nOPV1 / PATH, Batavia Biosci - LARVOL DELTA

Safety and immunogenicity of novel live attenuated type 1 and type 3 oral poliomyelitis vaccines in healthy adults in the USA: a first-in-human, observer-masked, multicentre, phase 1 randomised controlled trial. (PubMed, Lancet Infect Dis) - P1 | "nOPV1 and nOPV3 were well tolerated and showed similar immunogenicity and shedding profiles to mOPV1 and mOPV3, respectively, supporting progression of these vaccine candidates to phase 2 studies."

Journal • P1 data • Fatigue • Infectious Disease • Musculoskeletal Pain • Pain

Study of Trivalent and Bivalent (Types 1 & 2) Novel Oral Poliomyelitis Vaccines (clinicaltrials.gov) - P1/2 | N=2400 | Recruiting | Sponsor: PATH | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease

SCOPE: Study of Co-administered (Types 1 & 2) Novel Oral Poliomyelitis Vaccines Evaluation (clinicaltrials.gov) - P2 | N=675 | Not yet recruiting | Sponsor: PATH

New P2 trial • Infectious Disease

Study of a Novel Type 1 Oral Poliomyelitis Vaccine in Bangladesh (clinicaltrials.gov) - P2 | N=2012 | Recruiting | Sponsor: PATH | Trial completion date: Feb 2025 ➔ May 2026 | Trial primary completion date: Feb 2025 ➔ May 2026

Trial completion date • Trial primary completion date • Infectious Disease

Study of Trivalent and Bivalent (Types 1 & 2) Novel Oral Poliomyelitis Vaccines (clinicaltrials.gov) - P1/2 | N=2400 | Not yet recruiting | Sponsor: PATH | Trial completion date: Dec 2025 ➔ Dec 2027 | Initiation date: Dec 2023 ➔ Mar 2025 | Trial primary completion date: Dec 2025 ➔ Dec 2027

Trial completion date • Trial initiation date • Trial primary completion date • Infectious Disease

Study of a Novel Type 1 Oral Poliomyelitis Vaccine in Bangladesh (clinicaltrials.gov) - P2 | N=1683 | Recruiting | Sponsor: PATH | Trial completion date: Jun 2024 ➔ Feb 2025 | Trial primary completion date: Jun 2024 ➔ Feb 2025

Trial completion date • Trial primary completion date • Infectious Disease

Improvement of the qmosRT-PCR Assay and Its Application for the Detection and Quantitation of the Three Serotypes of the Novel Oral Polio Vaccine in Stool Samples. (PubMed, Vaccines (Basel)) - "In addition, the lowest viral concentration that the assay was able to detect in stool samples was 17 CCID/mL for nOPV1 and nOPV2 viruses and 6 CCID/mL for nOPV3. The qmosRT-PCR was specific and sensitive for the simultaneous identification and quantification of all three nOPV viruses. It can be used as an identity test during the nOPV manufacturing process and in evaluation of virus excretion in nOPV clinical trials."

Journal

Study of Trivalent and Bivalent (Types 1 & 2) Novel Oral Poliomyelitis Vaccines (clinicaltrials.gov) - P1/2 | N=2400 | Not yet recruiting | Sponsor: PATH

New P1/2 trial • Infectious Disease

Study of a Novel Type 1 Oral Poliomyelitis Vaccine in Bangladesh (clinicaltrials.gov) - P2 | N=1683 | Recruiting | Sponsor: PATH | Enrolling by invitation ➔ Recruiting

Enrollment status • Infectious Disease

Study of a Novel Type 1 Oral Poliomyelitis Vaccine in Bangladesh (clinicaltrials.gov) - P2 | N=1683 | Enrolling by invitation | Sponsor: PATH | Not yet recruiting ➔ Enrolling by invitation

Enrollment open • Infectious Disease

Study of Novel Types 1 and 3 Oral Poliomyelitis Vaccines (clinicaltrials.gov) - P1 | N=205 | Completed | Sponsor: PATH | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease

Study of a Novel Type 1 Oral Poliomyelitis Vaccine in Bangladesh (clinicaltrials.gov) - P2 | N=1683 | Not yet recruiting | Sponsor: PATH

New P2 trial • Infectious Disease

Study of Novel Types 1 and 3 Oral Poliomyelitis Vaccines (clinicaltrials.gov) - P1 | N=230 | Active, not recruiting | Sponsor: PATH | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease

Study of Novel Types 1 and 3 Oral Poliomyelitis Vaccines (clinicaltrials.gov) - P1 | N=230 | Recruiting | Sponsor: PATH | Trial completion date: Aug 2022 ➔ Jan 2023 | Trial primary completion date: Aug 2022 ➔ Jan 2023

Trial completion date • Trial primary completion date • Infectious Disease

Study of Novel Types 1 and 3 Oral Poliomyelitis Vaccines (clinicaltrials.gov) - P1; N=230; Recruiting; Sponsor: PATH; Trial primary completion date: Apr 2022 ➔ Aug 2022

Clinical • Trial primary completion date • Infectious Disease

Study of Novel Types 1 and 3 Oral Poliomyelitis Vaccines (clinicaltrials.gov) - P1; N=230; Recruiting; Sponsor: PATH; Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease

Study of Novel Types 1 and 3 Oral Poliomyelitis Vaccines (clinicaltrials.gov) - P1; N=230; Not yet recruiting; Sponsor: PATH; Initiation date: Jan 2021 ➔ Apr 2021

Clinical • Trial initiation date • CNS Disorders • Infectious Disease

Study of Novel Types 1 and 3 Oral Poliomyelitis Vaccines (clinicaltrials.gov) - P1; N=230; Not yet recruiting; Sponsor: PATH; Trial completion date: Dec 2021 ➔ Aug 2022; Trial primary completion date: Dec 2021 ➔ Apr 2022

Clinical • Trial completion date • Trial primary completion date • CNS Disorders • Infectious Disease

Study of Novel Types 1 and 3 Oral Poliomyelitis Vaccines (clinicaltrials.gov) - P1; N=230; Not yet recruiting; Sponsor: PATH

New P1 trial • CNS Disorders • Infectious Disease