Healthy VolunteersPhase 1NCT04415749
NasoShield in Healthy Adults to Study Safety and Immunogenicity
A Phase 1 study testing NasoShield in people with Healthy Volunteers, run by Altimmune, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety for up to two doses of NasoShield, to determine if antibodies that protect against anthrax are formed after treatment with NasoShield, and to determine whether the formation of these antibodies are affected by different positions of administration. 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
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2020to 15 Mar 2021
- 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
- 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 or who do not have laboratory confirmation of postmenopausal status, negative pregnancy test
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- Willingness to practice a highly effective method of contraception that may include, but is not limited to, 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
- 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:
- Daily symptoms
- Daily use of short acting beta 2 agonists
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- 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
- 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
- History of autoimmune or demyelinating disease
- Use of statin medication within 30 days before Day 1 (see list in Section 6.7.1)
- 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 in civilian or military life
- 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
- 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
1 site in 1 country.
About this study
Official title: A Double-blind, Randomized, Placebo-controlled, Study of the Safety and Immunogenicity of NasoShield Administered as One or Two Doses in Different Dosing Positions
The purpose of this study is to evaluate the safety for up to two doses of NasoShield, to determine if antibodies that protect against anthrax are formed after treatment with NasoShield, and to determine whether the formation of these antibodies are affected by different positions of administration.
Read the detailed description
After being informed about the study and potential risks, all healthy volunteers that have given written informed consent will undergo screening to determine eligibility for study entry. If the healthy volunteer qualifies for the study, they will be randomly assigned to 1 of 3 treatment groups. Within the treatment group, the participant will be randomized in a double-blind manner in a 5:2 ratio to NasoShield or placebo.
The investigational drug (either NasoShield or placebo) will be administered on Days 1 and 29 after qualifying into the study. The position of administration and the amount of time the subject will need to stay in the specified position will depend on the group to which the subject is assigned.
Participants will return to the investigational site for multiple visits through Day 210 (approximately 6 months after the second dose). At each visit, the participant will be asked about interim medical history and use of any medications, and safety and immunogenicity assessments will be performed.
- Conditions
- Healthy Volunteers
- Being tested
- NasoShield, 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
PlaceboOther
Normal saline
| Study group | Role | What they receive |
|---|---|---|
| NasoShield One Dose in Position 1 | Experimental | NasoShield (1 x 10^11 vp) on Day 1 and saline placebo on Day 29 in position 1 (Group 1) in normal sitting position (no dose holding time) Receives: Biological: NasoShield; Other: Placebo |
| Placebo in Position 1 | Placebo comparator | Saline placebo on Day 1 and saline placebo on Day 29 in position 1 (Group 1) Receives: Other: Placebo |
| NasoShield Two Doses in Position 2 | Experimental | NasoShield (1 x 10^11 vp) on Day 1 and Day 29 in position 2 (Group 2) in sitting position with nostrils elevated above head for 3 minutes followed by sitting for 27 minutes Receives: Biological: NasoShield |
| Placebo in Position 2 | Placebo comparator | Saline placebo on Day 1 and Day 29 in position 2 (Group 2) Receives: Other: Placebo |
| NasoShield Two Doses in Position 3 | Experimental | NasoShield (1 x 10^11 vp) on Day 1 and Day 29 in position 3 (Group 3) in supine position for 30 minutes Receives: Biological: NasoShield |
| Placebo in Position 3 | Placebo comparator | Saline placebo on Day 1 and Day 29 in position 3 (Group 3) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reactogenicity to evaluate the safety of NasoShield
Subjects will record solicited local and systemic events for 7 days after each dose
Measured: For 7 days after vaccination
Adverse Events (AEs) to evaluate the safety of NasoShield
All adverse events from Day 1 to Day 57; serious adverse events (SAE), medically attended adverse events (MAAE), and new-onset chronic illnesses (NCI) from Day 1 to Day 210
Measured: From Day 1 to Day 210
Secondary outcomes (3)
Anti-protective antigen (PA) immunoglobulin G (IgG) to evaluate humoral immunogenicity
Titer measured by enzyme-linked immunosorbent assay (ELISA) in serum
Measured: From Day 1 to Day 210
Toxin neutralization antibody 50% neutralization factor (TNA-NF50) titer measured in serum by cytotoxic assay to evaluate humoral immunogenicity
Measured: From Day 1 to Day 210
Anti-protective antigen (PA) immunoglobulin A (IgA) to evaluate mucosal immune response
Titer measured by enzyme-linked immunosorbent assay (ELISA) in serum
Measured: From Day 1 to Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start15 Jun 2020
- Primary completion15 Mar 2021
- Study completion15 Mar 2021
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
- Parallel groups
- Model description
- 3 parallel groups defined by dosing position and number of doses
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Altimmune, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04415749
- Sponsor's protocol ID
- ALT-201-102
- Other IDs
- HHSO100201600008C
- Status last verified
- Jun 2025
- First submitted
- 1 Jun 2020
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- 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 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled, Study of the Safety and Immunogenicity of NasoShield Administered as One or Two Doses in Different Dosing Positions
- ClinicalTrials.gov ID
- NCT04415749
- Acronym / sponsor ID
- ALT-201-102
- Conditions
- Healthy Volunteers
- Keywords
- Anthrax
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Altimmune, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 4 Jun 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.
