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SARS-CoV-2 InfectionPhase 1NCT06026514

Phase I Safety Study of B/HPIV3/S-6P Vaccine Via Nasal Spray in Adults

A Phase 1 study testing B/HPIV3/S-6P in people with SARS-CoV-2 Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This Phase 1 clinical trial will evaluate the safety and immunogenicity of an intranasal vaccine candidate, a recombinant, live-attenuated, bovine/human parainfluenza virus vector vaccine expressing the 6-P prefusion-stabilized version of the SARS-CoV-2 spike protein. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
SARS-CoV-2 Infection
What is being tested?
B/HPIV3/S-6P
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteUnited States
Study dates
18 Sep 2023to 30 Jun 2025
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 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Nonpregnant adults between 18 years and 50 years of age, inclusive.
  • General good health, without significant medical illness, physical examination findings, or significant laboratory abnormalities as determined by the investigator.
  • Demonstrates comprehension of the protocol procedures and knowledge of the trial by passing a written comprehension examination (passing grade > 70%).
  • Available for the duration of the trial.
  • Willingness to participate in the study and cooperate with the study procedures as evidenced by signing the informed consent document.
  • Persons of childbearing potential must have used effective birth control methods for at least one month prior to vaccination, and agree to continue with 'per label/fully effective use' for the chosen method for the duration of the study (30 days prior to first vaccination until 12 months after first vaccination), from amongst these:
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  • pharmacologic/hormonal contraceptives, including oral, parenteral, subcutaneous, and transcutaneous delivery;
  • condoms or diaphragm with spermicide;
  • intrauterine device;
  • absolute abstinence from heterosexual intercourse as a matter of normal preferred lifestyle;
  • or must be surgically sterile or have documented menopause, having had no menses at all for at least one full year.
  • All persons of childbearing potential must provide samples for urine and serum pregnancy testing prior to enrollment and prior to vaccination. Pregnancy risk assessment and pregnancy prevention counseling will occur at each point of contact.
  • Willingness to refrain from blood donation during participation in the study and for at least 1 year after receiving the second dose of vaccine.
  • Willingness to refrain from receiving vaccines or other investigational products during the first 90 days of the study after enrollment.

Who cannot join

  • Pregnancy as determined by a positive human choriogonadotropin (ßHCG) test in a person of reproductive capacity.
  • Currently breastfeeding.
  • Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, electrocardiogram (EKG), and/or laboratory studies.
  • Behavioral or cognitive impairment or psychiatric disease that in the opinion of the investigator affects the ability of the subject to understand and cooperate with the study protocol.
  • A history of asthma within the past 5 years, or a current diagnosis of asthma or reactive airway disease associated with exercise, seasonal hay fever or allergic rhinitis.
  • Presence of any febrile illness or symptoms suggestive of a respiratory infection within 2 weeks prior to inoculation.
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  • Use of systemic or nasal steroid preparations or immunosuppressive drugs within 30 days prior to vaccination. Topical steroid preparations are permitted.
  • Inhaled bronchodilator or inhaled steroid use within the last year or use after upper respiratory tract infections within the last 5 years.
  • Current or past (in the last 4 weeks) use of intranasal medications (including steroids, decongestants, or hormonal medications), or planning to use them within 28 days of study vaccination.
  • Evidence of current alcohol or illicit drug abuse or addiction.
  • Other condition that in the opinion of the investigator would jeopardize the safety or rights of a subject participating in the trial or would render the subject unable to comply with the protocol.
  • Positive ELISA and confirmatory tests for human immunodeficiency virus (HIV).
  • Positive ELISA and confirmatory test (e.g., recombinant immunoblot assay) for hepatitis C virus (HCV).
  • Positive hepatitis B virus surface antigen (HBsAg) by ELISA.
  • Known immunodeficiency syndrome.
  • Receipt of a live vaccine within 4 weeks or a killed vaccine within 2 weeks prior to receipt of the study vaccine or planned receipt within 90 days after vaccination. (Exception, influenza vaccine may be obtained more than 2 weeks after or prior to the study vaccine).
  • History of a surgical splenectomy.
  • Receipt of blood or blood-derived products (including immunoglobulin [Ig]) within 6 months prior to study inoculation.
  • Has participated in another investigational study involving any investigational product within 30 days, or 5 half-lives, whichever is longer, before the first vaccine administration.
  • Body mass index (BMI) < 18.5 or >40.
  • Any significant abnormality of the nose or nasopharynx, including recurrent epistaxis and including nasal or sinus surgery.
  • History of Bell's palsy.
  • Has a confirmed SARS-CoV-2 infection or COVID-19 vaccine/booster within 16 weeks prior to enrollment.
  • Unwillingness to have nasopharyngeal (NP) or blood samples saved for future respiratory virus research.
  • Pulmonary function test (PFT) testing for FVC, FEV1, FEV1% and PEF of <80 or incentive spirometer value < normal parameters based on gender, age, and height.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Johns Hopkins Bloomberg School of Public Health

