN in Influenza and Human, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Recruiting at 2 sites in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 2, Interventional, and Prevention

Updated Nov 10, 2026Start date movedStudy contact changedGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
129
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

Background:

Influenza (flu) infections are a serious global health threat. Each year, between 3 and 5 million people get the flu, and up to 500,000 die from it. Current vaccines protect against seasonal flus, but broader vaccines are needed to protect against potential flu pandemics.

Objective:

To test an experimental flu vaccine.

Eligibility:

Healthy people aged 18 to 55 years.

Design:

The study will last 5 to 8 months and has 2 phases, A and B.

The study vaccine will be given either as a shot in the arm or as a nasal spray. Participants will receive 1 of 3 combinations: (1) study vaccine in the nose and placebo in the arm; (2) placebo in the nose and study vaccine in the arm; or (3) placebo in the nose and placebo in the arm. A placebo is just like the real vaccine but contains no active ingredients.

Phase A: Participants will have 5 clinic visits over 56 days. They will receive a shot and a nasal spray at 2 of the visits, 28 days apart. At each visit, they will have a physical exam, with tests of their blood, urine, and nasal secretions. They will check their temperature at home and record any symptoms for 7 days after each vaccine.

Phase B: Participants will stay in the hospital for at least 9 days. They will be infected with a flu virus. They will provide blood, urine, and nasal fluid samples. They will have tests of their heart function. They will remain in the hospital until they test negative for the flu 2 days in a row.

They will have 2 follow-up visits, 4 and 8 weeks after leaving the hospital.

...

Read the detailed description

Study Description:

This is a randomized, double-blinded, placebo-controlled, multicenter, phase 2 clinical trial of beta-propiolactone (BPL)-inactivated quadruple influenza virus cocktail vaccine (BPL-1357) administered intramuscularly (IM) or intranasally (IN) in 2 doses 28 days apart. The study has 2 phases: a vaccination phase (Phase A) and a challenge phase (Phase B). In phase A participants will be randomized to 1 of 3 groups for treatment assignment: group A IM BPL-1357 plus IN placebo, group B IM placebo plus IN BPL-1357, or group C IM placebo and IN placebo. In phase B, participants will undergo influenza challenge as inpatients. The primary hypothesis is that IN and IM BPL-1357 will be safe and offer protection against mild-moderate influenza disease (MMID) caused by H1N1 influenza challenge compared to placebo.

Objectives:

Primary Objective:

  1. To measure the efficacy of BPL-1357, given IM or IN, in preventing MMID compared to placebo.
  2. To assess the safety of BPL-1357, given IM or IN as 2 doses 28 days apart, including after H1N1 influenza challenge.

Secondary Objective:

  1. To measure the efficacy of BPL-1357, given IM or IN, in reducing total InFLUenza Patient Reported Outcome (FLUPRO) scores compared to placebo.
  2. To measure the efficacy of BPL-1357, given IM or IN, in preventing shedding measured by real-time polymerase chain reaction (rtPCR) compared to placebo.
  3. To measure the efficacy of BPL-1357, given IM or IN, in reducing shedding duration measured by rtPCR compared to placebo.
  4. To assess the immunogenicity of BPL-1357 given IM or IN.

Tertiary Objective:

  1. To assess the correlates of protection associated with BPL-1357 against H1N1 influenza challenge.
  2. To characterize the systemic and mucosal humoral immune responses induced by BPL-1357 at multiple timepoints before and after influenza challenge.
  3. To further characterize the immune response induced by BPL-1357 and subsequent influenza challenge through variable, diversity, and joining (VDJ) gene repertoire analysis, cytokine analysis, cytometry, transcriptomics, and further assessment of B- and T-cell responses.
  4. To examine whether clinical outcomes and immune responses vary according to time elapsed since vaccination to clinical outcome.
  5. To characterize how specific HLA types influence the magnitude and type of immune response.
  6. To assess BPL-1357 vaccine efficacy against any community-acquired influenza during the study.

