Clinical trial NCT05109559: Ad26.COV2.S as a Heterologous Booster in Adults After Single- or Two-Dose of Inactivated COVID-19 Vaccine
Official title: A Phase 1/2 Study to Evaluate the Safety Reactogenicity and Immunogenicity of Ad26.COV2.S Administered as a Heterologous Booster Vaccination in Adults 18 Years of Age and Older Following Single- or Two-Dose Vaccination With an Inactivated COVID-19 Vaccine
Conditions: SARS-CoV-2 Infection
Summary: This study aims to address evidence gaps regarding the safety, reactogenicity and immune responses of a heterologous boost of a single dose of Ad26.COV2.S (half or full dose) at pre-specified time intervals in recipients who are documented to have received either 1-dose or 2-doses (primary series completion) of inactivated COVID-19 vaccines, Sinovac and/or Sinopharm.
Interventions:
description: A booster dose (3rd dose) of Ad26.COV2.S as an IM injection in the deltoid muscle in adults.
name: Full dose of Ad26.COV2. 5x10^10vp
type: Biological
description: A booster dose (3rd dose) of Ad26.COV2.S as an IM injection in the deltoid muscle in adults.
name: Half dose of Ad26.COV2. 2.5x10^10vp
type: Biological
description: A booster dose (2nd dose) of Ad26.COV2.S as an IM injection in the deltoid muscle in adults.
name: Full dose of Ad26.COV2. 5x10^10vp
type: Biological
Study arms:
design_group_description: Study Part A is a prospective, multi-center, Phase 2 study to assess a booster dose (3rd dose) of Ad26.COV2.S as an IM injection in the deltoid muscle in adults who have completed the two-dose homologous primary series of inactivated vaccine of Sinovac or Sinopharm, 21 to 35 days apart and who meet eligibility criteria.<br/>In study part A1, a total of 360 adult volunteers aged 18 years or older, will receive the full-dose (5x10^10 vp) of the study product, at later (90 days or more) time interval since the 2nd dose and followed from Visit 1 (V1) to Visit 7 (V7) at 336 days.
design_group_title: Ad26.COV2.S given at the interval ≥ 90 days after completing 2 doses of either Sinovac or Sinopharm
design_group_type: Experimental
design_group_description: Study Part A is a prospective, multi-center, Phase 2 study to assess a booster dose (3rd dose) of Ad26.COV2.S as an IM injection in the deltoid muscle in adults who have completed the two-dose homologous primary series of inactivated vaccine of Sinovac or Sinopharm, 21 to 35 days apart and who meet eligibility criteria.<br/>In study part A2, a total of 110 adult volunteers aged 18 years or older, will receive the full-dose (5x10^10 vp) of the study product, at early (45-75 days) time interval since the 2nd dose and followed from Visit 1 (V1) to Visit 7 (V7) at 336 days.
design_group_title: Ad26.COV2.S given at 45-75 days after completing 2 doses of either Sinovac or Sinopharm
design_group_type: Experimental
design_group_description: Study Part A is a prospective, multi-center, Phase 2 study to assess a booster dose (3rd dose) of Ad26.COV2.S as an IM injection in the deltoid muscle in adults who have completed the two-dose homologous primary series of inactivated vaccine of Sinovac or Sinopharm, 21 to 35 days apart and who meet eligibility criteria.<br/>In study part A3, a total of 110 adult volunteers aged 18 years or older, will receive the half-dose (2.5x10^10 vp) of the study product, at later (90 days or more) time interval since the 2nd dose and followed from Visit 1 (V1) to Visit 7 (V7) at 336 days.
design_group_title: Half dose of Ad26.COV2.S given ≥ 90 days after completing 2 doses of either Sinovac or Sinopharm
design_group_type: Experimental
design_group_description: Study Part B is a prospective, multi-center, open-label Phase 1/2 heterologous prime-boost study to assess the Ad26.COV2.S (full dose 5x10^10 vp) as the 2nd vaccination in subjects who are documented to all have received the 1st dose of Sinovac or all received the 1st dose of Sinopharm COVID-19 vaccine, with an interval of 28 days +/- 3 days, followed from Visit 1 (V1) to Visit 7 (V7) at 336 days.
design_group_title: Ad26.COV2.S given 28 days after receiving 1 dose of either Sinovac or Sinopharm
design_group_type: Experimental
Sponsor: Mahidol University
Collaborators: International Vaccine Institute
Janssen Pharmaceuticals, Inc.
National Vaccine Institute
Drug name mappings:
name: COVID-19 Vaccine(Janssen)
lang: EN
name: コロナウイルス（SARS-CoV-2）ワクチン（遺伝子組換えアデノウイルスベクター）(Janssen)
lang: JP