Actively Recruiting
Study Comparing Safety and Immunogenicity of Intranasal COVID-19 Vaccine and mRNA Booster in Healthy Adults
Led by ANRS, Emerging Infectious Diseases · Updated on 2025-12-18
238
Participants Needed
5
Research Sites
146 weeks
Total Duration
On this page
Sponsors
A
ANRS, Emerging Infectious Diseases
Lead Sponsor
U
University Hospital, Tours (Cosponsor)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This Phase I/II trial in France evaluates safety and immunogenicity of a booster dose of an intranasal COVID-19 vaccine (LVT-001) versus a booster dose of a COVID-19 mRNA vaccine (Pfizer-BioNTech) in healthy adult volunteers. As a first-in-human trial, Phase I will assess the safety and immunogenicity of three escalating doses of the LVT-001 vaccine across 3 cohorts of 12 volunteers per dose level. Based on cumulative data collected up to Day 28 visit from the last included participant in the Phase I, the go/no-go decision for Phase II and selection of the optimal dose will be performed. Phase II will then evaluate the immunogenicity of the selected intranasal dose of LVT-001 vaccine, compared to the standard of care of intramuscular COVID-19 mRNA Pfizer-BioNTech booster.
CONDITIONS
Official Title
Study Comparing Safety and Immunogenicity of Intranasal COVID-19 Vaccine and mRNA Booster in Healthy Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent.
- Be male or female aged 18 to 55 years for Phase I.
- Be male or female aged 18 to 60 years for Phase II.
- Be in good general health based on medical history, vital signs, and physical exam.
- Have a BMI between 18.5 and 30 kg/m².
- Have received at least 3 doses of COVID-19 mRNA vaccine with last booster at least 6 months ago, or 2 doses plus confirmed COVID-19 infection at least 6 months ago.
- Be willing and able to meet all trial requirements.
- If female of childbearing potential, plan to not be pregnant and use highly effective contraception from screening until trial end.
- Agree to avoid donating blood or bodily fluids from vaccination until 1 year after vaccination (only for LVT-001 vaccine).
- Agree to remain in the trial's geographical area for its duration.
- Agree to follow COVID-19 preventive measures (hand washing, mask wearing) between Day 0 and Day 28.
- Agree to be registered in the Ministry of Health computerized file (VRB).
- Be affiliated with the French social security system.
You will not qualify if you...
- Have a temperature of 38.0°C or higher or symptoms of acute illness within 3 days before vaccination.
- Have any contraindication to the trial vaccines.
- Have chronic rhinitis, nasal septal defect, cleft palate, nasal polyps, or other nasal abnormalities affecting mucosa.
- Have a piercing or obstruction in the nostrils that could block vaccine administration.
- Have had previous nasal surgery or nasal cauterization.
- Have a history of frequent nosebleeds.
- Have had a documented COVID-19 infection within the past 6 months.
- Test positive for COVID-19 at screening.
- Have medical problems related to alcohol use.
- Have used illicit drugs in the past 12 months.
- Participated in another clinical trial within 60 days prior to enrollment or plan to participate during this trial.
- Received influenza vaccine within 14 days or any other licensed vaccine within 4 weeks prior to vaccination.
- Received a COVID-19 vaccine other than mRNA vaccine.
- Have known allergies to vaccine ingredients or plastic.
- Test positive for hepatitis B, hepatitis C, or HIV.
- Have a history of severe allergic reactions to vaccines.
- Are pregnant or breastfeeding.
- Received immunoglobulin or blood products within 3 months prior or planned before trial completion.
- Received immunosuppressive or cytotoxic therapy or cancer treatment within 36 months.
- Used corticosteroids over 10 mg prednisone equivalent/day or inhaled corticosteroids within 3 months before inclusion.
- Have abnormal clinically significant lab results at screening.
- Have severe psychiatric disorders affecting trial participation.
- Have any serious chronic illness needing immediate specialist monitoring.
- Any other condition that could compromise safety or compliance.
- For Phase II only: Participants from Phase I cannot participate.
- Are under legal protection such as guardianship or tutorship.
AI-Screening
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Trial Site Locations
Total: 5 locations
1
CHU Dijon Bourgogne - Centre d'Investigation Clinique 1432
Dijon, France, 21079
Not Yet Recruiting
2
HCL - Hôpital de la Croix-Rousse - Service des Maladies Infectieuses et Tropicales
Lyon, France, 69004
Not Yet Recruiting
3
APHP - Hôpital Cochin - Centre d'Investigation Clinique de Vaccinologie Cochin-Pasteur 1417
Paris, France, 75679
Not Yet Recruiting
4
CHU de Saint-Etienne - Service des Maladies Infectieuses
Saint-Priest-en-Jarez, France, 42270
Not Yet Recruiting
5
CHRU de Tours - Centre d'Investigation Clinique 1415
Tours, France, 37044
Actively Recruiting
Research Team
A
Alizée PERROT
CONTACT
Y
Yoann DESVIGNES
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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