Phase 1 Study to Assess Safety, Reactogenicity and Immunogenicity of the HDT-301 Vaccine Against COVID-19

Summary

Participation Requirements

Description

In this phase 1 dose ranging study, four dose cohorts (1 µg, 5 µg and 25 µg) of 26 subjects will be sequentially enrolled, of which: 16 subjects without previous exposure to SARS-CoV-2, confirmed through the absence of anti-SARS-CoV-2 IgG; 5 subjects previously positive for SARS-CoV-2 confirmed by R...

In this phase 1 dose ranging study, four dose cohorts (1 µg, 5 µg and 25 µg) of 26 subjects will be sequentially enrolled, of which: 16 subjects without previous exposure to SARS-CoV-2, confirmed through the absence of anti-SARS-CoV-2 IgG; 5 subjects previously positive for SARS-CoV-2 confirmed by RT-PCR, with mandatory presence of antibodies against SARS-CoV-2; and 5 subjects with previous positive diagnosis for SARS-CoV-2 by RT- PCR, asymptomatic, and with persistent negative result for anti-SARS-CoV-2 IgG. The study will begin with the 16 subjects without previous exposure to SARS-CoV-2 (naïve subjects). Each dose cohort subjects will be randomized with equal probability to receive the second dose, of the same dosage, at either 28 days or 56 days after the first dose. For each of the three dose groups, a sentinel group of 4 subjects will be initially enrolled and followed through Day 8 post dose one for safety. If no halting rules are met by Day 8 enrollment will proceed to the remaining 12 subjects. Following enrollment of the first cohort, the second dose cohort will be enrolled in a similar fashion, with the sentinel group enrolled after a 7-day safety observation period has elapsed following vaccination of the last subject in the first cohort. Cohort 3 will be enrolled in a similar fashion following cohort 2. The 10 subjects with previous positive RT-PCR history for SARS-CoV-2 will be enrolled in the study only after the end of doses of each cohort they are inserted in. There is no placebo group in order to more easily perform important interim analyses and to avoid the time and expense of recruitment and enrollment of subjects, and collection of data and samples, including PBMC samples, from those not exposed to the vaccine. Inclusion of a small number of placebo subjects would likely not meaningfully improve assessment of causality of adverse events. At the screening visit, serum specimens will be obtained for testing by IgG ELISA to identify persons seropositive to SARS-CoV-2 S protein, who will be excluded from enrollment in order to perform this first assessment of safety and immunogenicity in a homogenous cohort of naïve subjects. Subjects that present IgG anti-SARS-CoV-2 in serum samples may be excluded of the study as long as they present positive history of RT-PCR for (5 subjects of each cohort) and the enrollment and investigation of these subjects in the study will only begin after the end of the immunization of the naïve subjects.

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