    Baltimore, Maryland, 20215

Other trials in United States

About this study

Official title: A Phase I Study of the Safety and Immunogenicity of the Recombinant, Live-Attenuated, Bovine/Human Parainfluenza Virus Vector Vaccine Expressing the 6P-Prefusion-Stabilized Version of the SARS-CoV-2 Spike Protein, Administered in Two Sequential Doses as Nasal Spray to Adults 18 to 50 Years of Age

This Phase 1 clinical trial will evaluate the safety and immunogenicity of an intranasal vaccine candidate, a recombinant, live-attenuated, bovine/human parainfluenza virus vector vaccine expressing the 6-P prefusion-stabilized version of the SARS-CoV-2 spike protein.

Read the detailed description

The proposed study is a single center, open label study to be conducted at the Johns Hopkins Bloomberg School of Public Health, Center for Immunization Research (CIR) in Baltimore, MD. Participants will be followed for 12 months after the first immunization, so the duration of study participation will be 12 months after receipt of initial vaccination.

Approximately 30 subjects will be enrolled in a rolling fashion to receive 2 doses of the B/HPIV3/S-6P vaccine intranasally 56 days apart. Participants who are enrolled and receive the first vaccine dose will not be replaced, even in the event they are ineligible or unable to take the second dose.

Up to 60 subjects will be consented to ensure that 30 subjects are eligible for enrollment and vaccination. Volunteers will be enrolled in a staggered fashion:

Group 1: Up to 5 volunteers will be enrolled and vaccinated. Group 2: Up to 10 volunteers will be enrolled and vaccinated. Group 3: The remaining volunteers (up to 15) will be enrolled and vaccinated.

Being tested
B/HPIV3/S-6P
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • B/HPIV3/S-6PBiological

    Intranasal vaccine.

Study groups in NCT06026514
Study groupRoleWhat they receive
Intranasal VaccineExperimentalB/HPIV3/S-6P vaccine intranasally given in 2 doses, 56 days apart.
Receives: Biological: B/HPIV3/S-6P

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To determine the frequency of vaccine-related solicited adverse events (AEs)

    Summary and line listing of individual clinical solicited of the frequency of solicited AEs

    Measured: During study days 0 to 28 and 56 to 84 (28 days after each dose)

  2. To determine the frequency of vaccine-related unsolicited AEs

    Summary and line listing of individual clinical solicited of the frequency of unsolicited AEs

    Measured: During study days 0 to 28 and 56 to 84 (28 days after each dose)

  3. To determine the frequency of vaccine-related lower respiratory illness

    Summary and line listing of individual clinical solicited of the frequency of vaccine-related lower respiratory illness

    Measured: During study days 0 to 28 and 56 to 84 (28 days after each dose)

  4. Vaccine virus shedding on 1 or more days

    As assessed by culture, or rRT-PCR

    Measured: On Days 4, 7, and 10, and 60, 63, and 66

  5. Evidence of a >4-fold rise in HPIV3 antibody titers

    Using PRNT60 or ELISA

    Measured: When comparing pre-vaccination titers day 29, 56 or 90

Secondary outcomes (1)

  1. Rise in serum neutralizing antibody titer to SARS-CoV-2 S protein

    Will be measured by ELISA and neutralization assay

    Measured: On days 63, 70, 84, 180, 360

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2023
  2. Study start18 Sep 2023
  3. Primary completion16 Jan 2025
  4. Study completion30 Jun 2025

Resources

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
Not applicable
Intervention model
Sequential
Model description
Recombinant, Live-Attenuated, Bovine/Human Parainfluenza Virus Vector Vaccine Expressing the 6P-Prefusion-Stabilized Version of the SARS-CoV-2 Spike Protein, Administered in two Sequential Doses as Nasal Spray to Adults 18 to 50 Years of Age
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06026514
Sponsor's protocol ID
CIR 355
Status last verified
Jan 2026
First submitted
30 Aug 2023
Last updated
20 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing B/HPIV3/S-6P in people with SARS-CoV-2 Infection, 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 14 inclusion and 25 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 20 Jan 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?

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?

To determine the frequency of vaccine-related solicited adverse events (AEs) (time frame: During study days 0 to 28 and 56 to 84 (28 days after each dose)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06026514.

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 20 Jan 2026.

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