Healthy VolunteerPhase 1NCT03878121
Safety and Immunogenicity of Ad4-HIV Envelope Vaccine Vectors in Healthy Volunteers
A Phase 1 study testing Ad4-Env145NFL, Ad4-Env150KN and VRC-HIVRGP096-00-VP (Trimer 4571) with alum in people with Healthy Volunteer, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Background: Researchers want see if three new HIV (human immunodeficiency virus) vaccines are safe. Two vaccines are carried by live adenoviruses, which are natural and typically cause cold symptoms or an eye infection. Researchers want to see if all the vaccines help fight HIV and if the adenoviruses are contagious. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Ad4-Env145NFL, Ad4-Env150KN and VRC-HIVRGP096-00-VP (Trimer 4571) with alum
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2019to 30 Nov 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All participants (vaccinees, household contacts, and intimate contacts) must meet all of the following criteria:
- Age 18 to 49 years for vaccinees. Age 18 to 65 years for household and intimate contacts.
- Negative FDA-approved HIV test.
- Available and willing to participate in follow-up visits and tests for the duration of the study.
- Willing to have samples stored for future research.
- The following inclusion criteria apply to vaccinees and intimate contacts, but not to household contacts:
Show all 37Show fewer
- In good general health without clinically significant medical history.
- Assessed as low risk for HIV infection by agreeing to discuss HIV infection risks with the study clinicians, agreeing to HIV risk reduction counseling, and agreeing to avoid behavior associated with high risk of HIV exposure through the last required clinic visit in the protocol schedule.
- Negative beta-HCG pregnancy test for females presumed to be of reproductive potential.
- Female vaccinees and male intimate contacts must meet one of the following criteria:
- -The female vaccinee has no reproductive potential because of menopause (1 year without menses) or because of a hysterectomy, bilateral oophorectomy, medically-documented ovarian failure, or tubal ligation.
- or
- -The female vaccinee and her male intimate contact(s) agree to be heterosexually inactive or consistently practice contraception at least 21 days prior to each vaccination through 21 days following each vaccination. Acceptable methods of contraception include any of
- the following:
- condoms, male or female, with a spermicide.
- diaphragm or cervical cap with spermicide.
- contraceptive pills, Norplant, or Depo-Provera (and is not on any medications that would interfere with the effectiveness of these contraceptive agents).
- male partner has previously undergone a vasectomy for which there is documentation.
- intrauterine device.
- Male vaccinees and female intimate contacts must agree to consistently practice abstinence or effective birth control (described above) and for 21 days following each vaccination.
- The following inclusion criteria apply only to vaccinees and not to household or intimate contacts:
- Willing to receive HIV test results and abide by NIH guidelines for partner notification of positive HIV results.
- Physical examination and laboratory results without clinically significant findings within the 8 weeks prior to enrollment.
- Willing to avoid other investigational and/or HIV vaccinations, other than the study agent, from screening through the end-of-study visit.
- Safety laboratory criteria within 8 weeks prior to enrollment:
- Hematologic:
- White blood cell count and lymphocyte count within 25% of both the lower limit and upper limit of normal for the NIH CC
- Platelet count of least 150,000/mm^3.
- Hemoglobin count within 10% of both the lower limit and upper limit of normal for the NIH CC
- Renal: Blood urea nitrogen (BUN) <23 mg/dL; creatinine within normal limits for the NIH CC
- Hepatic: Serum direct bilirubin within normal limits for the NIH CC
- Metabolic: Alanine aminotransferase (ALT) <2 times upper limit of normal range for the NIH CC
- Additional laboratory criteria:
- Immunologic: No history of hypogammaglobulinemia.
- Serologic: Ad4 neutralizing antibody 80% inhibitory dilution <1:100. (This criterion does not apply to participants in Arm B.)
- Willing to follow precautions for preventing the spread of adenovirus in the community.
- Males must agree not to donate sperm for 21 days following each study vaccination.
Who cannot join
- A participant (vaccinees, household contacts, and intimate contacts) will be excluded if they have the following:
- 1. Any condition that, in the investigator's judgement, places the subject at undue risk by participating in the study.
