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Virus Therapy

Nasal Spray Vaccine for COVID-19

Q: Is there a way for me to become involved in this research project?

<p>To be eligible for this <a href="https://www.withpower.com/clinical-trials/covid">covid</a>-19 related trial, potential subjects must have the virus and fall between 18-50 years old. The enrolment quota for this research is 30 individuals.</p>

Phase 1

Recruiting

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Nonpregnant adults between 18 years and 50 years of age, inclusive

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up on days 63, 70, 84, 180, 360

Awards & highlights

Study Summary

This trial tests a new vaccine to see if it is safe and effective against COVID-19.

Who is the study for?

Adults aged 18-50 in good health, not pregnant or breastfeeding, who haven't had a live vaccine within 4 weeks or killed vaccine within 2 weeks before the study. They must avoid other vaccines for 90 days post-enrollment and use effective birth control. Excludes those with significant illnesses, drug abuse history, recent investigational product use, BMI <18.5 or >40, certain medication uses including steroids and immunosuppressives.Check my eligibility

What is being tested?

The trial is testing an intranasal COVID-19 vaccine called B/HPIV3/S-6P to see if it's safe and can stimulate the immune system effectively. It's given as a nasal spray using a modified virus to deliver parts of the SARS-CoV-2 spike protein into the body.See study design

What are the potential side effects?

Potential side effects are not detailed but may include typical reactions to vaccines such as nasal irritation from the spray delivery method, sneezing, headache, feverish feeling or mild respiratory symptoms due to its nature as an intranasal live attenuated vector vaccine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 50 years old and not pregnant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ on days 63, 70, 84, 180, 360

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~on days 63, 70, 84, 180, 360

This trial's timeline: 3 weeks for screening, Varies for treatment, and on days 63, 70, 84, 180, 360 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

To determine the frequency of vaccine-related lower respiratory illness

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

+2 more

Secondary outcome measures

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Intranasal VaccineExperimental Treatment1 Intervention

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

0 / 1Eligibility criteria met

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor

3,270 Previous Clinical Trials

5,485,207 Total Patients Enrolled

78 Trials studying COVID-19

292,178 Patients Enrolled for COVID-19

Johns Hopkins Bloomberg School of Public HealthOTHER

410 Previous Clinical Trials

2,106,900 Total Patients Enrolled

5 Trials studying COVID-19

3,334 Patients Enrolled for COVID-19

National Institutes of Health (NIH)NIH

2,701 Previous Clinical Trials

7,506,820 Total Patients Enrolled

34 Trials studying COVID-19

332,284 Patients Enrolled for COVID-19

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the scope of the participants involved in this research?

"Affirmative. Clinicaltrials.gov details that this medical trial, originally posted on September 1st 2023, is actively enrolling individuals into the study. 30 participants are needed from one clinical site."

Answered by AI

Is there a way for me to become involved in this research project?

"To be eligible for this covid-19 related trial, potential subjects must have the virus and fall between 18-50 years old. The enrolment quota for this research is 30 individuals."

Answered by AI

Does the age eligibility for this trial extend to individuals younger than 30?

"The eligibility requirements for this experiment necessitate that participants are aged between 18 and 50. Conversely, there exist 102 trials open to minors, along with 638 studies recruiting patients over 65 years old."

Answered by AI

Has Intranasal Vaccine received authorization from the FDA?

"The safety of the intranasal vaccine is placed at a 1 on our scale due to it being an early-stage trial, where only preliminary evidence exists for its efficacy and security."

Answered by AI

Is recruitment currently ongoing for this experiment?

"According to clinicaltrials.gov, this research is actively recruiting participants. The original post date was September 1st 2023 and the trial has been amended on August 30th 2023 since then."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Phase I Safety Study of B/HPIV3/S-6P Vaccine Via Nasal Spray in Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06026514.