Endpoints:

Primary Endpoints:

  1. Efficacy: Rate of MMID, defined as a positive US Food and Drug Administration (FDA)-approved clinical test for influenza plus 1 or more influenza symptoms, in the 7 days after challenge.

  2. Safety:

    1. Solicited adverse events (AEs) occurring within 7 days of each vaccination dose recorded through questionnaires.
    2. Unsolicited AEs occurring within 28 days of each vaccination dose.
    3. Serious adverse events (SAEs) occurring through study completion or withdrawal from study.

    Secondary Endpoints:

  3. Total FLU-PRO questionnaire scores after influenza challenge.
  4. Proportion of patients who shed virus after influenza challenge as measured by rtPCR.
  5. Mean duration (days) of shedding as measured by rtPCR.

  6. Immunogenicity at 28 days after vaccine dose 2 (PAD56):

    1. Antibodies against H1, H3, H5, and H7 head and stalk as measured by hemagglutination inhibition (HAI) or enzyme-linked immunosorbent assay (ELISA) from blood and mucosal samples at PAD56.
    2. Antibodies against N1, N3, N8, and N9 as measured by neuraminidase inhibition (NAI) or ELISA from blood and mucosal samples at PAD56.
    3. Neutralizing antibodies in blood at PAD56.
    4. Mucosal response and seroresponse rate after vaccination, defined to be the proportion of patients having a 2.5-fold increase from baseline (PAD0) in ELISA titer and a 4-fold increase from baseline in neutralizing, HAI, or NAI titer.

    Tertiary Endpoints:

  7. Association between pre-challenge immune markers and the occurrence of MMID.

  8. Additional antibody titer characterization via:

    1. Antibodies against H1, H3, H5, and H7 head and stalk as measured by HAI or ELISA from blood and mucosal samples at all timepoints.
    2. Antibodies against N1, N3, N8, and N9 as measured by NAI or ELISA from blood and mucosal samples at all timepoints.
    3. Neutralizing antibodies in blood at all timepoints.
    4. Mucosal response and seroresponse rate after vaccination.

  9. Additional immune response characterization through:

    1. VDJ gene repertoire analysis.
    2. Cytokine analysis.
    3. Flow cytometric phenotyping of lymphocytes.
    4. Transcriptomic gene expression.
    5. B- and T-cell responses.
  10. Associations between time-from-vaccination to clinical outcome and immune responses.
  11. Associations between HLA types and immune response.
  12. Association of clinical endpoints such as MMID and community acquired influenza diagnosed while on study.
02

Conditions studied

  • Influenza
  • Human

Browse trials for

Keywords

  • Influenza
  • Vaccine
  • Human Challenge
03

In context

Influenza, Human

2,356 studies on the registry are indexed under Influenza, Human; 184 are open to participants now.

This study's planned enrollment of 129 is below the median of 227 across 1,957 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.

Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.

Browse National Institute of Allergy and Infectious Diseases (NIAID) studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Individuals must meet all of the following criteria to be eligible for study participation:

  1. Adults >=18 and \<= 55 years of age at the time of consent.
  2. Able to provide written .
  3. Non-smoker (i.e., tobacco and cannabis) and does not use vape or e-cigarette products currently. Also, must not have used any of these products extensively in the past (regular use more than 5 times per week, more than 6 months lifetime total).
  4. Has not received influenza vaccination of any type within 6 months prior to enrollment and consents to not receive influenza vaccination of any type until after the end of study participation (PBD63).
  5. Has not received any other vaccination of any type within 4 weeks prior to enrollment and consents to not receive any unlicensed vaccine until after the end of the study (PBD63).
  6. Has not received any broadly protective influenza vaccine in the past.