- The following exclusion criteria apply to vaccinees and intimate contacts, but not to household contacts:
- History of any prior disease or therapy which would affect immune or pulmonary function.
- Prior malignancy, except curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
- History of radiation therapy or cytotoxic/cancer chemotherapy.
Show all 38Show fewer
- History of uncontrolled diabetes mellitus (DM). Type 2 DM controlled with diet alone (and confirmed by HgbA1c <= 8% within the last 6 months) or a history of isolated gestational diabetes are not exclusionary. Enrollment of individuals with Type 2 DM that is well controlled on hypoglycemic agent(s) may be considered on a case-by-case basis, provided that the HgbA1c is <= 8% within the last 6 months
- Immunodeficiency or autoimmune disease.
- Acute infection or a recent history (within 6 months) of chronic infection suggestive of immunodeficiency.
- Taking any glucocorticoids or other immunosuppressive medications.
- Asthma is excluded if the participant has ANY of the following:
- Required either oral or parenteral corticosteroids for an exacerbation 2 or more times within the past year, OR
- Needed emergency care, urgent care, hospitalization, or intubation for an acute asthma exacerbation within the past year (eg, would NOT exclude individuals with asthma who meet all other criteria but sought urgent/emergent care solely for asthma medication refills or co-existing conditions unrelated to asthma); OR
- Uses a short-acting rescue inhaler more than 2 days/week for acute asthma symptoms (i.e., not for preventive treatment prior to athletic activity); OR
- Uses medium-to-high-dose inhaled corticosteroids (greater than 250 mcg fluticasone or therapeutic equivalent per day), whether in single-therapy or dual-therapy inhalers (i.e., with a long-acting beta agonist), OR
- Uses more than 1 medication for maintenance therapy daily. Inclusion of anyone on a stable dose of more than 1 medication for maintenance therapy daily for greater than 2 years requires OCRPRO Clinical Safety Office approval.
- Other chronic respiratory disorders including emphysema, interstitial lung disease, pulmonary hypertension, recurrent pneumonia, or recent or ongoing respiratory tract infection. If a respiratory disorder is transient, the study vaccination may be deferred without excluding the participant.
- Female of childbearing potential who is breast-feeding or planning pregnancy during the period from enrollment through 21 days following the last study vaccination.
- The following exclusion criteria apply only to vaccinees and not to household or intimate contacts:
- Any medical, psychiatric, or social condition, or occupational or other responsibility that, in the judgment of the investigator, would interfere with or serve as a contraindication to receipt of live virus vaccine, protocol adherence, or a participant's ability to give informed consent.
- Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder requiring therapy that has not been well controlled on medication for the past two years; disorder requiring lithium; or suicidal ideation occurring within five years prior to enrollment.
- Individuals that live in the same house or apartment with any of the following will be excluded:
- An individual under 18 years of age.
- An elderly individual (>65 years of age).
- An immunocompromised or immunosuppressed individual.
- An individual with chronic respiratory disease.
- A woman who is currently pregnant or breastfeeding or planning a pregnancy during the period of vaccination.
- Individuals who provide hands-on care to immunodeficient, unstable, elderly, or children <18 years of age within 21 days following each of the first and second vaccination timepoints.
- Receipt of any of the following:
- Antiviral medications within 30 days prior to vaccination.
- Blood products within 120 days prior to HIV screening.
- Immunoglobulin within 60 days prior to HIV screening.
- Investigational research drugs or any other investigational agent that in the judgement of the Principal Investigator might interact with the study vaccine within 30 days prior to initial study vaccine administration.
- Allergy treatment with antigen injections within 30 days of study vaccine administration.
- Active hepatitis B or C infection (i.e., hepatitis B or C positive serology with the presence of virus antigen or DNA). Ongoing viral replication will be confirmed by a hepatitis B antigen test or hepatitis C viral load.
- History of Guillain-Barre syndrome.
- Indeterminate HIV Western blot test.
