A Trial to Evaluate the Efficacy and Safety of TNM001 for the Prevention of Lower Respiratory Tract Infection Caused by Respiratory Syncytial Virus in Infants

Respiratory Syncytial Virus Infections Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled and Parallel Group Adaptive Phase 2b/3 Trial to Evaluate the Efficacy and Safety of TNM001 Injection for the Prevention of Lower Respiratory Tract Infection Caused by Respiratory Syncytial Virus in Infants Under One Year of Age

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06083623
• Other study ID #: TNM001-301
• Secondary ID: CTR20232792
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: October 6, 2023
• Est. completion date: August 31, 2026

Study information

• Verified date: September 2023
• Source: Zhuhai Trinomab Pharmaceutical Co., Ltd.
• Contact: Ying Wang
• Phone: +86 0756 7263999
• Email: emma.wang[@]trinomab.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), neutralizing antibody and antidrug antibody (ADA) response for TNM001 in infants entering their first RSV season.

Description:

This study adopts an adaptive seamless dose selection design and consists of two parts: Part 1 is a phase 2b dose ranging trial which will support to determine the dose for Part 2, the phase 3 trial. The study population includes early and mid-term preterm infants [gestational age (GA)﹤35 weeks 0 day] and late preterm infants or full-term infants (≥35 weeks 0 day GA), with or without Congenital Heart Disease (CHD) or premature infants Chronic Lung Disease (CLD). A total of approximately 2250 infants will be randomized 2:1 to receive either TNM001 or placebo. All subjects will be followed for 240 days after dosing. This study will be conducted in appropriately 50 sites in China.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2250
• Est. completion date: August 31, 2026
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Years to 1 Year

Eligibility

Inclusion Criteria:

• 1. Early and mid-term preterm infants (<35 weeks 0 day GA) and late preterm infants or full-term infants (=35 weeks 0 day GA) under 1 year of age, with or without Congenital Heart Disease (CHD) or premature infants Chronic Lung Disease (CLD),who are entering their first RSV season at the time of screening.

Exclusion Criteria:

• 1. Any fever (> 38.0°C) or acute illness within 7 days prior to randomization
• 2. History of RSV infection or active RSV infection prior to, or at the time of, randomization
• 3. Drug medication prior to randomization or expected to be treated by medicines during the study period.
• 4. Currently receiving or expected to receive immunosuppressive therapy during the study period.
• 5. Renal impairment or hepatic dysfunction
• 6. Nervous system disease or neuromuscular disease
• 7. Prior history of a suspected or actual acute life-threatening event
• 8. Known immunodeficiency including HIV, mother with HIV infection unless the child's infection has been excluded.
• 9. Known allergy history of immunoglobulin products, receipt or expected to receive immunoglobulins or blood products during the study period.
• 10.Receipt of RSV vaccine or mAb

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Respiratory Syncytial Virus Infections
• Respiratory Tract Infections

Intervention

Biological:
• TNM001
single dose intramuscular injection
• placebo
single dose intramuscular injection

Locations

Country	Name	City	State
China	Children's Hospital Capital Institute Pediatrics	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	The First People'S Hospital of Changde City	Changde	Hunan
China	The Maternal and Child Health Hospital of Hunan Province	Changsha	Hunan
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan
China	Xiangya Hospital Central South University	Changsha	Hunan
China	Chengdu Women's and Children's Central Hospital	Chengdu	Sichuan
China	West China Second University Hospital, Sichuan University	Chengdu	Sichuan
China	Children's Hospital of Chongqing Medical University	Chongqing	Sichuan
China	Jiangjin Central Hospital	Chongqing	Chongqing
China	The Third Affiliated Hospital of Guangzhou Medical University	Guangdong	Guangdong
China	Guangdong Maternal and Child Health Care Hospital	Guangzhou	Guangdong
China	Affiliated Hospital of Guilin Medical University	Guilin	Guangxi
China	HaiNan Women and Children's Medical Center	Haikou	Hainan
China	Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine/Hangzhou First People's Hospital	Hangzhou	Zhejiang
China	The Second Hospital University of South China	Hengyang	Hunan
China	Children's Hospital Affiliated to Shandong University	Jinan	Shandong
China	Hebei Petro China Central Hospital	Langfang	Hebei
China	Linfen Central Hospital	Linfen	Shanxi
China	Linfen People's Hospital	Linfen	Shanxi
China	LiuZhou People's Hospital	Liuzhou	Guangxi
China	Loudi Central Hospital	Loudi	Hunan
China	Mianyang Peoples Hospital	Mianyang	Sichuan
China	Jiangxi Maternal and Child Health Hospital	Nanchang	Jiangxi
China	Maternity and Child Health Care of Guangxi Zhuang Autonomous Region	Nanning	Guangxi
China	Ningbo Women&Children's Hospital	Ningbo	Zhejiang
China	Sanmenxia Central Hospital	Sanmenxia	Henan
China	The affiliated children'shospital fudan university	Shanghai	Shanghai
China	The First Affiliated Hospital of Shaoyang University	Shaoyang	Hunan
China	University of Chinese Academy of Sciense Shenzhen Hospital	Shenzhen	Guangdong
China	The Fourth Hospital of Hebei Medical University	Shijia Zhuang	Hebei
China	The Second Hospital of HeBei Medical University (HBMU)	Shijia Zhuang	Hebei
China	Tangshan Maternal and Child Health Hospitaltangshan Maternal and Child Health Hospital	Tangshan	Hebei
China	Renmin Hospital of Wuhan University	Wuhan	Hubei
China	The Central Hospital of Wuhan	Wuhan	Hubei
China	Xiamen maternal and Child Health Hospital	Xiamen	Fujian
China	Xinxiang First People's Hospital	Xinxiang	Henan
China	Yuncheng Central Hospital	Yuncheng	Shanxi
China	Henan (Zhengzhou) Children's Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Zhuhai Trinomab Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of medically attended LRTI due to RT-PCR confirmed RSV		150 days post dose
Secondary	Incidence of hospitalization due to RT-PCR confirmed RSV LRTI		150 days post dose
Secondary	Occurrence of adverse events (AEs)		240 days post dose
Secondary	Change in body temperature (celsius)		240 days post dose
Secondary	Change in blood pressure (mmHg)		240 days post dose
Secondary	Change in heart rate (beats per minute)		240 days post dose
Secondary	Change in respiratory rate (breaths per min)		240 days post dose
Secondary	Number of subjects with clinical significant abnormality in physical examinations		240 days post dose
Secondary	Serum concentration of single dose TNM001 at pre-specified timepoints		240 days post dose
Secondary	Serum level of neutralizing antibody to RSV		240 days post dose
Secondary	Positive rate of anti-drug antibody (ADA) to TNM001 in serum		240 days post dose