The purpose of this study is to evaluate the safety for up to two doses of NasoShield, to determine if antibodies that protect against anthrax are formed after treatment with NasoShield, and to determine whether the formation of these antibodies are affected by different positions of administration.
Detailed description
After being informed about the study and potential risks, all healthy volunteers that have given written informed consent will undergo screening to determine eligibility for study entry. If the healthy volunteer qualifies for the study, they will be randomly assigned to 1 of 3 treatment groups. Within the treatment group, the participant will be randomized in a double-blind manner in a 5:2 ratio to NasoShield or placebo.
The investigational drug (either NasoShield or placebo) will be administered on Days 1 and 29 after qualifying into the study. The position of administration and the amount of time the subject will need to stay in the specified position will depend on the group to which the subject is assigned.
Participants will return to the investigational site for multiple visits through Day 210 (approximately 6 months after the second dose). At each visit, the participant will be asked about 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
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
- Model description
- 3 parallel groups defined by dosing position and number of doses
| Arm | Type | Receives |
|---|---|---|
| NasoShield One Dose in Position 1 | Experimental | Biological: NasoShield, Other: PlaceboNasoShield (1 x 10^11 vp) on Day 1 and saline placebo on Day 29 in position 1 (Group 1) in normal sitting position (no dose holding time) |
| Placebo in Position 1 | Placebo comparator | Other: PlaceboSaline placebo on Day 1 and saline placebo on Day 29 in position 1 (Group 1) |
| NasoShield Two Doses in Position 2 | Experimental | Biological: NasoShieldNasoShield (1 x 10^11 vp) on Day 1 and Day 29 in position 2 (Group 2) in sitting position with nostrils elevated above head for 3 minutes followed by sitting for 27 minutes |
| Placebo in Position 2 | Placebo comparator | Other: PlaceboSaline placebo on Day 1 and Day 29 in position 2 (Group 2) |
| NasoShield Two Doses in Position 3 | Experimental | Biological: NasoShieldNasoShield (1 x 10^11 vp) on Day 1 and Day 29 in position 3 (Group 3) in supine position for 30 minutes |
| Placebo in Position 3 | Placebo comparator | Other: PlaceboSaline placebo on Day 1 and Day 29 in position 3 (Group 3) |
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
- 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 (33 listed)
- Pregnant, possibly pregnant, or lactating women
- 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:
- History of diabetes mellitus (gestational diabetes is allowed if treatment was not required postpartum and serum glucose is currently in the normal range)
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 One Dose in Position 1, NasoShield Two Doses in Position 2, NasoShield Two Doses in Position 3 |
| PlaceboNormal saline | Other | NasoShield One Dose in Position 1, Placebo in Position 1, Placebo in Position 2, Placebo in Position 3 |
Primary outcome
Reactogenicity to evaluate the safety of NasoShield
Time frame: For 7 days after vaccination
Subjects will record solicited local and systemic events for 7 days after each dose
Adverse Events (AEs) to evaluate the safety of NasoShield
Time frame: From Day 1 to Day 210
All adverse events from Day 1 to Day 57; serious adverse events (SAE), medically attended adverse events (MAAE), and new-onset chronic illnesses (NCI) from Day 1 to Day 210
3 secondary outcomes
Anti-protective antigen (PA) immunoglobulin G (IgG) to evaluate humoral immunogenicity
Time frame: From Day 1 to Day 210
Toxin neutralization antibody 50% neutralization factor (TNA-NF50) titer measured in serum by cytotoxic assay to evaluate humoral immunogenicity
Time frame: From Day 1 to Day 210
Anti-protective antigen (PA) immunoglobulin A (IgA) to evaluate mucosal immune response
Time frame: From Day 1 to Day 57
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.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 NasoShield in people with Healthy Volunteers, run by Altimmune, Inc. 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 9 inclusion and 33 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 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. 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 to evaluate the safety of NasoShield (time frame: For 7 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.