Healthy VolunteersPhase 1NasoShieldNCT03352466
NasoShield Study of Safety and Immunogenicity
A Phase 1 study testing NasoShield and BioThrax in people with Healthy Volunteers, run by Altimmune, Inc. at 2 sites in United States.
Trial summary
This study is a Phase 1, randomized, double-blind, placebo-controlled, dose-escalation clinical trial to evaluate the safety and immunogenicity of NasoShield in healthy adults 18 to 49 years of age. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- NasoShield and BioThrax
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 145 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Jan 2018to 13 May 2019
- 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 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women 18 to 49 years of age, inclusive
- Good general health status as determined by the Investigator
- Adequate venous access for repeated phlebotomies
- Screening laboratory results within institutional normal range or Grade 1 abnormality if the Investigator documents clinical insignificance. Creatine kinase or bilirubin may be Grade 2 if associated with normal alanine aminotransferase (ALT) and aspartate aminotransferase (AST) and the Investigator considers the result not to be clinically significant due to vigorous exercise or Gilbert's syndrome
- Negative drug and alcohol screen at Screening and predose on Day 1
- For women who have not been surgically sterilized and do not have laboratory confirmation of postmenopausal status, negative pregnancy test
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- Willingness to practice a highly effective method of contraception: abstinence, sex only with persons of the same sex, monogamous relationship with a postmenopausal partner, monogamous relationship with vasectomized partner, vasectomy, surgical sterilization (hysterectomy, bilateral tubal ligation, salpingectomy, or oophorectomy), licensed hormonal methods, intrauterine device (IUD), or consistent use of a barrier method (eg, condom, diaphragm) with spermicide for 28 days after the last IP dose
- Willingness to participate and comply with all aspects of the study through the entire study period, including nasopharyngeal swabs and blood and urine samples
- Provision of written informed consent
Who cannot join
- Pregnant, possibly pregnant, or lactating women
- Household contacts of pregnant women, children < 5 years of age, or immunocompromised individuals for the period up through 2 weeks postvaccination
- Persons who care for pregnant women, children < 5 years of age, or immunocompromised individuals for the period up through 2 weeks postvaccination
- Body mass index > 35.0 kg/m2
- Positive result for HIV, hepatitis B virus, or hepatitis C virus at Screening
- Asthma or other chronic lung disease that is greater than mild in severity. Specifically excluded are participants with any of the following events in the past year:
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- Daily symptoms
- Daily use of short acting beta 2 agonists
- Use of inhaled steroids or theophylline
- Use of pulse systemic steroids
- Emergency care or hospitalization related to asthma or other chronic lung disease
- Systemic steroids for asthma exacerbation
- History of diabetes mellitus (gestational diabetes is allowed if treatment was not required postpartum and serum glucose is currently in the normal range)
- History of coronary artery disease, arrhythmia, or congestive heart failure
- Clinically significant ECG abnormality as determined by the Investigator
- Poorly controlled hypertension (systolic blood pressure > 150 mmHg or diastolic blood pressure > 95 mmHg) at Screening or predose on Day 1
- History of anaphylaxis or angioedema
- Known allergy to any of the ingredients in the vaccine formulation
- Known allergy or sensitivity to latex
- History of chronic rhinitis, nasal septal defect, cleft palate, nasal polyps, or other nasal abnormality that might affect vaccine administration
- Previous nasal surgery or nasal cauterization
- Any symptoms of upper respiratory infection or temperature > 38°C within 3 days before Day 1
- Any symptoms within 24 hours before Day 1 of upper respiratory illness or allergy flare-up that, in the opinion of the Investigator, presents as nasal congestion or rhinorrhea that could inhibit the proper administration of the IP
- Known or suspected malignancy, excluding non-melanoma skin cancers and other early stage surgically excised malignancies that the Investigator considers to be exceedingly unlikely to recur
- Immunocompromised individuals, including those who have used corticosteroids (including intranasal steroids), alkylating drugs, antimetabolites, radiation, immune-modulating biologics, or other immunomodulating therapies within 90 days before Day 1 or those who plan use during the study period
- Use of statin medication within 30 days before Day 1 (see list in Section 6.8.1)
- Receipt of intranasal medications (including over-the-counter medications) within 30 days before Day 1
- Receipt of any IP within 30 days before Day 1
- Receipt of any vaccine within 30 days before Day 1
- Receipt of intranasal vaccine within 90 days before Day 1
- Receipt of any licensed or investigational anthrax vaccine
- Any change in medication for a chronic medical condition within 30 days before Day 1
- Past regular use or current use of intranasal illicit drugs
- Smokers, including smoking of any type (eg, cigarettes, electronic cigarettes, marijuana). Prior smokers must have quit smoking at least 30 days before Day 1.
