VLA15 / Valneva, Pfizer - LARVOL DELTA

C4601019: A Study to Learn About Different Dosing Schedules of a Lyme Disease Vaccine in Healthy Adults (clinicaltrials.gov) - P3 | N=200 | Recruiting | Sponsor: Pfizer | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Inflammatory Arthritis • Lyme Disease

Phase 2 Study Of VLA15, A Vaccine Candidate Against Lyme Borreliosis, In A Healthy Pediatric And Adult Study Population (clinicaltrials.gov) - P2 | N=625 | Completed | Sponsor: Pfizer | Active, not recruiting ➔ Completed | Trial completion date: Jan 2026 ➔ Jul 2025

Trial completion • Trial completion date • Inflammatory Arthritis • Lyme Disease • Pediatrics

Immunogenicity and safety of an 18-month booster dose of the VLA15 Lyme borreliosis vaccine candidate after primary immunisation in children, adolescents, and adults in the USA: a randomised, observer-blind, placebo-controlled, phase 2 trial. (PubMed, Lancet Infect Dis) - P2 | "The safety and robust anamnestic immune responses associated with VLA15 boosting support its use as a strategy to increase anti-OspA antibody levels before tick season among children, adolescents, and adults. Forthcoming data after administration of subsequent annual boosters will provide further information about VLA15 antibody persistence and boostability."

Journal • P2 data • Inflammatory Arthritis • Lyme Disease • Pediatrics

A Study to Learn About Different Dosing Schedules of a Lyme Disease Vaccine in Healthy Adults (clinicaltrials.gov) - P3 | N=200 | Not yet recruiting | Sponsor: Pfizer

New P3 trial • Infectious Disease • Inflammatory Arthritis • Lyme Disease

Antibody response and safety through 12 months after booster vaccination with an investigational Lyme disease vaccine in adults: a plain language summary. (PubMed, Curr Med Res Opin) - No abstract available

Journal • Infectious Disease • Inflammatory Arthritis • Lyme Disease

Safety Study of a Vaccine to Help Protect Against Lyme Disease in Healthy Children (clinicaltrials.gov) - P3 | N=3549 | Completed | Sponsor: Pfizer | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Inflammatory Arthritis • Lyme Disease

Immunogenicity and safety of different immunisation schedules of the VLA15 Lyme borreliosis vaccine candidate in adults, adolescents, and children: a randomised, observer-blind, placebo-controlled, phase 2 trial. (PubMed, Lancet Infect Dis) - P2 | "These findings confirm previously observed safety and immunogenicity profiles of VLA15 in adults and extend them to children aged 5 years and older and adolescents. The greater immunogenicity of VLA15 among children and adolescents might translate to increased flexibility in the real-world clinical setting."

Journal • P2 data • Inflammatory Arthritis • Lyme Disease

Valneva Reports Preliminary Unaudited 2024 Revenue and Cash and Provides 2025 Outlook (GlobeNewswire) - "Met 2024 growth targets for sales revenue (+13% vs 2023) and total revenues (+10% vs 2023); Key Upcoming Catalysts...Lyme disease Phase 3 first data readout by the end of 2025; Further chikungunya vaccine approvals, including the first endemic country (Brazil) and adolescent label extensions for IXCHIQ in major travel markets; Initiation of Phase 3 pediatric trial of IXCHIQ to support further potential label expansion; Phase 2b efficacy data from Human Challenge Study (CHIM) of tetravalent Shigella vaccine candidate in mid-2025 and launch of pediatric study; Phase 1 results for Zika vaccine candidate in the first half of 2025"

Commercial • New trial • P1 data • P3 data • Chikungunya • Infectious Disease • Lyme Disease

6-Valent, OspA-Based VLA15 Lyme Disease Vaccine Candidate Against Lyme Borreliosis in a Healthy Pediatric and Adult Study Population: A Phase 2 Study Update (IDWeek 2024) - No abstract available

Clinical • P2 data • Infectious Disease • Lyme Disease

Preclinical Evidence for the Protective Capacity of Antibodies Induced by Lyme Vaccine Candidate VLA15 in People. (PubMed, Open Forum Infect Dis) - "Passive transfer of sera from trial participants immunized with VLA15 protected mice from borreliosis in a tick challenge model. This indicates that VLA15 induces functional immune responses in people that can be linked to efficacy in a stringent preclinical model."

Journal • Preclinical • Infectious Disease • Inflammatory Arthritis • Lyme Disease

Immunogenicity and safety of an 18-month booster dose of the VLA15 Lyme borreliosis vaccine candidate after primary immunisation in healthy adults in the USA: results of the booster phase of a randomised, controlled, phase 2 trial. (PubMed, Lancet Infect Dis) - P2 | "A booster dose of VLA15 is safe and induces substantial anamnestic immune responses against all six OspA serotypes. As with previously investigated OspA-based Lyme borreliosis vaccines, waning immune responses were observed with VLA15, and annual boosters might therefore be required."

Journal • P2 data • Infectious Disease • Inflammatory Arthritis • Lyme Disease

VALOR: An Efficacy, Safety, Tolerability, Immunogenicity, and Lot-Consistency Clinical Trial of a 6-Valent OspA-Based Lyme Disease Vaccine (VLA15) (clinicaltrials.gov) - P3 | N=12550 | Active, not recruiting | Sponsor: Pfizer | N=8318 ➔ 12550

Enrollment change • Infectious Disease • Inflammatory Arthritis • Lyme Disease

Optimisation of dose level and vaccination schedule for the VLA15 Lyme borreliosis vaccine candidate among healthy adults: two randomised, observer-blind, placebo-controlled, multicentre, phase 2 studies. (PubMed, Lancet Infect Dis) - P2 | "VLA15 was safe, well tolerated, and elicited robust antibody responses to all six OspA serotypes. These findings support further clinical development of VLA15 using the 180 μg dose and 0-2-6-month schedule, which was associated with the greatest immune responses."