- Prior receipt of the Merck Ad5-based HIV vaccine.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
VRC Clinic, 301-451-8715, vaccines@nih.gov
About this study
Official title: Phase I Open-Label Study of Safety and Immunogenicity of AD4-HIV Envelope Vaccine Vectors in Healthy Volunteers
Background:
Researchers want see if three new HIV (human immunodeficiency virus) vaccines are safe. Two vaccines are carried by live adenoviruses, which are natural and typically cause cold symptoms or an eye infection. Researchers want to see if all the vaccines help fight HIV and if the adenoviruses are contagious.
Read more
Objectives:
To test the safety and effects of three new HIV vaccines.
Eligibility:
Healthy adults 18-49 years old (vaccinees)
Their household and intimate contacts 18-65 years old
Design:
Vaccinees will be screened with:
Physical exam
Medical history
Blood and urine tests
Questions about HIV risk
Vaccinees will learn how to prevent spreading the viruses and about required contraception during the study.
Vaccinees will get consent forms for their household and intimate contacts. All contacts must be age 18-65. All intimate contacts must sign a consent form. Contacts will have 4 visits over 8 months for blood tests and a physical exam.
All applicable participants will have a pregnancy test at every visit.
Vaccinees will have about 9 visits over 12 months. They will repeat screening tests and get:
1 of the 2 adenovirus vaccines sprayed in the nose at 2 visits
The booster vaccine by needle in an arm at 1 visit
Nasal swabs taken at some visits
Vaccinees will note their temperature and symptoms for at least 1-4 weeks after each vaccine.
Vaccinees may choose to have:
Leukapheresis. Blood will be removed by needle in a vein in one arm. A machine will remove white blood cells. The rest of the blood will be returned into the other arm.
Small pieces of the tonsil removed
Sponsoring Institute: National Institute of Allergy and Infectious Diseases
...
Read the detailed description
This is a Phase 1 study to evaluate the immunogenicity and safety of adenovirus serotype 4 (Ad4)-based HIV vaccines when administered via the intranasal route to healthy human volunteers. It is hypothesized that the vaccines will be safe for human administration and will elicit immune responses to the HIV components. All study activities will be carried out at the NIH.
Each study vaccinee will receive 5x10^8 viral particles of either Ad4-Env150KN or Ad4-Env145NFL, administered as an intranasal spray at months 0 and 2. An intramuscular protein booster vaccination with the heterologous soluble trimeric protein VRC-HIVRGP096-00-VP (Trimer 4571) with alum will be administered to all vaccinees at month 6. Specimens to evaluate immunogenicity will be taken at baseline and at specified time points through month 12. The HIV-specific immune responses will be assessed by cellular immune function assays (intracellular cytokine analysis, flow cytometry-based killing assays), as well as measures of humoral immunity such as neutralization assays.
The overall goal will be to compare the safety and immunogenicity of the Ad-HIV vaccine regimens. Participants who have previously received another HIV vaccine and/or are Ad4 seropositive will be enrolled into an exploratory arm to be analyzed separately.
Household and intimate contacts willing to participate will also be enrolled and monitored for transmission of the vaccine virus by serology. Intimate contacts (current and/or those expected within the first 3 weeks after vaccination) will be required to enroll if the partner and participant choose not to abstain from mouth-to-mouth kissing, sexual intercourse, or oral sex within the first 21 days following each Ad4-Env vaccination.
- Conditions
- Healthy Volunteer
- Being tested
- Ad4-Env145NFL, Ad4-Env150KN, VRC-HIVRGP096-00-VP (Trimer 4571) with alum
- Keywords
- Ad4-Env150KN, Ad4-Env145NFL, VRC-HIVRGP096-00-VP (Trimer 4571) with alum, Adenovirus, HIV Vaccine
- Medical subject headings
- Adenoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ad4-Env145NFLBiological
10^8 vp doses of Ad4-Env145NFL formulated as a liquid for intranasal administration.
Ad4-Env150KNBiological
10^8 vp doses of Ad4-Env150KN formulated as a liquid for intranasal administration.
