Study Comparing Safety and Immunogenicity of Intranasal COVID-19 Vaccine and mRNA Booster in Healthy Adults

NCT06821126 | Recruiting Phase 1 DMC

• 2 other identifiers: DR230330 - ANRS0514s MUCOBOOST2024-510589-17-00
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 5

Brief Summary

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

Healthy

Keywords

COVID-19; Healthy; Nasal; vaccine; intranasal

Outcome Measures

Primary Outcomes (6)

• Phase I: Proportion of participants experiencing an immediate adverse event

  Within an hour and half following the vaccination at Day 0

• Phase I: Proportion of participants experiencing solicited local reactogenicity

  Vaccines are associated with a number of well-characterised reactions referred to as "solicited adverse events"

  Between Day 0 and Day 7 (Day 0 is the day of the vaccination)

• Phase I: Proportion of participants experiencing solicited systemic signs and symptoms

  Vaccines are associated with a number of well-characterised reactions referred to as "solicited adverse events"

  Between Day 0 and Day 14 (Day 0 is the day of the vaccination)

• Phase I: Proportion of participants experiencing an unsolicited adverse events

  Unsolisited adverse events (AEs) are AEs other than solicited AEs

  Between Day 0 and Day 28 (Day 0 is the day of the vaccination)

• Phase I: Proportion of participants experiencing serious adverse events (SAEs), serious adverse reactions (SARs), suspected unexpected serious adverse reactions (SUSARs) and adverse events of special interest (AESI) respectively throughout the study

  Between Day 0 to Month 12 (Day 0 is the day of the vaccination)

• Phase II: Crude variation of the mucosal humoral immune response specific to the vaccine N/S recombinant protein in each arm

  sIgA from nose swabs measured by ELISA

  Between Day 0 and Day 28 (Day 0 is the day of the vaccination)

Secondary Outcomes (13)

• Crude variation of the mucosal humoral immune response specific to the vaccine N/S recombinant protein

  Between Day 0 and Day 7 (Phase I), Day 14, D28 (Phase I), Month 3, Month 6 and Month 12 (Day 0 is the day of the vaccination)

• Neutralizing capacity of the mucosal humoral immune response specific to the vaccine N/S recombinant protein

  At Day 0, Day 7 (Phase I), Day 14, Day 28, Month 3, Month 6, Month 12 (Day 0 is the day of the vaccination)

• Crude variation of the systemic humoral immune response specific to the vaccine N/S recombinant protein

  At Day 0, Day 7 (Phase I), Day 14, Day 28, Month 3, Month 6, Month 12 (Day 0 is the day of the vaccination)

• Neutralizing capacity of the systemic humoral immune response specific to the vaccine N/S recombinant protein

  at Day 0, Day 7 (Phase I), Day 14, Day 28, Month 3, Month 6, Month 12 (Day 0 is the day of the vaccination)

• Percentage of responder against N and S antigens

  at Day 0, Day 7 (Phase I), Day 14, Day 28, Month 3, Month 6, Month 12 (Day 0 is the day of the vaccination)

Study Arms (2)

LVT-001

EXPERIMENTAL

One booster dose of the intranasal vaccine LVT-001 administered as a nasal spray in each nostril at Day 0. Phase I - 3 cohortes with dose escalation (low, middle and high doses) Phase II - 1 arm at the selected dose

Biological: LVT-001

Comirnaty

ACTIVE COMPARATOR

One booster dose of the intramuscular COVID-19 mRNA vaccine (Pfizer-BioNTech - recommended at the beginning of the Phase II in France) at Day 0.