- 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 protocol adherence, assessment of safety (including reactogenicity), or a subject's ability to give informed consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Optimal Research, LLC
Melbourne, Florida, 32934
ICON Early Phase Services, LLC
San Antonio, Texas, 78209
About this study
Official title: First-in-human, Randomized, Placebo-controlled, Double-blind, Dose-escalation Study of the Safety and Immunogenicity of NasoShield
This study is a Phase 1, randomized, double-blind, placebo-controlled, dose-escalation clinical trial to evaluate the safety and immunogenicity of NasoShield in healthy adults 18 to 49 years of age.
Read the detailed description
This study is a Phase 1, randomized, double-blind, placebo-controlled, dose-escalation clinical trial to evaluate the safety and immunogenicity of NasoShield in healthy adults 18 to 49 years of age. Subjects will be screened within 28 days of randomization (Day 1). The study is comprised of 2 parts:
- Part A: Approximately 120 subjects who meet all inclusion and no exclusion criteria and provide written informed consent will be enrolled into 4 sequential cohorts of 30 subjects each defined by the NasoShield dose (1×108, 1×109, 1×1010, and 1×1011 vp). Within each cohort (and the sentinel group in the first dose cohort), subjects will be randomized in a 4:1:1 ratio to receive 1 intranasal dose of NasoShield (Day 1), 1 intranasal dose of placebo (Day 1), or 3 subcutaneous 0.5 mL doses of BioThrax 14 days apart (Days 1, 15, and 29). NasoShield and placebo will be administered in a double-blind fashion, and BioThrax will be administered in an open-label fashion.
- Part B: Approximately 25 subjects who meet all inclusion and no exclusion criteria and provide written informed consent will be randomized in a 4:1 ratio to receive 2 intranasal doses of NasoShield at the highest well tolerated dose from Part A or placebo 21 days apart (Days 1 and 22). NasoShield and placebo will be administered in a double-blind fashion.
Subjects will return to the investigational site for multiple visits through Day 361. At each visit, the subject will be asked about the interim medical history and use of any medications, and safety and immunogenicity assessments will be performed.
- Conditions
- Healthy Volunteers
- Being tested
- NasoShield, BioThrax, Placebo
- Keywords
- Anthrax
- Medical subject headings
- Anthrax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NasoShieldBiological
NasoShield is an adenovirus-vectored anthrax vaccine.
BioThraxBiological
Commercially available anthrax vaccine
PlaceboOther
Normal saline
| Study group | Role | What they receive |
|---|---|---|
| NasoShield very low dose - 1 X 10^8 vp | Experimental | Single intranasal spray (Part A) Receives: Biological: NasoShield |
| NasoShield low dose - 1 X 10^9 vp | Experimental | Single intranasal spray (Part A) Receives: Biological: NasoShield |
| NasoShield medium dose - 1 X 10^10 vp | Experimental | Single intranasal spray (Part A) Receives: Biological: NasoShield |
| NasoShield high dose - Part A -1 X 10^11 vp | Experimental | Single intranasal spray (Part A) Receives: Biological: NasoShield |
| NasoShield high dose - Part B - 1 X 10^11 vp | Experimental | 2 intranasal sprays 21 days apart (Part B) Receives: Biological: NasoShield |
| Placebo | Placebo comparator | Normal saline, single intranasal spray (Part A) or two intranasal sprays 21 days apart (Part B) Receives: Other: Placebo |
| BioThrax | Active comparator | Three intramuscular injections 15 days apart (Part A) Receives: Biological: BioThrax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reactogenicity
Subjects will record solicited local and systemic events for 14 days after each dose
Measured: For 14 days after vaccination
Adverse events (AEs)
All adverse events from Day 1 to Day 57, SAEs, medically attended AEs and new onset chronic illnesses Day 1 to Day 361
Measured: From Day 1 to Day 361
Secondary outcomes (2)
Anti-PA immunoglobulin G (IgG)
Titer measured by enzyme-linked immunosorbent assay (ELISA) in serum
Measured: From Day 1 to Day 361
Toxin neutralization assay (TNA)
50% neutralization factor (NF50) titer measured by cytotoxic assay in serum
Measured: From Day 1 to Day 361
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study start18 Jan 2018
- Primary completion13 May 2019
- Study completion13 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Altimmune, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emanuel DeNoia, MD, Principal investigator, ICON plc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03352466
- Sponsor's protocol ID
- ALT201-101
- Acronym
- NasoShield
- Status last verified
- Jun 2025
- First submitted
- 21 Nov 2017
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-in-human, Randomized, Placebo-controlled, Double-blind, Dose-escalation Study of the Safety and Immunogenicity of NasoShield
- ClinicalTrials.gov ID
- NCT03352466
- Acronym / sponsor ID
- NasoShield / ALT201-101
- Conditions
- Healthy Volunteers
- Keywords
- Anthrax
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Altimmune, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Jan 2018 (actual)
- Primary completion
- 13 May 2019 (actual)
- Study completion
- 13 May 2019 (actual)
- First posted
- 24 Nov 2017 (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.
This study is a Phase 1, randomized, double-blind, placebo-controlled, dose-escalation clinical trial to evaluate the safety and immunogenicity of NasoShield in healthy adults 18 to 49 years of age.