VRC-HIVRGP096-00-VP (Trimer 4571) with alumBiological
500-mcg dose of protein boost vaccine formulated for intramuscular administration.
| Study group | Role | What they receive |
|---|---|---|
| A1 | Experimental | Ad4-Env150KN at Day 0 and 2 months followed VRC-HIVRGP096-00-VP at 6 months. Receives: Biological: Ad4-Env150KN; Biological: VRC-HIVRGP096-00-VP (Trimer 4571) with alum |
| A2 | Experimental | Ad4-Env145NFL at Day 0 and 2 months followed VRC-HIVRGP096-00-VP at 6 months. Receives: Biological: Ad4-Env145NFL; Biological: VRC-HIVRGP096-00-VP (Trimer 4571) with alum |
| B1 (exploratory) | Experimental | Previously vaccinated; Ad4-Env150KN at Day 0 and 2 months followed VRC-HIVRGP096-00-VP at 6 months. Receives: Biological: Ad4-Env150KN; Biological: VRC-HIVRGP096-00-VP (Trimer 4571) with alum |
| B2 (exploratory) | Experimental | Previously vaccinated; Ad4-Env145NFL at Day 0 and 2 months followed VRC-HIVRGP096-00-VP at 6 months. Receives: Biological: Ad4-Env145NFL; Biological: VRC-HIVRGP096-00-VP (Trimer 4571) with alum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and immunogenicity
Laboratory results and Adverse Events
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start17 Apr 2019
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Mark Connors, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03878121
- Sponsor's protocol ID
- 190069
- Other IDs
- 19-I-0069
- Status last verified
- 17 Apr 2026
- First submitted
- 15 Mar 2019
- Last updated
- 21 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Open-Label Study of Safety and Immunogenicity of AD4-HIV Envelope Vaccine Vectors in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03878121
- Acronym / sponsor ID
- 190069
- Conditions
- Healthy Volunteer
- Keywords
- Ad4-Env150KN, Ad4-Env145NFL, VRC-HIVRGP096-00-VP (Trimer 4571) with alum, Adenovirus, HIV Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 17 Apr 2019 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 18 Mar 2019 (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.
Background:
Researchers want see if three new HIV (human immunodeficiency virus) vaccines are safe. Two vaccines are carried by live adenoviruses, which are natural and typically cause cold symptoms or an eye infection. Researchers want to see if all the vaccines help fight HIV and if the adenoviruses are contagious.
Objectives:
To test the safety and effects of three new HIV vaccines.
Eligibility:
Healthy adults 18-49 years old (vaccinees)
Their household and intimate contacts 18-65 years old
Design:
Vaccinees will be screened with:
Physical exam
Medical history
Blood and urine tests
Questions about HIV risk
Vaccinees will learn how to prevent spreading the viruses and about required contraception during the study.
Vaccinees will get consent forms for their household and intimate contacts. All contacts must be age 18-65. All intimate contacts must sign a consent form. Contacts will have 4 visits over 8 months for blood tests and a physical exam.
All applicable participants will have a pregnancy test at every visit.
Vaccinees will have about 9 visits over 12 months. They will repeat screening tests and get:
1 of the 2 adenovirus vaccines sprayed in the nose at 2 visits
The booster vaccine by needle in an arm at 1 visit
Nasal swabs taken at some visits
Vaccinees will note their temperature and symptoms for at least 1-4 weeks after each vaccine.
Vaccinees may choose to have:
Leukapheresis. Blood will be removed by needle in a vein in one arm. A machine will remove white blood cells. The rest of the blood will be returned into the other arm.
Small pieces of the tonsil removed
Sponsoring Institute: National Institute of Allergy and Infectious Diseases
...
Detailed description
This is a Phase 1 study to evaluate the immunogenicity and safety of adenovirus serotype 4 (Ad4)-based HIV vaccines when administered via the intranasal route to healthy human volunteers. It is hypothesized that the vaccines will be safe for human administration and will elicit immune responses to the HIV components. All study activities will be carried out at the NIH.
