Phase 2/3 clinical trial shows Clover vaccine candidate reduces transmission of SARS-CoV-2 in the home



Clover Biopharmaceuticals, Ltd., a global clinical-stage biotechnology company developing novel vaccines and biological therapeutics, and the International Vaccine Institute, an international non-profit organization dedicated to providing vaccines important to global public health and headquartered in Seoul, Korea, today announced that Clinical infectious diseases published additional data from SPECTRA, a global phase 2/3 clinical trial, that showed that vaccination with SCB-2019 (CpG 1018/Alum) reduced the risk of transmitting SARS-CoV-2 infection to family members, compared to participants using placebo.

These findings are important to public health officials striving to control future outbreaks and suggest that vaccination with SCB-2019 significantly reduces the risk of SARS-CoV-2 spreading within communities. New data on impact at the community level reinforce our confidence in SCB-2019 as a key vaccine that can play an important role in large-scale vaccination campaigns in China and globally.


Dr. Nicholas Jackson, head of global research and development at Clover

The study showed that household contacts were 84% less likely to contract SARS-CoV-2 infection when the infected family member received SCB-2019, compared to families where the infected family member was not vaccinated. Of the 134 household contacts of infected family members who received SCB-2019, there was one case of COVID-19; Of the 250 household contacts of infected family members who were not vaccinated, there were 12 cases.

“As the world grapples with disease outbreaks and new variants, IVI is proud to advance our scientific understanding of the benefits of a COVID-19 vaccine beyond personal protection,” said Jerome Kim, Director General of the International Vaccine Institute. “The clear takeaway from this study with Clover’s SCB-2019 is that the vaccines have demonstrated safety and effectiveness They can reduce the risk of home transmission and should continue to play a central role in the ongoing global response strategy to COVID-19. “

There were no cases of symptomatic SARS-CoV-2 infection among household contacts who were partially or fully vaccinated and where the infected family member was vaccinated with SCB-2019. This indicates that the SCB-2019 vaccination reduced household transmission and that vaccinated persons also benefited from the protection afforded by their vaccination.

This prospective, exploratory study was part of the SPECTRA Phase 2/3 trial and compared reductions in SARS-CoV-2 discharges in households and household contacts of infected SCB-2019 vaccine recipients in households and household contacts of placebo recipients. The study was conducted at eight Spectra Phase 2/3 sites in the Philippines. A total of 154 participants who received placebo or SCB-2019 who subsequently experienced SARS-CoV-2 infection were enrolled in this study as well as 388 of their household contacts. The study team was blinded to assigning participants to the SPECTRA vaccine or placebo groups. Registered households and household contacts were monitored for three weeks for new COVID-19 infections. Symptomatic cases of participants and household contacts were confirmed with reverse transcription polymerase chain reaction (rRT-PCR) testing, while asymptomatic cases were identified using rapid anti-N.

Clover is working to complete regulatory submissions to the China National Medical Products Administration, European Medicines Agency and WHO for SCB-2019 by the end of 2022, while at the same time preparing to commercialize it in China and globally upon receiving regulatory approvals.

source:

Journal reference:

Tadesse, BT, et al. (2022) Effect of vaccination with the SCB-2019 COVID-19 vaccine on transmission of SARS-CoV-2 infection: a household contact study in the Philippines. Clinical infectious diseases. doi.org/10.1093/cid/ciac914.



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