ChulaCov19 mRNA Vaccine / Chulalongkorn University - LARVOL DELTA

Phase II prefusion non-stabilised Covid-19 mRNA vaccine randomised study. (PubMed, Sci Rep) - P1/2 | "T-cell IFN-γ-ELISpot showed the highest responses at one week (Day29) after dose 2 then gradually declined. ChulaCov19 50 µg is well tolerated and elicited high neutralizing antibodies and strong T-cell responses in healthy adults.Trial registration number: ClinicalTrials.gov Identifier NCT04566276, 28/09/2020."

Journal • P2 data • Infectious Disease • Novel Coronavirus Disease • IFNG

Immunogenicity and protective efficacy of SARS-CoV-2 mRNA vaccine encoding secreted non-stabilized spike in female mice. (PubMed, Nat Commun) - "In a heterologous prime-boost study, ChulaCov19 booster dose generates a 7-fold increase of NAb against Wuhan-Hu1 WT virus and also significantly increases NAb response against Omicron (BA.1 and BA.4/5) when compared to homologous CoronaVac or AZD1222 vaccination...Moreover, anamnestic NAb response is undetectable in challenge animals. ChulaCov19 is therefore a promising mRNA vaccine candidate either as a primary or boost vaccination and has entered clinical development."

Journal • Preclinical • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

The Future of Epidemic and Pandemic Vaccines to Serve Global Public Health Needs. (PubMed, Vaccines (Basel)) - "This will only happen if we question all prior assumptions and learn the lessons offered by the current pandemic. We invite submissions to the special issue, which we hope will help guide the world towards a global vaccine research, development, and manufacturing ecosystem that better balances and integrates scientific, clinical trial, regulatory, and commercial interests and puts global public health needs first."

Journal • Review • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

ChulaCov19 Vaccine in Healthy Adults (clinicaltrials.gov) - P1/2 | N=192 | Completed | Sponsor: Chulalongkorn University | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • CD4 • CD8 • CRP

Safety and immunogenicity of a prefusion non-stabilized spike protein mRNA COVID-19 vaccine: a phase I trial. (PubMed, Nat Microbiol) - P1/2 | "ChulaCov19 has proceeded to phase 2 clinical trials. We conclude that the mRNA vaccine expressing a prefusion non-stabilized spike protein is safe and highly immunogenic."

Journal • P1 data • Fatigue • Infectious Disease • Novel Coronavirus Disease • Pain • Respiratory Diseases • IFNG

Safety and Immunogenicity of ChulaCov19 BNA159 mRNA Vaccine (clinicaltrials.gov) - P1/2 | N=60 | Not yet recruiting | Sponsor: Chulalongkorn University

New P1/2 trial

ChulaCov19 Vaccine in Healthy Adults (clinicaltrials.gov) - P1/2 | N=222 | Active, not recruiting | Sponsor: Chulalongkorn University | Recruiting ➔ Active, not recruiting | Trial primary completion date: Sep 2021 ➔ Sep 2022

Enrollment closed • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • CD4 • CD8 • CRP • IFNG

ChulaCov19 Vaccine in Healthy Adults (clinicaltrials.gov) - P1/2; N=222; Recruiting; Sponsor: Chulalongkorn University; N=72 ➔ 222; Trial completion date: Sep 2021 ➔ Nov 2022

Clinical • Enrollment change • Trial completion date • Infectious Disease • Novel Coronavirus Disease • CD4 • CD8 • CRP • IFNG

ChulaCov19 Vaccine in Healthy Adults (clinicaltrials.gov) - P1/2; N=72; Recruiting; Sponsor: Chulalongkorn University; Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Novel Coronavirus Disease • CD4 • CD8 • CRP • IFNG

Thailand plans November human testing for potential coronavirus vaccine (The Times of India) - "Thai researchers plan to begin human trials of a potential vaccine for the new coronavirus in November and are preparing 10,000 doses...aiming for a vaccine that could be ready for use by late next year. Following favourable results in trials on primates, the next step is to manufacture doses for human trials, said Kiat Ruxrungtham, director of the Bangkok's Chulalongkorn University vaccine development program....The trials will not accept volunteers 'until we receive approval from the Thai Food and Drug Administration and an ethics committee,' Kiat said."

New trial • Infectious Disease • Novel Coronavirus Disease

Thailand’s Covid-19 vaccines human trials could start by October (ThePrint) - "Thailand aims to produce its own Covid-19 vaccine rather than waiting to buy inoculations from abroad, and human trials could start as early as October....If this vaccine reaches clinical trials, it’ll be among the first done outside high-income countries to reach that stage....Thailand has seven Covid-19 vaccine studies underway using a variety of methods..."

New trial • Infectious Disease • Novel Coronavirus Disease