Each study vaccinee will receive 5x10^8 viral particles of either Ad4-Env150KN or Ad4-Env145NFL, administered as an intranasal spray at months 0 and 2. An intramuscular protein booster vaccination with the heterologous soluble trimeric protein VRC-HIVRGP096-00-VP (Trimer 4571) with alum will be administered to all vaccinees at month 6. Specimens to evaluate immunogenicity will be taken at baseline and at specified time points through month 12. The HIV-specific immune responses will be assessed by cellular immune function assays (intracellular cytokine analysis, flow cytometry-based killing assays), as well as measures of humoral immunity such as neutralization assays.
The overall goal will be to compare the safety and immunogenicity of the Ad-HIV vaccine regimens. Participants who have previously received another HIV vaccine and/or are Ad4 seropositive will be enrolled into an exploratory arm to be analyzed separately.
Household and intimate contacts willing to participate will also be enrolled and monitored for transmission of the vaccine virus by serology. Intimate contacts (current and/or those expected within the first 3 weeks after vaccination) will be required to enroll if the partner and participant choose not to abstain from mouth-to-mouth kissing, sexual intercourse, or oral sex within the first 21 days following each Ad4-Env vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A1 | Experimental | Biological: Ad4-Env150KN, Biological: VRC-HIVRGP096-00-VP (Trimer 4571) with alumAd4-Env150KN at Day 0 and 2 months followed VRC-HIVRGP096-00-VP at 6 months. |
| A2 | Experimental | Biological: Ad4-Env145NFL, Biological: VRC-HIVRGP096-00-VP (Trimer 4571) with alumAd4-Env145NFL at Day 0 and 2 months followed VRC-HIVRGP096-00-VP at 6 months. |
| B1 (exploratory) | Experimental | Biological: Ad4-Env150KN, Biological: VRC-HIVRGP096-00-VP (Trimer 4571) with alumPreviously vaccinated; Ad4-Env150KN at Day 0 and 2 months followed VRC-HIVRGP096-00-VP at 6 months. |
| B2 (exploratory) | Experimental | Biological: Ad4-Env145NFL, Biological: VRC-HIVRGP096-00-VP (Trimer 4571) with alumPreviously vaccinated; Ad4-Env145NFL at Day 0 and 2 months followed VRC-HIVRGP096-00-VP at 6 months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (37 listed)
- All participants (vaccinees, household contacts, and intimate contacts) must meet all of the following criteria:
- Age 18 to 49 years for vaccinees. Age 18 to 65 years for household and intimate contacts.
- Negative FDA-approved HIV test.
- Available and willing to participate in follow-up visits and tests for the duration of the study.
- Willing to have samples stored for future research.
Key exclusion criteria (38 listed)
- A participant (vaccinees, household contacts, and intimate contacts) will be excluded if they have the following:
- 1. Any condition that, in the investigator's judgement, places the subject at undue risk by participating in the study.
- The following exclusion criteria apply to vaccinees and intimate contacts, but not to household contacts:
- History of any prior disease or therapy which would affect immune or pulmonary function.
- Prior malignancy, except curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
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 |
|---|---|---|
| Ad4-Env145NFL10^8 vp doses of Ad4-Env145NFL formulated as a liquid for intranasal administration. | Biological | A2, B2 (exploratory) |
| Ad4-Env150KN10^8 vp doses of Ad4-Env150KN formulated as a liquid for intranasal administration. | Biological | A1, B1 (exploratory) |
| VRC-HIVRGP096-00-VP (Trimer 4571) with alum500-mcg dose of protein boost vaccine formulated for intramuscular administration. | Biological | A1, A2, B1 (exploratory), B2 (exploratory) |
Primary outcome
Safety and immunogenicity
Time frame: ongoing
Laboratory results and Adverse Events
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteer
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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.
Mark Connors, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
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 Ad4-Env145NFL, Ad4-Env150KN and VRC-HIVRGP096-00-VP (Trimer 4571) with alum in people with Healthy Volunteer, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 37 inclusion and 38 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: looking for participants now, as of the sponsor's last update on 21 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mark Connors, M.D. ((301) 496-8057, mconnors@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and immunogenicity (time frame: ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Apr 2026.