Detailed description
This study is a Phase 1, randomized, double-blind, placebo-controlled, dose-escalation clinical trial to evaluate the safety and immunogenicity of NasoShield in healthy adults 18 to 49 years of age. Subjects will be screened within 28 days of randomization (Day 1). The study is comprised of 2 parts:
- Part A: Approximately 120 subjects who meet all inclusion and no exclusion criteria and provide written informed consent will be enrolled into 4 sequential cohorts of 30 subjects each defined by the NasoShield dose (1×108, 1×109, 1×1010, and 1×1011 vp). Within each cohort (and the sentinel group in the first dose cohort), subjects will be randomized in a 4:1:1 ratio to receive 1 intranasal dose of NasoShield (Day 1), 1 intranasal dose of placebo (Day 1), or 3 subcutaneous 0.5 mL doses of BioThrax 14 days apart (Days 1, 15, and 29). NasoShield and placebo will be administered in a double-blind fashion, and BioThrax will be administered in an open-label fashion.
- Part B: Approximately 25 subjects who meet all inclusion and no exclusion criteria and provide written informed consent will be randomized in a 4:1 ratio to receive 2 intranasal doses of NasoShield at the highest well tolerated dose from Part A or placebo 21 days apart (Days 1 and 22). NasoShield and placebo will be administered in a double-blind fashion.
Subjects will return to the investigational site for multiple visits through Day 361. At each visit, the subject will be asked about the interim medical history and use of any medications, and safety and immunogenicity assessments will be performed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| NasoShield very low dose - 1 X 10^8 vp | Experimental | Biological: NasoShieldSingle intranasal spray (Part A) |
| NasoShield low dose - 1 X 10^9 vp | Experimental | Biological: NasoShieldSingle intranasal spray (Part A) |
| NasoShield medium dose - 1 X 10^10 vp | Experimental | Biological: NasoShieldSingle intranasal spray (Part A) |
| NasoShield high dose - Part A -1 X 10^11 vp | Experimental | Biological: NasoShieldSingle intranasal spray (Part A) |
| NasoShield high dose - Part B - 1 X 10^11 vp | Experimental | Biological: NasoShield2 intranasal sprays 21 days apart (Part B) |
| Placebo | Placebo comparator | Other: PlaceboNormal saline, single intranasal spray (Part A) or two intranasal sprays 21 days apart (Part B) |
| BioThrax | Active comparator | Biological: BioThraxThree intramuscular injections 15 days apart (Part A) |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Men and women 18 to 49 years of age, inclusive
- Good general health status as determined by the Investigator
- Adequate venous access for repeated phlebotomies
- Screening laboratory results within institutional normal range or Grade 1 abnormality if the Investigator documents clinical insignificance. Creatine kinase or bilirubin may be Grade 2 if associated with normal alanine aminotransferase (ALT) and aspartate aminotransferase (AST) and the Investigator considers the result not to be clinically significant due to vigorous exercise or Gilbert's syndrome
- Negative drug and alcohol screen at Screening and predose on Day 1
Key exclusion criteria (35 listed)
- Pregnant, possibly pregnant, or lactating women
- Household contacts of pregnant women, children < 5 years of age, or immunocompromised individuals for the period up through 2 weeks postvaccination
- Persons who care for pregnant women, children < 5 years of age, or immunocompromised individuals for the period up through 2 weeks postvaccination
- Body mass index > 35.0 kg/m2
- Positive result for HIV, hepatitis B virus, or hepatitis C virus at Screening
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 |
|---|---|---|
| NasoShieldNasoShield is an adenovirus-vectored anthrax vaccine. | Biological | NasoShield high dose - Part A -1 X 10^11 vp, NasoShield high dose - Part B - 1 X 10^11 vp, NasoShield low dose - 1 X 10^9 vp, NasoShield medium dose - 1 X 10^10 vp, NasoShield very low dose - 1 X 10^8 vp |
| BioThraxCommercially available anthrax vaccine | Biological | BioThrax |
| PlaceboNormal saline | Other | Placebo |
Primary outcome
Reactogenicity
Time frame: For 14 days after vaccination
Subjects will record solicited local and systemic events for 14 days after each dose
Adverse events (AEs)
Time frame: From Day 1 to Day 361
All adverse events from Day 1 to Day 57, SAEs, medically attended AEs and new onset chronic illnesses Day 1 to Day 361
2 secondary outcomes
Anti-PA immunoglobulin G (IgG)
Time frame: From Day 1 to Day 361
Toxin neutralization assay (TNA)
Time frame: From Day 1 to Day 361
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 24 Jun 2025.
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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.
Emanuel DeNoia, MD principal investigator
ICON plc
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NasoShield and BioThrax in people with Healthy Volunteers, run by Altimmune, Inc. at 2 sites 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 9 inclusion and 35 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 24 Jun 2025. 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. 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. Some participants in this study may receive a placebo. 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?
Reactogenicity (time frame: For 14 days after vaccination). 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?
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 24 Jun 2025.