October 11, 2023
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Key takeaways:
- CoviLiv, an intranasal COVID-19 vaccine candidate, generated a robust immune response when given as a primary vaccine series.
- An additional advantage of the vaccine includes the absence of cold-chain storage.
BOSTON — Two doses of an experimental live-attenuated intranasal COVID-19 vaccine generated a robust immune response, according to phase one data presented at IDWeek.
“Live-attenuated virus vaccines are a modality that have been around for decades. The trial that [these data are] from is a first in-human clinical trial that was a placebo-controlled dose escalation trial using CoviLiv that is delivered intranasally,” Johanna K. Kaufmann, PhD, executive vice president of oncology and immunology at Codagenix Inc., said during an IDWeek press conference.
“In contrast to the currently authorized vaccines, we will present immune response data in the initial observation period within about 2 months after one or two doses of a variety of dose levels and we will focus our data on the highest dose level,” she said.
To gather these data, Kaufmann and colleagues conducted a randomized, double-blind, placebo-controlled dose-escalation study in healthy adults to determine the safety and tolerability of CoviLiv.
Through this study, the researchers characterized the immune response to CoviLiv in participants of the high-dose cohort (n = 6) measured through sera taken on days 1, 29 and 57 with a spike-specific IgG enzyme-linked immunosorbent assay, as well as both microneutralization (MNT) and pseudovirus neutralization (PVN) assays.
Overall, the study showed that after two doses of CoviLiv, all participants exceeded a twofold increase in spike-specific IgG, with a geometric average fold rise of 19.5 (95% CI, 3.4-113.8) on day 57.
Using MNT and PVN, they found that neutralizing antibodies were induced 2.6-fold (95% CI, 1-7) and 4.9-fold (95% CI, 1.4-16.6) at day 57. Additionally, they found that on day 36, interferon gamma response increased 4.5-fold (95% CI, 2.8-7.4) in the two-dose cohort and 2.5-fold (95% CI, 1.4-4.2) in the one-dose cohort.
Aside from the positive immune response elicited by CoviLiv — although Kaufmann emphasized that no clinician trials formally proving efficacy have been completed — Kaufmann explained that there are other advantages to the vaccine candidate, including the impact it could have on equitable access with the absence of cold-chain storage needed to store and transport the vaccine. She added that the vaccine will also be “fairly competitive” cost-wise.
“As mentioned, the data we are presenting here [are] relayed from a trial within which this virus was used as a primary vaccination series. The immune response we have observed provides opportunity to also explore this virus in the booster context,” Kaufmann said. “We look forward to understanding better how CoviLiv can contribute to what is known as hybrid immunity, which is one of the most effective forms of immunity against COVID-19 based on the current understanding.”
References:
- Kaufmann JK, et al. Abstract 1938. Presented at: IDWeek; Oct. 11-15, 2023; Boston.
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Sources/Disclosures
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Source:
Press conference.
Disclosures:
Kaufmann is employed by Codagenix Inc. Please see the study for all other authors’ relevant financial disclosures.
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