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

NCT06026514 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: CIR 355
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

SARS-CoV-2 Infection

Outcome Measures

Primary Outcomes (5)

• 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

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

• To determine the frequency of vaccine-related unsolicited AEs

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

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

• 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

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

• Vaccine virus shedding on 1 or more days

  As assessed by culture, or rRT-PCR

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

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

  Using PRNT60 or ELISA

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

Secondary Outcomes (1)

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

  On days 63, 70, 84, 180, 360

Study Arms (1)

Intranasal Vaccine

EXPERIMENTAL

B/HPIV3/S-6P vaccine intranasally given in 2 doses, 56 days apart.

Biological: B/HPIV3/S-6P

Interventions

B/HPIV3/S-6P BIOLOGICAL

Intranasal vaccine.

Intranasal Vaccine

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: collaborator
• National Institutes of Health (NIH): collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 20215, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: September 7, 2023
• Study Start: September 18, 2023
• Primary Completion: January 16, 2025
• Study Completion: June 30, 2025
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

US (1)