  7. Participants of must meet one of the following criteria through the end of study participation (PBD63):

    1. Is infertile, including status (as defined by age >=45 years plus no menses for >= 1 year without an alternative medical cause) or history of hysterectomy or bilateral oophorectomy.
    2. Agrees that, when engaging in intercourse that can result in pregnancy, they will use an acceptable or highly effective form of , and their male partner will use a condom with spermicide. Acceptable methods of female contraception include

    the following:

    • Bilateral tubal ligation
    • Implant of levonorgestrel
    • Injectable progestogen
    • Oral contraceptive pills
    • Diaphragm with spermicide
    • Intrauterine device (IUD)
    • Sexual abstinence
    • Vasectomized partner
  8. Able to speak and understand English.
  9. A negative test within 6 months before enrollment.
  10. Has not used IN medications (including but not limited to nasal sprays, sinus rinses), and has not routinely used over-the-counter medications (including but not limited to aspirin, decongestants, antihistamines, and other nonsteroidal anti-inflammatory drugs), and herbal medications (including but not limited to herbal tea or St. John's Wort) within 14 days (about 2 weeks) prior to study enrollment and agrees not to use these medications until after the end of study participation (PBD63), unless approved by the investigator.
  11. Agrees not to donate blood or blood products from enrollment through the final study visit (PBD63).
  12. Not planning on cohabitating with any high-risk individuals (e.g., infants, elderly, those with high-risk conditions (e.g., pregnancy, medical conditions such as those outlined in exclusion criterion 1) for at least 2 weeks after discharge from the inpatient portion of this study.
  13. Participant is willing and able to comply with all trial procedures.

Exclusion criteria

EXCLUSION CRITERIA

Individuals meeting any of the following criteria will be excluded from study participation:

  1. Current medical conditions (self-reported or medically documented) including but not limited to:

    1. Chronic pulmonary disease (e.g., asthma, emphysema).
    2. Chronic cardiovascular disease (e.g., cardiomyopathy, congestive heart failure, cardiac surgery, ischemic heart disease, known anatomic defects).
    3. Chronic medical conditions requiring close medical follow-up or hospitalization (e.g., insulin-dependent diabetes mellitus, renal dysfunction, hemoglobinopathies).
    4. , immune deficiency, or ongoing .
    5. Neurological and neurodevelopmental condition (e.g., Bell s palsy, cerebral palsy, epilepsy, seizures).
  2. (BMI) \<18 and >35.
  3. Pregnant or breastfeeding.
  4. History of postinfectious or postvaccine neurological sequelae including GBS.
  5. History of stroke within the past 5 years.
  6. Acute illness within 7 days prior to enrollment (PAD0).
  7. Known allergy to influenza vaccination or components contained in the influenza vaccine being used.
  8. Known allergy to influenza treatments (including oseltamivir or nonsteroidal anti-inflammatory medications).
  9. Known allergy to 2 or more classes of antibiotics (e.g., penicillins, cephalosporins, fluoroquinolones, or glycopeptides).
  10. Receipt of blood or blood products (including immunoglobulins) within 3 months prior to enrollment.
  11. Receipt of any unlicensed drug or agent within 3 months or 5.5 half-life (whichever is greater) prior to enrollment.
  12. Receipt of any unlicensed vaccine within 6 months prior to enrollment.
  13. Self-reported or known history of alcoholism or drug abuse or use within 6 months prior to enrollment, or positive urine test for illicit drugs (i.e., amphetamines, cocaine metabolites, benzodiazepines, opiates, but not tetrahydrocannabinol) prior to vaccination on PAD0.
  14. Self-reported or known history of psychiatric or psychological issues that require treatment and are deemed by the PI to be a to protocol participation.
  15. History of angioedema or anaphylaxis.
  16. Study site staff who directly report to the study or site PI are excluded from participation.
  17. Any condition, event or lab value that, in the judgment of the investigator, is a contraindication to protocol participation or would place the participant at increased risk for participation.
  18. Any condition or event that, in the judgment of the investigator, impairs the participant's ability to give .