Journal • P2 data • Inflammatory Arthritis • Lyme Disease

6-VALENT, OSPA-BASED LYME DISEASE VACCINE PHASE-2 PROGRAM UPDATE: VLA15 IS SAFE, WELL-TOLERATED, INDUCED A STRONG IMMUNE RESPONSE CORRELATED TO SERUM BACTERICIDAL ACTIVITY AFTER PRIMING SCHEDULES (ESPID 2024) - "Conclusions/Learning Points VLA15 was well tolerated and immunogenic in children and adults. The Serum Bactericidal Assay is correlated to binding antibody GMTs and confirms that VLA15-induced antibodies provide a bactericidal effect across all age groups and serotypes tested."

P2 data • Infectious Disease • Inflammatory Arthritis • Lyme Disease • Pediatrics

VALOR: An Efficacy, Safety, Tolerability, Immunogenicity, and Lot-Consistency Clinical Trial of a 6-Valent OspA-Based Lyme Disease Vaccine (VLA15) (clinicaltrials.gov) - P3 | N=8318 | Active, not recruiting | Sponsor: Pfizer | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Inflammatory Arthritis • Lyme Disease

Background incidence rates of health outcomes in populations at risk for Lyme disease using US administrative claims data. (PubMed, Vaccine) - "This study identified potential differences between Lyme endemic and non-endemic regions of the US in background IRs of health conditions during pre-COVID and COVID era timeframes to inform Lyme disease vaccine safety monitoring. These regional and temporal differences in background IRs should be considered when contextualizing possible safety signals in clinical trials and post-marketing of a vaccine targeted at Lyme disease prevention."

HEOR • Journal • Acute Kidney Injury • Cardiovascular • CNS Disorders • Congestive Heart Failure • Dermatology • Heart Failure • Immunology • Infectious Disease • Inflammation • Inflammatory Arthritis • Lupus • Lyme Disease • Myositis • Nephrology • Novel Coronavirus Disease • Renal Disease • Systemic Lupus Erythematosus

Prospective incidence epidemiology study protocol: conducting active surveillance to assess the burden of Lyme disease (BOLD) in primary care practices in endemic areas of six European countries. (PubMed, BMJ Open) - "This study will inform the phase III efficacy study for Pfizer and Valneva's investigational Lyme disease vaccine, VLA15...This study has been approved by all sites' local ethics committees. The results will be presented at conferences and published in peer-reviewed journals."

Journal • Infectious Disease • Inflammatory Arthritis • Lyme Disease

VALOR: An Efficacy, Safety, Tolerability, Immunogenicity, and Lot-Consistency Clinical Trial of a 6-Valent OspA-Based Lyme Disease Vaccine (VLA15) (clinicaltrials.gov) - P3 | N=9000 | Recruiting | Sponsor: Pfizer | N=18000 ➔ 9000

Enrollment change • Infectious Disease • Inflammatory Arthritis • Lyme Disease

VALOR: An Efficacy, Safety, Tolerability, Immunogenicity, and Lot-Consistency Clinical Trial of a 6-Valent OspA-Based Lyme Disease Vaccine (VLA15) (clinicaltrials.gov) - P3 | N=18000 | Recruiting | Sponsor: Pfizer | N=6400 ➔ 18000

Enrollment change • Infectious Disease • Inflammatory Arthritis • Lyme Disease

Safety Study of a Vaccine to Help Protect Against Lyme Disease in Healthy Children (clinicaltrials.gov) - P3 | N=3496 | Active, not recruiting | Sponsor: Pfizer | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Inflammatory Arthritis • Lyme Disease

VALOR: An Efficacy, Safety, Tolerability, Immunogenicity, and Lot-Consistency Clinical Trial of a 6-Valent OspA-Based Lyme Disease Vaccine (VLA15) (clinicaltrials.gov) - P3 | N=6400 | Recruiting | Sponsor: Pfizer | N=18000 ➔ 6400

Enrollment change • Infectious Disease • Inflammatory Arthritis • Lyme Disease

Safety and immunogenicity of a novel multivalent OspA-based vaccine candidate against Lyme borreliosis: a randomised, phase 1 study in healthy adults. (PubMed, Lancet Infect Dis) - P1 | "This novel multivalent vaccine candidate against Lyme borreliosis was safe and immunogenic and paves the way to further clinical development."

Journal • P1 data • Fatigue • Infectious Disease • Inflammatory Arthritis • Lyme Disease • Musculoskeletal Pain • Pain

Alternative Schedule Study For VLA15, a Vaccine Candidate Against Lyme Borreliosis (clinicaltrials.gov) - P2 | N=246 | Completed | Sponsor: Pfizer | Active, not recruiting ➔ Completed

Trial completion • Inflammatory Arthritis • Lyme Disease

VALOR: An Efficacy, Safety, Tolerability, Immunogenicity, and Lot-Consistency Clinical Trial of a 6-Valent OspA-Based Lyme Disease Vaccine (VLA15) (clinicaltrials.gov) - P3 | N=18000 | Recruiting | Sponsor: Pfizer | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Dec 2024 ➔ Dec 2025

Trial completion date • Trial primary completion date • Infectious Disease • Inflammatory Arthritis • Lyme Disease

Safety Study of a Vaccine to Help Protect Against Lyme Disease in Healthy Children (clinicaltrials.gov) - P3 | N=3000 | Recruiting | Sponsor: Pfizer | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Inflammatory Arthritis • Lyme Disease