Biological: Cormirnaty

Interventions

LVT-001 BIOLOGICAL

Intranasal administration

LVT-001

Cormirnaty BIOLOGICAL

Intramuscular administration

Comirnaty

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Written informed consent obtained from the participant.
• Be male or female between the ages of:
• ≥ 18 and ≤ 55 years for phase I
• ≥ 18 and ≤ 60 years for phase II.
• Good general health as determined at the discretion of the investigator (vital signs, medical history, and physical examination).
• BMI: 18,5 kg/m² ≤ BMI ˂30 kg/m².
• Has expressed interest and availability to meet the trial requirements.
• For a woman of childbearing potential, plan to be non-pregnant AND use of highly effective contraception from screening until the end of the trial.
• Agree to abstain from donating blood/plasma or any other bodily fluids from the time of vaccination until 1 year after vaccination (only for LVT-001 vaccine).
• Agree to stay in the geographical area of one of the clinical sites for the duration of the trial.
• Agree to implement barrier measures as much as possible (washing hands and wearing a mask) against COVID-19 and respiratory infections between D0 and D28.
• Agree to be registered in the computerized file of the Ministry of Health (VRB).
• Be affiliated to French social security system.

You may not qualify if:

• Temperature ≥ 38.0°C or symptoms of acute self-limiting illness such as upper respiratory tract infection or gastroenteritis within three days prior to vaccine dose.
• Any form of contraindication to the trial vaccines tested.
• History of chronic rhinitis, nasal septal defect, cleft palate, nasal polyps, or other nasal abnormality that might alter nasal mucosa and affect vaccine response.
• A piercing or obstruction in the nostrils that could impede vaccine administration.
• Previous nasal surgery or nasal cauterization.
• History of frequent epistaxis.
• Virologically documented (PCR or antigenic test) history of COVID-19 in the past 6 months.
• Positive COVID-19 PCR test at screening visit.
• Medical problems due to alcohol.
• Illicit drug use within the past 12 months.
• Participation in another trial within 60 days prior to the enrolment visit or planned participation during the present trial period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
• Note: Participation in an observational study is allowed.
• Received influenza vaccination within 14 days prior to trial vaccination, or any other licensed vaccine within 4 weeks prior to study vaccination.
• Vaccination with a COVID-19 vaccine other than mRNA vaccine.
• Known sensitivity to any of the ingredients of the trial vaccines.

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead
• University Hospital, Tours (Cosponsor): collaborator
• UMS 54 MART: collaborator
• INSERM CIC 1415: collaborator
• LovalTech: collaborator
• INSERM U1259 MAVIVHe: collaborator
• BioMAP - UMR ISP 1282 - Tours University - INRAE: collaborator
• Virology unit, University Hospital, Tours: collaborator
• I-REIVAC Innovative Clinical Research Network In Vaccinology: collaborator

Study Sites (5)

CHU Dijon Bourgogne - Centre d'Investigation Clinique 1432

Dijon, 21079, France

NOT YET RECRUITING

HCL - Hôpital de la Croix-Rousse - Service des Maladies Infectieuses et Tropicales

Lyon, 69004, France

NOT YET RECRUITING

APHP - Hôpital Cochin - Centre d'Investigation Clinique de Vaccinologie Cochin-Pasteur 1417

Paris, 75679, France

NOT YET RECRUITING

CHU de Saint-Etienne - Service des Maladies Infectieuses

Saint-Priest-en-Jarez, 42270, France

NOT YET RECRUITING

CHRU de Tours - Centre d'Investigation Clinique 1415

Tours, 37044, France

RECRUITING

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 Officials

• Zoha MAAKAROUN-VERMESSE, Dr.

  University Hospital, Tours

  STUDY CHAIR

• Odile LAUNAY, Prof.

  Cochin Hospital, Paris, France

  STUDY CHAIR

• Isabelle DIMIER-POISSON, Prof.

  University, Tours, France

  STUDY CHAIR

Central Study Contacts

Alizée PERROT

CONTACT

0033153948074; cdp.clinique@anrs.fr

Yoann DESVIGNES

CONTACT

0033247474632; cpcq@chu-tours.fr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Phase I : Dose escalation Phase II : open label, superiority, controlled, randomized

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 11, 2025
• Study Start: May 9, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): March 1, 2028
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

FR (5)