Individuals meeting any of the following criteria will be excluded from participation in Phase B:

  1. Positive urine test for illicit drugs (i.e., amphetamines, cocaine metabolites, benzodiazepines, opiates, but not tetrahydrocannabinol) prior to inoculation (PBD0).
  2. Acute illness within 7 days prior to inoculation with the human challenge virus (PBD0).
  3. Grade 3 or greater sign, symptom, or lab abnormality that is and (in the opinion of the site PI) puts the participant at higher risk of adverse effects with influenza challenge.
  4. Pregnant or breastfeeding.
  5. Positive test for influenza within 8 weeks prior to challenge.
Terms in these criteria, in plain language(11)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
129 participants (estimated)

Study arms

  • Experimental
    Group A

    BPL-1357 given intramuscularly. Placebo given intranasally.

    Biological: BPL-1357 IM · Other: Placebo IN

  • Experimental
    Group B

    BPL-1357 given intranasally. Placebo given intramuscularly.

    Biological: BPL-1357 IN · Other: Placebo IM

  • Placebo comparator
    Group C

    Placebo given intramuscularly and intranasally.

    Other: Placebo IM · Other: Placebo IN

Interventions

  • BiologicalBPL-1357 IM

    Quadrivalent, inactivated, whole-virus vaccine containing 4 different wild-type avian viruses given intramuscularly.

  • BiologicalBPL-1357 IN

    Quadrivalent, inactivated, whole-virus vaccine containing 4 different wild-type avian viruses given intranasally.

  • OtherPlacebo IM

    Placebo given intramuscularly.

  • OtherPlacebo IN

    Placebo given intranasally.

06

What researchers measure

Primary outcomes

  1. Safety (solicited AEs 7 days after vaccination, unsolicited adverse events (AEs) within 28 days post-vaccination, serious AEs (SAEs)

    Safety of the vaccine will be assessed, including standardized measurement of immediate reactogenicity by symptom survey, as well as long-term follow-up for any SAEs, including after challenge, will be performed.

    Time frame: 15-25 weeks

  2. Rate of mild-to-moderate influenza disease (MMID), defined as a positive US FDA-approved clinical test for influenza plus one or more influenza symptoms

    Rate of MMID will be compared across groups to estimate vaccine efficacy.

    Time frame: 7-17 weeks

Secondary outcomes

  1. Immunogenicity at 28 days after vaccine dose 2 (PAD56):

    Antibodies against N1, N3, N8, and N9 and H1, H3, H5, H7 head and stalk as measured by NAI, HAI and/or ELISA from blood and mucosal samples to assess immunogenicity.

    Time frame: 8 weeks

  2. Mean duration (days) of shedding as measured by rtPCR.

    Vaccine, IM or IN, may affect the duration of shedding.

    Time frame: 7-17 weeks

  3. Proportion of patients who shed virus after influenza challenge as measured by rtPCR.

    Vaccine, IM or IN, may affect the rate of infection (whether symptomatic or asymptomatic).

    Time frame: 7-17 weeks

  4. Total FLU-PRO questionnaire scores after influenza challenge.

    Vaccine, IM or IN, may affect duration and severity of symptoms as measured by FLU-PRO, a validated survey tool for measuring severity of symptoms with influenza.

    Time frame: 7-17 weeks

07

Study locations

1 of 2 sites recruiting
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
    Recruiting
    • NIH Clinical Center Office of Patient Recruitment (OPR) · Contactccopr@nih.gov · 800-411-1222
  • University of Texas Medical Branch, Galveston
    Galveston, Texas 77555, United States
    Not yet recruiting
08

References and documents

Individual participant data

Plan to share: No

09

Timeline

32 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Mar 2028, 15 months later.

Of 36 non-industry phase 2 interventional studies under Influenza, Human, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 56. This study's planned 15 months is below that.

Counting every sponsor, half of 122 studies reached it within 10 months; a quarter within 5 and three quarters within 19.

