ChulaCov19 Vaccine in Healthy Adults

Phase 1/2 Completed 192 enrolled Chulalongkorn University Chula Vaccine Research Center (ChulaVRC), Bangkok, Thailand · collab King Chulalongkorn Memorial Hospital · collab Mahidol University · collab National Vaccine Institute, Thailand · collab

RandomizedSequentialTriple-blindOther

Summary

This study will be conducted in 2 phases. Phase 1 of this study will be a single-centre, open label, dose escalation first in human (FIH) study conducted in 2 groups of healthy participants. Group 1 will enrol adults aged 18-55 years (inclusive); Group 2 will enroll elderly adults (elderly) aged 56-75 years (inclusive). Phase 2 of this study will be a single centre, the proposed design will be observer-blind, placebo-controlled study to assess the safety, reactogenicity, and immunogenicity of ChulaCov19 vaccine in healthy adults (18-75 years of age inclusive).

Timeline

Start: 2021-05-03
Primary completion: 2022-10-01
Completion: 2022-12-06

Publications

Puthanakit T, Prompetchara E, Gatechompol S, Ketloy C, Thitithanyanont A, Jongkaewwattana A, Buranapraditkun S, Ubolyam S, Kerr SJ, Sophonphan J, Apornpong T, Kittanamongkolchai W, Siwamogsatham S, Sriplienchan S, Patarakul K, Theerawit T, Promsena P, Nantanee R, Manomaisantiphap S, Chokyakorn S, Hong L, Samija M, Montefiori DC, Gao H, Eaton A, Wijagkanalan W, Alameh MG, Weissman D, Ruxrungtham K; ChulaVac001-Phase 2 study team. Phase II prefusion non-stabilised Covid-19 mRNA vaccine randomised study. Sci Rep. 2024 Jan 29;14(1):2373. doi: 10.1038/s41598-023-49653-6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ChulaCov19	Messenger RNA (mRNA)	10 ug	Intramuscular
Subject	ChulaCov19	Messenger RNA (mRNA)	25 ug	Intramuscular
Subject	ChulaCov19	Messenger RNA (mRNA)	50 ug	Intramuscular

Indications

No indication recorded.