Start moved 32 times since we started tracking on Sep 25, 2026: Sep 2026 → Nov 2026, last on Nov 10, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Oct 10, 2025
First posted
Oct 14, 2025
StartEst.
Nov 15, 2026was Sep 2026
Primary completionEst.
Mar 1, 2028
CompletionEst.
Mar 1, 2028
Last update
Nov 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Sep 29, 2026→Nov 15, 2026
moved 32 times, Sep 25, 2026 – Nov 10, 2026
Contact
Study contact changed: added r•••@nih.gov · •••0803. See the current contact
Oct 19, 2026
Show all 32 updates
  1. Nov 10, 2026
    Start date Nov 12, 2026→Nov 15, 2026
  2. Nov 9, 2026
    Start date Nov 11, 2026→Nov 12, 2026
  3. Nov 6, 2026
    Start date Nov 10, 2026→Nov 11, 2026
  4. Nov 5, 2026
    Start date Nov 9, 2026→Nov 10, 2026
  5. Nov 4, 2026
    Start date Nov 8, 2026→Nov 9, 2026
  6. Nov 3, 2026
    Start date Nov 5, 2026→Nov 8, 2026
  7. Nov 2, 2026
    Start date Nov 4, 2026→Nov 5, 2026
  8. Oct 30, 2026
    Start date Nov 3, 2026→Nov 4, 2026
  9. Oct 29, 2026
    Start date Nov 2, 2026→Nov 3, 2026
  10. Oct 28, 2026
    Start date Nov 1, 2026→Nov 2, 2026
  11. Oct 27, 2026
    Start date Oct 29, 2026→Nov 1, 2026
  12. Oct 26, 2026
    Start date Oct 28, 2026→Oct 29, 2026
  13. Oct 23, 2026
    Start date Oct 27, 2026→Oct 28, 2026
  14. Oct 22, 2026
    Start date Oct 26, 2026→Oct 27, 2026
  15. Oct 21, 2026
    Start date Oct 25, 2026→Oct 26, 2026
  16. Oct 20, 2026
    Start date Oct 22, 2026→Oct 25, 2026
  17. Oct 19, 2026
    Start date Oct 21, 2026→Oct 22, 2026
    Contact Study contact changed: added r•••@nih.gov · •••0803. See the current contact
    + 1 other change: verification date
  18. Oct 16, 2026
    Start date Oct 20, 2026→Oct 21, 2026
  19. Oct 15, 2026
    Start date Oct 19, 2026→Oct 20, 2026
  20. Oct 14, 2026
    Start date Oct 18, 2026→Oct 19, 2026
  21. Oct 13, 2026
    Start date Oct 14, 2026→Oct 18, 2026
  22. Oct 9, 2026
    Start date Oct 13, 2026→Oct 14, 2026
  23. Oct 8, 2026
    Start date Oct 12, 2026→Oct 13, 2026
  24. Oct 7, 2026
    Start date Oct 11, 2026→Oct 12, 2026
  25. Oct 6, 2026
    Start date Oct 8, 2026→Oct 11, 2026
  26. Oct 5, 2026
    Start date Oct 7, 2026→Oct 8, 2026
  27. Oct 2, 2026
    Start date Oct 6, 2026→Oct 7, 2026
  28. Oct 1, 2026
    Start date Oct 5, 2026→Oct 6, 2026
  29. Sep 30, 2026
    Start date Oct 4, 2026→Oct 5, 2026
  30. Sep 29, 2026
    Start date Oct 1, 2026→Oct 4, 2026
  31. Sep 28, 2026
    Start date Sep 30, 2026→Oct 1, 2026
  32. Sep 25, 2026
    Start date Sep 29, 2026→Sep 30, 2026

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07215858
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Responsible party
Sponsor
First posted
Oct 14, 2025
Start date
Nov 15, 2026 (estimated)
Primary completion
Mar 1, 2028 (estimated)
Completion
Mar 1, 2028 (estimated)
Last update
Nov 10, 2026

Study contacts

Rani S Athota, Ph.D.
Contact
rani.athota@nih.gov
(301) 594-0803
Luca T Giurgea, M.D.
Contact
luca.giurgea@nih.gov
(301) 538-5235
Luca T Giurgea, M.D.
principal investigator · National Institute of Allergy and Infectious Diseases (NIAID)

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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